Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 034, 4913-4935 [2014-01847]

Download as PDF 4913 Federal Register / Vol. 79, No. 20 / Thursday, January 30, 2014 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2004–N–0451] Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 034 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ‘‘Modifications to the List of Recognized Standards, Recognition List Number: 034’’ (Recognition List Number: 034), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. DATES: Submit written or electronic comments concerning this document at any time. See section VII for the effective date of the recognition of standards announced in this document. ADDRESSES: Submit written requests for single copies of ‘‘Modifications to the List of Recognized Standards, Recognition List Number: 034’’ to the Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993. Send two selfaddressed adhesive labels to assist that office in processing your requests, or fax your request to 301–847–8149. Submit written comments concerning this SUMMARY: document, or recommendations for additional standards for recognition, to the contact person (see FOR FURTHER INFORMATION CONTACT). Submit electronic comments by email: standards@cdrh.fda.gov. This document may also be accessed on FDA’s Internet site at https://www.fda.gov/Medical Devices/DeviceRegulationandGuidance/ Standards/ucm123792.htm. See section VI for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 034 modifications and other standards related information. FOR FURTHER INFORMATION CONTACT: Scott A. Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3632, Silver Spring, MD 20993, 301–796–6287. I. Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105–115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements. In a notice published in the Federal Register of February 25, 1998 (63 FR 9561), FDA announced the availability of a guidance entitled ‘‘Recognition and Use of Consensus Standards.’’ The notice described how FDA would implement its standard recognition program and provided the initial list of recognized standards. Modifications to the initial list of recognized standards, as published in the Federal Register, can be accessed at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ Standards/ucm123792.htm. These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The Agency maintains hypertext markup language (HTML) and portable document format (PDF) versions of the list of FDA Recognized Consensus Standards. Both versions are publicly accessible at the Agency’s Internet site. See section VI for electronic access information. Interested persons should review the supplementary information sheet for the standard to understand fully the extent to which FDA recognizes the standard. II. Modifications to the List of Recognized Standards, Recognition List Number: 034 FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the Agency will recognize for use in premarket submissions and other requirements for devices. FDA will incorporate these modifications in the list of FDA Recognized Consensus Standards in the Agency’s searchable database. FDA will use the term ‘‘Recognition List Number: 034’’ to identify these current modifications. In table 1 of this document, FDA describes the following modifications: (1) The withdrawal of standards and their replacement by others, if applicable; (2) the correction of errors made by FDA in listing previously recognized standards; and (3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards. In section III of this document, FDA lists modifications the Agency is making that involve the initial addition of standards not previously recognized by FDA. TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS Old recognition No. Replacement recognition No. Title of standard 1 Change A. Anesthesia mstockstill on DSK4VPTVN1PROD with NOTICES 1–15 ................... 1–18 ................... ........................... 1–94 ................. 1–36 ................... 1–95 ................. 1–44 ................... ........................... VerDate Mar<15>2010 18:24 Jan 29, 2014 ISO 5361–4:1987, Tracheal tubes—Part 4: Cole type ........................ ISO 8359 Second edition 1996–12–15, Oxygen concentrators for medical use—Safety requirements [Including: AMENDMENT 1 2012–07–01]. ISO 5366–3 Second edition 2001–08–15, Anaesthetic and respiratory equipment—Tracheostomy tubes—Part 3: Pediatric tracheostomy tubes [Including: TECHNICAL CORRIGENDUM 1 Published 2003–01–15]. ISO 5366–1 Fourth edition 2000–12–15, Anaesthetic and respiratory equipment—Tracheostomy tubes—Part 1: Tubes and connectors for use in adults. Jkt 232001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\30JAN1.SGM Withdrawn. See 1–93. Withdrawn and replaced with newer version including amendment. Withdrawn and replaced with newer version including technical corrigendum. Extent of recognition. 30JAN1 4914 Federal Register / Vol. 79, No. 20 / Thursday, January 30, 2014 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. 1–46 ................... ........................... 1–47 ................... 1–56 ................... ........................... 1–97 ................. 1–57 ................... ........................... 1–58 ................... ........................... 1–65 ................... ........................... 1–69 ................... ........................... 1–70 ................... ........................... 1–78 ................... ........................... 1–81 ................... ........................... 1–83 ................... ........................... 1–84 ................... ........................... 1–86 ................... ........................... 1–88 ................... 1–98 ................. 1–89 ................... ........................... 1–90 ................... ........................... 1–92 ................... ........................... 1–93 ................... ISO 5361 .......... Title of standard 1 Change ISO 5367 Fourth edition 2000–06–01 Breathing tubes intended for use with anaesthetic apparatus and ventilators. AS 4259–1995 Ancillary devices for expired air resuscitation .......... CGA V–7.1:2011 Standard Method of Determining Cylinder Valve Outlet Connections for Medical Gases. ASTM F1101–90 (Reapproved 2003) ε1, Standard Specification for Ventilators Intended for Use During Anesthesia. ASTM G175–03 (Reapproved 2011), Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications. ISO 21647:2004 Medical electrical equipment—Particular requirements for the basic safety and essential performance of respiratory gas monitors. ASTM F1464–93 (Reapproved 2005) Standard Specification for Oxygen Concentrators for Domiciliary Use. ASTM F1246–91 (Reapproved 2005) Standard Specification for Electrically Powered Home Care Ventilators, Part 1—PositivePressure Ventilators and Ventilator Circuits. ASME PVHO–1–2007 Safety Standard for Pressure Vessels for Human Occupancy. CGA V–5:2008 (Reaffirmed 2013), Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications). ISO 21647:2004 TECHNICAL CORRIGENDUM 1, Medical electrical equipment—Particular requirements for the basic safety and essential performance of respiratory gas monitors. ISO 5366–3:2001 Anaesthetic and Respiratory Equipment—Tracheostomy Tubes—Part 3: Pediatric Tracheostomy Tubes TECHNICAL CORRIGENDUM 1. ISO 8185 Third edition 2007–07–01 Corrected versions 2008–06–15 Respiratory tract humidifiers for medical use—Particular requirements for respiratory humidification systems. ISO 80601–2–12 First edition 2011–04–15 Medical electrical equipment—Part 2–12: Particular requirements for the safety of lung ventilators—Critical care ventilators [Including: TECHNICAL CORRIGENDUM 1 Published 2011–10–15]. ISO 80601–2–12 TECHNICAL CORRIGENDUM 1 Medical electrical equipment Part 2–12: Particular requirements for basic safety and essential performance of critical care ventilators. ISO 8359 Second edition 1996–12–15 AMENDMENT 1 2012–07–01 Oxygen concentrators for medical use—Safety requirements. ISO 17510–2 Second Edition 2007–10–01, Sleep apnoea breathing therapy—Part 2: Masks and application accessories. Second edition 2012–10–01 Anaesthetic and respiratory equipment—Tracheal tubes and connectors. Extent of recognition. Extent of recognition. Withdrawn and replaced newer version. Extent of recognition. with Extent of recognition. Withdrawn. See 1–96. Extent of recognition. Extent of recognition. Extent of recognition. Reaffirmation. Withdrawn. See 1–96. Withdrawn. See 1–95. Extent of recognition. Withdrawn and replaced with newer version including technical corrigendum. Withdrawn. See 1–98. Withdrawn. See 1–94. Extent of recognition. Extent of recognition. B. Biocompatibility 2–204 ............... 2–182 ................. 2–205 ............... 2–183 ................. ........................... 2–93 ................... ........................... 2–94 ................... mstockstill on DSK4VPTVN1PROD with NOTICES 2–123 ................. ........................... 2–114 ................. ........................... 2–118 ................. ........................... 2–120 ................. ........................... 2–126 ................. ........................... VerDate Mar<15>2010 22:04 Jan 29, 2014 ASTM F720–13 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test. ISO 14155 Second edition 2011–02–01 Clinical investigations of medical devices for human subjects—Good clinical practices [Including TECHNICAL CORRIGENDUM 1:2011]. ISO 14155:2011 and TECHNICAL CORRIGENDUM 1 Published 2011–07–15 Clinical investigation of medical devices for human subjects—Good clinical practice. ASTM F763–04 (Reapproved 2010), Standard Practice for ShortTerm Screening of Implant Materials. ASTM F981–04 (Reapproved 2010) Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone. ASTM F1877–05 (Reapproved 2010) Standard Practice for Characterization of Particles. ANSI/AAMI/ISO 10993–11:2006/(R) 2010 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity. ANSI/AAMI/ISO 10993–6:2007/(R) 2010 Biological evaluation of medical devices—Part 06: Tests for local effects after implantation. ASTM F748–06 (Reapproved 2010) Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices. Jkt 232001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\30JAN1.SGM Withdrawn and replaced with newer version. Withdrawn and replaced with newer version including technical corrigendum. Withdrawn. See 2–205. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. 30JAN1 4915 Federal Register / Vol. 79, No. 20 / Thursday, January 30, 2014 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Replacement recognition No. 2–133 ................. ........................... 2–134 ................. ........................... 2–136 ................. ........................... 2–137 ................. ........................... 2–138 ................. ........................... 2–139 ................. ........................... 2–140 ................. ........................... 2–141 ................. ........................... 2–142 ................. ........................... 2–143 ................. ........................... 2–144 ................. ........................... 2–145 ................. ........................... 2–153 ................. ........................... 2–154 ................. ........................... 2–155 ................. ........................... 2–156 ................. ........................... 2–162 ................. ........................... 2–163 ................. ........................... 2–165 ................. ........................... 2–167 ................. ........................... 2–168 ................. ........................... 2–169 ................. ........................... 2–170 ................. ........................... 2–171 ................. ........................... 2–172 ................. mstockstill on DSK4VPTVN1PROD with NOTICES Old recognition No. ........................... 2–173 ................. ........................... 2–174 ................. ........................... 2–175 ................. ........................... VerDate Mar<15>2010 22:00 Jan 29, 2014 Title of standard 1 Change ASTM F1408–97 (Reapproved 2008) Standard Practice for Subcutaneous Screening Test for Implant Materials. ASTM F2065–00 (Reapproved 2010) Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials. ASTM E1262–88 (Reapproved 2008) Standard Guide for Performance of the Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay. ASTM E1263–97 (Reapproved 2008) Standard Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow Erythrocytes. ASTM E1280–97 (Reapproved 2008) Standard Guide for Performing the Mouse Lymphoma Assay for Mammalian Cell Mutagenicity. ASTM E1397–91 (Reapproved 2008) Standard Practice for the In Vitro Rat Hepatocyte DNA Repair Assay. ASTM E1398–91 (Reapproved 2008) Standard Practice for the In Vivo Rat Hepatocyte DNA Repair Assay. ASTM F1984–99 (Reapproved 2008) Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials. ASTM F1983–99 (Reapproved 2008) Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Application. ASTM F1904–98 (Reapproved 2008) Standard Practice for Testing the Biological Responses to Particles in vivo. ASTMF619–03 (Reapproved 2008) Standard Practice for Extraction of Medical Plastics. ASTM F1439–03 (Reapproved 2008) Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials. ANSI/AAMI/ISO 10993–5:2009, Biological evaluation of medical devices—Part 5: Tests for In Vitro cytotoxicity. ASTM F756–08 Standard Practice for Assessment of Hemolytic Properties of Materials. ASTM F2147–01 (Reapproved 2010) Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens. ANSI/AAMI/ISO 10993–1:2009 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management. ASTM F1903–10 Standard Practice for Testing for Biological Responses to Particles in vitro. ANSI/AAMI/ISO 10993–9:2009 Biological evaluation of medical devices—Part 9: Framework for identification and quantification of potential degradation products. ANSI/AAMI/ISO 10993–14:2001/(R) 2011 Biological evaluation of medical devices—Part 14: Identification and quantification of degradation products from ceramics. ISO/TS 10993–19 First edition 2006–06–01 Biological evaluation of medical devices—Part 19: Physico-chemical, morphological, and topographical characterization of materials. ISO 10993–9 Second edition 2009–12–15 Biological evaluation of medical devices—Part 9: Framework for identification and quantification of potential degradation products. ISO 10993–13 Second edition 2010–06–15 Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices. ISO 10993–14 First edition 2001–11–15 Biological evaluation of medical devices—Part 14: Identification and quantification of degradation products from ceramics. ISO 10993–16 Second edition 2010–02–15 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables. ANSI/AAMI/ISO TIR 10993–19:2006 Biological evaluation of medical devices—Part 19: Physicochemical, morphological, and topographical characterization of materials. ANSI/AAMI/ISO 10993–10:2010 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization. ISO 10993–10:2010 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization. ISO 10993–3 Second edition 2003–10–15 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity. Jkt 232001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\30JAN1.SGM Extent of recognition. Extent of recognition. Extent of recognition. Withdrawn. Withdrawn. Withdrawn. Withdrawn. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. 30JAN1 4916 Federal Register / Vol. 79, No. 20 / Thursday, January 30, 2014 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. 2–176 ................. ........................... 2–177 ................. ........................... 2–179 ................. ........................... 2–181 ................. ........................... 2–189 ................. ........................... 2–190 ................. ........................... 2–191 ................. ........................... Title of standard 1 Change ISO 10993–11 Second edition 2006–08–15 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity. ISO 10993–06 Second edition 2007–04–15 Biological evaluation of medical devices—Part 6: Tests for local effects after implantation. ISO 10993–1 Fourth edition 2009–10–15 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process. ANSI/AAMI/ISO 14155:2011, Clinical investigation of medical devices for human subjects—Good clinical practice. ASTM F895–11, Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity. ANSI/AAMI/ISO 10993–13:2010, Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices. ISO 10993–12 Fourth edition 2012–07–01, Biological evaluation of medical devices—Part 12: Sample preparation and reference materials. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. C. Cardiovascular ........................... 3–52 ................... 3–54 ................... ........................... ........................... 3–58 ................... ........................... 3–63 ................... ........................... 3–72 ................... 3–73 ................... ........................... 3–118 ............... 3–75 ................... ........................... 3–76 ................... ........................... 3–78 ................... ........................... 3–80 ................... ........................... 3–83 ................... ........................... 3–85 ................... 3–120 ............... 3–88 ................... ........................... 3–90 ................... ........................... 3–93 ................... ........................... 3–97 ................... 3–122 ............... 3–98 ................... mstockstill on DSK4VPTVN1PROD with NOTICES 3–41 ................... ........................... 3–100 ................. ........................... 3–107 ................. 3–123 ............... VerDate Mar<15>2010 18:24 Jan 29, 2014 ANSI/AAMI EC11:1991/(R)2007 Diagnostic electrocardiographic devices. ANSI/AAMIEC12:2000/(R)2010 Disposable ECG electrodes .............. ANSI/AAMI/ISO 7198:1998/2001/(R)2010 Cardiovascular implants—Tubular vascular prostheses. ANSI/AAMI/ISO 5840:2005/(R)2010 Cardiovascular implants—Cardiac valve prostheses. ISO 11318 Second edition 2002–08–01 Cardiac Defibrillators— Connector assembly DF–1 for implantable defibrillators—Dimensions and test requirements. ANSI/AAMI EC53:1995/(R) 2008 ECG cables and leadwires ............. ANSI/AAMI EC57:2012 Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms. ANSI/AAMI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003, Manual, electronic or automated sphygmomanometers. ASTM F2129–08 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices. ANSI/AAMI/IEC 80601–2–30:2009 Medical electrical equipment— Part 2–30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers. ANSI/AAMI/ISO 81060–1:2007/(R) 2013 Non-invasive sphygmomanometers—Part 1: Requirements and test methods for nonautomated measurement type. ANSI/AAMI/ISO 14708–5:2010 Implants for surgery—Active implantable medical devices—Part 5: Circulatory support devices. ANSI/AAMI/ISO 25539–2:2012 Cardiovascular implants— Endovascular devices—Part 2: Vascular stents. ASTM F2514–08 Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial. ISO 7198 First edition 1998–08–01 Cardiovascular implants—Tubular vascular prostheses. ISO 25539–1:2003 First edition 2001–11–13 AMENDMENT 1 2005– 07–15 Cardiovascular implants—Endovascular devices—Part 1: Endovascular prostheses Amendment 1: Test methods. ISO 81060–2 Second edition 2013–05–01 Non-invasive sphygmomanometers—Part 2: Clinical validation of automated measurement type. ISO 81060–2:2009 TECHNICAL CORRIGENDUM Published 2011– 02–15 Non-invasive sphygmomanometers—Part 2: Clinical validation of automated measurement type. ANSI/AAMI/IEC 60601–2–27:2011 Medical electrical equipment— Part 2–27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment. IEC 80601–2–30 Edition 1.1 2013–07 Medical electrical equipment—Part 2–30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers. Jkt 232001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\30JAN1.SGM Withdrawn. See 3–106. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Withdrawn and replaced with newer version. Withdrawn. See 3–80, 3–122 and 3–123. Extent of recognition. Extent of recognition. Reaffirmation. Extent of recognition. Withdrawn and replaced newer version. Extent of recognition. with Extent of recognition. Withdrawn. See 3–121. Withdrawn and replace with newer version. Withdrawn. See 3–122. Withdrawn. See 3–101. Withdrawn and newer version. 30JAN1 replaced with 4917 Federal Register / Vol. 79, No. 20 / Thursday, January 30, 2014 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. 3–108 ................. ........................... 3–113 ................. 3–124 ............... 3–114 ................. 3–119 ............... Title of standard 1 Change IEC 80601–2–30 (First edition 2009) Medical electrical equipment— Part 2–30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers CORRIGENDUM 1. ISO 7199 Second edition 2009–04–15 Cardiovascular implants and artificial organs—Blood-gas exchangers (oxygenators) [Including: AMENDMENT 1 (2012)]. ISO 5841–3 Third edition 2013–40–15 Implants for surgery—Cardiac pacemakers—Part 3: Low-profile connectors (IS–1) for implantable pacemakers. Withdrawn. See 3–123. Withdrawn and replaced with newer version including amendment. Withdrawn and replace with newer version. D. Dental/ENT ........................... ........................... 4–63 ................... ........................... 4–86 ................... ........................... 4–89 ................... ........................... 4–91 ................... ........................... 4–92 ................... ........................... 4–96 ................... ........................... 4–97 ................... ........................... 4–105 ................. ........................... 4–109 ................. ........................... 4–126 ................. ........................... 4–130 ................. ........................... 4–134 ................. 4–207 ............... 4–135 ................. 4–213 ............... 4–137 ................. ........................... 4–139 ................. ........................... 4–143 ................. 4–208 ............... 4–144 ................. 4–209 ............... ISO 24234 First edition 2004–10–15 Dentistry—Mercury and alloys for dental amalgam [Including: AMENDMENT 1 (2011)]. 4–146 ................. ........................... 4–149 ................. ........................... 4–150 ................. ........................... 4–151 ................. mstockstill on DSK4VPTVN1PROD with NOTICES 4–50 ................... 4–62 ................... ........................... 4–153 ................. ........................... 4–154 ................. 4–210 ............... ISO 22674 First edition 2006–11–15 Dentistry—Metallic materials for fixed and removable restorations and appliances. ANSI/ADA Specification No. 39/ISO 6874:2005 (Reaffirmed 2011) Pit and Fissure Sealants. ANSI/ADA Specification No. 19:2004/ISO 4823:2000 Dental— Elastometric Impression Materials. ISO 22112 First edition 2005–11–01 Dentistry—Artificial teeth for dental prostheses. ISO 9917–1 Second edition 2007–10–01 Dentistry—Water-based cements—Part 1: Powder/liquid acid-base cements. ISO 4823 Third edition 2000–12–15 Dentistry—Elastometric impression materials [Including: AMENDMENT 1 (2000) TECHNICAL CORRIGENDUM 1(2004)]. 4–155 ................. ........................... VerDate Mar<15>2010 18:24 Jan 29, 2014 ADA Specification No.18:1992 Alginate Impression Materials .......... ISO 1563 Second edition 1990–09–01 Dental alginate impression material. ISO 1564 Second edition 1995–11–01 Dental aqueous impression materials based on agar. ANSI/ADA Specification No. 38 2000 (Reaffirmed 2010), Metal-Ceramic Dental Restorative Systems. ANSI/ADA Specification No. 53: 1999 (Reaffirmed 2008) PolymerBased Crowns and Bridge Materials. ANSI/ADA Specification No. 80/ISO 7491:2000 (Reaffirmed 2013) Dental Materials—Determination of Color Stability. ANSI/ADA Specification No. 88:2000 (Reaffirmed 2010) Dental Brazing Alloys. ANSI/ADA Specification No. 30:2000 (Reaffirmed 2012) Dental Zinc Oxide-Eugenol and Zinc Oxide Non-Eugenol Cements. ANSI/ADA Specification No. 57: (Reaffirmed 2012) Endodontic Sealing Materials. ANSI/ADA Specification No. 75:1997 (Reapproved 2003) Resilient Lining Materials for Removable Dentures—Part 1: Short-Term Materials. ISO 13716 First edition 1999–05–01 Dentistry—reversible-irreversible hydrocolloid impression material system. ISO 10477 Second edition 2004–10–01 Dentistry—Polymer-based crown and bridge materials. ADA Specification No. 17:1983 (Reaffirmed 2006) Denture Base Temporary Relining Resins. ISO 7494–1 Second edition 2011–08–15 Dentistry—Dental units— Part 1: General requirements and test methods. ISO 10139–1 Second edition 2005–02–15 Dentistry—Soft lining materials for removable dentures—Part 1: Materials for short-term use [Including: TECHNICAL CORRIGENDUM 1 (2006)]. ISO 6877 Second edition 2006–04–01 Dentistry—Root-canal obturating points. ANSI/ADA Specification No. 48 (Reaffirmed 2009) Visible Light Curing Units. ANSI/ADA Specification No. 96:2012 Dental-Water-Based Cements ISO 4823: Technical Corrigendum 1 Published 2004–07–15—Dentistry—Elastometric impression materials—Third Edition. Jkt 232001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\30JAN1.SGM Extent of recognition. Withdrawn. Withdrawn. Extent of recognition. Extent of recognition. Reaffirmation and extent of recognition. Reaffirmation and extent of recognition. Reaffirmation and extent of recognition. Extent of recognition. Extent of recognition. Withdrawn. Extent of recognition. Extent of recognition. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version including technical corrigendum. Extent of recognition. Reaffirmation and extent of recognition. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version including amendment. Extent of recognition. Reaffirmation and extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Withdrawn and replaced with newer version including amendment and technical corrigendum. Withdrawn. See 4–210. 30JAN1 4918 Federal Register / Vol. 79, No. 20 / Thursday, January 30, 2014 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. 4–156 ................. ........................... 4–157 ................. ........................... 4–159 ................. 4–211 ............... 4–170 ................. 4–212 ............... 4–178 ................. 4–179 ................. ........................... ........................... 4–180 ................. ........................... 4–181 ................. ........................... 4–182 ................. ........................... 4–188 ................. ........................... 4–189 ................. ........................... 4–195 ................. ........................... 4–196 ................. ........................... 4–198 ................. ........................... 4–199 ................. ........................... 4–200 ................. ........................... 4–201 ................. ........................... 4–205 ................. ........................... Title of standard 1 Change ISO 4823 Third edition 2000–12–15 Amendment 1 2007–07–01 Dentistry—Elastometric impression materials—Third Edition. ISO 3107 Third edition 2004–10–01 Dentistry—Zinc oxide/Eugenol and zinc oxide/non-eugenol cements—Third edition. ANSI/IEEE C63.19:2007 American National Standard Methods of Measurement of Compatibility between Wireless Communications Devices and Hearing Aids. ANSI/ASA S3.36–2012 American National Standard Specification for a Manikin for Simulated in situ Airborne Acoustic Measurements. ISO 6872 Third edition 2008–09–01 Dentistry—Ceramic materials .. ISO 7405 Second edition 2008–12–15 Dentistry—Evaluation of biocompatibility of medical devices used in dentistry. ISO 9168 Third edition 2009–07–15 Dentistry—Hose connectors for air driven dental handpieces. ISO 4049 Fourth edition 2009–10–01 Dentistry—Polymer-based restorative materials. ISO 10139–2 Second edition 2009–08–01 Dentistry—Soft lining materials for removable dentures—Part 2: Materials for long-term use. ISO 9917–2 Second edition 2010–04–15 Dentistry—Water-based cements—Part 2: Resin-modified cements. ISO 10139–1:2005 TECHNICAL CORRIGENDUM 1 2006–03–01 Dentistry—Soft lining materials for removable dentures—Part 1: Materials for short-term use. ISO 14801 Second edition 2007–11–15 Dentistry—Implants-Dynamic fatigue test for endosseous dental implants. ANSI/ADA Specification No.69:2010/ISO 6872:2008 Dental Ceramic. ISO 3107 Fourth edition 2011–03–01 Dentistry—Zinc oxide/eugenol and zinc oxide/non-eugenol cements. ISO 6876 Third edition 2012–06–01 Dentistry—Root Canal Sealing Materials. ISO 24234 First edition 2004–10–15 Dentistry—Mercury and alloys for dental amalgam AMENDMENT 1. ISO 9693–2012 Dentistry—Compatibility testing—Metal-ceramic systems. ISO 14457 First edition 2012–09–15 Dentistry—Handpieces and motors. Withdrawn. See 4–210. Withdrawn. See 4–198. Withdrawn and newer version. replaced with Withdrawn and newer version. replaced with Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Withdrawn. See 4–213. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Withdrawn. See 4–209. Extent of recognition. Withdrawn. See 4–206. E. General ........................... 5–23 ................... ........................... 5–36 ................... ........................... 5–37 ................... 5–81 ................. 5–43 ................... ........................... 5–45 ................... mstockstill on DSK4VPTVN1PROD with NOTICES 5–22 ................... 5–79 ................. 5–46 ................... ........................... 5–47 ................... ........................... 5–50 ................... ........................... VerDate Mar<15>2010 18:24 Jan 29, 2014 ISO 2768–1 First edition 1989–11–15 General tolerances—Part 1: Tolerances for linear and angular dimensions without individual tolerance indications. ISO 2768–2 First edition 1989–11–15 General Tolerances—Part 2: Geometrical tolerances for features without individual tolerance indications. ISO/TR 16142 Second edition 2006–01–15 Medical devices—Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices. ISO 2859–1 Second edition 1999–11–15 Sampling procedures for inspection by attributes—Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection [Including: TECHNICAL CORRIGENDUM 1 (2001)]. ANSI/ESD S20.20–2007 For the Development of an Electrostatic Discharge Control Program for Protection of Electrical and Electronic Parts, Assemblies and Equipment (Excluding Electrically Initiated Explosive Devices). ASTM D7386–12 Standard Practice for Performance Testing of Packages for Single Parcel Delivery Systems. ISO 2859–1:1999/Cor 1:2001 Sampling procedures for inspection by attributes—Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection. ISO 10012 First edition 2003–01–15 Measurement management systems—Requirements for measurement processes and measuring equipment. IEC 62366 Edition 1.0 2007–10 Medical devices—Application of usability engineering to medical devices. Jkt 232001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\30JAN1.SGM Extent of recognition. Extent of recognition. Extent of recognition. Withdrawn and replaced with newer version including technical corrigendum. Extent of recognition. Withdrawn and replaced with new version. Withdrawn. See 5–81. Extent of recognition. Extent of recognition. 30JAN1 4919 Federal Register / Vol. 79, No. 20 / Thursday, January 30, 2014 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. 5–51 ................... 5–80 ................. 5–53 ................... ........................... 5–54 ................... ........................... 5–57 ................... ........................... 5–58 ................... 5–82 ................. 5–62 ................... ........................... 5–66 ................... ........................... 5–67 ................... ........................... 5–69 ................... ........................... Title of standard 1 Change ASTM D–4332–13 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing. IEC 60601–1–2 Edition 3.0 2007–03 Medical electrical equipment— Part 1–2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic compatibility—Requirements and tests. ANSI/AAMI/IEC 60601–1–2:2007/(R)2012 Medical electrical equipment—Part 1–2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic compatibility—Requirements and tests. ANSI/AAMI HE75:2009 Human factors engineering—Design of medical devices. IEC 60601–1–11 Edition 1.0:2010 Medical electrical equipment— Part 1–11: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment [Including: TECHNICAL CORRIGENDUM 1 (2011)]. ANSI/ASQ Z1.4–2008 Sampling Procedures and Tables for Inspection by Attributes. IEC 60601–1–10 Edition 1.0: 2007–11 Medical electrical equipment—Part 1–10: General requirements for basic safety and essential performance—Collateral Standard: Requirements for the development of physiologic closed-loop controllers. ANSI/AAMI/IEC 62366:2007/(R)2013 Medical devices—Application of usability engineering to medical devices. IEC 60601–1–11 (First edition 2010) April 2011 Medical electrical equipment—Part 1–11: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment CORRIGENDUM 1. Withdrawn and replaced with new version. Relevant guidance. Reaffirmation and relevant guidance. Extent of recognition. Withdrawn and replaced with newer version including technical corrigendum. Extent of recognition. Extent of recognition. Reaffirmation and extent of recognition. Withdrawn. See 5–82. F. General Hospital/General Plastic Surgery ........................... 6–14 ................... ........................... 6–117 ................. ........................... 6–142 ................. ........................... 6–143 ................. ........................... 6–150 ................. ........................... 6–161 ................. 6–301 ............... 6–163 ................. ........................... 6–164 ................. 6–303 ............... 6–170 ................. mstockstill on DSK4VPTVN1PROD with NOTICES 6–13 ................... 6–304 ............... 6–171 ................. 6–305 ............... 6–176 ................. ........................... 6–187 ................. 6–306 ............... VerDate Mar<15>2010 18:24 Jan 29, 2014 ISO 595–1 First edition 1986–12–15 Reusable all-glass or metaland-glass syringes for medical use—Part 1: Dimensions. ISO 595–2 First edition 1987–12–15 Reusable all-glass or metaland-glass syringes for medical use—Part 2: Design, performance requirements and tests. ASTM F2172–02 (Reapproved 2011) Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers. ANSI/AAMI II36:2004 Medical electrical equipment—Part 2: Particular requirements for safety of baby incubators. ANSI/AAMI II51:2004 Medical electrical equipment—Part 2: Particular requirements for safety of transport incubators. ASTM D7161–05 (Reapproved 2010) Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions. ISO 10555–1 Second edition 2013–06–15 Corrected version 2013– 07–01 Intravascular catheters—Sterile and single-use catheters— Part 1: General requirements. ISO 9626 First edition 1991–09–01 AMENDMENT 1 2001–06–01 Stainless steel needle tubing for the manufacture of medical devices. ISO 10555–5 Second edition 2013–06–15 Intravascular catheters— Sterile and single-use catheters—Part 5: Over-needle peripheral catheters. ISO 7886–1 First edition 1993–10–01 Sterile hypodermic syringes for single use—Part 1: Syringes for manual use [Including: TECHNICAL CORRIGENDUM 1 Published 1995–11–01]. ISO 10555–3 Second edition 2013–06–15 Intravascular catheters— Sterile and single-use catheters—Part 3: Central venous catheters. ASTM D7103–06 (Reapproved 2013) Standard Guide for Assessment of Medical Gloves. ASTM F1671/F1671M–13 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by BloodBorne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System. Jkt 232001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\30JAN1.SGM Withdrawn. Withdrawn. Extent of recognition. Withdrawn. See 6–230. Withdrawn. See 6–231. Withdrawn. Withdrawn and newer version. replaced with Withdrawn. See 6–302. Withdrawn and newer version. replaced with Withdrawn and replaced with newer version including technical corrigendum. Withdrawn and replaced with newer version. Extent of recognition. Withdrawn and newer version. 30JAN1 replaced with 4920 Federal Register / Vol. 79, No. 20 / Thursday, January 30, 2014 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Replacement recognition No. 6–233 ................. ........................... 6–236 ................. 6–307 ............... 6–237 ................. ........................... 6–238 ................. 6–308 ............... 6–245 ................. ........................... 6–253 ................. ........................... 6–264 ................. ........................... 6–265 ................. ........................... 6–266 ................. ........................... 6–267 ................. ........................... 6–273 ................. ........................... 6–279 ................. ........................... 6–280 ................. ........................... 6–281 ................. ........................... 6–283 ................. 6–309 ............... IEC 60601–2–52 Edition 1.0 2009–12 Medical electrical equipment—Part 2–52: Particular requirements for basic safety and essential performance of medical beds. IEC 80601–2–59 Edition 1.0 2008–10 Medical Electrical Equipment—Part 2–59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening [Including: CORRIGENDUM 1 (April 2009)]. IEC 80601–2–59 (First edition 2008) Medical Electrical Equipment— Part 2–59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening CORRIGENDUM 1. IEC 80601–2–35 Edition 2.0 2009–10 Medical electrical equipment—Part 2–35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use [Including: CORRIGENDUM 1 (March 2012)]. ISO 8536–4 Fifth edition 2010–10–01 Infusion equipment for medical use—Part 4: Infusion sets for single use, gravity feed. ISO 10535 Second edition 2006–12–15 Hoists for the transfer of disabled persons—Requirements and test methods. ISO 10555–1 First edition 1995–06–15 AMENDMENT 1 1999–07– 15 Sterile, single-use intravascular catheters—Part 1: General requirements. ISO 10555–1 First edition 1995–06–5 AMENDMENT 2 2004–05–15 Sterile, single-use intravascular catheters—Part 1: General requirements. ISO 10555–5 First edition 1996–06–15 AMENDMENT 1 Sterile, single-use intravascular catheters—Part 5: Over-needle peripheral catheters. ISO 10555–5 1996 TECHNICAL CORRIGENDUM 1 Published 2002–06–15 Sterile, single-use intravascular catheters—Part 5: Over-needle peripheral catheters. ISO 23908 First edition 2011–06–11 Sharps injury protection—Requirements and test methods—Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling. IEC 60601–2–19 (Second Edition 2009) Medical electrical equipment—Part 2–19: Particular requirements for the basic safety and essential performance of infant incubators CORRIGENDUM 1. IEC 60601–2–20 (Second edition 2009) Medical electrical equipment—Part 2–20: Particular requirements for the basic safety and essential performance of infant transport incubators CORRIGENDUM 1. IEC 80601–2–35 (Second edition 2009) Medical electrical equipment—Part 2–35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use CORRIGENDUM 1. USP 36–NF31:2013 Sodium Chloride Irrigation ................................ 6–284 ................. 6–310 ............... USP 36–NF31:2013 Sodium Chloride Injection ................................. 6–285 ................. 6–311 ............... USP 36–NF31:2013 Nonabsorbable Surgical Suture ........................ 6–286 ................. 3–312 ............... USP 36–NF31:2013 <881> Tensile Strength ....................................... 6–287 ................. 6–313 ............... USP 36–NF31:2013 <861> Sutures—Diameter .................................. 6–288 ................. mstockstill on DSK4VPTVN1PROD with NOTICES Old recognition No. 6–314 ............... USP 36–NF 31:2013 <871> Sutures—Needle Attachment ................. 6–289 ................. 6–315 ............... USP 36–NF31:2013 Sterile Water for Irrigation ................................... 6–290 ................. 6–316 ............... USP 36–NF31:2013 Heparin Lock Flush Solution ............................... 6–291 ................. 6–317 ............... USP 36–NF31:2013 Absorbable Surgical Suture ................................ 6–292 ................. ........................... ISO 7886–1:1993 TECHNICAL CORRIGENDUM 1 Published 1995– 11–01 Sterile hypodermic syringes for single-use—Part 1: Syringes for manual use. VerDate Mar<15>2010 18:24 Jan 29, 2014 Title of standard 1 Jkt 232001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 Change E:\FR\FM\30JAN1.SGM Withdrawn. See 6–321. Withdrawn and replaced with newer version including technical corrigendum. Withdrawn. See 6–307. Withdrawn and replaced with newer version including technical corrigendum. Withdrawn. See 6–318. Extent of recognition. Withdrawn. See 6–301. Withdrawn. See 6–301. Withdrawn. See 6–303. Withdrawn. See 6–303. Extent of recognition. Withdrawn. See 6–319. Withdrawn. See 6–320. Withdrawn. See 6–308. Withdrawn and replaced newer version. Withdrawn and replaced newer version. Withdrawn and replaced newer version. Withdrawn and replaced newer version. Withdrawn and replaced newer version. Withdrawn and replaced newer version. Withdrawn and replaced newer version. Withdrawn and replaced newer version. Withdrawn and replaced newer version. Withdrawn. See 6–304. 30JAN1 with with with with with with with with with 4921 Federal Register / Vol. 79, No. 20 / Thursday, January 30, 2014 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. 6–298 ................. 6–319 ............... 6–299 ................. ........................... Title of standard 1 Change IEC 60601–2–19 Edition 2.0 2009–02 Medical electrical equipment—Part 2–19: Particular requirements for the basic safety and essential performance of infant incubators [Including: CORRIGENDUM 1 (2012)]. IEC 60601–2–20 Edition 2.0 2009–02 Medical electrical equipment—Part 2–20: Particular requirements for the basic safety and essential performance of infant transport incubators. Withdrawn and replaced with newer version including technical corrigendum. Withdrawn. See 6–320. G. In Vitro Diagnostics 7–100 ................. ........................... 7–137 ................. 7–244 ............... 7–239 ................. ........................... 7–226 ................. ........................... 7–224 ................. ........................... 7–223 ................. ........................... 7–92 ................... 7–245 ............... 7–210 ................. ........................... 7–152 ................. ........................... 7–174 ................. ........................... 7–178 ................. ........................... 7–193 ................. ........................... 7–220 ................. ........................... ISO 15197 First edition 2003–05–01 In Vitro diagnostic test systems—Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. CLSI NBS01–A6 Blood Collection on Filter Paper for Newborn Screening Programs; Approved Standard—Sixth Edition. CLSI EP32–R (Formerly X05–R) Metrological Traceability and Its Implementation; A Report. CLSI QMS01–A4 (Formerly GP26–A4) Quality Management System: A Model for Laboratory Services; Approved Guideline—Fourth Edition. CLSI EP28–A3c (Formerly C28–A3c) Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline—Third Edition. CLSI QSM06–A3 (Formerly GP22–A3) Quality Management System: Continual Improvement; Approved Guideline—Third Edition. CLSI EP09–A3 Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Third Edition. CLSI H26–A2 Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard—Second Edition. CLSI EP12–A2 User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline—Second Edition. CLSI EP21–A Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline. CLSI M22–A3 Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard—Third Edition. CLSI EP06–A Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. CLSI H59–A Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline. Withdrawn. Withdrawn and replaced newer version. Designation number. with Designation number. Designation number. Designation number. Withdrawn and newer version. replaced with Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. H. Materials 8–344 ............... 8–138 ................. ........................... 8–139 ................. 8–345 ............... 8–140 ................. 8–346 ............... 8–141 ................. mstockstill on DSK4VPTVN1PROD with NOTICES 8–67 ................... 8–347 ............... 8–169 ................. 8–348 ............... 8–176 ................. 8–349 ............... 8–149 ................. 8–350 ............... VerDate Mar<15>2010 18:24 Jan 29, 2014 ISO 7153–1 Second edition 1991–04–01 Surgical instruments— Metallic materials—Part 1: Stainless steel [Including: AMENDMENT 1(1999)]. ASTM F745–07 Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications. ASTM F1314–13 Standard Specification for Wrought Nitrogen Strengthened 22 Chromium-13 Nickel-5 Manganese-2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910). ASTM F1813–13 Standard Specification for Wrought Titanium-12 Molybdenum-6 Zirconium-2 Iron Alloy for Surgical Implant (UNS R58120). ASTM F2146–13 Standard Specification for Wrought Titanium-3 Aluminum-2.5 Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320). ASTM F138–13 Standard Specification for Wrought 18 Chromium14 Nickel-2.5 Molybendum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673). ASTM F2503–13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. ISO 5832–1 Fourth edition 2007–06–15 Implants for surgery—Metallic materials—Part 1: Wrought stainless steel [Including: TECHNICAL CORRIGENDUM 1(2008)]. Jkt 232001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\30JAN1.SGM Withdrawn and replaced with newer version including amendment. Withdrawn. Withdrawn and newer version. replaced with Withdrawn and newer version. replaced with Withdrawn and newer version. replaced with Withdrawn and newer version. replaced with Withdrawn and newer version. replaced with Withdrawn and replaced with newer version including technical corrigendum. 30JAN1 4922 Federal Register / Vol. 79, No. 20 / Thursday, January 30, 2014 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Replacement recognition No. 8–196 ................. ........................... 8–151 ................. 8–351 ............... 8–197 ................. ........................... 8–211 ................. 8–352 ............... 8–212 ................. ........................... 8–228 ................. 8–353 ............... 8–175 ................. 8–354 ............... 8–163 ................. 8–355 ............... 8–129 ................. 8–356 ............... 8–208 ................. 8–357 ............... 8–103 ................. ........................... 8–107 ................. ........................... 8–111 ................. ........................... 8–112 ................. ........................... 8–113 ................. ........................... 8–114 ................. ........................... 8–115 ................. ........................... 8–116 ................. ........................... 8–121 ................. ........................... 8–123 ................. ........................... 8–124 ................. ........................... 8–125 ................. mstockstill on DSK4VPTVN1PROD with NOTICES Old recognition No. ........................... 8–126 ................. 8–370 ............... 8–128 ................. ........................... 8–132 ................. ........................... VerDate Mar<15>2010 21:23 Jan 29, 2014 Title of standard 1 Change ISO 5832–1: 2007 Implants for surgery—Metallic materials—Part 1: Wrought stainless steel TECHNICAL CORRIGENDUM 1. ISO 5832–12 Second edition 2007–05–01 Implants for surgery— Metallic materials—Part 12: Wrought cobalt-chromium-molybdenum alloy [Including: TECHNICAL CORRIGENDUM 1 2008]. ISO 5832–12:2007 TECHNICAL CORRIGENDUM 1 2008–09–05, Implants for surgery—Metallic materials—Part 12: Wrought cobaltchromium-molybdenum alloy TECHNICAL CORRIGENDUM 1. ISO 5834–1 Third edition 2005–06–01 Implants for surgery—Ultrahigh-molecular-weight polyethylene—Part 1: Powder form [Including: TECHNICAL CORRIGENDUM 1 2007]. ISO 5834–1:2005 Technical Corrigendum 1 Published 2007–05–01 Implants for surgery—Ultra-high-molecular-weight polyethylene— Part 1: Powder form TECHNICAL CORRIGENDUM 1. ASTM F86–13 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants. ASTM F1377–13 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075). ASTM F1586/F 1586M–13ε1 Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-10 Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675). ASTM F67–13 Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700). ASTM F648–13 Standard Specification for Ultra-High-MolecularWeight Polyethylene Powder and Fabricated Form for Surgical Implants. ASTM F1801–97 (Reapproved 2009) ε1 Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials. ASTM F746–04 (Reapproved 2009) ε1 Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials. ASTM F1160–05 (Reapproved 2011) ε1 Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings. ASTM F1044–05 (Reapproved 2011) ε1 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings. ASTM F1147–05 (Reapproved 2011) Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coatings. ASTM F2255 (Reapproved 2010) Standard Test Method for Strength Properties of Tissue Adhesives in Lap Shear by Tension Loading. ASTM F2256–05 (Reapproved 2010) Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading. ASTM F2258–05 (Reapproved 2010) Standard Test Method for Strength Properties of Tissue Adhesives in Tension. ASTM F2005–05 (Reapproved 2010) Standard Terminology for Nickel-Titanium Shape Memory Alloys. ISO 5832–5 Third edition 2005–10–15 Implants for surgery—Metallic materials—Part 5: Wrought cobalt-chromium-tungsten-nickel alloy. ASTM F2052–06 ε Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment. ASTM F2004–05 (Reapproved 2010) Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis. ASTM F561–13 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids. ASTM F2213–06 (Reapproved 2011) Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment. ASTM F1088–04a (Reapproved 2010) Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation. Jkt 232001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\30JAN1.SGM Withdrawn. See 8–350. Withdrawn and replaced with newer version including technical corrigendum. Withdrawn. See 8–351. Withdrawn and replaced with newer version including technical corrigendum. Withdrawn. See 8–352. Withdrawn and newer version. Withdrawn and newer version. replaced with replaced with Withdrawn and newer version. replaced with Withdrawn and newer version. replaced with Withdrawn and newer version. replaced with Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Withdrawn and replaced newer version. Extent of recognition. Extent of recognition. 30JAN1 with 4923 Federal Register / Vol. 79, No. 20 / Thursday, January 30, 2014 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Replacement recognition No. 8–134 ................. ........................... 8–135 ................. ........................... 8–136 ................. ........................... 8–150 ................. ........................... 8–157 ................. ........................... 8–159 ................. ........................... 8–165 ................. ........................... 8–167 ................. ........................... 8–168 ................. ........................... 8–170 ................. ........................... 8–171 ................. ........................... 8–173 ................. ........................... 8–177 ................. ........................... 8–179 ................. ........................... 8–183 ................. ........................... 8–184 ................. ........................... 8–185 ................. 8–187 ................. ........................... ........................... 8–188 ................. ........................... 8–189 ................. ........................... 8–190 ................. ........................... 8–192 ................. ........................... 8–193 ................. ........................... 8–194 ................. ........................... 8–195 ................. mstockstill on DSK4VPTVN1PROD with NOTICES Old recognition No. ........................... 8–199 ................. ........................... 8–204 ................. ........................... 8–205 ................. ........................... VerDate Mar<15>2010 21:23 Jan 29, 2014 Title of standard 1 Change ASTM F2082–06 Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery. ASTM F2392–04 (Reapproved 2010) Standard Test Method for Burst Strength of Surgical Sealants. ASTM F2458–05 (Reapproved 2010) Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants. ISO 5832–9 Second edition 2007–06–15 Implants for surgery—Metallic materials—Part 9: Wrought high nitrogen stainless steel. ISO 9583 First edition 1993–10–15 Implants for surgery—Non-destructive testing—Liquid penetrant inspection of metallic surgical implants. ISO 9584 First edition 1993–10–15 Implants for surgery—Non-destructive testing—Radiographic examination of cast metallic surgical implants. ASTM F1058–08ε1 Standard Specification for Wrought 40 Cobalt20 Chromium-16 Iron-15 Nickel-7 Molybdenum Alloy Wire and Strip for Surgical Implant Applications (UNS R30003 and UNS R30008). ASTM F1350–08 Standard Specification for Wrought 18 Chromium14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673). ASTM F1472–08ε1 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium Alloy for Surgical Implant Applications (UNS R56400). ASTM F961–08 Standard Specification for 35 Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants (UNS R30035). ASTM F1609–08 Standard Specification for Calcium Phosphate Coatings for Implantable Materials. ASTM F601–03 (Reapproved 2008) Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants. ASTM F2129–08 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices. ASTM F754–08 Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders. ASTM F560–08 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400). ASTM F2516–07ε2 Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials. ASTM F451–08 Standard Specification for Acrylic Bone Cement .... ISO 13779–1 Second edition 2008–10–01 Implants for surgery— Hydroxyapatite—Part 1: Ceramic hydroxyapatite. ISO 13779–2 Second edition 2008–10–01 Implants for surgery— Hydroxyapatite—Part 2: Coatings of hydroxyapatite. ASTM F 1108–04 (Reapproved 2009) Standard Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants (UNS R56406). ASTM F 90–09 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605). ASTM F1854–09 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants. ASTM F2754/F 2754M–09 Standard Test Method for Measurement of Camber, Cast, Helix and Direction of Helix of Coiled Wire. ISO 6474–1 First edition 2010–02–15 Implants for surgery—Ceramic materials—Part 1: Ceramic materials based on high purity alumina. ASTM F2024–10 Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings. ASTM F2633–07 Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants. ASTM F2118–10 Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials. ASTM F1635–11 Standard Test Method for In Vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants. Jkt 232001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\30JAN1.SGM Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. 30JAN1 4924 Federal Register / Vol. 79, No. 20 / Thursday, January 30, 2014 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. 8–206 ................. ........................... 8–207 ................. ........................... 8–213 ................. ........................... 8–214 ................. ........................... 8–215 ................. ........................... 8–216 ................. ........................... 8–217 ................. ........................... 8–218 ................. ........................... 8–220 ................. ........................... 8–221 ................. ........................... 8–224 ................. ........................... 8–225 ................. ........................... 8–226 ................. ........................... 8–229 ................. ........................... 8–330 ................. ........................... 8–331 ................. ........................... 8–333 ................. ........................... 8–334 ................. ........................... Title of standard 1 Change ASTM F688–10 Standard Specification for Wrought Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035). ASTM F1926/F1926M–10 Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Granules, Fabricated Forms, and Coatings. ISO 5834–3 First edition 2005–07–15 Implants for surgery—Ultrahigh-molecular-weight polyethylene—Part 3: Accelerated ageing methods. ISO 5834–4 First edition 2005–05–01 Implants for surgery—Ultrahigh-molecular-weight polyethylene—Part 4: Oxidation index measurement method. ISO 5834–5 First edition 2005–06–01 Implants for surgery—Ultrahigh-molecular-weight polyethylene—Part 5: Morphology assessment method. ASTM F1295–11 Standard Specification for Wrought Titanium-6 Aluminum-7 Niobium Alloy for Surgical Implant Applications (UNS R56700). ASTM F620–11 Standard Specification for Alpha Plus Beta Titanium Alloy Forgings for Surgical Implants. ASTM F799–11 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539). ASTM F629–11 Standard Practice for Radiography of Cast Metallic Surgical Implants. ASTM F2066–11 Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150). ASTM F2102–06ε1 Standard Guide for Evaluating the Extent of Oxidation in Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants. ASTM F2003–02 (Reapproved 2008) Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air. ASTM F603–12 Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application. ASTM F75–12 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075). ASTM F1978–12 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser. ASTM F1580–12 Standard Specification for Titanium and Titanium6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants. ASTM F2393–12 Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications. ASTM F2459–12 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. I. Nanotechnology ........................... 18–2 ................... mstockstill on DSK4VPTVN1PROD with NOTICES 18–1 ................... ........................... ASTM E2490–09 Standard Guide for Measurement of Particle Size Extent of recognition. Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS). ASTM E2535–07 (Reapproved 2013) Standard Guide for Handling Reaffirmation and extent of recUnbound Engineered Nanoscale Particles in Occupational Settings. ognition. J. Neurology 17–3 ................... 17–12 ............... 17–7 ................... ........................... 17–1 ................... ........................... VerDate Mar<15>2010 21:23 Jan 29, 2014 ISO 7197 Third edition 2006–06–01 Neurosurgical Implants—Ster- Withdrawn and replaced with ile, single-use hydrocephalus shunts and components [Including newer version including techTECHNICAL CORRIGENDUM 1 (2007)]. nical corrigendum. ISO 7197: 2006 Neurosurgical implants—Sterile, single-use hydro- Withdrawn. See 17–12. cephalus shunts and components TECHNICAL CORRIGENDUM 1. ANSI/AAMI NS28:1988/(R) 2010 Intracranial pressure monitoring de- Extent of recognition. vices. Jkt 232001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\30JAN1.SGM 30JAN1 4925 Federal Register / Vol. 79, No. 20 / Thursday, January 30, 2014 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. 17–4 ................... ........................... 17–9 ................... ........................... Title of standard 1 Change ASTM F647–94 (Reapproved 2006) Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application. ASTM F2129–08 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices. Extent of recognition. Extent of recognition. K. OB–GYN/Gastroenterology/Urology 9–34 ................... 9–82 ................. 9–57 ................... ........................... 9–75 ................... 9–84 ................. 9–36 ................... 9–90 ................. 9–37 ................... 9–83 ................. 9–38 ................... ........................... 9–44 ................... ........................... 9–54 ................... 9–85 ................. 9–56 ................... ........................... 9–65 ................... 9–91 ................. 9–66 ................... ........................... 9–67 ................... ........................... 9–68 ................... ........................... 9–73 ................... ........................... 9–74 ................... ........................... 9–79 ................... ........................... ISO 4074 First edition 2002–02–15 Corrected version 2002–12–01 Natural latex rubber condoms—Requirements and test methods [Including TECHNICAL CORRIGENDUM 1 (2002), TECHNICAL CORRIGENDUM 2 (2002)]. ISO 4074:2002 TECHNICAL CORRIGENDUM 2, Natural latex rubber condoms—Requirements and test methods TECHNICAL CORRIGENDUM 2. ISO 8600–3 First edition 1997–07–01 Optics and Optical instruments—Medical endoscopes and endoscopic accessories—Part 3: Determination of field of view and direction of view of endoscopes with optics [Including AMENDMENT 1 (2003)]. ISO 8009 First edition 2004–10–01 Mechanical contraceptives— Reusable natural and silicone rubber contraceptive diaphragms— Requirements and tests [Including AMENDMENT 1(2012)]. ISO 8600–1 Third edition 2013–03–01 Endoscopes—Medical endoscopes and endotherapy devices—Part 1: General requirements. ISO 8600–3 First edition 1997–07–01 AMENDMENT 1, Optics and optical instruments—Medical endoscopes and endoscopic accessories Part 3: Determination of field of view and direction of view of endoscopes with optics. ASTM F623–99 (Reapproved 2006) Standard Performance Specification for Foley Catheter. ASTM D6976–13 Standard Specification for Rubber Contraceptives—Vaginal Diaphragms. ASTM D3492–08 Standard Specification for Rubber Contraceptives (Male Condoms). ANSI/AAMI/ISO 8637:2010 Cardiovascular implants and extracorporeal systems—Hemodialyzers, hemodiafilters, hemofilters, and hemoconcentrators [Including AMENDMENT 1 (2013)]. ANSI/AAMI/ISO 8638:2010 Cardiovascular implants and Extracorporeal blood circuit for hemodialyzers, hemodiafilters, and hemofilters. ASTM D7661–10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. ISO 23409 First edition 2011–02–15 Male Condoms—Requirements and test methods for condoms made from synthetic materials. ANSI/AAMI/ISO 13958:2009 Concentrates for hemodialysis and related therapies. ISO 13958 Second edition 2009–04–15 Concentrates for haemodialysis and related therapies. ISO 26722 First edition 2009–04–15 Water treatment equipment for haemodialysis applications and related therapies. Withdrawn and replaced with newer version including technical corrigendum. Withdrawn. See 9–82. Withdrawn and replaced with newer version including amendment. Withdrawn and replaced with newer version including amendment. Withdrawn and replaced with newer version. Withdrawn. See 9–84. Extent of recognition. Withdrawn and replaced with a newer version. Extent of recognition. Withdrawn and replaced with newer version including amendment. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. L. Ophthalmic mstockstill on DSK4VPTVN1PROD with NOTICES 10–41 ................. 10–81 ............... 10–75 ................. ........................... 10–42 ................. 10–82 ............... 10–53 ................. 10–83 ............... VerDate Mar<15>2010 18:24 Jan 29, 2014 ISO 11979–7 Second edition 2006–05–01 Ophthalmic implants— Intraocular lenses—Part 7: Clinical investigations [Including Amendment 1:2012]. ISO 11979–7/Amendment 1:2012 Ophthalmic implants—Intraocular lenses—Part 7: Clinical investigations. ISO 11979–2 First edition 1999–12–15 Ophthalmic implants—Intraocular lenses—Part 2: Optical properties and test methods [Including TECHNICAL CORRIGENDUM 1 (2003)]. ISO 18369–1 First edition 2006–08–15 Ophthalmic optics—Contact lenses—Part 1: Vocabulary, classification system and recommendations for labeling specifications [Including AMENDMENT 1 2009]. Jkt 232001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\30JAN1.SGM Withdrawn and replaced with newer version including amendment. Withdrawn. See 10–81. Withdrawn and replaced with newer version including technical corrigendum. Withdrawn and replaced with newer version including amendment. 30JAN1 4926 Federal Register / Vol. 79, No. 20 / Thursday, January 30, 2014 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. 10–61 ................. ........................... 10–58 ................. 10–84 ............... 10–59 ................. 10–85 ............... 10–71 ................. 10–86 ............... 10–43 ................. ........................... 10–54 ................. ........................... 10–55 ................. ........................... 10–56 ................. ........................... 10–57 ................. ........................... 10–60 ................. ........................... 10–62 ................. 10–64 ................. ........................... 10–89 ............... 10–68 ................. ........................... 10–69 ................. ........................... 10–74 ................. ........................... Title of standard 1 Change ISO 18369–1:2006 Ophthalmic optics—Contact lenses Part 1: Vocabulary, classification system and recommendations for labeling specifications. ISO 18369–1 First edition 2006–08–05 AMENDMENT 1 2009–02–15. ANSI Z80.11–2012 American National Standard for Ophthalmics— Laser Systems for Corneal Reshaping. ISO 11980 Third edition 2012–11–15 Corrected version 2013–12–01 Ophthalmic optics—Contact lenses and contact lens care products—Guidance for clinical investigations. ISO 14729 First edition 2001–04–15 Ophthalmic optics—Contact lens care products—Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses [Including: AMENDMENT 1 2010]. ISO 11979–8 Second edition 2006–07–01 Ophthalmic implants— Intraocular lenses—Part 8: Fundamental requirements. ISO 18369–4 First edition 2006–08–15 Ophthalmic optics—contact lenses—Part 4: Physicochemical properties of contact lens materials. ISO 11979–6 Second edition 2007–07–15 Ophthalmic implants— Intraocular lenses—Part 6: Shelf-life and transport stability. ANSI Z80.12–2007 (R2012) American National Standard for Ophthalmics—Multifocal Intraocular Lenses. ANSI Z80.13–2007 (R2012) American National Standard for Ophthalmics—Phakic Intraocular Lenses. ISO 11981 Second edition 2009–07–01 Ophthalmic optics—Contact lenses and contact lens care products—Determination of physical compatibility of contact lens care products with contact lenses. ANSI Z80.10–2009 Ophthalmic Instruments—Tonometers ............... ANSI Z80.7–2013 Ophthalmics—Intraocular Lenses ........................ ISO 13212 Second edition 2011–05–15 Ophthalmic optics—Contact lens care products—Guidelines for determination of shelf-life. ANSI Z80.18–2010 American National Standard for Ophthalmics— Contact Lens Care Products—Vocabulary, Performance Specifications and Test Methodology. ISO 10940 Second edition 2009–08–01 Ophthalmic instruments— Fundus Cameras. Withdrawn. See 10–83. Withdrawn and newer version. Withdrawn and newer version. replaced with replaced with Withdrawn and replaced with newer version including amendment. Extent of recognition. Extent of recognition. Extent of recognition. Reaffirmation and extent of recognition. Reaffirmation and extent of recognition. Extent of recognition. Extent of recognition. Withdrawn and replaced newer version. Extent of recognition. with Extent of recognition. Extent of recognition. M. Orthopedic 11–256 ............. 11–218 ............... ........................... 11–210 ............... 11–257 ............. 11–212 ............... ........................... 11–241 ............... ........................... 11–244 ............... 11–258 ............. 11–74 ................. mstockstill on DSK4VPTVN1PROD with NOTICES 11–190 ............... ........................... 11–75 ................. ........................... 11–80 ................. ........................... 11–83 ................. ........................... 11–168 ............... ........................... VerDate Mar<15>2010 18:24 Jan 29, 2014 ISO 14243–3 First edition 2004–09–15 Implants for surgery—Wear of total knee-joint prostheses—Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test [Including: TECHNICAL CORRIGENDUM 1(2006)]. ISO 14243–3:2004 TECHNICAL CORRIGENDUM 1 Implants for surgery—Wear of total knee-joint prostheses—Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test. ASTM F543–13 Standard Specification and Test Methods for Metallic Medical Bone Screws. ASTM F1440–92 (Reapproved 2008) Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components Without Torsion. ASTM F543–07 Standard Specification and Test Methods for Metallic Medical Bone Screws. ASTM F2083–12 Standard Specification for Knee Replacement Prosthesis. ISO 5838–2 First edition 1991–01–15 Implants for surgery—Skeletal pins and wires—Part 2: Steinmann skeletal pins—Dimensions. ISO 5838–3 First edition 1993–09–15 Implants for surgery—Skeletal pins and wires—Part 3: Kirschner skeletal wires. ISO 8828 First edition 1988–10–15 Implants for surgery—Guidance on care and handling of orthopaedic implants. ISO 13402 First edition 1995–08–01 Surgical and dental hand instruments—Determination of resistance against autoclaving, corrosion and thermal exposure. ASTM F1781–03 (Reapproved 2009) Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants. Jkt 232001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\30JAN1.SGM Withdrawn and replaced with newer version including technical corrigendum. Withdrawn. See 11–256. Withdrawn and replaced with a newer version. Withdrawn. Withdrawn duplicate. See 11–257. Withdrawn and replaced with a newer version. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. 30JAN1 4927 Federal Register / Vol. 79, No. 20 / Thursday, January 30, 2014 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Replacement recognition No. 11–171 ............... ........................... 11–183 ............... ........................... 11–184 ............... ........................... 11–185 ............... ........................... 11–191 ............... ........................... 11–196 ............... ........................... 11–197 ............... ........................... 11–199 ............... ........................... 11–203 ............... ........................... 11–207 ............... ........................... 11–211 ............... ........................... 11–214 ............... ........................... 11–216 ............... ........................... 11–220 ............... ........................... 11–222 ............... ........................... 11–223 ............... ........................... 11–224 ............... ........................... 11–225 ............... ........................... 11–226 ............... ........................... 11–227 ............... 11–228 ............... ........................... ........................... 11–231 ............... ........................... 11–232 ............... ........................... 11–234 ............... mstockstill on DSK4VPTVN1PROD with NOTICES Old recognition No. ........................... 11–235 ............... ........................... 11–237 ............... ........................... 11–238 ............... ........................... VerDate Mar<15>2010 21:23 Jan 29, 2014 Title of standard 1 Change ASTM F1814–97a (Reapproved 2009) Standard Guide for Evaluating Modular Hip and Knee Joint Components. ASTM F1875–98 (Reapproved 2009) Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-bore and Cone Taper Interface. ISO 8827 First edition 1988–10–15 Implants for surgery—Staples with parallel legs for orthopaedic use—General requirements. ASTM F2267–04 (Reapproved 2011) Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression. ISO 14879–1 First edition 2000–06–01 Implants for surgery—Total knee-joint prostheses—Part 1: Determination of endurance properties of knee tibial trays. ASTM F1672–95 (Reapproved 2011) Standard Specification for Resurfacing Patellar Prosthesis. ASTM F983–86 (Reapproved 2013) Standard Practice for Permanent Marking of Orthopaedic Implant Components. ASTM F565–04 (Reapproved 2013) Standard Practice for Care and Handling of Orthopedic Implants and Instruments. ASTM F1541–02 (Reapproved 2011) 1 Standard Specification and Test Methods for External Skeletal Fixation Devices. ASTM F2193–02 (Reapproved 2007) Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System. ASTM F1798–97 (Reapproved 2008) Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants. ASTM F382–99 (Reapproved 2008) 1 Standard Specification and Test Method for Metallic Bone Plates. ASTM F1264–03 (Reapproved 2012) Standard Specification and Test Methods for Intramedullary Fixation Devices. ASTM F2068–09 Standard Specification for Femoral Prostheses— Metallic Implants. ISO 14243–1 Second edition 2009–11–15 Implants for surgery— Wear of total knee-joint prostheses—Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test. ISO 14243–2 Second edition 2009–11–15 Implants for surgery— Wear of total knee-joint prostheses—Part 2: Methods of measurement. ASTM F2706–08 Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model. ISO 7206–4 Third edition 2010–06–15 Implants for surgery—Partial and total hip-joint prostheses—Part 4: Determination of endurance properties and performance of stemmed femoral components. ASTM F1089–10 Standard Test Method for Corrosion of Surgical Instruments. ASTM F366–10 Standard Specification for Fixation Pins and Wires .. ASTM F564–10 Standard Specification and Test Methods for Metallic Bone Staples. ISO 7207–2 Second edition 2011–07–01 Implants for surgery— Components for partial and total knee joint prostheses—Part 2: Articulating surfaces made of metal, ceramic and plastics materials. ISO 7207–1 Third edition 2007–02–01 Implants for surgery—Components for partial and total knee joint prostheses—Part 1: Classification, definitions and designation of dimensions. ASTM F732–00 (Reapproved 2011) Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses. ASTM F2077–11 Test Methods for Intervertebral Body Fusion Devices. ISO 7206–6 First edition 1992–03–15 Implants for surgery—Partial and total hip joint prostheses—Part 6: Determination of endurance properties of head and neck region of stemmed femoral components. ASTM F2033–12 Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials. Jkt 232001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\30JAN1.SGM Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Reaffirmation and extent of recognition. Reaffirmation and extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. 30JAN1 4928 Federal Register / Vol. 79, No. 20 / Thursday, January 30, 2014 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. 11–239 ............... ........................... 11–240 ............... ........................... 11–243 ............... ........................... 11–245 ............... ........................... 11–247 ............... ........................... 11–248 ............... ........................... 11–249 ............... ........................... 11–250 ............... ........................... Title of standard 1 Change ASTM F 2345–03 (Reapproved 2013) Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads. ASTM F382–99 (Reapproved 2008) 1 Standard Specification and Test Method for Metallic Bone Plates. ASTM F2346–05 (Reapproved 2011) Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs. ASTM F384–12 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices. ASTM F2789–10 Standard Guide for Mechanical and Functional Characterization of Nucleus Devices. ISO 14242–1 Second edition 2012–01–15 Implants for surgery— Wear of total hip-joint prostheses—Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test. ISO 14242–2 First edition 2000–09–15 Implants for surgery—Wear of total hip-joint prostheses—Part 2: Methods of measurement. ISO 14242–3 First edition 2009–03–15 Implants for surgery—Wear of total hip-joint prostheses—Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test. Extent of recognition. Reaffirmation. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. N. Physical Medicine ........................... 16–27 ................. ........................... 16–29 ................. ........................... 16–158 ............... ........................... 16–159 ............... ........................... 16–162 ............... ........................... 16–163 ............... ........................... 16–164 ............... ........................... 16–165 ............... ........................... 16–166 ............... ........................... 16–167 ............... ........................... 16–168 ............... ........................... 16–169 ............... mstockstill on DSK4VPTVN1PROD with NOTICES 16–25 ................. ........................... 16–170 ............... ........................... 16–171 ............... ........................... VerDate Mar<15>2010 18:24 Jan 29, 2014 ISO 7176–13 First edition 1989–08–01 Wheelchairs—Part 13: Determination of coefficient of friction of test surfaces. ISO 7176–15 First edition 1996–11–15 Wheelchairs—Part 15: Requirements for information disclosure, documentation and labeling. ISO 7176–6 Second edition 2001–10–01 Wheelchairs—Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs. ISO 7176–1 Second edition 1999–10–01 Wheelchairs—Part 1: Determination of static stability. ISO 7176–2 Second edition 2001–06–15 Wheelchairs—Part 2: Determination of dynamic stability of electric wheelchairs. ISO 7176–4 Third edition 2008–10–01 Wheelchairs—Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range. ISO 7176–5 Second edition 2008–06–01 Wheelchairs—Part 5: Determination of overall dimensions, mass and manoeuvring space. ISO 7176–10 Second edition 2008–11–01 Wheelchairs—Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs. ISO 7176–14 Second edition 2008–02–15 Wheelchairs—Part 14: Power and control systems for electrically powered wheelchairs and scooters—Requirements and test methods. ISO 7176–21 Second edition 2009–04–01 Wheelchairs—Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers. ISO 7176–9: Third edition 2009–11–15 Wheelchairs—Part 9: Climatic tests for electric wheelchairs. ANSI/RESNA WC–1:2009 American National Standard for Wheelchairs—Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 1: Determination of static stability. ANSI/RESNA WC–2:2009 American National Standard for Wheelchairs—Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 2: Determination of dynamic stability of electrically powered wheelchairs. ANSI/RESNA WC–2:2009 American National Standard for Wheelchairs—Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 3: Determination of effectiveness of brakes. ANSI/RESNA WC–2:2009 Section 4: Energy consumption of electrically powered wheelchairs and scooters for determination of theoretical distance range. Jkt 232001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\30JAN1.SGM Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. 30JAN1 4929 Federal Register / Vol. 79, No. 20 / Thursday, January 30, 2014 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Replacement recognition No. 16–172 ............... ........................... 16–173 ............... ........................... 16–174 ............... ........................... 16–175 ............... ........................... 16–176 ............... ........................... 16–177 ............... ........................... 16–178 ............... ........................... 16–179 ............... ........................... 16–180 ............... ........................... 16–181 ............... ........................... 16–182 ............... ........................... 16–183 ............... ........................... 16–184 ............... ........................... 16–185 ............... ........................... 16–187 ............... mstockstill on DSK4VPTVN1PROD with NOTICES Old recognition No. ........................... Title of standard 1 Change ANSI/RESNA WC–1:2009 American National Standard for Wheelchairs—Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 5: Determination of dimensions, mass and maneuvering space. ANSI/RESNA WC–2:2009 American National Standard for Wheelchairs—Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 6: Determination of maximum speed, acceleration and deceleration of electrically powered wheelchairs. ANSI/RESNA WC–1:2009 American National Standard for Wheelchairs Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 7: Method of Measurement of Seating and Wheel Dimensions. ANSI/RESNA WC–1:2009 American National Standard for Wheelchairs—Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 8: Requirements and test methods for static, impact and fatigue strengths. ANSI/RESNA WC–2:2009 American National Standard for Wheelchairs—Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 9: Climatic tests for electrically powered wheelchairs. ANSI/RESNA WC–2:2009 American National Standard for Wheelchairs—Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 10: Determination of obstacle-climbing ability of electrically powered wheelchairs. ANSI/RESNA WC–1:2009 American National Standard for Wheelchairs—Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 11: Test dummies. ANSI/RESNA WC–1:2009 American National Standard for Wheelchairs—Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 13: Determination of coefficient of friction of test surfaces. ANSI/RESNA WC–2:2009 American National Standard for Wheelchairs—Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 14: Power and control systems for electrically powered wheelchairs—Requirements and test methods. ANSI/RESNA WC–1:2009 American National Standard for Wheelchairs—Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 15: Requirements for information disclosure, documentation and labeling. ANSI/RESNA WC–1:2009 American National Standard for Wheelchairs—Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 16: Resistance to ignition of upholstered parts—Requirements and test methods. ANSI/RESNA WC–1:2009 American National Standard for Wheelchairs—Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 20: Determination of the performance of stand-up type wheelchairs. ANSI/RESNA WC–1:2009 American National Standard for Wheelchairs—Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 22: Set-up procedures. ANSI/RESNA WC–2:2009,American National Standard for Wheelchairs—Volume 2, Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters. ANSI/RESNA WC–1:2009 American National Standard for Wheelchairs—Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 26: Vocabulary. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition. Extent of recognition Extent of recognition. Extent of recognition. Extent of recognition. O. Radiology 12–53 ................. 12–257 ............. 12–59 ................. ........................... 12–66 ................. ........................... VerDate Mar<15>2010 21:23 Jan 29, 2014 ISO 2919 Third edition 2012–02–15 Radiological protection— Sealed radioactive sources—General requirements and classification. IEC 61168 First edition 1993–12 Radiotherapy simulators—Functional performance characteristics. AIUM MUS, Medical Ultrasound Safety ............................................... Jkt 232001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\30JAN1.SGM Withdrawn and newer version. replaced Extent of recognition. Extent of recognition. 30JAN1 with 4930 Federal Register / Vol. 79, No. 20 / Thursday, January 30, 2014 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Replacement recognition No. 12–139 ............... ........................... 12–140 ............... ........................... 12–145 ............... 12–259 ............. 12–149 ............... 12–260 ............. 12–150 ............... ........................... 12–156 ............... ........................... 12–157 ............... ........................... 12–159 ............... 12–264 ............. 12–167 ............... 12–265 ............. 12–179 ............... ........................... 12–180 ............... 12–266 ............. 12–190 ............... 12–267 ............. 12–194 ............... 12–207 ............... ........................... 12–271 ............. 12–208 ............... 12–268 ............. 12–210 ............... 12–269 ............. 12–219 ............... ........................... 12–222 ............... 12–270 ............. 12–223 ............... ........................... 12–227 ............... ........................... 12–228 ............... mstockstill on DSK4VPTVN1PROD with NOTICES Old recognition No. ........................... 12–233 ............... 12–262 ............. 12–237 ............... 12–258 ............. VerDate Mar<15>2010 18:24 Jan 29, 2014 Title of standard 1 Change AIUM AOMS–2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment. AIUM RTD2–2004 Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Revision 2. IEC 61674 Edition 2.0 2012–11 Medical electrical equipment— Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging. IEC 60336 Fourth edition 2005–04 Medical electrical equipment— X-ray tube assemblies for medical diagnosis—Characteristics of focal spots [Including: Technical Corrigendum 1 (2006)]. ISO/IEC 10918–1:1994 TECHNICAL CORRIGENDUM 1:2005 Information technology—Digital compression and coding of continuoustone still image—Part 1: Requirements and guidelines. ISO 11670:2003 TECHNICAL CORRIGENDUM 1:2004 Lasers and laser-related equipment—Test methods for laser beam parameters—Beam positional stability. ISO 13694:2000 TECHNICAL CORRIGENDUM 1:2005 Optics and optical instruments—Lasers and laser-related equipment—Test methods for laser beam power (energy) density distribution. NEMA MS 11–2010 Determination of Gradient-Induced Electric Fields In Diagnostic Magnetic Resonance Imaging. NEMA NU 2–2012 Performance Measurements of Positron Emission Tomographs (PETs). ANSI/IESNA RP–27.3–2007, Recommended Practice for Photobiological Safety for Lamps—Risk Group Classification and Labeling. IEC 61689 Edition 3.0 2013–02 Ultrasonic-Physiotherapy systems—Field specifications and methods of measurement in the frequency range 0. 5 MHz to 5 MHz. IEC 61217 Edition 2.0 2011–12 Radiotherapy equipment—Coordinates, movements and scales. ANSI/HPS N43.6–2007, Sealed Radioactive Sources—Classification IEC 60601–2–33 Edition 3.1 2013–04 Medical electrical equipment—Part 2–33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis. IEC 60601–2–22 Edition 3.1 2012–10 Medical electrical equipment—Part 2–22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment. IEC 60601–1–3 Edition 2.1 2013–04 Medical electrical equipment— Part 1–3: General requirements for basic safety and essential performance—Collateral Standard: Radiation protection in diagnostic X-ray equipment. IEC 60336 (2005) Medical electrical equipment—X-ray tube assemblies for medical diagnosis—Characteristics of focal spots. IEC 61223–3–5 First edition 2004–08 Evaluation and routine testing in medical imaging departments—Part 3–5: Acceptance tests— Imaging performance of computed tomography X-ray equipment [Including: TECHNICAL CORRIGENDUM 1 (2006)]. IEC 61223–3–5 (First edition 2004) Evaluation and routine testing in medical imaging departments—Part 3–5: Acceptance tests—Imaging performance of computed tomography X-ray equipment CORRIGENDUM 1. IEC 61391–1 First edition 2006–07 Ultrasonics—Pulse-echo scanners—Part 1: Techniques for calibrating spatial measurement systems and measurement of system point-spread function response. IEC 61391–2 Edition 1.0 2010–01 Ultrasonics—Pulse-echo scanners—Part 2: Measurement of maximum depth of penetration and local dynamic range. ISO 11670 Second edition 2003–04–01 Lasers and laser-related equipment—Test methods for laser beam parameters—Beam positional stability [Including: TECHNICAL CORRIGENDUM 1 (2004)]. IEC 62359 Edition 2.0 2010–10 Ultrasonics—Field characterization—Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields [Including TECHNICAL CORRIGENDUM 1 (2011)]. Jkt 232001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 E:\FR\FM\30JAN1.SGM Extent of recognition. Withdrawn. See 12–209 and 12– 258. Withdrawn and newer version. replaced with Withdrawn and replaced with newer version including technical corrigendum. Withdrawn. See 12–261. Withdrawn. See 12–262. Withdrawn. See 12–263. Withdrawn and replaced newer version. Withdrawn and replaced newer version. Extent of recognition. with Withdrawn and newer version. replaced with Withdrawn and replaced newer version. Extent of recognition. Withdrawn and replaced newer version. with Withdrawn and newer version. replaced with Withdrawn and newer version. replaced with with with Withdrawn. See 12–260. Withdrawn and replaced with newer version including technical corrigendum. Withdrawn. See 12–270. Extent of recognition. Extent of recognition. Withdrawn and replaced with newer version including technical corrigendum. Withdrawn and replaced with newer version including technical corrigendum. 30JAN1 4931 Federal Register / Vol. 79, No. 20 / Thursday, January 30, 2014 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. 12–243 ............... 12–263 ............. 12–244 ............... ........................... 12–247 ............... ........................... Title of standard 1 Change ISO 13694 First edition 2000–04–01 Optics and optical instruments—Lasers and laser-related equipment—Test methods for laser beam power [energy] density distribution [Including: TECHNICAL CORRIGENDUM 1 (2005)]. IEC 62359 (Second edition 2010) March 2011 Ultrasonics—Field characterization—Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields CORRIGENDUM 1. ISO 11990–1 First edition 2011–08–01, Lasers and laser-related equipment—Determination of laser resistance of tracheal tubes— Part 1: Tracheal tube shaft. Withdrawn and replaced with newer version including technical corrigendum. Withdrawn. See 12–258. Extent of recognition. P. Software/Informatics 13–4 ................... ........................... ANSI/UL 1998 Standards for Safety Software in Programmable Components, Second Edition. [This Standard contains revisions through and including October 28, 2008.] Extent of recognition. Q. Sterility 14–395 ............. 14–193 ............... ........................... 14–194 ............... ........................... 14–195 ............... ........................... 14–201 ............... 14–396 ............. 14–214 ............... 14–397 ............. 14–218 ............... 14–398 ............. 14–219 ............... 14–399 ............. 14–230 ............... 14–400 ............. 14–231 ............... 14–401 ............. 14–235 ............... 14–402 ............. 14–236 ............... 14–403 ............. 14–241 ............... 14–424 ............. 14–258 ............... 14–404 ............. 14–260 ............... 14–405 ............. 14–264 ............... mstockstill on DSK4VPTVN1PROD with NOTICES 14–143 ............... 14–406 ............. 14–274 ............... ........................... 14–285 ............... ........................... 14–289 ............... ........................... VerDate Mar<15>2010 21:23 Jan 29, 2014 ISO 14698–2 First edition 2003–09–15 Cleanrooms and associated controlled environments—Biocontamination control—Part 2: Evaluation and interpretation of biocontamination data. [Including: TECHNICAL CORRIGENDUM 1 Published 2004–11–01]. ANSI/AAMI/ISO 11607–1:2006/(R)2010 Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems. ANSI/AAMI/ISO 11607–2:2006/(R)2010 Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes. ANSI/AAMI/ISO 11140–1:2005(R)2010 Sterilization of health care products—Chemical indicators—Part 1: General requirements. ANSI/AAMI ST77:2013 Containment devices for reusable medical device sterilization. AOAC 6.2.04:2013 Official Method 955.15 Testing Disinfectants Against Staphylococcus aureus, Use-Dilution Method. AOAC 6.3.05:2013 Official Method 966.04 Sporicidal Activity of Disinfectants Method I. AOAC 6.3.06:2012 Official Method 965.12 Tuberculocidal Activity of Disinfectants. ASTM F2203–13 Standard Test Method for Linear Measurement Using Precision Steel Rule. ASTM F2217/F2217M–13 Standard Practice for Coating/Adhesive Weight Determination. ASTM F1140/F1140M–13 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages. ASTM F2054/F2054M–13 Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates. ISO 13408–6 First edition 2005–06–15 Aseptic processing of health care products—Part 6: Isolator systems [Including AMENDMENT 1 (2013)]. ASTM F2250–13 Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials. ASTM F2252/F2252M–13ε1 Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape. ANSI/AAMI ST8:2013 Hospital steam sterilizers ............................... ANSI/AAMI/ISO 15882:2008 Sterilization of health care products— Chemical indicators—Guidance for selection, use, and interpretation of results. ANSI/AAMI/ISO 14161:2009 Sterilization of health care products— Biological indicators—Guidance for the selection, use and interpretation of results. ISO 14698–2:2003 TECHNICAL CORRIGENDUM Cleanrooms and associated controlled environments—Biocontamination control— Part 2: Evaluation and interpretation of biocontamination data. Jkt 232001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\30JAN1.SGM Withdrawn and replaced with newer version including technical corrigendum. Extent of recognition and relevant guidance. Extent of recognition and relevant guidance. Extent of recognition. Withdrawn and newer version. Withdrawn and newer version. Withdrawn and newer version. Withdrawn and newer version. Withdrawn and newer version. Withdrawn and newer version. Withdrawn and newer version. Withdrawn and newer version. replaced with replaced with replaced with replaced with replaced with replaced with replaced with replaced with Withdrawn and replaced with newer version including amendment. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Extent of recognition and relevant guidance. Extent of recognition. Withdrawn. See 14–395. 30JAN1 4932 Federal Register / Vol. 79, No. 20 / Thursday, January 30, 2014 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Replacement recognition No. 14–296 ............... ........................... 14–300 ............... ........................... 14–326 ............... 14–407 ............. 14–328 ............... 14–428 ............. 14–334 ............... ........................... 14–335 ............... 14–408 ............. 14–336 ............... ........................... 14–338 ............... ........................... 14–352 ............... 14–425 ............. 14–353 ............... ........................... 14–355 ............... ........................... 14–356 ............... ........................... 14–357 ............... ........................... 14–360 ............... ........................... 14–362 ............... 14–412 ............. 14–363 ............... 14–413 ............. 14–365 ............... 14–409 ............. 14–366 ............... 14–414 ............. 14–367 ............... 14–415 ............. ANSI/AAMI/ISO 11138–1:2006/(R)2010, Sterilization of health care products—Biological indicators—Part 1: General requirements. ASTM D4169–09 Standard Practice for Performance Testing of Shipping Containers and Systems. ISO 11737–1 Second edition 2006–04–01, Sterilization of medical devices—Microbiological methods—Part 1: Determination of a population of microorganisms on products [Including: TECHNICAL CORRIGENDUM 1 Published 2007–05–15]. ISO 11137–1 First edition 2006–04–15 Sterilization of health care products—Radiation—Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including AMENDMENT 1 (2013)]. ISO 15882 Second edition 2008–09–01 Sterilization of health care products—Chemical indicators—Guidance for selection, use and interpretation of results. ISO 10993–7 Second edition 2008–10–15 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals [Including: TECHNICAL CORRIGENDUM 1 Published 2009–11–15]. ISO 14161 Second edition 2009–09–15 Sterilization of health care products—Biological indicators—Guidance for the selection, use and interpretation of results. ISO 11138–1 Second edition 2006–07–01, Sterilization of health care products—Biological indicators—Part 1: General requirements. ANSI/AAMI/ISO 13408–6:2005 Aseptic processing of health care products—Part 6: Isolator systems [Including AMENDMENT 1 (2013)]. ISO 11140–1 Second edition 2005–07–15 Sterilization of health care products—Chemical indicators—Part 1: General requirements. ISO 11607–1 First edition 2006–04–15 Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems. ISO 11607–2 First edition 2006–04–15 Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes. ISO 11737–1:2006 TECHNICAL CORRIGENDUM 1 Published 2007–05–15 Sterilization of medical devices—Microbiological methods—Part 1: Determination of a population of microorganisms on products. ANSI/AAMI ST72:2011, Bacterial endotoxins—Test methods, routine monitoring, and alternatives to batch testing. AOAC 6.2.01:2013 Official Method 955.14, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution Method. AOAC 6.2.06:2013 Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use-Dilution Method. ISO 11137–2 Third edition 2013–06–01 Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose. USP 36–NF31:2013 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests. USP 36–NF31:2013 <71> Sterility Tests ............................................. 14–368 ............... 14–416 ............. USP 36–NF31:2013 <85> Bacterial Endotoxins Test .......................... 14–369 ............... 14–417 ............. USP 36–NF31:2013 <151> Pyrogen Test (USP Rabbit Test) ............. 14–370 ............... 14–418 ............. 14–371 ............... 14–419 ............. 14–372 ............... mstockstill on DSK4VPTVN1PROD with NOTICES Old recognition No. 14–420 ............. 14–373 ............... 14–421 ............. 14–374 ............... 14–422 ............. 14–375 ............... 14–423 ............. 14–380 ............... 14–410 ............. USP 36–NF31:2013 <161> Transfusion and Infusion Assemblies and Similar Medical Devices. USP 36–NF31:2013 Biological Indicator for Steam Sterilization, Self-Contained. USP 36–NF31:2013 Biological Indicator for Dry-Heat Sterilization, Paper Carrier. USP 36–NF31:2013 Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier. USP 36–NF31:2013 Biological Indicator for Steam Sterilization, Paper Carrier. USP 36–NF31:2013 <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms. ASTM F17–13 Standard Terminology Relating to Flexible Barrier Packaging. VerDate Mar<15>2010 18:24 Jan 29, 2014 Title of standard 1 Jkt 232001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 Change E:\FR\FM\30JAN1.SGM Relevant guidance. Extent of recognition. Withdrawn and replaced with newer version including technical corrigendum. Withdrawn and replaced with newer version including amendment. Extent of recognition, title. Withdrawn and replaced with newer version including technical corrigendum. Extent of recognition. Relevant guidance. Withdrawn and replaced with newer version including amendment. Extent of recognition. Extent of recognition and relevant guidance. Extent of recognition. Withdrawn. See 14–407. Relevant guidance. Withdrawn and newer version. Withdrawn and newer version. Withdrawn and newer version. Withdrawn and newer version. Withdrawn and newer version. Withdrawn and newer version. Withdrawn and newer version. Withdrawn and newer version. Withdrawn and newer version. Withdrawn and newer version. Withdrawn and newer version. Withdrawn and newer version. Withdrawn and newer version. Withdrawn and newer version. 30JAN1 replaced with replaced with replaced with replaced with replaced with replaced with replaced with replaced with replaced with replaced with replaced with replaced with replaced with replaced with 4933 Federal Register / Vol. 79, No. 20 / Thursday, January 30, 2014 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. 14–384 ............... ........................... 14–385 ............... 14–426 ............. 14–386 ............... 14–427 ............. 14–393 ............... 14–411 ............. 1 All Title of standard 1 Change ISO 10993–7:2008 TECHNICAL CORRIGENDUM 1, Published 2009–11–15 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals. ANSI/AAMI/ISO 13408–1:2008 (R2011) Aseptic processing of health care products—Part 1: General requirements [Including AMENDMENT 1 (2013)]. ISO 13408–1 Second edition 2008–06–15 Aseptic processing of health care products—Part 1: General requirements [Including AMENDMENT 1 (2013)]. ISO/ASTM 51818 Third edition 2013–06–01 Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV. Withdrawn. See 14–408. Withdrawn and replaced with newer version including amendment. Withdrawn and replaced with newer version including amendment. Withdrawn and replaced with newer version. standard titles in this table conform to the style requirements of the respective organizations. III. Listing of New Entries In table 2 of this document, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 034. TABLE 2.—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS Title of standard 1 Recognition No. Reference No. and date A. Anesthesia 1–96 ................... Medical electrical equipment—Part 2–55: Particular requirements for the basic safety and essential performance of respiratory gas monitors. ISO 80601–2–55 First edition 2011–12– 15. B. Cardiovascular 3–121 ................. Cardiovascular implants—Endovascular devices—Part 1: Endovascular prostheses [Including: Amendment 1 (2005)]. ISO 25539–1 First edition 2003–03–01. C. General 5–83 ................... 5–84 ................... 5–85 ................... 5–86 ................... MEDICAL ELECTRICAL EQUIPMENT—Part 1–11: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601–1–11:2010, MOD). Design of training and instructional materials for medical devices used in non-clinical environments. Medical electrical equipment—Part 1–6: General requirements for basic safety and essential performance—Collateral standard: Usability. Medical electrical equipment—Part 1–8: General requirements for basic safety and essential performance—Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. ANSI/AAMI HA60601–1–1:2011. AAMI TIR49:2013. IEC 60601–1–6 Edition 3.0 2010–01. IEC 60601–1–8 Edition 2.0 2006–10. D. General Hospital/General Plastic Surgery 6–302 ................. 6–318 ................. 6–320 ................. mstockstill on DSK4VPTVN1PROD with NOTICES 6–321 ................. 6–322 ................. Stainless steel needle tubing for the manufacture of medical devices [Including: AMENDMENT 1 2001–06–01]. Infusion equipment for medical use—Part 4: Infusion sets for single use, gravity feed [Including: AMENDMENT 1 2013–03–01]. Medical electrical equipment—Part 2–20: Particular requirements for the basic safety and essential performance of infant transport incubators [Including: CORRIGENDUM 1 (February 2012) and CORRIGENDUM 2 (February 2013)]. Medical electrical equipment—Part 2–52: Particular requirements for basic safety and essential performance of medical beds [Including: CORRIGENDUM 1 (September 2010)]. Intravascular catheters—Sterile and single-use catheters—Part 4: Balloon dilatation catheters. ISO 9626 First edition 1991–09–01. ISO 8536–4 Fifth edition 2010–10–01. IEC 60601–2–20 Edition 2.0 2009–02. IEC 60601–2–52 Edition 1.0 2009–12. ISO 10555–4 Second edition 2013–06– 15. E. Material 8–358 ................. 8–359 ................. VerDate Mar<15>2010 Standard Specification for Polyoxymethylene (Acetal) for Medical Applications ...... Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials. 18:24 Jan 29, 2014 Jkt 232001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\30JAN1.SGM ASTM F1855–00 (Reapproved 2011). ASTM F2038–00 (Reapproved 2011). 30JAN1 4934 Federal Register / Vol. 79, No. 20 / Thursday, January 30, 2014 / Notices TABLE 2.—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued Recognition No. Title of standard 1 8–360 ................. Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Cross-Linking and Fabrication. Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants. Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications. Standard Test Method for Tensile Properties of Plastics ......................................... Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement. Standard Test Method for Density of Plastics by the Density-Gradient Technique Ultra-high-molecular-weight polyethylene (PE–UHMW) moulding and extrusion materials—Part 2: Preparation of test specimens and determination of properties. Standard Test Method for Measurement of Fatigue Crack Growth Rates ............... Standard Test Method for Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry. Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air. 8–361 ................. 8–362 ................. 8–363 ................. 8–364 ................. 8–365 ................. 8–366 ................. 8–367 ................. 8–368 ................. 8–369 ................. Reference No. and date ASTM F2042–00 (Reapproved 2011). ASTM F755–99 (Reapproved 2011). ASTM F2989–13. ASTM D638–10. ASTM D792–08. ASTM D1505–10. ISO 11542–2 First edition 1998–11–15. ASTM E647–13ε1. ASTM F2625–10. ASTM F2003–02 (Reapproved 2008). F. OB–GYN/Gastroenterology/Urology 9–86 ................... 9–87 ................... 9–88 ................... 9–89 ................... 9–92 ................... Rubber condoms for clinical trials—Measurement of physical properties Including [AMENDMENT 1 2011–02–15)]. Female condoms—Requirements and test methods ................................................ Prophylactic dams—Requirements and test methods .............................................. Cardiovascular implants and extracorporeal blood circuit for haemodialysers, haemodiafilters, and haemofilters. Cardiovascular implants and extracorporeal systems—Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators Including [AMENDMENT 1 2013–04–01)]. ISO 16037 First Edition 2002–05–15. ISO 25841 First Edition 2011–07–15. ISO 29942 First Edition 2011–07–01. ISO 8638 Third edition 2010–07–01. ISO 8637 Third edition 2010–07–01. G. Ophthalmics 10–87 ................. 10–88 ................. Standard Test Method for Tensile Properties of Thin Plastic Sheeting ................... Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials. ASTM D882–12. ASTM D790–10. H. Orthopedics 11–259 ............... 11–260 ............... 11–261 ............... 11–262 ............... 11–263 ............... 11–264 ............... 11–265 ............... 11–266 ............... 11–267 ............... 11–268 ............... 11–269 ............... 11–270 ............... mstockstill on DSK4VPTVN1PROD with NOTICES 11–271 ............... 11–272 ............... 11–273 ............... 11–274 ............... 11–275 ............... VerDate Mar<15>2010 Standard Specification For Total Elbow Prostheses ................................................. Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in Joint Arthroplasty. Standard Specification for Shoulder Prostheses ...................................................... Standard Specification for Acetabular Prostheses .................................................... Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation. Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices. Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis. Standard Specification for Total Ankle Replacement Prosthesis ............................. Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses. Standard Test Method for Static Evaluation of Glenoid Locking Mechanism in Shear. Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses. Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants. Standard Specification for Metallic Implantable Strands and Cables ....................... Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices. Implants for surgery—Wear of total intervertebral spinal disc prostheses—Part 1 Loading and displacement parameters for wear testing and corresponding environmental conditions for test. Implants for surgery—Wear of total intervertebral spinal disc prostheses—Part 2: Nucleus replacements. Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy. 21:55 Jan 29, 2014 Jkt 232001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 E:\FR\FM\30JAN1.SGM ASTM F2887–12. ASTM F2943–13. ASTM F1378–12 ASTM F2091–01 (Reapproved 2012). ASTM F2028–08 (Reapproved 2012) 1. ASTM F1820–13. ASTM F2580–13. ASTM F2665–09. ASTM F2009–00 (Reapproved 2011). ASTM F1829–98 (Reapproved 2009). ASTM F2423–11. ASTM F2502–11. ASTM F2180–02 (Reapproved 2011). ASTM F1714–96 (Reapproved 2013). ISO 18192–1 Second edition 2011–03– 01. ISO 18192–2 First edition 2010–06–15. ASTM F2381–10. 30JAN1 Federal Register / Vol. 79, No. 20 / Thursday, January 30, 2014 / Notices 4935 TABLE 2.—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued Title of standard 1 Recognition No. Reference No. and date I. Radiology 12–261 ............... Information technology—Digital compression and coding of continuous-tone still images: Requirements and guidelines [Including: TECHNICAL CORRIGENDUM 1 (2005)]. ISO/IEC 10918–1 First edition 1994–02– 15. J. Software/Informatics 13–63 ................. 13–64 ................. Application of risk management for IT-networks incorporating medical devices— Part 2–4: Application guidance—General implementation guidance for healthcare delivery organizations. Application of risk management for IT-networks incorporating medical devices— Part 2–4: General implementation guidance for healthcare delivery organizations. IEC/TR 80001–2–4 Edition 1.0 2012–11. ANSI/AAMI/IEC TIR80001–2–4:2012. K. Sterility 14–429 ............... Practice for use of a radiochromic film dosimetry system ........................................ 14–430 ............... Practice for use of an alanine-EPR dosimetry system ............................................. 14–431 ............... Guide for estimating uncertainties in dosimetry for radiation processing ................. 1 All standard titles in this table conform to the style requirements of the respective organizations. IV. List of Recognized Standards FDA maintains the Agency’s current list of FDA recognized consensus standards in a searchable database that may be accessed directly at FDA’s Internet site at https://www.accessdata. fda.gov/scripts/cdrh/cfdocs/ cfStandards/search.cfm. FDA will incorporate the modifications and revisions described in this notice into the database and, upon publication in the Federal Register, this recognition of consensus standards will be effective. FDA will announce additional modifications and revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often, if necessary. Beginning with recognition list 033, FDA no longer announces minor revisions to the list of recognized consensus standards such as technical contact person, relevant guidance, processes affected, CFR citations, and product codes. V. Recommendation of Standards for Recognition by FDA mstockstill on DSK4VPTVN1PROD with NOTICES ISO/ASTM 51275 Third edition 2013– 06–01. ISO/ASTM 51607 Third edition 2013– 06–01. ISO/ASTM 51707 Second edition 2005– 05–15. Any person may recommend consensus standards as candidates for recognition under section 514 of the FD&C Act by submitting such recommendations, with reasons for the recommendation, to the contact person (see FOR FURTHER INFORMATION CONTACT). To be properly considered, such recommendations should contain, at a minimum, the following information: (1) The title of the standard, (2) any reference number and date, (3) the name VerDate Mar<15>2010 18:24 Jan 29, 2014 Jkt 232001 and address of the national or international standards development organization, (4) a proposed list of devices for which a declaration of conformity to this standard should routinely apply, and (5) a brief identification of the testing or performance or other characteristics of the device(s) that would be addressed by a declaration of conformity. VI. Electronic Access This Federal Register document on modifications in FDA’s recognition of consensus standards is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ Standards/ucm123792.htm. VII. Submission of Comments and Effective Date Interested persons may submit to the contact person (see FOR FURTHER INFORMATION CONTACT) either electronic or written comments regarding this document. It is only necessary to send one set of comments. Comments are to be identified with the docket number found in brackets in the heading of this document. FDA will consider any comments received in determining whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 034. These modifications to the list of recognized standards are effective upon publication of this notice in the Federal Register. You may obtain a copy of ‘‘Guidance on the Recognition and Use of Consensus Standards’’ by using the Internet. The Center for Devices and Radiological Health (CDRH) maintains a site on the Internet for easy access to information including text, graphics, and files that you may download to a personal computer with access to the Internet. Updated on a regular basis, the CDRH home page includes the guidance as well as the current list of recognized standards and other standards-related documents. After publication in the Federal Register, this notice announcing ‘‘Modification to the List of Dated: January 23, 2014. Recognized Standards, Recognition List Leslie Kux, Number: 034’’ will be available on the Assistant Commissioner for Policy. CDRH home page. You may access the CDRH home page at https://www.fda.gov/ [FR Doc. 2014–01847 Filed 1–29–14; 8:45 am] BILLING CODE 4160–01–P MedicalDevices. You may access ‘‘Guidance on the Recognition and Use of Consensus Standards,’’ and the searchable database for ‘‘FDA Recognized Consensus Standards’’ at https://www.fda.gov/ MedicalDevices/DeviceRegulationand Guidance/Standards. PO 00000 Frm 00072 Fmt 4703 Sfmt 9990 E:\FR\FM\30JAN1.SGM 30JAN1

Agencies

[Federal Register Volume 79, Number 20 (Thursday, January 30, 2014)]
[Notices]
[Pages 4913-4935]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01847]

[[Page 4913]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0451]

Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 034

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing a
publication containing modifications the Agency is making to the list
of standards FDA recognizes for use in premarket reviews (FDA
recognized consensus standards). This publication, entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 034'' (Recognition List Number: 034), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.

DATES: Submit written or electronic comments concerning this document
at any time. See section VII for the effective date of the recognition
of standards announced in this document.

ADDRESSES: Submit written requests for single copies of ``Modifications
to the List of Recognized Standards, Recognition List Number: 034'' to
the Division of Small Manufacturers, International and Consumer
Assistance, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD
20993. Send two self-addressed adhesive labels to assist that office in
processing your requests, or fax your request to 301-847-8149. Submit
written comments concerning this document, or recommendations for
additional standards for recognition, to the contact person (see FOR
FURTHER INFORMATION CONTACT). Submit electronic comments by email:
standards@cdrh.fda.gov. This document may also be accessed on FDA's
Internet site at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section VI for
electronic access to the searchable database for the current list of
FDA recognized consensus standards, including Recognition List Number:
034 modifications and other standards related information.

FOR FURTHER INFORMATION CONTACT: Scott A. Colburn, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3632, Silver Spring, MD 20993, 301-796-
6287.

I. Background

Section 204 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). Amended
section 514 allows FDA to recognize consensus standards developed by
international and national organizations for use in satisfying portions
of device premarket review submissions or other requirements.
In a notice published in the Federal Register of February 25, 1998
(63 FR 9561), FDA announced the availability of a guidance entitled
``Recognition and Use of Consensus Standards.'' The notice described
how FDA would implement its standard recognition program and provided
the initial list of recognized standards.
Modifications to the initial list of recognized standards, as
published in the Federal Register, can be accessed at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.
These notices describe the addition, withdrawal, and revision of
certain standards recognized by FDA. The Agency maintains hypertext
markup language (HTML) and portable document format (PDF) versions of
the list of FDA Recognized Consensus Standards. Both versions are
publicly accessible at the Agency's Internet site. See section VI for
electronic access information. Interested persons should review the
supplementary information sheet for the standard to understand fully
the extent to which FDA recognizes the standard.

II. Modifications to the List of Recognized Standards, Recognition List
Number: 034

FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the Agency will recognize for
use in premarket submissions and other requirements for devices. FDA
will incorporate these modifications in the list of FDA Recognized
Consensus Standards in the Agency's searchable database. FDA will use
the term ``Recognition List Number: 034'' to identify these current
modifications.
In table 1 of this document, FDA describes the following
modifications: (1) The withdrawal of standards and their replacement by
others, if applicable; (2) the correction of errors made by FDA in
listing previously recognized standards; and (3) the changes to the
supplementary information sheets of recognized standards that describe
revisions to the applicability of the standards.
In section III of this document, FDA lists modifications the Agency
is making that involve the initial addition of standards not previously
recognized by FDA.

Table 1--Modifications to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
Old recognition No. Replacement recognition No. Title of standard \1\ Change
----------------------------------------------------------------------------------------------------------------
A. Anesthesia
----------------------------------------------------------------------------------------------------------------
1-15........................ ............................ ISO 5361-4:1987, Tracheal Withdrawn. See 1-93.
tubes--Part 4: Cole type.
1-18........................ 1-94........................ ISO 8359 Second edition 1996- Withdrawn and replaced
12-15, Oxygen concentrators with newer version
for medical use--Safety including amendment.
requirements [Including:
AMENDMENT 1 2012-07-01].
1-36........................ 1-95........................ ISO 5366-3 Second edition Withdrawn and replaced
2001-08-15, Anaesthetic and with newer version
respiratory equipment-- including technical
Tracheostomy tubes--Part 3: corrigendum.
Pediatric tracheostomy
tubes [Including: TECHNICAL
CORRIGENDUM 1 Published
2003-01-15].
1-44........................ ............................ ISO 5366-1 Fourth edition Extent of recognition.
2000-12-15, Anaesthetic and
respiratory equipment--
Tracheostomy tubes--Part 1:
Tubes and connectors for
use in adults.

[[Page 4914]]

1-46........................ ............................ ISO 5367 Fourth edition 2000- Extent of recognition.
06-01 Breathing tubes
intended for use with
anaesthetic apparatus and
ventilators.
1-47........................ ............................ AS 4259-1995 Ancillary Extent of recognition.
devices for expired air
resuscitation.
1-56........................ 1-97........................ CGA V-7.1:2011 Standard Withdrawn and replaced
Method of Determining with newer version.
Cylinder Valve Outlet
Connections for Medical
Gases.
1-57........................ ............................ ASTM F1101-90 (Reapproved Extent of recognition.
2003) [egr]1, Standard
Specification for
Ventilators Intended for
Use During Anesthesia.
1-58........................ ............................ ASTM G175-03 (Reapproved Extent of recognition.
2011), Standard Test Method
for Evaluating the Ignition
Sensitivity and Fault
Tolerance of Oxygen
Regulators Used for Medical
and Emergency Applications.
1-65........................ ............................ ISO 21647:2004 Medical Withdrawn. See 1-96.
electrical equipment--
Particular requirements for
the basic safety and
essential performance of
respiratory gas monitors.
1-69........................ ............................ ASTM F1464-93 (Reapproved Extent of recognition.
2005) Standard
Specification for Oxygen
Concentrators for
Domiciliary Use.
1-70........................ ............................ ASTM F1246-91 (Reapproved Extent of recognition.
2005) Standard
Specification for
Electrically Powered Home
Care Ventilators, Part 1--
Positive-Pressure
Ventilators and Ventilator
Circuits.
1-78........................ ............................ ASME PVHO-1-2007 Safety Extent of recognition.
Standard for Pressure
Vessels for Human Occupancy.
1-81........................ ............................ CGA V-5:2008 (Reaffirmed Reaffirmation.
2013), Diameter-Index
Safety System
(Noninterchangeable Low
Pressure Connections for
Medical Gas Applications).
1-83........................ ............................ ISO 21647:2004 TECHNICAL Withdrawn. See 1-96.
CORRIGENDUM 1, Medical
electrical equipment--
Particular requirements for
the basic safety and
essential performance of
respiratory gas monitors.
1-84........................ ............................ ISO 5366-3:2001 Anaesthetic Withdrawn. See 1-95.
and Respiratory Equipment--
Tracheostomy Tubes--Part 3:
Pediatric Tracheostomy
Tubes TECHNICAL CORRIGENDUM
1.
1-86........................ ............................ ISO 8185 Third edition 2007- Extent of recognition.
07-01 Corrected versions
2008-06-15 Respiratory
tract humidifiers for
medical use--Particular
requirements for
respiratory humidification
systems.
1-88........................ 1-98........................ ISO 80601-2-12 First edition Withdrawn and replaced
2011-04-15 Medical with newer version
electrical equipment--Part including technical
2-12: Particular corrigendum.
requirements for the safety
of lung ventilators--
Critical care ventilators
[Including: TECHNICAL
CORRIGENDUM 1 Published
2011-10-15].
1-89........................ ............................ ISO 80601-2-12 TECHNICAL Withdrawn. See 1-98.
CORRIGENDUM 1 Medical
electrical equipment Part 2-
12: Particular requirements
for basic safety and
essential performance of
critical care ventilators.
1-90........................ ............................ ISO 8359 Second edition 1996- Withdrawn. See 1-94.
12-15 AMENDMENT 1 2012-07-
01 Oxygen concentrators for
medical use--Safety
requirements.
1-92........................ ............................ ISO 17510-2 Second Edition Extent of recognition.
2007-10-01, Sleep apnoea
breathing therapy--Part 2:
Masks and application
accessories.
1-93........................ ISO 5361................... Second edition 2012-10-01 Extent of recognition.
Anaesthetic and respiratory
equipment--Tracheal tubes
and connectors.
----------------------------------------------------------------------------------------------------------------
B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-123....................... 2-204....................... ASTM F720-13 Standard Withdrawn and replaced
Practice for Testing Guinea with newer version.
Pigs for Contact Allergens:
Guinea Pig Maximization
Test.
2-182....................... 2-205....................... ISO 14155 Second edition Withdrawn and replaced
2011-02-01 Clinical with newer version
investigations of medical including technical
devices for human subjects-- corrigendum.
Good clinical practices
[Including TECHNICAL
CORRIGENDUM 1:2011].
2-183....................... ............................ ISO 14155:2011 and TECHNICAL Withdrawn. See 2-205.
CORRIGENDUM 1 Published
2011-07-15 Clinical
investigation of medical
devices for human subjects--
Good clinical practice.
2-93........................ ............................ ASTM F763-04 (Reapproved Extent of recognition.
2010), Standard Practice
for Short-Term Screening of
Implant Materials.
2-94........................ ............................ ASTM F981-04 (Reapproved Extent of recognition.
2010) Standard Practice for
Assessment of Compatibility
of Biomaterials for
Surgical Implants with
Respect to Effect of
Materials on Muscle and
Bone.
2-114....................... ............................ ASTM F1877-05 (Reapproved Extent of recognition.
2010) Standard Practice for
Characterization of
Particles.
2-118....................... ............................ ANSI/AAMI/ISO 10993-11:2006/ Extent of recognition.
(R) 2010 Biological
evaluation of medical
devices--Part 11: Tests for
systemic toxicity.
2-120....................... ............................ ANSI/AAMI/ISO 10993-6:2007/ Extent of recognition.
(R) 2010 Biological
evaluation of medical
devices--Part 06: Tests for
local effects after
implantation.
2-126....................... ............................ ASTM F748-06 (Reapproved Extent of recognition.
2010) Standard Practice for
Selecting Generic
Biological Test Methods for
Materials and Devices.

[[Page 4915]]

2-133....................... ............................ ASTM F1408-97 (Reapproved Extent of recognition.
2008) Standard Practice for
Subcutaneous Screening Test
for Implant Materials.
2-134....................... ............................ ASTM F2065-00 (Reapproved Extent of recognition.
2010) Standard Practice for
Testing for Alternative
Pathway Complement
Activation in Serum by
Solid Materials.
2-136....................... ............................ ASTM E1262-88 (Reapproved Extent of recognition.
2008) Standard Guide for
Performance of the Chinese
Hamster Ovary Cell/
Hypoxanthine Guanine
Phosphoribosyl Transferase
Gene Mutation Assay.
2-137....................... ............................ ASTM E1263-97 (Reapproved Withdrawn.
2008) Standard Guide for
Conduct of Micronucleus
Assays in Mammalian Bone
Marrow Erythrocytes.
2-138....................... ............................ ASTM E1280-97 (Reapproved Withdrawn.
2008) Standard Guide for
Performing the Mouse
Lymphoma Assay for
Mammalian Cell Mutagenicity.
2-139....................... ............................ ASTM E1397-91 (Reapproved Withdrawn.
2008) Standard Practice for
the In Vitro Rat Hepatocyte
DNA Repair Assay.
2-140....................... ............................ ASTM E1398-91 (Reapproved Withdrawn.
2008) Standard Practice for
the In Vivo Rat Hepatocyte
DNA Repair Assay.
2-141....................... ............................ ASTM F1984-99 (Reapproved Extent of recognition.
2008) Standard Practice for
Testing for Whole
Complement Activation in
Serum by Solid Materials.
2-142....................... ............................ ASTM F1983-99 (Reapproved Extent of recognition.
2008) Standard Practice for
Assessment of Compatibility
of Absorbable/Resorbable
Biomaterials for Implant
Application.
2-143....................... ............................ ASTM F1904-98 (Reapproved Extent of recognition.
2008) Standard Practice for
Testing the Biological
Responses to Particles in
vivo.
2-144....................... ............................ ASTMF619-03 (Reapproved Extent of recognition.
2008) Standard Practice for
Extraction of Medical
Plastics.
2-145....................... ............................ ASTM F1439-03 (Reapproved Extent of recognition.
2008) Standard Guide for
Performance of Lifetime
Bioassay for the
Tumorigenic Potential of
Implant Materials.
2-153....................... ............................ ANSI/AAMI/ISO 10993-5:2009, Extent of recognition.
Biological evaluation of
medical devices--Part 5:
Tests for In Vitro
cytotoxicity.
2-154....................... ............................ ASTM F756-08 Standard Extent of recognition.
Practice for Assessment of
Hemolytic Properties of
Materials.
2-155....................... ............................ ASTM F2147-01 (Reapproved Extent of recognition.
2010) Standard Practice for
Guinea Pig: Split Adjuvant
and Closed Patch Testing
for Contact Allergens.
2-156....................... ............................ ANSI/AAMI/ISO 10993-1:2009 Extent of recognition.
Biological evaluation of
medical devices--Part 1:
Evaluation and testing
within a risk management.
2-162....................... ............................ ASTM F1903-10 Standard Extent of recognition.
Practice for Testing for
Biological Responses to
Particles in vitro.
2-163....................... ............................ ANSI/AAMI/ISO 10993-9:2009 Extent of recognition.
Biological evaluation of
medical devices--Part 9:
Framework for
identification and
quantification of potential
degradation products.
2-165....................... ............................ ANSI/AAMI/ISO 10993-14:2001/ Extent of recognition.
(R) 2011 Biological
evaluation of medical
devices--Part 14:
Identification and
quantification of
degradation products from
ceramics.
2-167....................... ............................ ISO/TS 10993-19 First Extent of recognition.
edition 2006-06-01
Biological evaluation of
medical devices--Part 19:
Physico-chemical,
morphological, and
topographical
characterization of
materials.
2-168....................... ............................ ISO 10993-9 Second edition Extent of recognition.
2009-12-15 Biological
evaluation of medical
devices--Part 9: Framework
for identification and
quantification of potential
degradation products.
2-169....................... ............................ ISO 10993-13 Second edition Extent of recognition.
2010-06-15 Biological
evaluation of medical
devices--Part 13:
Identification and
quantification of
degradation products from
polymeric medical devices.
2-170....................... ............................ ISO 10993-14 First edition Extent of recognition.
2001-11-15 Biological
evaluation of medical
devices--Part 14:
Identification and
quantification of
degradation products from
ceramics.
2-171....................... ............................ ISO 10993-16 Second edition Extent of recognition.
2010-02-15 Biological
evaluation of medical
devices--Part 16:
Toxicokinetic study design
for degradation products
and leachables.
2-172....................... ............................ ANSI/AAMI/ISO TIR 10993- Extent of recognition.
19:2006 Biological
evaluation of medical
devices--Part 19:
Physicochemical,
morphological, and
topographical
characterization of
materials.
2-173....................... ............................ ANSI/AAMI/ISO 10993-10:2010 Extent of recognition.
Biological evaluation of
medical devices--Part 10:
Tests for irritation and
skin sensitization.
2-174....................... ............................ ISO 10993-10:2010 Biological Extent of recognition.
evaluation of medical
devices--Part 10: Tests for
irritation and skin
sensitization.
2-175....................... ............................ ISO 10993-3 Second edition Extent of recognition.
2003-10-15 Biological
evaluation of medical
devices Part 3: Tests for
genotoxicity,
carcinogenicity and
reproductive toxicity.

[[Page 4916]]

2-176....................... ............................ ISO 10993-11 Second edition Extent of recognition.
2006-08-15 Biological
evaluation of medical
devices--Part 11: Tests for
systemic toxicity.
2-177....................... ............................ ISO 10993-06 Second edition Extent of recognition.
2007-04-15 Biological
evaluation of medical
devices--Part 6: Tests for
local effects after
implantation.
2-179....................... ............................ ISO 10993-1 Fourth edition Extent of recognition.
2009-10-15 Biological
evaluation of medical
devices--Part 1: Evaluation
and testing within a risk
management process.
2-181....................... ............................ ANSI/AAMI/ISO 14155:2011, Extent of recognition.
Clinical investigation of
medical devices for human
subjects--Good clinical
practice.
2-189....................... ............................ ASTM F895-11, Standard Test Extent of recognition.
Method for Agar Diffusion
Cell Culture Screening for
Cytotoxicity.
2-190....................... ............................ ANSI/AAMI/ISO 10993-13:2010, Extent of recognition.
Biological evaluation of
medical devices--Part 13:
Identification and
quantification of
degradation products from
polymeric medical devices.
2-191....................... ............................ ISO 10993-12 Fourth edition Extent of recognition.
2012-07-01, Biological
evaluation of medical
devices--Part 12: Sample
preparation and reference
materials.
----------------------------------------------------------------------------------------------------------------
C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-41........................ ............................ ANSI/AAMI EC11:1991/(R)2007 Withdrawn. See 3-106.
Diagnostic
electrocardiographic
devices.
3-52........................ ............................ ANSI/AAMIEC12:2000/(R)2010 Extent of recognition.
Disposable ECG electrodes.
3-54........................ ............................ ANSI/AAMI/ISO 7198:1998/2001/ Extent of recognition.
(R)2010 Cardiovascular
implants--Tubular vascular
prostheses.
3-58........................ ............................ ANSI/AAMI/ISO 5840:2005/ Extent of recognition.
(R)2010 Cardiovascular
implants--Cardiac valve
prostheses.
3-63........................ ............................ ISO 11318 Second edition Extent of recognition.
2002-08-01 Cardiac
Defibrillators--Connector
assembly DF-1 for
implantable defibrillators--
Dimensions and test
requirements.
3-72........................ ............................ ANSI/AAMI EC53:1995/(R) 2008 Extent of recognition.
ECG cables and leadwires.
3-73........................ 3-118....................... ANSI/AAMI EC57:2012 Testing Withdrawn and replaced
and reporting performance with newer version.
results of cardiac rhythm
and ST-segment measurement
algorithms.
3-75........................ ............................ ANSI/AAMI SP10:2002/(R) 2008 Withdrawn. See 3-80, 3-
& ANSI/AAMI SP10:2002/ 122 and 3-123.
A1:2003, Manual, electronic
or automated
sphygmomanometers.
3-76........................ ............................ ASTM F2129-08 Standard Test Extent of recognition.
Method for Conducting
Cyclic Potentiodynamic
Polarization Measurements
to Determine the Corrosion
Susceptibility of Small
Implant Devices.
3-78........................ ............................ ANSI/AAMI/IEC 80601-2- Extent of recognition.
30:2009 Medical electrical
equipment--Part 2-30:
Particular requirements for
the basic safety and
essential performance of
automated noninvasive
sphygmomanometers.
3-80........................ ............................ ANSI/AAMI/ISO 81060-1:2007/ Reaffirmation.
(R) 2013 Non-invasive
sphygmomanometers--Part 1:
Requirements and test
methods for non-automated
measurement type.
3-83........................ ............................ ANSI/AAMI/ISO 14708-5:2010 Extent of recognition.
Implants for surgery--
Active implantable medical
devices--Part 5:
Circulatory support devices.
3-85........................ 3-120....................... ANSI/AAMI/ISO 25539-2:2012 Withdrawn and replaced
Cardiovascular implants-- with newer version.
Endovascular devices--Part
2: Vascular stents.
3-88........................ ............................ ASTM F2514-08 Standard Guide Extent of recognition.
for Finite Element Analysis
(FEA) of Metallic Vascular
Stents Subjected to Uniform
Radial.
3-90........................ ............................ ISO 7198 First edition 1998- Extent of recognition.
08-01 Cardiovascular
implants--Tubular vascular
prostheses.
3-93........................ ............................ ISO 25539-1:2003 First Withdrawn. See 3-121.
edition 2001-11-13
AMENDMENT 1 2005-07-15
Cardiovascular implants--
Endovascular devices--Part
1: Endovascular prostheses
Amendment 1: Test methods.
3-97........................ 3-122....................... ISO 81060-2 Second edition Withdrawn and replace
2013-05-01 Non-invasive with newer version.
sphygmomanometers--Part 2:
Clinical validation of
automated measurement type.
3-98........................ ............................ ISO 81060-2:2009 TECHNICAL Withdrawn. See 3-122.
CORRIGENDUM Published 2011-
02-15 Non-invasive
sphygmomanometers--Part 2:
Clinical validation of
automated measurement type.
3-100....................... ............................ ANSI/AAMI/IEC 60601-2- Withdrawn. See 3-101.
27:2011 Medical electrical
equipment--Part 2-27:
Particular requirements for
the basic safety and
essential performance of
electrocardiographic
monitoring equipment.
3-107....................... 3-123....................... IEC 80601-2-30 Edition 1.1 Withdrawn and replaced
2013-07 Medical electrical with newer version.
equipment--Part 2-30:
Particular requirements for
the basic safety and
essential performance of
automated non-invasive
sphygmomanometers.

[[Page 4917]]

3-108....................... ............................ IEC 80601-2-30 (First Withdrawn. See 3-123.
edition 2009) Medical
electrical equipment--Part
2-30: Particular
requirements for the basic
safety and essential
performance of automated
non-invasive
sphygmomanometers
CORRIGENDUM 1.
3-113....................... 3-124....................... ISO 7199 Second edition 2009- Withdrawn and replaced
04-15 Cardiovascular with newer version
implants and artificial including amendment.
organs--Blood-gas
exchangers (oxygenators)
[Including: AMENDMENT 1
(2012)].
3-114....................... 3-119....................... ISO 5841-3 Third edition Withdrawn and replace
2013-40-15 Implants for with newer version.
surgery--Cardiac
pacemakers--Part 3: Low-
profile connectors (IS-1)
for implantable pacemakers.
----------------------------------------------------------------------------------------------------------------
D. Dental/ENT
----------------------------------------------------------------------------------------------------------------
4-50........................ ............................ ADA Specification No.18:1992 Extent of recognition.
Alginate Impression
Materials.
4-62........................ ............................ ISO 1563 Second edition 1990- Withdrawn.
09-01 Dental alginate
impression material.
4-63........................ ............................ ISO 1564 Second edition 1995- Withdrawn.
11-01 Dental aqueous
impression materials based
on agar.
4-86........................ ............................ ANSI/ADA Specification No. Extent of recognition.
38 2000 (Reaffirmed 2010),
Metal-Ceramic Dental
Restorative Systems.
4-89........................ ............................ ANSI/ADA Specification No. Extent of recognition.
53: 1999 (Reaffirmed 2008)
Polymer-Based Crowns and
Bridge Materials.
4-91........................ ............................ ANSI/ADA Specification No. Reaffirmation and
80/ISO 7491:2000 extent of
(Reaffirmed 2013) Dental recognition.
Materials--Determination of
Color Stability.
4-92........................ ............................ ANSI/ADA Specification No. Reaffirmation and
88:2000 (Reaffirmed 2010) extent of
Dental Brazing Alloys. recognition.
4-96........................ ............................ ANSI/ADA Specification No. Reaffirmation and
30:2000 (Reaffirmed 2012) extent of
Dental Zinc Oxide-Eugenol recognition.
and Zinc Oxide Non-Eugenol
Cements.
4-97........................ ............................ ANSI/ADA Specification No. Extent of recognition.
57: (Reaffirmed 2012)
Endodontic Sealing
Materials.
4-105....................... ............................ ANSI/ADA Specification No. Extent of recognition.
75:1997 (Reapproved 2003)
Resilient Lining Materials
for Removable Dentures--
Part 1: Short-Term
Materials.
4-109....................... ............................ ISO 13716 First edition 1999- Withdrawn.
05-01 Dentistry--reversible-
irreversible hydrocolloid
impression material system.
4-126....................... ............................ ISO 10477 Second edition Extent of recognition.
2004-10-01 Dentistry--
Polymer-based crown and
bridge materials.
4-130....................... ............................ ADA Specification No. Extent of recognition.
17:1983 (Reaffirmed 2006)
Denture Base Temporary
Relining Resins.
4-134....................... 4-207....................... ISO 7494-1 Second edition Withdrawn and replaced
2011-08-15 Dentistry-- with newer version.
Dental units--Part 1:
General requirements and
test methods.
4-135....................... 4-213....................... ISO 10139-1 Second edition Withdrawn and replaced
2005-02-15 Dentistry--Soft with newer version
lining materials for including technical
removable dentures--Part 1: corrigendum.
Materials for short-term
use [Including: TECHNICAL
CORRIGENDUM 1 (2006)].
4-137....................... ............................ ISO 6877 Second edition 2006- Extent of recognition.
04-01 Dentistry--Root-canal
obturating points.
4-139....................... ............................ ANSI/ADA Specification No. Reaffirmation and
48 (Reaffirmed 2009) extent of
Visible Light Curing Units. recognition.
4-143....................... 4-208....................... ANSI/ADA Specification No. Withdrawn and replaced
96:2012 Dental-Water-Based with newer version.
Cements.
4-144....................... 4-209....................... ISO 24234 First edition 2004- Withdrawn and replaced
10-15 Dentistry--Mercury with newer version
and alloys for dental including amendment.
amalgam [Including:
AMENDMENT 1 (2011)].
4-146....................... ............................ ISO 22674 First edition 2006- Extent of recognition.
11-15 Dentistry--Metallic
materials for fixed and
removable restorations and
appliances.
4-149....................... ............................ ANSI/ADA Specification No. Reaffirmation and
39/ISO 6874:2005 extent of
(Reaffirmed 2011) Pit and recognition.
Fissure Sealants.
4-150....................... ............................ ANSI/ADA Specification No. Extent of recognition.
19:2004/ISO 4823:2000
Dental--Elastometric
Impression Materials.
4-151....................... ............................ ISO 22112 First edition 2005- Extent of recognition.
11-01 Dentistry--Artificial
teeth for dental prostheses.
4-153....................... ............................ ISO 9917-1 Second edition Extent of recognition.
2007-10-01 Dentistry--Water-
based cements--Part 1:
Powder/liquid acid-base
cements.
4-154....................... 4-210....................... ISO 4823 Third edition 2000- Withdrawn and replaced
12-15 Dentistry-- with newer version
Elastometric impression including amendment
materials [Including: and technical
AMENDMENT 1 (2000) corrigendum.
TECHNICAL CORRIGENDUM
1(2004)].
4-155....................... ............................ ISO 4823: Technical Withdrawn. See 4-210.
Corrigendum 1 Published
2004-07-15--Dentistry--Elas
tometric impression
materials--Third Edition.

[[Page 4918]]

4-156....................... ............................ ISO 4823 Third edition 2000- Withdrawn. See 4-210.
12-15 Amendment 1 2007-07-
01 Dentistry--Elastometric
impression materials--Third
Edition.
4-157....................... ............................ ISO 3107 Third edition 2004- Withdrawn. See 4-198.
10-01 Dentistry--Zinc oxide/
Eugenol and zinc oxide/non-
eugenol cements--Third
edition.
4-159....................... 4-211....................... ANSI/IEEE C63.19:2007 Withdrawn and replaced
American National Standard with newer version.
Methods of Measurement of
Compatibility between
Wireless Communications
Devices and Hearing Aids.
4-170....................... 4-212....................... ANSI/ASA S3.36-2012 American Withdrawn and replaced
National Standard with newer version.
Specification for a Manikin
for Simulated in situ
Airborne Acoustic
Measurements.
4-178....................... ............................ ISO 6872 Third edition 2008- Extent of recognition.
09-01 Dentistry--Ceramic
materials.
4-179....................... ............................ ISO 7405 Second edition 2008- Extent of recognition.
12-15 Dentistry--Evaluation
of biocompatibility of
medical devices used in
dentistry.
4-180....................... ............................ ISO 9168 Third edition 2009- Extent of recognition.
07-15 Dentistry--Hose
connectors for air driven
dental handpieces.
4-181....................... ............................ ISO 4049 Fourth edition 2009- Extent of recognition.
10-01 Dentistry--Polymer-
based restorative materials.
4-182....................... ............................ ISO 10139-2 Second edition Extent of recognition.
2009-08-01 Dentistry--Soft
lining materials for
removable dentures--Part 2:
Materials for long-term use.
4-188....................... ............................ ISO 9917-2 Second edition Extent of recognition.
2010-04-15 Dentistry--Water-
based cements--Part 2:
Resin-modified cements.
4-189....................... ............................ ISO 10139-1:2005 TECHNICAL Withdrawn. See 4-213.
CORRIGENDUM 1 2006-03-01
Dentistry--Soft lining
materials for removable
dentures--Part 1: Materials
for short-term use.
4-195....................... ............................ ISO 14801 Second edition Extent of recognition.
2007-11-15 Dentistry--
Implants-Dynamic fatigue
test for endosseous dental
implants.
4-196....................... ............................ ANSI/ADA Specification Extent of recognition.
No.69:2010/ISO 6872:2008
Dental Ceramic.
4-198....................... ............................ ISO 3107 Fourth edition 2011- Extent of recognition.
03-01 Dentistry--Zinc oxide/
eugenol and zinc oxide/non-
eugenol cements.
4-199....................... ............................ ISO 6876 Third edition 2012- Extent of recognition.
06-01 Dentistry--Root Canal
Sealing Materials.
4-200....................... ............................ ISO 24234 First edition 2004- Withdrawn. See 4-209.
10-15 Dentistry--Mercury
and alloys for dental
amalgam AMENDMENT 1.
4-201....................... ............................ ISO 9693-2012 Dentistry-- Extent of recognition.
Compatibility testing--
Metal-ceramic systems.
4-205....................... ............................ ISO 14457 First edition 2012- Withdrawn. See 4-206.
09-15 Dentistry--Handpieces
and motors.
----------------------------------------------------------------------------------------------------------------
E. General
----------------------------------------------------------------------------------------------------------------
5-22........................ ............................ ISO 2768-1 First edition Extent of recognition.
1989-11-15 General
tolerances--Part 1:
Tolerances for linear and
angular dimensions without
individual tolerance
indications.
5-23........................ ............................ ISO 2768-2 First edition Extent of recognition.
1989-11-15 General
Tolerances--Part 2:
Geometrical tolerances for
features without individual
tolerance indications.
5-36........................ ............................ ISO/TR 16142 Second edition Extent of recognition.
2006-01-15 Medical devices--
Guidance on the selection
of standards in support of
recognized essential
principles of safety and
performance of medical
devices.
5-37........................ 5-81........................ ISO 2859-1 Second edition Withdrawn and replaced
1999-11-15 Sampling with newer version
procedures for inspection including technical
by attributes--Part 1: corrigendum.
Sampling schemes indexed by
acceptance quality limit
(AQL) for lot-by-lot
inspection [Including:
TECHNICAL CORRIGENDUM 1
(2001)].
5-43........................ ............................ ANSI/ESD S20.20-2007 For the Extent of recognition.
Development of an
Electrostatic Discharge
Control Program for
Protection of Electrical
and Electronic Parts,
Assemblies and Equipment
(Excluding Electrically
Initiated Explosive
Devices).
5-45........................ 5-79........................ ASTM D7386-12 Standard Withdrawn and replaced
Practice for Performance with new version.
Testing of Packages for
Single Parcel Delivery
Systems.
5-46........................ ............................ ISO 2859-1:1999/Cor 1:2001 Withdrawn. See 5-81.
Sampling procedures for
inspection by attributes--
Part 1: Sampling schemes
indexed by acceptance
quality limit (AQL) for lot-
by-lot inspection.
5-47........................ ............................ ISO 10012 First edition 2003- Extent of recognition.
01-15 Measurement
management systems--
Requirements for
measurement processes and
measuring equipment.
5-50........................ ............................ IEC 62366 Edition 1.0 2007- Extent of recognition.
10 Medical devices--
Application of usability
engineering to medical
devices.

[[Page 4919]]

5-51........................ 5-80........................ ASTM D-4332-13 Standard Withdrawn and replaced
Practice for Conditioning with new version.
Containers, Packages, or
Packaging Components for
Testing.
5-53........................ ............................ IEC 60601-1-2 Edition 3.0 Relevant guidance.
2007-03 Medical electrical
equipment--Part 1-2:
General requirements for
basic safety and essential
performance--Collateral
standard: Electromagnetic
compatibility--Requirements
and tests.
5-54........................ ............................ ANSI/AAMI/IEC 60601-1-2:2007/ Reaffirmation and
(R)2012 Medical electrical relevant guidance.
equipment--Part 1-2:
General requirements for
basic safety and essential
performance--Collateral
standard: Electromagnetic
compatibility--Requirements
and tests.
5-57........................ ............................ ANSI/AAMI HE75:2009 Human Extent of recognition.
factors engineering--Design
of medical devices.
5-58........................ 5-82........................ IEC 60601-1-11 Edition Withdrawn and replaced
1.0:2010 Medical electrical with newer version
equipment--Part 1-11: including technical
General requirements for corrigendum.
basic safety and essential
performance--Collateral
Standard: Requirements for
medical electrical
equipment and medical
electrical systems used in
the home healthcare
environment [Including:
TECHNICAL CORRIGENDUM 1
(2011)].
5-62........................ ............................ ANSI/ASQ Z1.4-2008 Sampling Extent of recognition.
Procedures and Tables for
Inspection by Attributes.
5-66........................ ............................ IEC 60601-1-10 Edition 1.0: Extent of recognition.
2007-11 Medical electrical
equipment--Part 1-10:
General requirements for
basic safety and essential
performance--Collateral
Standard: Requirements for
the development of
physiologic closed-loop
controllers.
5-67........................ ............................ ANSI/AAMI/IEC 62366:2007/ Reaffirmation and
(R)2013 Medical devices-- extent of
Application of usability recognition.
engineering to medical
devices.
5-69........................ ............................ IEC 60601-1-11 (First Withdrawn. See 5-82.
edition 2010) April 2011
Medical electrical
equipment--Part 1-11:
General requirements for
basic safety and essential
performance--Collateral
Standard: Requirements for
medical electrical
equipment and medical
electrical systems used in
the home healthcare
environment CORRIGENDUM 1.
----------------------------------------------------------------------------------------------------------------
F. General Hospital/General Plastic Surgery
----------------------------------------------------------------------------------------------------------------
6-13........................ ............................ ISO 595-1 First edition 1986- Withdrawn.
12-15 Reusable all-glass or
metal-and-glass syringes
for medical use--Part 1:
Dimensions.
6-14........................ ............................ ISO 595-2 First edition 1987- Withdrawn.
12-15 Reusable all-glass or
metal-and-glass syringes
for medical use--Part 2:
Design, performance
requirements and tests.
6-117....................... ............................ ASTM F2172-02 (Reapproved Extent of recognition.
2011) Standard
Specification for Blood/
Intravenous Fluid/
Irrigation Fluid Warmers.
6-142....................... ............................ ANSI/AAMI II36:2004 Medical Withdrawn. See 6-230.
electrical equipment--Part
2: Particular requirements
for safety of baby
incubators.
6-143....................... ............................ ANSI/AAMI II51:2004 Medical Withdrawn. See 6-231.
electrical equipment--Part
2: Particular requirements
for safety of transport
incubators.
6-150....................... ............................ ASTM D7161-05 (Reapproved Withdrawn.
2010) Standard Practice for
Determination of Real Time
Expiration Dating of Mature
Medical Gloves Stored Under
Typical Warehouse
Conditions.
6-161....................... 6-301....................... ISO 10555-1 Second edition Withdrawn and replaced
2013-06-15 Corrected with newer version.
version 2013-07-01
Intravascular catheters--
Sterile and single-use
catheters--Part 1: General
requirements.
6-163....................... ............................ ISO 9626 First edition 1991- Withdrawn. See 6-302.
09-01 AMENDMENT 1 2001-06-
01 Stainless steel needle
tubing for the manufacture
of medical devices.
6-164....................... 6-303....................... ISO 10555-5 Second edition Withdrawn and replaced
2013-06-15 Intravascular with newer version.
catheters--Sterile and
single-use catheters--Part
5: Over-needle peripheral
catheters.
6-170....................... 6-304....................... ISO 7886-1 First edition Withdrawn and replaced
1993-10-01 Sterile with newer version
hypodermic syringes for including technical
single use--Part 1: corrigendum.
Syringes for manual use
[Including: TECHNICAL
CORRIGENDUM 1 Published
1995-11-01].
6-171....................... 6-305....................... ISO 10555-3 Second edition Withdrawn and replaced
2013-06-15 Intravascular with newer version.
catheters--Sterile and
single-use catheters--Part
3: Central venous catheters.
6-176....................... ............................ ASTM D7103-06 (Reapproved Extent of recognition.
2013) Standard Guide for
Assessment of Medical
Gloves.
6-187....................... 6-306....................... ASTM F1671/F1671M-13 Withdrawn and replaced
Standard Test Method for with newer version.
Resistance of Materials
Used in Protective Clothing
to Penetration by Blood-
Borne Pathogens Using Phi-
X174 Bacteriophage
Penetration as a Test
System.

[[Page 4920]]

6-233....................... ............................ IEC 60601-2-52 Edition 1.0 Withdrawn. See 6-321.
2009-12 Medical electrical
equipment--Part 2-52:
Particular requirements for
basic safety and essential
performance of medical beds.
6-236....................... 6-307....................... IEC 80601-2-59 Edition 1.0 Withdrawn and replaced
2008-10 Medical Electrical with newer version
Equipment--Part 2-59: including technical
Particular requirements for corrigendum.
the basic safety and
essential performance of
screening thermographs for
human febrile temperature
screening [Including:
CORRIGENDUM 1 (April 2009)].
6-237....................... ............................ IEC 80601-2-59 (First Withdrawn. See 6-307.
edition 2008) Medical
Electrical Equipment--Part
2-59: Particular
requirements for the basic
safety and essential
performance of screening
thermographs for human
febrile temperature
screening CORRIGENDUM 1.
6-238....................... 6-308....................... IEC 80601-2-35 Edition 2.0 Withdrawn and replaced
2009-10 Medical electrical with newer version
equipment--Part 2-35: including technical
Particular requirements for corrigendum.
the basic safety and
essential performance of
heating devices using
blankets, pads or
mattresses and intended for
heating in medical use
[Including: CORRIGENDUM 1
(March 2012)].
6-245....................... ............................ ISO 8536-4 Fifth edition Withdrawn. See 6-318.
2010-10-01 Infusion
equipment for medical use--
Part 4: Infusion sets for
single use, gravity feed.
6-253....................... ............................ ISO 10535 Second edition Extent of recognition.
2006-12-15 Hoists for the
transfer of disabled
persons--Requirements and
test methods.
6-264....................... ............................ ISO 10555-1 First edition Withdrawn. See 6-301.
1995-06-15 AMENDMENT 1 1999-
07-15 Sterile, single-use
intravascular catheters--
Part 1: General
requirements.
6-265....................... ............................ ISO 10555-1 First edition Withdrawn. See 6-301.
1995-06-5 AMENDMENT 2 2004-
05-15 Sterile, single-use
intravascular catheters--
Part 1: General
requirements.
6-266....................... ............................ ISO 10555-5 First edition Withdrawn. See 6-303.
1996-06-15 AMENDMENT 1
Sterile, single-use
intravascular catheters--
Part 5: Over-needle
peripheral catheters.
6-267....................... ............................ ISO 10555-5 1996 TECHNICAL Withdrawn. See 6-303.
CORRIGENDUM 1 Published
2002-06-15 Sterile, single-
use intravascular
catheters--Part 5: Over-
needle peripheral catheters.
6-273....................... ............................ ISO 23908 First edition 2011- Extent of recognition.
06-11 Sharps injury
protection--Requirements
and test methods--Sharps
protection features for
single-use hypodermic
needles, introducers for
catheters and needles used
for blood sampling.
6-279....................... ............................ IEC 60601-2-19 (Second Withdrawn. See 6-319.
Edition 2009) Medical
electrical equipment--Part
2-19: Particular
requirements for the basic
safety and essential
performance of infant
incubators CORRIGENDUM 1.
6-280....................... ............................ IEC 60601-2-20 (Second Withdrawn. See 6-320.
edition 2009) Medical
electrical equipment--Part
2-20: Particular
requirements for the basic
safety and essential
performance of infant
transport incubators
CORRIGENDUM 1.
6-281....................... ............................ IEC 80601-2-35 (Second Withdrawn. See 6-308.
edition 2009) Medical
electrical equipment--Part
2-35: Particular
requirements for the basic
safety and essential
performance of heating
devices using blankets,
pads or mattresses and
intended for heating in
medical use CORRIGENDUM 1.
6-283....................... 6-309....................... USP 36-NF31:2013 Sodium Withdrawn and replaced
Chloride Irrigation. with newer version.
6-284....................... 6-310....................... USP 36-NF31:2013 Sodium Withdrawn and replaced
Chloride Injection. with newer version.
6-285....................... 6-311....................... USP 36-NF31:2013 Withdrawn and replaced
Nonabsorbable Surgical with newer version.
Suture.
6-286....................... 3-312....................... USP 36-NF31:2013 <881> Withdrawn and replaced
Tensile Strength. with newer version.
6-287....................... 6-313....................... USP 36-NF31:2013 <861> Withdrawn and replaced
Sutures--Diameter. with newer version.
6-288....................... 6-314....................... USP 36-NF 31:2013 <871> Withdrawn and replaced
Sutures--Needle Attachment. with newer version.
6-289....................... 6-315....................... USP 36-NF31:2013 Sterile Withdrawn and replaced
Water for Irrigation. with newer version.
6-290....................... 6-316....................... USP 36-NF31:2013 Heparin Withdrawn and replaced
Lock Flush Solution. with newer version.
6-291....................... 6-317....................... USP 36-NF31:2013 Absorbable Withdrawn and replaced
Surgical Suture. with newer version.
6-292....................... ............................ ISO 7886-1:1993 TECHNICAL Withdrawn. See 6-304.
CORRIGENDUM 1 Published
1995-11-01 Sterile
hypodermic syringes for
single-use--Part 1:
Syringes for manual use.

[[Page 4921]]

6-298....................... 6-319....................... IEC 60601-2-19 Edition 2.0 Withdrawn and replaced
2009-02 Medical electrical with newer version
equipment--Part 2-19: including technical
Particular requirements for corrigendum.
the basic safety and
essential performance of
infant incubators
[Including: CORRIGENDUM 1
(2012)].
6-299....................... ............................ IEC 60601-2-20 Edition 2.0 Withdrawn. See 6-320.
2009-02 Medical electrical
equipment--Part 2-20:
Particular requirements for
the basic safety and
essential performance of
infant transport incubators.
----------------------------------------------------------------------------------------------------------------
G. In Vitro Diagnostics
----------------------------------------------------------------------------------------------------------------
7-100....................... ............................ ISO 15197 First edition 2003- Withdrawn.
05-01 In Vitro diagnostic
test systems--Requirements
for blood-glucose
monitoring systems for self-
testing in managing
diabetes mellitus.
7-137....................... 7-244....................... CLSI NBS01-A6 Blood Withdrawn and replaced
Collection on Filter Paper with newer version.
for Newborn Screening
Programs; Approved
Standard--Sixth Edition.
7-239....................... ............................ CLSI EP32-R (Formerly X05-R) Designation number.
Metrological Traceability
and Its Implementation; A
Report.
7-226....................... ............................ CLSI QMS01-A4 (Formerly GP26- Designation number.
A4) Quality Management
System: A Model for
Laboratory Services;
Approved Guideline--Fourth
Edition.
7-224....................... ............................ CLSI EP28-A3c (Formerly C28- Designation number.
A3c) Defining,
Establishing, and Verifying
Reference Intervals in the
Clinical Laboratory;
Approved Guideline--Third
Edition.
7-223....................... ............................ CLSI QSM06-A3 (Formerly GP22- Designation number.
A3) Quality Management
System: Continual
Improvement; Approved
Guideline--Third Edition.
7-92........................ 7-245....................... CLSI EP09-A3 Measurement Withdrawn and replaced
Procedure Comparison and with newer version.
Bias Estimation Using
Patient Samples; Approved
Guideline--Third Edition.
7-210....................... ............................ CLSI H26-A2 Validation, Extent of recognition.
Verification, and Quality
Assurance of Automated
Hematology Analyzers;
Approved Standard--Second
Edition.
7-152....................... ............................ CLSI EP12-A2 User Protocol Extent of recognition.
for Evaluation of
Qualitative Test
Performance; Approved
Guideline--Second Edition.
7-174....................... ............................ CLSI EP21-A Estimation of Extent of recognition.
Total Analytical Error for
Clinical Laboratory
Methods; Approved Guideline.
7-178....................... ............................ CLSI M22-A3 Quality Control Extent of recognition.
for Commercially Prepared
Microbiological Culture
Media; Approved Standard--
Third Edition.
7-193....................... ............................ CLSI EP06-A Evaluation of Extent of recognition.
the Linearity of
Quantitative Measurement
Procedures: A Statistical
Approach; Approved
Guideline.
7-220....................... ............................ CLSI H59-A Quantitative D- Extent of recognition.
dimer for the Exclusion of
Venous Thromboembolic
Disease; Approved Guideline.
----------------------------------------------------------------------------------------------------------------
H. Materials
----------------------------------------------------------------------------------------------------------------
8-67........................ 8-344....................... ISO 7153-1 Second edition Withdrawn and replaced
1991-04-01 Surgical with newer version
instruments--Metallic including amendment.
materials--Part 1:
Stainless steel [Including:
AMENDMENT 1(1999)].
8-138....................... ............................ ASTM F745-07 Standard Withdrawn.
Specification for 18
Chromium-12.5 Nickel-2.5
Molybdenum Stainless Steel
for Cast and Solution-
Annealed Surgical Implant
Applications.
8-139....................... 8-345....................... ASTM F1314-13 Standard Withdrawn and replaced
Specification for Wrought with newer version.
Nitrogen Strengthened 22
Chromium-13 Nickel-5
Manganese-2.5 Molybdenum
Stainless Steel Alloy Bar
and Wire for Surgical
Implants (UNS S20910).
8-140....................... 8-346....................... ASTM F1813-13 Standard Withdrawn and replaced
Specification for Wrought with newer version.
Titanium-12 Molybdenum-6
Zirconium-2 Iron Alloy for
Surgical Implant (UNS
R58120).
8-141....................... 8-347....................... ASTM F2146-13 Standard Withdrawn and replaced
Specification for Wrought with newer version.
Titanium-3 Aluminum-2.5
Vanadium Alloy Seamless
Tubing for Surgical Implant
Applications (UNS R56320).
8-169....................... 8-348....................... ASTM F138-13 Standard Withdrawn and replaced
Specification for Wrought with newer version.
18 Chromium-14 Nickel-2.5
Molybendum Stainless Steel
Bar and Wire for Surgical
Implants (UNS S31673).
8-176....................... 8-349....................... ASTM F2503-13 Standard Withdrawn and replaced
Practice for Marking with newer version.
Medical Devices and Other
Items for Safety in the
Magnetic Resonance
Environment.
8-149....................... 8-350....................... ISO 5832-1 Fourth edition Withdrawn and replaced
2007-06-15 Implants for with newer version
surgery--Metallic including technical
materials--Part 1: Wrought corrigendum.
stainless steel [Including:
TECHNICAL CORRIGENDUM
1(2008)].

[[Page 4922]]

8-196....................... ............................ ISO 5832-1: 2007 Implants Withdrawn. See 8-350.
for surgery--Metallic
materials--Part 1: Wrought
stainless steel TECHNICAL
CORRIGENDUM 1.
8-151....................... 8-351....................... ISO 5832-12 Second edition Withdrawn and replaced
2007-05-01 Implants for with newer version
surgery--Metallic including technical
materials--Part 12: Wrought corrigendum.
cobalt-chromium-molybdenum
alloy [Including: TECHNICAL
CORRIGENDUM 1 2008].
8-197....................... ............................ ISO 5832-12:2007 TECHNICAL Withdrawn. See 8-351.
CORRIGENDUM 1 2008-09-05,
Implants for surgery--
Metallic materials--Part
12: Wrought cobalt-chromium-
molybdenum alloy TECHNICAL
CORRIGENDUM 1.
8-211....................... 8-352....................... ISO 5834-1 Third edition Withdrawn and replaced
2005-06-01 Implants for with newer version
surgery--Ultra-high- including technical
molecular-weight corrigendum.
polyethylene--Part 1:
Powder form [Including:
TECHNICAL CORRIGENDUM 1
2007].
8-212....................... ............................ ISO 5834-1:2005 Technical Withdrawn. See 8-352.
Corrigendum 1 Published
2007-05-01 Implants for
surgery--Ultra-high-
molecular-weight
polyethylene--Part 1:
Powder form TECHNICAL
CORRIGENDUM 1.
8-228....................... 8-353....................... ASTM F86-13 Standard Withdrawn and replaced
Practice for Surface with newer version.
Preparation and Marking of
Metallic Surgical Implants.
8-175....................... 8-354....................... ASTM F1377-13 Standard Withdrawn and replaced
Specification for Cobalt-28 with newer version.
Chromium-6 Molybdenum
Powder for Coating of
Orthopedic Implants (UNS
R30075).
8-163....................... 8-355....................... ASTM F1586/F 1586M-13[egr]1 Withdrawn and replaced
Standard Specification for with newer version.
Wrought Nitrogen
Strengthened 21 Chromium-10
Nickel-3 Manganese-2.5
Molybdenum Stainless Steel
Alloy Bar for Surgical
Implants (UNS S31675).
8-129....................... 8-356....................... ASTM F67-13 Standard Withdrawn and replaced
Specification for Unalloyed with newer version.
Titanium, for Surgical
Implant Applications (UNS
R50250, UNS R50400, UNS
R50550, UNS R50700).
8-208....................... 8-357....................... ASTM F648-13 Standard Withdrawn and replaced
Specification for Ultra- with newer version.
High-Molecular-Weight
Polyethylene Powder and
Fabricated Form for
Surgical Implants.
8-103....................... ............................ ASTM F1801-97 (Reapproved Extent of recognition.
2009) [egr]1 Standard
Practice for Corrosion
Fatigue Testing of Metallic
Implant Materials.
8-107....................... ............................ ASTM F746-04 (Reapproved Extent of recognition.
2009) [egr]1 Standard Test
Method for Pitting or
Crevice Corrosion of
Metallic Surgical Implant
Materials.
8-111....................... ............................ ASTM F1160-05 (Reapproved Extent of recognition.
2011) [egr]1 Standard Test
Method for Shear and
Bending Fatigue Testing of
Calcium Phosphate and
Metallic Medical and
Composite Calcium Phosphate/
Metallic Coatings.
8-112....................... ............................ ASTM F1044-05 (Reapproved Extent of recognition.
2011) [egr]1 Standard Test
Method for Shear Testing of
Calcium Phosphate Coatings
and Metallic Coatings.
8-113....................... ............................ ASTM F1147-05 (Reapproved Extent of recognition.
2011) Standard Test Method
for Tension Testing of
Calcium Phosphate and Metal
Coatings.
8-114....................... ............................ ASTM F2255 (Reapproved 2010) Extent of recognition.
Standard Test Method for
Strength Properties of
Tissue Adhesives in Lap
Shear by Tension Loading.
8-115....................... ............................ ASTM F2256-05 (Reapproved Extent of recognition.
2010) Standard Test Method
for Strength Properties of
Tissue Adhesives in T-Peel
by Tension Loading.
8-116....................... ............................ ASTM F2258-05 (Reapproved Extent of recognition.
2010) Standard Test Method
for Strength Properties of
Tissue Adhesives in Tension.
8-121....................... ............................ ASTM F2005-05 (Reapproved Extent of recognition.
2010) Standard Terminology
for Nickel-Titanium Shape
Memory Alloys.
8-123....................... ............................ ISO 5832-5 Third edition Extent of recognition.
2005-10-15 Implants for
surgery--Metallic
materials--Part 5: Wrought
cobalt-chromium-tungsten-
nickel alloy.
8-124....................... ............................ ASTM F2052-06 [egr] Standard Extent of recognition.
Test Method for Measurement
of Magnetically Induced
Displacement Force on
Medical Devices in the
Magnetic Resonance
Environment.
8-125....................... ............................ ASTM F2004-05 (Reapproved Extent of recognition.
2010) Standard Test Method
for Transformation
Temperature of Nickel-
Titanium Alloys by Thermal
Analysis.
8-126....................... 8-370....................... ASTM F561-13 Standard Withdrawn and replaced
Practice for Retrieval and with newer version.
Analysis of Medical
Devices, and Associated
Tissues and Fluids.
8-128....................... ............................ ASTM F2213-06 (Reapproved Extent of recognition.
2011) Standard Test Method
for Measurement of
Magnetically Induced Torque
on Medical Devices in the
Magnetic Resonance
Environment.
8-132....................... ............................ ASTM F1088-04a (Reapproved Extent of recognition.
2010) Standard
Specification for Beta-
Tricalcium Phosphate for
Surgical Implantation.

[[Page 4923]]

8-134....................... ............................ ASTM F2082-06 Standard Test Extent of recognition.
Method for Determination of
Transformation Temperature
of Nickel-Titanium Shape
Memory Alloys by Bend and
Free Recovery.
8-135....................... ............................ ASTM F2392-04 (Reapproved Extent of recognition.
2010) Standard Test Method
for Burst Strength of
Surgical Sealants.
8-136....................... ............................ ASTM F2458-05 (Reapproved Extent of recognition.
2010) Standard Test Method
for Wound Closure Strength
of Tissue Adhesives and
Sealants.
8-150....................... ............................ ISO 5832-9 Second edition Extent of recognition.
2007-06-15 Implants for
surgery--Metallic
materials--Part 9: Wrought
high nitrogen stainless
steel.
8-157....................... ............................ ISO 9583 First edition 1993- Extent of recognition.
10-15 Implants for surgery--
Non-destructive testing--
Liquid penetrant inspection
of metallic surgical
implants.
8-159....................... ............................ ISO 9584 First edition 1993- Extent of recognition.
10-15 Implants for surgery--
Non-destructive testing--
Radiographic examination of
cast metallic surgical
implants.
8-165....................... ............................ ASTM F1058-08[egr]1 Standard Extent of recognition.
Specification for Wrought
40 Cobalt-20 Chromium-16
Iron-15 Nickel-7 Molybdenum
Alloy Wire and Strip for
Surgical Implant
Applications (UNS R30003
and UNS R30008).
8-167....................... ............................ ASTM F1350-08 Standard Extent of recognition.
Specification for Wrought
18 Chromium-14 Nickel-2.5
Molybdenum Stainless Steel
Surgical Fixation Wire (UNS
S31673).
8-168....................... ............................ ASTM F1472-08[egr]1 Standard Extent of recognition.
Specification for Wrought
Titanium-6 Aluminum-4
Vanadium Alloy for Surgical
Implant Applications (UNS
R56400).
8-170....................... ............................ ASTM F961-08 Standard Extent of recognition.
Specification for 35 Cobalt-
35 Nickel-20 Chromium-10
Molybdenum Alloy Forgings
for Surgical Implants (UNS
R30035).
8-171....................... ............................ ASTM F1609-08 Standard Extent of recognition.
Specification for Calcium
Phosphate Coatings for
Implantable Materials.
8-173....................... ............................ ASTM F601-03 (Reapproved Extent of recognition.
2008) Standard Practice for
Fluorescent Penetrant
Inspection of Metallic
Surgical Implants.
8-177....................... ............................ ASTM F2129-08 Standard Test Extent of recognition.
Method for Conducting
Cyclic Potentiodynamic
Polarization Measurements
to Determine the Corrosion
Susceptibility of Small
Implant Devices.
8-179....................... ............................ ASTM F754-08 Standard Extent of recognition.
Specification for
Implantable
Polytetrafluoroethylene
(PTFE) Sheet, Tube, and Rod
Shapes Fabricated from
Granular Molding Powders.
8-183....................... ............................ ASTM F560-08 Standard Extent of recognition.
Specification for Unalloyed
Tantalum for Surgical
Implant Applications (UNS
R05200, UNS R05400).
8-184....................... ............................ ASTM F2516-07[egr]2 Standard Extent of recognition.
Test Method for Tension
Testing of Nickel-Titanium
Superelastic Materials.
8-185....................... ............................ ASTM F451-08 Standard Extent of recognition.
Specification for Acrylic
Bone Cement.
8-187....................... ............................ ISO 13779-1 Second edition Extent of recognition.
2008-10-01 Implants for
surgery--Hydroxyapatite--Pa
rt 1: Ceramic
hydroxyapatite.
8-188....................... ............................ ISO 13779-2 Second edition Extent of recognition.
2008-10-01 Implants for
surgery--Hydroxyapatite--Pa
rt 2: Coatings of
hydroxyapatite.
8-189....................... ............................ ASTM F 1108-04 (Reapproved Extent of recognition.
2009) Standard
Specification for Titanium-
6 Aluminum-4 Vanadium Alloy
Castings for Surgical
Implants (UNS R56406).
8-190....................... ............................ ASTM F 90-09 Standard Extent of recognition.
Specification for Wrought
Cobalt-20 Chromium-15
Tungsten-10 Nickel Alloy
for Surgical Implant
Applications (UNS R30605).
8-192....................... ............................ ASTM F1854-09 Standard Test Extent of recognition.
Method for Stereological
Evaluation of Porous
Coatings on Medical
Implants.
8-193....................... ............................ ASTM F2754/F 2754M-09 Extent of recognition.
Standard Test Method for
Measurement of Camber,
Cast, Helix and Direction
of Helix of Coiled Wire.
8-194....................... ............................ ISO 6474-1 First edition Extent of recognition.
2010-02-15 Implants for
surgery--Ceramic materials--
Part 1: Ceramic materials
based on high purity
alumina.
8-195....................... ............................ ASTM F2024-10 Standard Extent of recognition.
Practice for X-Ray
Diffraction Determination
of Phase Content of Plasma-
Sprayed Hydroxyapatite
Coatings.
8-199....................... ............................ ASTM F2633-07 Standard Extent of recognition.
Specification for Wrought
Seamless Nickel-Titanium
Shape Memory Alloy Tube for
Medical Devices and
Surgical Implants.
8-204....................... ............................ ASTM F2118-10 Standard Test Extent of recognition.
Method for Constant
Amplitude of Force
Controlled Fatigue Testing
of Acrylic Bone Cement
Materials.
8-205....................... ............................ ASTM F1635-11 Standard Test Extent of recognition.
Method for In Vitro
Degradation Testing of
Hydrolytically Degradable
Polymer Resins and
Fabricated Forms for
Surgical Implants.

[[Page 4924]]

8-206....................... ............................ ASTM F688-10 Standard Extent of recognition.
Specification for Wrought
Cobalt-35 Nickel-20
Chromium-10 Molybdenum
Alloy Plate, Sheet, and
Foil for Surgical Implants
(UNS R30035).
8-207....................... ............................ ASTM F1926/F1926M-10 Extent of recognition.
Standard Test Method for
Evaluation of the
Environmental Stability of
Calcium Phosphate Granules,
Fabricated Forms, and
Coatings.
8-213....................... ............................ ISO 5834-3 First edition Extent of recognition.
2005-07-15 Implants for
surgery--Ultra-high-
molecular-weight
polyethylene--Part 3:
Accelerated ageing methods.
8-214....................... ............................ ISO 5834-4 First edition Extent of recognition.
2005-05-01 Implants for
surgery--Ultra-high-
molecular-weight
polyethylene--Part 4:
Oxidation index measurement
method.
8-215....................... ............................ ISO 5834-5 First edition Extent of recognition.
2005-06-01 Implants for
surgery--Ultra-high-
molecular-weight
polyethylene--Part 5:
Morphology assessment
method.
8-216....................... ............................ ASTM F1295-11 Standard Extent of recognition.
Specification for Wrought
Titanium-6 Aluminum-7
Niobium Alloy for Surgical
Implant Applications (UNS
R56700).
8-217....................... ............................ ASTM F620-11 Standard Extent of recognition.
Specification for Alpha
Plus Beta Titanium Alloy
Forgings for Surgical
Implants.
8-218....................... ............................ ASTM F799-11 Standard Extent of recognition.
Specification for Cobalt-28
Chromium-6 Molybdenum Alloy
Forgings for Surgical
Implants (UNS R31537,
R31538, R31539).
8-220....................... ............................ ASTM F629-11 Standard Extent of recognition.
Practice for Radiography of
Cast Metallic Surgical
Implants.
8-221....................... ............................ ASTM F2066-11 Standard Extent of recognition.
Specification for Wrought
Titanium-15 Molybdenum
Alloy for Surgical Implant
Applications (UNS R58150).
8-224....................... ............................ ASTM F2102-06[egr]1 Standard Extent of recognition.
Guide for Evaluating the
Extent of Oxidation in
Ultra-High-Molecular-Weight
Polyethylene Fabricated
Forms Intended for Surgical
Implants.
8-225....................... ............................ ASTM F2003-02 (Reapproved Extent of recognition.
2008) Standard Practice for
Accelerated Aging of Ultra-
High Molecular Weight
Polyethylene after Gamma
Irradiation in Air.
8-226....................... ............................ ASTM F603-12 Standard Extent of recognition.
Specification for High-
Purity Dense Aluminum Oxide
for Medical Application.
8-229....................... ............................ ASTM F75-12 Standard Extent of recognition.
Specification for Cobalt-28
Chromium-6 Molybdenum Alloy
Castings and Casting Alloy
for Surgical Implants (UNS
R30075).
8-330....................... ............................ ASTM F1978-12 Standard Test Extent of recognition.
Method for Measuring
Abrasion Resistance of
Metallic Thermal Spray
Coatings by Using the Taber
Abraser.
8-331....................... ............................ ASTM F1580-12 Standard Extent of recognition.
Specification for Titanium
and Titanium-6 Aluminum-4
Vanadium Alloy Powders for
Coatings of Surgical
Implants.
8-333....................... ............................ ASTM F2393-12 Standard Extent of recognition.
Specification for High-
Purity Dense Magnesia
Partially Stabilized
Zirconia (Mg-PSZ) for
Surgical Implant
Applications.
8-334....................... ............................ ASTM F2459-12 Standard Test Extent of recognition.
Method for Extracting
Residue from Metallic
Medical Components and
Quantifying via Gravimetric
Analysis.
----------------------------------------------------------------------------------------------------------------
I. Nanotechnology
----------------------------------------------------------------------------------------------------------------
18-1........................ ............................ ASTM E2490-09 Standard Guide Extent of recognition.
for Measurement of Particle
Size Distribution of
Nanomaterials in Suspension
by Photon Correlation
Spectroscopy (PCS).
18-2........................ ............................ ASTM E2535-07 (Reapproved Reaffirmation and
2013) Standard Guide for extent of
Handling Unbound Engineered recognition.
Nanoscale Particles in
Occupational Settings.
----------------------------------------------------------------------------------------------------------------
J. Neurology
----------------------------------------------------------------------------------------------------------------
17-3........................ 17-12....................... ISO 7197 Third edition 2006- Withdrawn and replaced
06-01 Neurosurgical with newer version
Implants--Sterile, single- including technical
use hydrocephalus shunts corrigendum.
and components [Including
TECHNICAL CORRIGENDUM 1
(2007)].
17-7........................ ............................ ISO 7197: 2006 Neurosurgical Withdrawn. See 17-12.
implants--Sterile, single-
use hydrocephalus shunts
and components TECHNICAL
CORRIGENDUM 1.
17-1........................ ............................ ANSI/AAMI NS28:1988/(R) 2010 Extent of recognition.
Intracranial pressure
monitoring devices.

[[Page 4925]]

17-4........................ ............................ ASTM F647-94 (Reapproved Extent of recognition.
2006) Standard Practice for
Evaluating and Specifying
Implantable Shunt
Assemblies for
Neurosurgical Application.
17-9........................ ............................ ASTM F2129-08 Standard Test Extent of recognition.
Method for Conducting
Cyclic Potentiodynamic
Polarization Measurements
to Determine the Corrosion
Susceptibility of Small
Implant Devices.
----------------------------------------------------------------------------------------------------------------
K. OB-GYN/Gastroenterology/Urology
----------------------------------------------------------------------------------------------------------------
9-34........................ 9-82........................ ISO 4074 First edition 2002- Withdrawn and replaced
02-15 Corrected version with newer version
2002-12-01 Natural latex including technical
rubber condoms-- corrigendum.
Requirements and test
methods [Including
TECHNICAL CORRIGENDUM 1
(2002), TECHNICAL
CORRIGENDUM 2 (2002)].
9-57........................ ............................ ISO 4074:2002 TECHNICAL Withdrawn. See 9-82.
CORRIGENDUM 2, Natural
latex rubber condoms--
Requirements and test
methods TECHNICAL
CORRIGENDUM 2.
9-75........................ 9-84........................ ISO 8600-3 First edition Withdrawn and replaced
1997-07-01 Optics and with newer version
Optical instruments-- including amendment.
Medical endoscopes and
endoscopic accessories--
Part 3: Determination of
field of view and direction
of view of endoscopes with
optics [Including AMENDMENT
1 (2003)].
9-36........................ 9-90........................ ISO 8009 First edition 2004- Withdrawn and replaced
10-01 Mechanical with newer version
contraceptives--Reusable including amendment.
natural and silicone rubber
contraceptive diaphragms--
Requirements and tests
[Including AMENDMENT
1(2012)].
9-37........................ 9-83........................ ISO 8600-1 Third edition Withdrawn and replaced
2013-03-01 Endoscopes-- with newer version.
Medical endoscopes and
endotherapy devices--Part
1: General requirements.
9-38........................ ............................ ISO 8600-3 First edition Withdrawn. See 9-84.
1997-07-01 AMENDMENT 1,
Optics and optical
instruments--Medical
endoscopes and endoscopic
accessories Part 3:
Determination of field of
view and direction of view
of endoscopes with optics.
9-44........................ ............................ ASTM F623-99 (Reapproved Extent of recognition.
2006) Standard Performance
Specification for Foley
Catheter.
9-54........................ 9-85........................ ASTM D6976-13 Standard Withdrawn and replaced
Specification for Rubber with a newer version.
Contraceptives--Vaginal
Diaphragms.
9-56........................ ............................ ASTM D3492-08 Standard Extent of recognition.
Specification for Rubber
Contraceptives (Male
Condoms).
9-65........................ 9-91........................ ANSI/AAMI/ISO 8637:2010 Withdrawn and replaced
Cardiovascular implants and with newer version
extracorporeal systems-- including amendment.
Hemodialyzers,
hemodiafilters,
hemofilters, and
hemoconcentrators
[Including AMENDMENT 1
(2013)].
9-66........................ ............................ ANSI/AAMI/ISO 8638:2010 Extent of recognition.
Cardiovascular implants and
Extracorporeal blood
circuit for hemodialyzers,
hemodiafilters, and
hemofilters.
9-67........................ ............................ ASTM D7661-10 Standard Test Extent of recognition.
Method for Determining
Compatibility of Personal
Lubricants with Natural
Rubber Latex Condoms.
9-68........................ ............................ ISO 23409 First edition 2011- Extent of recognition.
02-15 Male Condoms--
Requirements and test
methods for condoms made
from synthetic materials.
9-73........................ ............................ ANSI/AAMI/ISO 13958:2009 Extent of recognition.
Concentrates for
hemodialysis and related
therapies.
9-74........................ ............................ ISO 13958 Second edition Extent of recognition.
2009-04-15 Concentrates for
haemodialysis and related
therapies.
9-79........................ ............................ ISO 26722 First edition 2009- Extent of recognition.
04-15 Water treatment
equipment for haemodialysis
applications and related
therapies.
----------------------------------------------------------------------------------------------------------------
L. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-41....................... 10-81....................... ISO 11979-7 Second edition Withdrawn and replaced
2006-05-01 Ophthalmic with newer version
implants--Intraocular including amendment.
lenses--Part 7: Clinical
investigations [Including
Amendment 1:2012].
10-75....................... ............................ ISO 11979-7/Amendment 1:2012 Withdrawn. See 10-81.
Ophthalmic implants--
Intraocular lenses--Part 7:
Clinical investigations.
10-42....................... 10-82....................... ISO 11979-2 First edition Withdrawn and replaced
1999-12-15 Ophthalmic with newer version
implants--Intraocular including technical
lenses--Part 2: Optical corrigendum.
properties and test methods
[Including TECHNICAL
CORRIGENDUM 1 (2003)].
10-53....................... 10-83....................... ISO 18369-1 First edition Withdrawn and replaced
2006-08-15 Ophthalmic with newer version
optics--Contact lenses-- including amendment.
Part 1: Vocabulary,
classification system and
recommendations for
labeling specifications
[Including AMENDMENT 1
2009].

[[Page 4926]]

10-61....................... ............................ ISO 18369-1:2006 Ophthalmic Withdrawn. See 10-83.
optics--Contact lenses Part
1: Vocabulary,
classification system and
recommendations for
labeling specifications.
ISO 18369-1 First edition
2006-08-05 AMENDMENT 1 2009-
02-15.
10-58....................... 10-84....................... ANSI Z80.11-2012 American Withdrawn and replaced
National Standard for with newer version.
Ophthalmics--Laser Systems
for Corneal Reshaping.
10-59....................... 10-85....................... ISO 11980 Third edition 2012- Withdrawn and replaced
11-15 Corrected version with newer version.
2013-12-01 Ophthalmic
optics--Contact lenses and
contact lens care products--
Guidance for clinical
investigations.
10-71....................... 10-86....................... ISO 14729 First edition 2001- Withdrawn and replaced
04-15 Ophthalmic optics-- with newer version
Contact lens care products-- including amendment.
Microbiological
requirements and test
methods for products and
regimens for hygienic
management of contact
lenses [Including:
AMENDMENT 1 2010].
10-43....................... ............................ ISO 11979-8 Second edition Extent of recognition.
2006-07-01 Ophthalmic
implants--Intraocular
lenses--Part 8: Fundamental
requirements.
10-54....................... ............................ ISO 18369-4 First edition Extent of recognition.
2006-08-15 Ophthalmic
optics--contact lenses--
Part 4: Physicochemical
properties of contact lens
materials.
10-55....................... ............................ ISO 11979-6 Second edition Extent of recognition.
2007-07-15 Ophthalmic
implants--Intraocular
lenses--Part 6: Shelf-life
and transport stability.
10-56....................... ............................ ANSI Z80.12-2007 (R2012) Reaffirmation and
American National Standard extent of
for Ophthalmics--Multifocal recognition.
Intraocular Lenses.
10-57....................... ............................ ANSI Z80.13-2007 (R2012) Reaffirmation and
American National Standard extent of
for Ophthalmics--Phakic recognition.
Intraocular Lenses.
10-60....................... ............................ ISO 11981 Second edition Extent of recognition.
2009-07-01 Ophthalmic
optics--Contact lenses and
contact lens care products--
Determination of physical
compatibility of contact
lens care products with
contact lenses.
10-62....................... ............................ ANSI Z80.10-2009 Ophthalmic Extent of recognition.
Instruments--Tonometers.
10-64....................... 10-89....................... ANSI Z80.7-2013 Ophthalmics-- Withdrawn and replaced
Intraocular Lenses. with newer version.
10-68....................... ............................ ISO 13212 Second edition Extent of recognition.
2011-05-15 Ophthalmic
optics--Contact lens care
products--Guidelines for
determination of shelf-life.
10-69....................... ............................ ANSI Z80.18-2010 American Extent of recognition.
National Standard for
Ophthalmics--Contact Lens
Care Products--Vocabulary,
Performance Specifications
and Test Methodology.
10-74....................... ............................ ISO 10940 Second edition Extent of recognition.
2009-08-01 Ophthalmic
instruments--Fundus Cameras.
----------------------------------------------------------------------------------------------------------------
M. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-190...................... 11-256...................... ISO 14243-3 First edition Withdrawn and replaced
2004-09-15 Implants for with newer version
surgery--Wear of total knee- including technical
joint prostheses--Part 3: corrigendum.
Loading and displacement
parameters for wear-testing
machines with displacement
control and corresponding
environmental conditions
for test [Including:
TECHNICAL CORRIGENDUM
1(2006)].
11-218...................... ............................ ISO 14243-3:2004 TECHNICAL Withdrawn. See 11-256.
CORRIGENDUM 1 Implants for
surgery--Wear of total knee-
joint prostheses--Part 3:
Loading and displacement
parameters for wear-testing
machines with displacement
control and corresponding
environmental conditions
for test.
11-210...................... 11-257...................... ASTM F543-13 Standard Withdrawn and replaced
Specification and Test with a newer version.
Methods for Metallic
Medical Bone Screws.
11-212...................... ............................ ASTM F1440-92 (Reapproved Withdrawn.
2008) Standard Practice for
Cyclic Fatigue Testing of
Metallic Stemmed Hip
Arthroplasty Femoral
Components Without Torsion.
11-241...................... ............................ ASTM F543-07 Standard Withdrawn duplicate.
Specification and Test See 11-257.
Methods for Metallic
Medical Bone Screws.
11-244...................... 11-258...................... ASTM F2083-12 Standard Withdrawn and replaced
Specification for Knee with a newer version.
Replacement Prosthesis.
11-74....................... ............................ ISO 5838-2 First edition Extent of recognition.
1991-01-15 Implants for
surgery--Skeletal pins and
wires--Part 2: Steinmann
skeletal pins--Dimensions.
11-75....................... ............................ ISO 5838-3 First edition Extent of recognition.
1993-09-15 Implants for
surgery--Skeletal pins and
wires--Part 3: Kirschner
skeletal wires.
11-80....................... ............................ ISO 8828 First edition 1988- Extent of recognition.
10-15 Implants for surgery--
Guidance on care and
handling of orthopaedic
implants.
11-83....................... ............................ ISO 13402 First edition 1995- Extent of recognition.
08-01 Surgical and dental
hand instruments--
Determination of resistance
against autoclaving,
corrosion and thermal
exposure.
11-168...................... ............................ ASTM F1781-03 (Reapproved Extent of recognition.
2009) Standard
Specification for
Elastomeric Flexible Hinge
Finger Total Joint Implants.

[[Page 4927]]

11-171...................... ............................ ASTM F1814-97a (Reapproved Extent of recognition.
2009) Standard Guide for
Evaluating Modular Hip and
Knee Joint Components.
11-183...................... ............................ ASTM F1875-98 (Reapproved Extent of recognition.
2009) Standard Practice for
Fretting Corrosion Testing
of Modular Implant
Interfaces: Hip Femoral
Head-bore and Cone Taper
Interface.
11-184...................... ............................ ISO 8827 First edition 1988- Extent of recognition.
10-15 Implants for surgery--
Staples with parallel legs
for orthopaedic use--
General requirements.
11-185...................... ............................ ASTM F2267-04 (Reapproved Extent of recognition.
2011) Standard Test Method
for Measuring Load Induced
Subsidence of
Intervertebral Body Fusion
Device Under Static Axial
Compression.
11-191...................... ............................ ISO 14879-1 First edition Extent of recognition.
2000-06-01 Implants for
surgery--Total knee-joint
prostheses--Part 1:
Determination of endurance
properties of knee tibial
trays.
11-196...................... ............................ ASTM F1672-95 (Reapproved Extent of recognition.
2011) Standard
Specification for
Resurfacing Patellar
Prosthesis.
11-197...................... ............................ ASTM F983-86 (Reapproved Reaffirmation and
2013) Standard Practice for extent of
Permanent Marking of recognition.
Orthopaedic Implant
Components.
11-199...................... ............................ ASTM F565-04 (Reapproved Reaffirmation and
2013) Standard Practice for extent of
Care and Handling of recognition.
Orthopedic Implants and
Instruments.
11-203...................... ............................ ASTM F1541-02 (Reapproved Extent of recognition.
2011) 1 Standard
Specification and Test
Methods for External
Skeletal Fixation Devices.
11-207...................... ............................ ASTM F2193-02 (Reapproved Extent of recognition.
2007) Standard
Specifications and Test
Methods for Components Used
in the Surgical Fixation of
the Spinal Skeletal System.
11-211...................... ............................ ASTM F1798-97 (Reapproved Extent of recognition.
2008) Standard Guide for
Evaluating the Static and
Fatigue Properties of
Interconnection Mechanisms
and Subassemblies Used in
Spinal Arthrodesis Implants.
11-214...................... ............................ ASTM F382-99 (Reapproved Extent of recognition.
2008) \1\ Standard
Specification and Test
Method for Metallic Bone
Plates.
11-216...................... ............................ ASTM F1264-03 (Reapproved Extent of recognition.
2012) Standard
Specification and Test
Methods for Intramedullary
Fixation Devices.
11-220...................... ............................ ASTM F2068-09 Standard Extent of recognition.
Specification for Femoral
Prostheses--Metallic
Implants.
11-222...................... ............................ ISO 14243-1 Second edition Extent of recognition.
2009-11-15 Implants for
surgery--Wear of total knee-
joint prostheses--Part 1:
Loading and displacement
parameters for wear-testing
machines with load control
and corresponding
environmental conditions
for test.
11-223...................... ............................ ISO 14243-2 Second edition Extent of recognition.
2009-11-15 Implants for
surgery--Wear of total knee-
joint prostheses--Part 2:
Methods of measurement.
11-224...................... ............................ ASTM F2706-08 Standard Test Extent of recognition.
Methods for Occipital-
Cervical and Occipital-
Cervical-Thoracic Spinal
Implant Constructs in a
Vertebrectomy Model.
11-225...................... ............................ ISO 7206-4 Third edition Extent of recognition.
2010-06-15 Implants for
surgery--Partial and total
hip-joint prostheses--Part
4: Determination of
endurance properties and
performance of stemmed
femoral components.
11-226...................... ............................ ASTM F1089-10 Standard Test Extent of recognition.
Method for Corrosion of
Surgical Instruments.
11-227...................... ............................ ASTM F366-10 Standard Extent of recognition.
Specification for Fixation
Pins and Wires.
11-228...................... ............................ ASTM F564-10 Standard Extent of recognition
Specification and Test
Methods for Metallic Bone
Staples.
11-231...................... ............................ ISO 7207-2 Second edition Extent of recognition.
2011-07-01 Implants for
surgery--Components for
partial and total knee
joint prostheses--Part 2:
Articulating surfaces made
of metal, ceramic and
plastics materials.
11-232...................... ............................ ISO 7207-1 Third edition Extent of recognition.
2007-02-01 Implants for
surgery--Components for
partial and total knee
joint prostheses--Part 1:
Classification, definitions
and designation of
dimensions.
11-234...................... ............................ ASTM F732-00 (Reapproved Extent of recognition.
2011) Standard Test Method
for Wear Testing of
Polymeric Materials Used in
Total Joint Prostheses.
11-235...................... ............................ ASTM F2077-11 Test Methods Extent of recognition.
for Intervertebral Body
Fusion Devices.
11-237...................... ............................ ISO 7206-6 First edition Extent of recognition.
1992-03-15 Implants for
surgery--Partial and total
hip joint prostheses--Part
6: Determination of
endurance properties of
head and neck region of
stemmed femoral components.
11-238...................... ............................ ASTM F2033-12 Standard Extent of recognition.
Specification for Total Hip
Joint Prosthesis and Hip
Endoprosthesis Bearing
Surfaces Made of Metallic,
Ceramic, and Polymeric
Materials.

[[Page 4928]]

11-239...................... ............................ ASTM F 2345-03 (Reapproved Extent of recognition.
2013) Standard Test Methods Reaffirmation.
for Determination of Static
and Cyclic Fatigue Strength
of Ceramic Modular Femoral
Heads.
11-240...................... ............................ ASTM F382-99 (Reapproved Extent of recognition.
2008) \1\ Standard
Specification and Test
Method for Metallic Bone
Plates.
11-243...................... ............................ ASTM F2346-05 (Reapproved Extent of recognition.
2011) Standard Test Methods
for Static and Dynamic
Characterization of Spinal
Artificial Discs.
11-245...................... ............................ ASTM F384-12 Standard Extent of recognition.
Specifications and Test
Methods for Metallic Angled
Orthopedic Fracture
Fixation Devices.
11-247...................... ............................ ASTM F2789-10 Standard Guide Extent of recognition.
for Mechanical and
Functional Characterization
of Nucleus Devices.
11-248...................... ............................ ISO 14242-1 Second edition Extent of recognition.
2012-01-15 Implants for
surgery--Wear of total hip-
joint prostheses--Part 1:
Loading and displacement
parameters for wear-testing
machines and corresponding
environmental conditions
for test.
11-249...................... ............................ ISO 14242-2 First edition Extent of recognition.
2000-09-15 Implants for
surgery--Wear of total hip-
joint prostheses--Part 2:
Methods of measurement.
11-250...................... ............................ ISO 14242-3 First edition Extent of recognition.
2009-03-15 Implants for
surgery--Wear of total hip-
joint prostheses--Part 3:
Loading and displacement
parameters for orbital
bearing type wear testing
machines and corresponding
environmental conditions
for test.
----------------------------------------------------------------------------------------------------------------
N. Physical Medicine
----------------------------------------------------------------------------------------------------------------
16-25....................... ............................ ISO 7176-13 First edition Extent of recognition.
1989-08-01 Wheelchairs--
Part 13: Determination of
coefficient of friction of
test surfaces.
16-27....................... ............................ ISO 7176-15 First edition Extent of recognition.
1996-11-15 Wheelchairs--
Part 15: Requirements for
information disclosure,
documentation and labeling.
16-29....................... ............................ ISO 7176-6 Second edition Extent of recognition.
2001-10-01 Wheelchairs--
Part 6: Determination of
maximum speed, acceleration
and deceleration of
electric wheelchairs.
16-158...................... ............................ ISO 7176-1 Second edition Extent of recognition.
1999-10-01 Wheelchairs--
Part 1: Determination of
static stability.
16-159...................... ............................ ISO 7176-2 Second edition Extent of recognition.
2001-06-15 Wheelchairs--
Part 2: Determination of
dynamic stability of
electric wheelchairs.
16-162...................... ............................ ISO 7176-4 Third edition Extent of recognition.
2008-10-01 Wheelchairs--
Part 4: Energy consumption
of electric wheelchairs and
scooters for determination
of theoretical distance
range.
16-163...................... ............................ ISO 7176-5 Second edition Extent of recognition.
2008-06-01 Wheelchairs--
Part 5: Determination of
overall dimensions, mass
and manoeuvring space.
16-164...................... ............................ ISO 7176-10 Second edition Extent of recognition.
2008-11-01 Wheelchairs--
Part 10: Determination of
obstacle-climbing ability
of electrically powered
wheelchairs.
16-165...................... ............................ ISO 7176-14 Second edition Extent of recognition.
2008-02-15 Wheelchairs--
Part 14: Power and control
systems for electrically
powered wheelchairs and
scooters--Requirements and
test methods.
16-166...................... ............................ ISO 7176-21 Second edition Extent of recognition.
2009-04-01 Wheelchairs--
Part 21: Requirements and
test methods for
electromagnetic
compatibility of
electrically powered
wheelchairs and scooters,
and battery chargers.
16-167...................... ............................ ISO 7176-9: Third edition Extent of recognition.
2009-11-15 Wheelchairs--
Part 9: Climatic tests for
electric wheelchairs.
16-168...................... ............................ ANSI/RESNA WC-1:2009 Extent of recognition.
American National Standard
for Wheelchairs--Volume 1:
Requirements and Test
Methods for Wheelchairs
(including Scooters)
Section 1: Determination of
static stability.
16-169...................... ............................ ANSI/RESNA WC-2:2009 Extent of recognition.
American National Standard
for Wheelchairs--Volume 2:
Additional Requirements for
Wheelchairs (including
Scooters) with Electrical
Systems Section 2:
Determination of dynamic
stability of electrically
powered wheelchairs.
16-170...................... ............................ ANSI/RESNA WC-2:2009 Extent of recognition.
American National Standard
for Wheelchairs--Volume 2:
Additional Requirements for
Wheelchairs (including
Scooters) with Electrical
Systems Section 3:
Determination of
effectiveness of brakes.
16-171...................... ............................ ANSI/RESNA WC-2:2009 Section Extent of recognition.
4: Energy consumption of
electrically powered
wheelchairs and scooters
for determination of
theoretical distance range.

[[Page 4929]]

16-172...................... ............................ ANSI/RESNA WC-1:2009 Extent of recognition.
American National Standard
for Wheelchairs--Volume 1:
Requirements and Test
Methods for Wheelchairs
(including Scooters)
Section 5: Determination of
dimensions, mass and
maneuvering space.
16-173...................... ............................ ANSI/RESNA WC-2:2009 Extent of recognition.
American National Standard
for Wheelchairs--Volume 2:
Additional Requirements for
Wheelchairs (including
Scooters) with Electrical
Systems Section 6:
Determination of maximum
speed, acceleration and
deceleration of
electrically powered
wheelchairs.
16-174...................... ............................ ANSI/RESNA WC-1:2009 Extent of recognition.
American National Standard
for Wheelchairs Volume 1:
Requirements and Test
Methods for Wheelchairs
(including Scooters)
Section 7: Method of
Measurement of Seating and
Wheel Dimensions.
16-175...................... ............................ ANSI/RESNA WC-1:2009 Extent of recognition.
American National Standard
for Wheelchairs--Volume 1:
Requirements and Test
Methods for Wheelchairs
(including Scooters)
Section 8: Requirements and
test methods for static,
impact and fatigue
strengths.
16-176...................... ............................ ANSI/RESNA WC-2:2009 Extent of recognition.
American National Standard
for Wheelchairs--Volume 2:
Additional Requirements for
Wheelchairs (including
Scooters) with Electrical
Systems Section 9: Climatic
tests for electrically
powered wheelchairs.
16-177...................... ............................ ANSI/RESNA WC-2:2009 Extent of recognition.
American National Standard
for Wheelchairs--Volume 2:
Additional Requirements for
Wheelchairs (including
Scooters) with Electrical
Systems Section 10:
Determination of obstacle-
climbing ability of
electrically powered
wheelchairs.
16-178...................... ............................ ANSI/RESNA WC-1:2009 Extent of recognition.
American National Standard
for Wheelchairs--Volume 1:
Requirements and Test
Methods for Wheelchairs
(including Scooters)
Section 11: Test dummies.
16-179...................... ............................ ANSI/RESNA WC-1:2009 Extent of recognition.
American National Standard
for Wheelchairs--Volume 1:
Requirements and Test
Methods for Wheelchairs
(including Scooters)
Section 13: Determination
of coefficient of friction
of test surfaces.
16-180...................... ............................ ANSI/RESNA WC-2:2009 Extent of recognition.
American National Standard
for Wheelchairs--Volume 2:
Additional Requirements for
Wheelchairs (including
Scooters) with Electrical
Systems Section 14: Power
and control systems for
electrically powered
wheelchairs--Requirements
and test methods.
16-181...................... ............................ ANSI/RESNA WC-1:2009 Extent of recognition.
American National Standard
for Wheelchairs--Volume 1:
Requirements and Test
Methods for Wheelchairs
(including Scooters)
Section 15: Requirements
for information disclosure,
documentation and labeling.
16-182...................... ............................ ANSI/RESNA WC-1:2009 Extent of recognition.
American National Standard
for Wheelchairs--Volume 1:
Requirements and Test
Methods for Wheelchairs
(including Scooters)
Section 16: Resistance to
ignition of upholstered
parts--Requirements and
test methods.
16-183...................... ............................ ANSI/RESNA WC-1:2009 Extent of recognition
American National Standard
for Wheelchairs--Volume 1:
Requirements and Test
Methods for Wheelchairs
(including Scooters)
Section 20: Determination
of the performance of stand-
up type wheelchairs.
16-184...................... ............................ ANSI/RESNA WC-1:2009 Extent of recognition.
American National Standard
for Wheelchairs--Volume 1:
Requirements and Test
Methods for Wheelchairs
(including Scooters)
Section 22: Set-up
procedures.
16-185...................... ............................ ANSI/RESNA WC- Extent of recognition.
2:2009,American National
Standard for Wheelchairs--
Volume 2, Additional
Requirements for
Wheelchairs (including
Scooters) with Electrical
Systems Section 21:
Requirements and test
methods for electromagnetic
compatibility of
electrically powered
wheelchairs and motorized
scooters.
16-187...................... ............................ ANSI/RESNA WC-1:2009 Extent of recognition.
American National Standard
for Wheelchairs--Volume 1:
Requirements and Test
Methods for Wheelchairs
(including Scooters)
Section 26: Vocabulary.
----------------------------------------------------------------------------------------------------------------
O. Radiology
----------------------------------------------------------------------------------------------------------------
12-53....................... 12-257...................... ISO 2919 Third edition 2012- Withdrawn and replaced
02-15 Radiological with newer version.
protection--Sealed
radioactive sources--
General requirements and
classification.
12-59....................... ............................ IEC 61168 First edition 1993- Extent of recognition.
12 Radiotherapy simulators--
Functional performance
characteristics.
12-66....................... ............................ AIUM MUS, Medical Ultrasound Extent of recognition.
Safety.

[[Page 4930]]

12-139...................... ............................ AIUM AOMS-2004, Acoustic Extent of recognition.
Output Measurement Standard
for Diagnostic Ultrasound
Equipment.
12-140...................... ............................ AIUM RTD2-2004 Standard for Withdrawn. See 12-209
Real-Time Display of and 12-258.
Thermal and Mechanical
Acoustic Output Indices on
Diagnostic Ultrasound
Equipment Revision 2.
12-145...................... 12-259...................... IEC 61674 Edition 2.0 2012- Withdrawn and replaced
11 Medical electrical with newer version.
equipment--Dosimeters with
ionization chambers and/or
semiconductor detectors as
used in X-ray diagnostic
imaging.
12-149...................... 12-260...................... IEC 60336 Fourth edition Withdrawn and replaced
2005-04 Medical electrical with newer version
equipment--X-ray tube including technical
assemblies for medical corrigendum.
diagnosis--Characteristics
of focal spots [Including:
Technical Corrigendum 1
(2006)].
12-150...................... ............................ ISO/IEC 10918-1:1994 Withdrawn. See 12-261.
TECHNICAL CORRIGENDUM
1:2005 Information
technology--Digital
compression and coding of
continuous-tone still
image--Part 1: Requirements
and guidelines.
12-156...................... ............................ ISO 11670:2003 TECHNICAL Withdrawn. See 12-262.
CORRIGENDUM 1:2004 Lasers
and laser-related
equipment--Test methods for
laser beam parameters--Beam
positional stability.
12-157...................... ............................ ISO 13694:2000 TECHNICAL Withdrawn. See 12-263.
CORRIGENDUM 1:2005 Optics
and optical instruments--
Lasers and laser-related
equipment--Test methods for
laser beam power (energy)
density distribution.
12-159...................... 12-264...................... NEMA MS 11-2010 Withdrawn and replaced
Determination of Gradient- with newer version.
Induced Electric Fields In
Diagnostic Magnetic
Resonance Imaging.
12-167...................... 12-265...................... NEMA NU 2-2012 Performance Withdrawn and replaced
Measurements of Positron with newer version.
Emission Tomographs (PETs).
12-179...................... ............................ ANSI/IESNA RP-27.3-2007, Extent of recognition.
Recommended Practice for
Photobiological Safety for
Lamps--Risk Group
Classification and Labeling.
12-180...................... 12-266...................... IEC 61689 Edition 3.0 2013- Withdrawn and replaced
02 Ultrasonic-Physiotherapy with newer version.
systems--Field
specifications and methods
of measurement in the
frequency range 0. 5 MHz to
5 MHz.
12-190...................... 12-267...................... IEC 61217 Edition 2.0 2011- Withdrawn and replaced
12 Radiotherapy equipment-- with newer version.
Coordinates, movements and
scales.
12-194...................... ............................ ANSI/HPS N43.6-2007, Sealed Extent of recognition.
Radioactive Sources--
Classification.
12-207...................... 12-271...................... IEC 60601-2-33 Edition 3.1 Withdrawn and replaced
2013-04 Medical electrical with newer version.
equipment--Part 2-33:
Particular requirements for
the basic safety and
essential performance of
magnetic resonance
equipment for medical
diagnosis.
12-208...................... 12-268...................... IEC 60601-2-22 Edition 3.1 Withdrawn and replaced
2012-10 Medical electrical with newer version.
equipment--Part 2-22:
Particular requirements for
basic safety and essential
performance of surgical,
cosmetic, therapeutic and
diagnostic laser equipment.
12-210...................... 12-269...................... IEC 60601-1-3 Edition 2.1 Withdrawn and replaced
2013-04 Medical electrical with newer version.
equipment--Part 1-3:
General requirements for
basic safety and essential
performance--Collateral
Standard: Radiation
protection in diagnostic X-
ray equipment.
12-219...................... ............................ IEC 60336 (2005) Medical Withdrawn. See 12-260.
electrical equipment--X-ray
tube assemblies for medical
diagnosis--Characteristics
of focal spots.
12-222...................... 12-270...................... IEC 61223-3-5 First edition Withdrawn and replaced
2004-08 Evaluation and with newer version
routine testing in medical including technical
imaging departments--Part 3- corrigendum.
5: Acceptance tests--
Imaging performance of
computed tomography X-ray
equipment [Including:
TECHNICAL CORRIGENDUM 1
(2006)].
12-223...................... ............................ IEC 61223-3-5 (First edition Withdrawn. See 12-270.
2004) Evaluation and
routine testing in medical
imaging departments--Part 3-
5: Acceptance tests--
Imaging performance of
computed tomography X-ray
equipment CORRIGENDUM 1.
12-227...................... ............................ IEC 61391-1 First edition Extent of recognition.
2006-07 Ultrasonics--Pulse-
echo scanners--Part 1:
Techniques for calibrating
spatial measurement systems
and measurement of system
point-spread function
response.
12-228...................... ............................ IEC 61391-2 Edition 1.0 2010- Extent of recognition.
01 Ultrasonics--Pulse-echo
scanners--Part 2:
Measurement of maximum
depth of penetration and
local dynamic range.
12-233...................... 12-262...................... ISO 11670 Second edition Withdrawn and replaced
2003-04-01 Lasers and laser- with newer version
related equipment--Test including technical
methods for laser beam corrigendum.
parameters--Beam positional
stability [Including:
TECHNICAL CORRIGENDUM 1
(2004)].
12-237...................... 12-258...................... IEC 62359 Edition 2.0 2010- Withdrawn and replaced
10 Ultrasonics--Field with newer version
characterization--Test including technical
methods for the corrigendum.
determination of thermal
and mechanical indices
related to medical
diagnostic ultrasonic
fields [Including TECHNICAL
CORRIGENDUM 1 (2011)].

[[Page 4931]]

12-243...................... 12-263...................... ISO 13694 First edition 2000- Withdrawn and replaced
04-01 Optics and optical with newer version
instruments--Lasers and including technical
laser-related equipment-- corrigendum.
Test methods for laser beam
power [energy] density
distribution [Including:
TECHNICAL CORRIGENDUM 1
(2005)].
12-244...................... ............................ IEC 62359 (Second edition Withdrawn. See 12-258.
2010) March 2011
Ultrasonics--Field
characterization--Test
methods for the
determination of thermal
and mechanical indices
related to medical
diagnostic ultrasonic
fields CORRIGENDUM 1.
12-247...................... ............................ ISO 11990-1 First edition Extent of recognition.
2011-08-01, Lasers and
laser-related equipment--
Determination of laser
resistance of tracheal
tubes--Part 1: Tracheal
tube shaft.
----------------------------------------------------------------------------------------------------------------
P. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-4........................ ............................ ANSI/UL 1998 Standards for Extent of recognition.
Safety Software in
Programmable Components,
Second Edition. [This
Standard contains revisions
through and including
October 28, 2008.]
----------------------------------------------------------------------------------------------------------------
Q. Sterility
----------------------------------------------------------------------------------------------------------------
14-143...................... 14-395...................... ISO 14698-2 First edition Withdrawn and replaced
2003-09-15 Cleanrooms and with newer version
associated controlled including technical
environments--Biocontaminat corrigendum.
ion control--Part 2:
Evaluation and
interpretation of
biocontamination data.
[Including: TECHNICAL
CORRIGENDUM 1 Published
2004-11-01].
14-193...................... ............................ ANSI/AAMI/ISO 11607-1:2006/ Extent of recognition
(R)2010 Packaging for and relevant
terminally sterilized guidance.
medical devices--Part 1:
Requirements for materials,
sterile barrier systems and
packaging systems.
14-194...................... ............................ ANSI/AAMI/ISO 11607-2:2006/ Extent of recognition
(R)2010 Packaging for and relevant
terminally sterilized guidance.
medical devices--Part 2:
Validation requirements for
forming, sealing and
assembly processes.
14-195...................... ............................ ANSI/AAMI/ISO 11140- Extent of recognition.
1:2005(R)2010 Sterilization
of health care products--
Chemical indicators--Part
1: General requirements.
14-201...................... 14-396...................... ANSI/AAMI ST77:2013 Withdrawn and replaced
Containment devices for with newer version.
reusable medical device
sterilization.
14-214...................... 14-397...................... AOAC 6.2.04:2013 Official Withdrawn and replaced
Method 955.15 Testing with newer version.
Disinfectants Against
Staphylococcus aureus, Use-
Dilution Method.
14-218...................... 14-398...................... AOAC 6.3.05:2013 Official Withdrawn and replaced
Method 966.04 Sporicidal with newer version.
Activity of Disinfectants
Method I.
14-219...................... 14-399...................... AOAC 6.3.06:2012 Official Withdrawn and replaced
Method 965.12 with newer version.
Tuberculocidal Activity of
Disinfectants.
14-230...................... 14-400...................... ASTM F2203-13 Standard Test Withdrawn and replaced
Method for Linear with newer version.
Measurement Using Precision
Steel Rule.
14-231...................... 14-401...................... ASTM F2217/F2217M-13 Withdrawn and replaced
Standard Practice for with newer version.
Coating/Adhesive Weight
Determination.
14-235...................... 14-402...................... ASTM F1140/F1140M-13 Withdrawn and replaced
Standard Test Methods for with newer version.
Internal Pressurization
Failure Resistance of
Unrestrained Packages.
14-236...................... 14-403...................... ASTM F2054/F2054M-13 Withdrawn and replaced
Standard Test Method for with newer version.
Burst Testing of Flexible
Package Seals Using
Internal Air Pressurization
Within Restraining Plates.
14-241...................... 14-424...................... ISO 13408-6 First edition Withdrawn and replaced
2005-06-15 Aseptic with newer version
processing of health care including amendment.
products--Part 6: Isolator
systems [Including
AMENDMENT 1 (2013)].
14-258...................... 14-404...................... ASTM F2250-13 Standard Withdrawn and replaced
Practice for Evaluation of with newer version.
Chemical Resistance of
Printed Inks and Coatings
on Flexible Packaging
Materials.
14-260...................... 14-405...................... ASTM F2252/F2252M-13[egr]1 Withdrawn and replaced
Standard Practice for with newer version.
Evaluating Ink or Coating
Adhesion to Flexible
Packaging Materials Using
Tape.
14-264...................... 14-406...................... ANSI/AAMI ST8:2013 Hospital Withdrawn and replaced
steam sterilizers. with newer version.
14-274...................... ............................ ANSI/AAMI/ISO 15882:2008 Extent of recognition
Sterilization of health and relevant
care products--Chemical guidance.
indicators--Guidance for
selection, use, and
interpretation of results.
14-285...................... ............................ ANSI/AAMI/ISO 14161:2009 Extent of recognition.
Sterilization of health
care products--Biological
indicators--Guidance for
the selection, use and
interpretation of results.
14-289...................... ............................ ISO 14698-2:2003 TECHNICAL Withdrawn. See 14-395.
CORRIGENDUM Cleanrooms and
associated controlled
environments--Biocontaminat
ion control--Part 2:
Evaluation and
interpretation of
biocontamination data.

[[Page 4932]]

14-296...................... ............................ ANSI/AAMI/ISO 11138-1:2006/ Relevant guidance.
(R)2010, Sterilization of
health care products--
Biological indicators--Part
1: General requirements.
14-300...................... ............................ ASTM D4169-09 Standard Extent of recognition.
Practice for Performance
Testing of Shipping
Containers and Systems.
14-326...................... 14-407...................... ISO 11737-1 Second edition Withdrawn and replaced
2006-04-01, Sterilization with newer version
of medical devices-- including technical
Microbiological methods-- corrigendum.
Part 1: Determination of a
population of
microorganisms on products
[Including: TECHNICAL
CORRIGENDUM 1 Published
2007-05-15].
14-328...................... 14-428...................... ISO 11137-1 First edition Withdrawn and replaced
2006-04-15 Sterilization of with newer version
health care products-- including amendment.
Radiation--Part 1:
Requirements for
development, validation and
routine control of a
sterilization process for
medical devices [Including
AMENDMENT 1 (2013)].
14-334...................... ............................ ISO 15882 Second edition Extent of recognition,
2008-09-01 Sterilization of title.
health care products--
Chemical indicators--
Guidance for selection, use
and interpretation of
results.
14-335...................... 14-408...................... ISO 10993-7 Second edition Withdrawn and replaced
2008-10-15 Biological with newer version
evaluation of medical including technical
devices--Part 7: Ethylene corrigendum.
oxide sterilization
residuals [Including:
TECHNICAL CORRIGENDUM 1
Published 2009-11-15].
14-336...................... ............................ ISO 14161 Second edition Extent of recognition.
2009-09-15 Sterilization of
health care products--
Biological indicators--
Guidance for the selection,
use and interpretation of
results.
14-338...................... ............................ ISO 11138-1 Second edition Relevant guidance.
2006-07-01, Sterilization
of health care products--
Biological indicators--Part
1: General requirements.
14-352...................... 14-425...................... ANSI/AAMI/ISO 13408-6:2005 Withdrawn and replaced
Aseptic processing of with newer version
health care products--Part including amendment.
6: Isolator systems
[Including AMENDMENT 1
(2013)].
14-353...................... ............................ ISO 11140-1 Second edition Extent of recognition.
2005-07-15 Sterilization of
health care products--
Chemical indicators--Part
1: General requirements.
14-355...................... ............................ ISO 11607-1 First edition Extent of recognition
2006-04-15 Packaging for and relevant
terminally sterilized guidance.
medical devices--Part 1:
Requirements for materials,
sterile barrier systems and
packaging systems.
14-356...................... ............................ ISO 11607-2 First edition Extent of recognition.
2006-04-15 Packaging for
terminally sterilized
medical devices--Part 2:
Validation requirements for
forming, sealing and
assembly processes.
14-357...................... ............................ ISO 11737-1:2006 TECHNICAL Withdrawn. See 14-407.
CORRIGENDUM 1 Published
2007-05-15 Sterilization of
medical devices--
Microbiological methods--
Part 1: Determination of a
population of
microorganisms on products.
14-360...................... ............................ ANSI/AAMI ST72:2011, Relevant guidance.
Bacterial endotoxins--Test
methods, routine
monitoring, and
alternatives to batch
testing.
14-362...................... 14-412...................... AOAC 6.2.01:2013 Official Withdrawn and replaced
Method 955.14, Testing with newer version.
Disinfectants Against
Salmonella choleraesuis,
Use-Dilution Method.
14-363...................... 14-413...................... AOAC 6.2.06:2013 Official Withdrawn and replaced
Method 964.02, Testing with newer version.
Disinfectants Against
Pseudomonas aeruginosa, Use-
Dilution Method.
14-365...................... 14-409...................... ISO 11137-2 Third edition Withdrawn and replaced
2013-06-01 Sterilization of with newer version.
health care products--
Radiation--Part 2:
Establishing the
sterilization dose.
14-366...................... 14-414...................... USP 36-NF31:2013 <61> Withdrawn and replaced
Microbiological Examination with newer version.
of Nonsterile Products:
Microbial Enumeration Tests.
14-367...................... 14-415...................... USP 36-NF31:2013 <71> Withdrawn and replaced
Sterility Tests. with newer version.
14-368...................... 14-416...................... USP 36-NF31:2013 <85> Withdrawn and replaced
Bacterial Endotoxins Test. with newer version.
14-369...................... 14-417...................... USP 36-NF31:2013 <151> Withdrawn and replaced
Pyrogen Test (USP Rabbit with newer version.
Test).
14-370...................... 14-418...................... USP 36-NF31:2013 <161> Withdrawn and replaced
Transfusion and Infusion with newer version.
Assemblies and Similar
Medical Devices.
14-371...................... 14-419...................... USP 36-NF31:2013 Biological Withdrawn and replaced
Indicator for Steam with newer version.
Sterilization, Self-
Contained.
14-372...................... 14-420...................... USP 36-NF31:2013 Biological Withdrawn and replaced
Indicator for Dry-Heat with newer version.
Sterilization, Paper
Carrier.
14-373...................... 14-421...................... USP 36-NF31:2013 Biological Withdrawn and replaced
Indicator for Ethylene with newer version.
Oxide Sterilization, Paper
Carrier.
14-374...................... 14-422...................... USP 36-NF31:2013 Biological Withdrawn and replaced
Indicator for Steam with newer version.
Sterilization, Paper
Carrier.
14-375...................... 14-423...................... USP 36-NF31:2013 <62> Withdrawn and replaced
Microbiological Examination with newer version.
of Nonsterile Products:
Tests for Specified
Microorganisms.
14-380...................... 14-410...................... ASTM F17-13 Standard Withdrawn and replaced
Terminology Relating to with newer version.
Flexible Barrier Packaging.

[[Page 4933]]

14-384...................... ............................ ISO 10993-7:2008 TECHNICAL Withdrawn. See 14-408.
CORRIGENDUM 1, Published
2009-11-15 Biological
evaluation of medical
devices--Part 7: Ethylene
oxide sterilization
residuals.
14-385...................... 14-426...................... ANSI/AAMI/ISO 13408-1:2008 Withdrawn and replaced
(R2011) Aseptic processing with newer version
of health care products-- including amendment.
Part 1: General
requirements [Including
AMENDMENT 1 (2013)].
14-386...................... 14-427...................... ISO 13408-1 Second edition Withdrawn and replaced
2008-06-15 Aseptic with newer version
processing of health care including amendment.
products--Part 1: General
requirements [Including
AMENDMENT 1 (2013)].
14-393...................... 14-411...................... ISO/ASTM 51818 Third edition Withdrawn and replaced
2013-06-01 Practice for with newer version.
dosimetry in an electron
beam facility for radiation
processing at energies
between 80 and 300 keV.
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.

III. Listing of New Entries

In table 2 of this document, FDA provides the listing of new
entries and consensus standards added as modifications to the list of
recognized standards under Recognition List Number: 034.

Table 2.--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
Reference No. and
Recognition No. Title of standard \1\ date
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
1-96..................... Medical electrical ISO 80601-2-55
equipment--Part 2-55: First edition 2011-
Particular requirements 12-15.
for the basic safety
and essential
performance of
respiratory gas
monitors.
------------------------------------------------------------------------
B. Cardiovascular
------------------------------------------------------------------------
3-121.................... Cardiovascular implants-- ISO 25539-1 First
Endovascular devices-- edition 2003-03-
Part 1: Endovascular 01.
prostheses [Including:
Amendment 1 (2005)].
------------------------------------------------------------------------
C. General
------------------------------------------------------------------------
5-83..................... MEDICAL ELECTRICAL ANSI/AAMI HA60601-1-
EQUIPMENT--Part 1-11: 1:2011.
General requirements
for basic safety and
essential performance--
Collateral Standard:
Requirements for
medical electrical
equipment and medical
electrical systems used
in the home healthcare
environment (IEC 60601-
1-11:2010, MOD).
5-84..................... Design of training and AAMI TIR49:2013.
instructional materials
for medical devices
used in non-clinical
environments.
5-85..................... Medical electrical IEC 60601-1-6
equipment--Part 1-6: Edition 3.0 2010-
General requirements 01.
for basic safety and
essential performance--
Collateral standard:
Usability.
5-86..................... Medical electrical IEC 60601-1-8
equipment--Part 1-8: Edition 2.0 2006-
General requirements 10.
for basic safety and
essential performance--
Collateral Standard:
General requirements,
tests and guidance for
alarm systems in
medical electrical
equipment and medical
electrical systems.
------------------------------------------------------------------------
D. General Hospital/General Plastic Surgery
------------------------------------------------------------------------
6-302.................... Stainless steel needle ISO 9626 First
tubing for the edition 1991-09-
manufacture of medical 01.
devices [Including:
AMENDMENT 1 2001-06-01].
6-318.................... Infusion equipment for ISO 8536-4 Fifth
medical use--Part 4: edition 2010-10-
Infusion sets for 01.
single use, gravity
feed [Including:
AMENDMENT 1 2013-03-01].
6-320.................... Medical electrical IEC 60601-2-20
equipment--Part 2-20: Edition 2.0 2009-
Particular requirements 02.
for the basic safety
and essential
performance of infant
transport incubators
[Including: CORRIGENDUM
1 (February 2012) and
CORRIGENDUM 2 (February
2013)].
6-321.................... Medical electrical IEC 60601-2-52
equipment--Part 2-52: Edition 1.0 2009-
Particular requirements 12.
for basic safety and
essential performance
of medical beds
[Including: CORRIGENDUM
1 (September 2010)].
6-322.................... Intravascular catheters-- ISO 10555-4 Second
Sterile and single-use edition 2013-06-
catheters--Part 4: 15.
Balloon dilatation
catheters.
------------------------------------------------------------------------
E. Material
------------------------------------------------------------------------
8-358.................... Standard Specification ASTM F1855-00
for Polyoxymethylene (Reapproved 2011).
(Acetal) for Medical
Applications.
8-359.................... Standard Guide for ASTM F2038-00
Silicone Elastomers, (Reapproved 2011).
Gels, and Foams Used in
Medical Applications
Part I--Formulations
and Uncured Materials.

[[Page 4934]]

8-360.................... Standard Guide for ASTM F2042-00
Silicone Elastomers, (Reapproved 2011).
Gels, and Foams Used in
Medical Applications
Part II--Cross-Linking
and Fabrication.
8-361.................... Standard Specification ASTM F755-99
for Selection of Porous (Reapproved 2011).
Polyethylene for Use in
Surgical Implants.
8-362.................... Standard Specification ASTM F2989-13.
for Metal Injection
Molded Unalloyed
Titanium Components for
Surgical Implant
Applications.
8-363.................... Standard Test Method for ASTM D638-10.
Tensile Properties of
Plastics.
8-364.................... Standard Test Methods ASTM D792-08.
for Density and
Specific Gravity
(Relative Density) of
Plastics by
Displacement.
8-365.................... Standard Test Method for ASTM D1505-10.
Density of Plastics by
the Density-Gradient
Technique.
8-366.................... Ultra-high-molecular- ISO 11542-2 First
weight polyethylene (PE- edition 1998-11-
UHMW) moulding and 15.
extrusion materials--
Part 2: Preparation of
test specimens and
determination of
properties.
8-367.................... Standard Test Method for ASTM E647-13[egr]1.
Measurement of Fatigue
Crack Growth Rates.
8-368.................... Standard Test Method for ASTM F2625-10.
Measurement of Enthalpy
of Fusion, Percent
Crystallinity, and
Melting Point of Ultra-
High-Molecular Weight
Polyethylene by Means
of Differential
Scanning Calorimetry.
8-369.................... Standard Practice for ASTM F2003-02
Accelerated Aging of (Reapproved 2008).
Ultra-High Molecular
Weight Polyethylene
after Gamma Irradiation
in Air.
------------------------------------------------------------------------
F. OB-GYN/Gastroenterology/Urology
------------------------------------------------------------------------
9-86..................... Rubber condoms for ISO 16037 First
clinical trials-- Edition 2002-05-
Measurement of physical 15.
properties Including
[AMENDMENT 1 2011-02-
15)].
9-87..................... Female condoms-- ISO 25841 First
Requirements and test Edition 2011-07-
methods. 15.
9-88..................... Prophylactic dams-- ISO 29942 First
Requirements and test Edition 2011-07-
methods. 01.
9-89..................... Cardiovascular implants ISO 8638 Third
and extracorporeal edition 2010-07-
blood circuit for 01.
haemodialysers,
haemodiafilters, and
haemofilters.
9-92..................... Cardiovascular implants ISO 8637 Third
and extracorporeal edition 2010-07-
systems--Haemodialysers 01.
, haemodiafilters,
haemofilters and
haemoconcentrators
Including [AMENDMENT 1
2013-04-01)].
------------------------------------------------------------------------
G. Ophthalmics
------------------------------------------------------------------------
10-87.................... Standard Test Method for ASTM D882-12.
Tensile Properties of
Thin Plastic Sheeting.
10-88.................... Standard Test Methods ASTM D790-10.
for Flexural Properties
of Unreinforced and
Reinforced Plastics and
Electrical Insulating
Materials.
------------------------------------------------------------------------
H. Orthopedics
------------------------------------------------------------------------
11-259................... Standard Specification ASTM F2887-12.
For Total Elbow
Prostheses.
11-260................... Standard Guide for ASTM F2943-13.
Presentation of End
User Labeling
Information for
Orthopedic Implants
Used in Joint
Arthroplasty.
11-261................... Standard Specification ASTM F1378-12
for Shoulder Prostheses.
11-262................... Standard Specification ASTM F2091-01
for Acetabular (Reapproved 2012).
Prostheses.
11-263................... Standard Test Methods ASTM F2028-08
for Dynamic Evaluation (Reapproved 2012)
of Glenoid Loosening or \1\.
Disassociation.
11-264................... Standard Test Method for ASTM F1820-13.
Determining the Forces
for Disassembly of
Modular Acetabular
Devices.
11-265................... Standard Practice for ASTM F2580-13.
Evaluation of Modular
Connection of
Proximally Fixed
Femoral Hip Prosthesis.
11-266................... Standard Specification ASTM F2665-09.
for Total Ankle
Replacement Prosthesis.
11-267................... Standard Test Method for ASTM F2009-00
Determining the Axial (Reapproved 2011).
Disassembly Force of
Taper Connections of
Modular Prostheses.
11-268................... Standard Test Method for ASTM F1829-98
Static Evaluation of (Reapproved 2009).
Glenoid Locking
Mechanism in Shear.
11-269................... Standard Guide for ASTM F2423-11.
Functional, Kinematic,
and Wear Assessment of
Total Disc Prostheses.
11-270................... Standard Specification ASTM F2502-11.
and Test Methods for
Absorbable Plates and
Screws for Internal
Fixation Implants.
11-271................... Standard Specification ASTM F2180-02
for Metallic (Reapproved 2011).
Implantable Strands and
Cables.
11-272................... Standard Guide for ASTM F1714-96
Gravimetric Wear (Reapproved 2013).
Assessment of
Prosthetic Hip Designs
in Simulator Devices.
11-273................... Implants for surgery-- ISO 18192-1 Second
Wear of total edition 2011-03-
intervertebral spinal 01.
disc prostheses--Part 1
Loading and
displacement parameters
for wear testing and
corresponding
environmental
conditions for test.
11-274................... Implants for surgery-- ISO 18192-2 First
Wear of total edition 2010-06-
intervertebral spinal 15.
disc prostheses--Part
2: Nucleus replacements.
11-275................... Standard Test Method for ASTM F2381-10.
Evaluating Trans-
Vinylene Yield in
Irradiated Ultra-High
Molecular Weight
Polyethylene Fabricated
Forms Intended for
Surgical Implants by
Infrared Spectroscopy.
------------------------------------------------------------------------

[[Page 4935]]

I. Radiology
------------------------------------------------------------------------
12-261................... Information technology-- ISO/IEC 10918-1
Digital compression and First edition 1994-
coding of continuous- 02-15.
tone still images:
Requirements and
guidelines [Including:
TECHNICAL CORRIGENDUM 1
(2005)].
------------------------------------------------------------------------
J. Software/Informatics
------------------------------------------------------------------------
13-63.................... Application of risk IEC/TR 80001-2-4
management for IT- Edition 1.0 2012-
networks incorporating 11.
medical devices--Part 2-
4: Application
guidance--General
implementation guidance
for healthcare delivery
organizations.
13-64.................... Application of risk ANSI/AAMI/IEC
management for IT- TIR80001-2-4:2012.
networks incorporating
medical devices--Part 2-
4: General
implementation guidance
for healthcare delivery
organizations.
------------------------------------------------------------------------
K. Sterility
------------------------------------------------------------------------
14-429................... Practice for use of a ISO/ASTM 51275
radiochromic film Third edition 2013-
dosimetry system. 06-01.
14-430................... Practice for use of an ISO/ASTM 51607
alanine-EPR dosimetry Third edition 2013-
system. 06-01.
14-431................... Guide for estimating ISO/ASTM 51707
uncertainties in Second edition
dosimetry for radiation 2005-05-15.
processing.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
of the respective organizations.

IV. List of Recognized Standards

FDA maintains the Agency's current list of FDA recognized consensus
standards in a searchable database that may be accessed directly at
FDA's Internet site at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA will incorporate the modifications
and revisions described in this notice into the database and, upon
publication in the Federal Register, this recognition of consensus
standards will be effective. FDA will announce additional modifications
and revisions to the list of recognized consensus standards, as needed,
in the Federal Register once a year, or more often, if necessary.
Beginning with recognition list 033, FDA no longer announces minor
revisions to the list of recognized consensus standards such as
technical contact person, relevant guidance, processes affected, CFR
citations, and product codes.

V. Recommendation of Standards for Recognition by FDA

Any person may recommend consensus standards as candidates for
recognition under section 514 of the FD&C Act by submitting such
recommendations, with reasons for the recommendation, to the contact
person (see FOR FURTHER INFORMATION CONTACT). To be properly
considered, such recommendations should contain, at a minimum, the
following information: (1) The title of the standard, (2) any reference
number and date, (3) the name and address of the national or
international standards development organization, (4) a proposed list
of devices for which a declaration of conformity to this standard
should routinely apply, and (5) a brief identification of the testing
or performance or other characteristics of the device(s) that would be
addressed by a declaration of conformity.

VI. Electronic Access

You may obtain a copy of ``Guidance on the Recognition and Use of
Consensus Standards'' by using the Internet. The Center for Devices and
Radiological Health (CDRH) maintains a site on the Internet for easy
access to information including text, graphics, and files that you may
download to a personal computer with access to the Internet. Updated on
a regular basis, the CDRH home page includes the guidance as well as
the current list of recognized standards and other standards-related
documents. After publication in the Federal Register, this notice
announcing ``Modification to the List of Recognized Standards,
Recognition List Number: 034'' will be available on the CDRH home page.
You may access the CDRH home page at https://www.fda.gov/MedicalDevices.
You may access ``Guidance on the Recognition and Use of Consensus
Standards,'' and the searchable database for ``FDA Recognized Consensus
Standards'' at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards.
This Federal Register document on modifications in FDA's
recognition of consensus standards is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.

VII. Submission of Comments and Effective Date

Interested persons may submit to the contact person (see FOR
FURTHER INFORMATION CONTACT) either electronic or written comments
regarding this document. It is only necessary to send one set of
comments. Comments are to be identified with the docket number found in
brackets in the heading of this document. FDA will consider any
comments received in determining whether to amend the current listing
of modifications to the list of recognized standards, Recognition List
Number: 034. These modifications to the list of recognized standards
are effective upon publication of this notice in the Federal Register.

Dated: January 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01847 Filed 1-29-14; 8:45 am]
BILLING CODE 4160-01-P

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