Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 030, 2998-3005 [2013-00605]

Download as PDF 2998 Federal Register / Vol. 78, No. 10 / Tuesday, January 15, 2013 / Notices services and supports for persons with intellectual disabilities. The PCPID Executive Order stipulates that the Committee shall: (1) Provide such advice concerning intellectual disabilities as the President or the Secretary of Health and Human Services may request; and (2) provide advice to the President concerning the following for people with intellectual disabilities: (A) Expansion of educational opportunities; (B) promotion of homeownership; (C) assurance of workplace integration; (D) improvement of transportation options; (E) expansion of full access to community living; and (F) increasing access to assistive and universally designed technologies. Dated: January 9, 2013. Kathy Greenlee, Administrator. [FR Doc. 2013–00661 Filed 1–14–13; 8:45 am] BILLING CODE 4154–01–P 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: 030 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: 030’’ (Recognition List Number: 030), 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 of this document 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: 030’’ to the Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological srobinson on DSK4SPTVN1PROD with SUMMARY: VerDate Mar<15>2010 17:00 Jan 14, 2013 Jkt 229001 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 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 of this document for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 030 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, are identified in table 1 of this document. TABLE 1—PREVIOUS PUBLICATIONS OF STANDARD RECOGNITION LISTS February 25, 1998 (63 FR 9561) October 16, 1998 (63 FR 55617) July 12, 1999 (64 FR 37546) November 15, 2000 (65 FR 69022) May 7, 2001 (66 FR 23032) January 14, 2002 (67 FR 1774) October 2, 2002 (67 FR 61893) PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 TABLE 1—PREVIOUS PUBLICATIONS OF STANDARD RECOGNITION LISTS— Continued April 28, 2003 (68 FR 22391) March 8, 2004 (69 FR 10712) June 18, 2004 (69 FR 34176) October 4, 2004 (69 FR 59240) May 27, 2005 (70 FR 30756) November 8, 2005 (70 FR 67713) March 31, 2006 (71 FR 16313) June 23, 2006 (71 FR 36121) November 3, 2006 (71 FR 64718). May 21, 2007 (72 FR 28500). September 12, 2007 (72 FR 52142). December 19, 2007 (72 FR 71924). September 9, 2008 (73 FR 52358). March 18, 2009 (74 FR 11586). September 8, 2009 (74 FR 46203). May 5, 2010 (75 FR 24711). June 10, 2010 (75 FR 32943). October 4, 2010 (75 FR 61148). March 14, 2011 (76 FR 13631). August 2, 2011 (76 FR 46300). March 16, 2012 (77 FR 15765). August 20, 2012 (77 FR 50114). 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 of this document 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: 030 FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the Agency will recognize for use in satisfying premarket reviews 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: 030’’ to identify these current modifications. In table 2 of this document, FDA describes the following modifications: (1) The withdrawal of standards and their replacement by others; (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 E:\FR\FM\15JAN1.SGM 15JAN1 2999 Federal Register / Vol. 78, No. 10 / Tuesday, January 15, 2013 / Notices that involve the initial addition of standards not previously recognized by FDA. TABLE 2—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS Old recognition No. Replacement recognition No. Title of standard 1 Change A. Biocompatibility 2–156 ............. 2–178 ............. 2–191 2–184 ............. 2–192 2–185 ............. 2–193 2–186 ............. 2–194 2–187 ............. 2–195 2–188 ............. 2–196 AAMI/ANSI/ISO 10993–1:2009 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process. ISO 10993–12 Fourth edition 2012–07–01 Biological evaluation of medical devices—Part 12: Sample preparation and reference materials. USP 35–NF30:2012<87> Biological Reactivity Test, In Vitro—Direct Contact Test. USP 35–NF30:2012 Biological Tests <87> Biological Reactivity Test, In Vitro—Elution Test. USP 35–NF30:2012 Biological Tests <88> Biological Reactivity Tests, In Vivo, Procedure Preparation of Sample. USP 35–NF30:2012 Biological Tests <88> Biological Reactivity Test, In Vitro, Classification of Plastics—Intracutaneous Test. USP 35–NF30:2012 Biological Tests <88> Biological Reactivity Tests, In Vivo, Classification of Plastics—Systemic Injection Test. Extent of recognition. Withdrawn and replaced with newer version. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. and replaced with newer and replaced with newer and replaced with newer and replaced with newer and replaced with newer B. Cardiovascular 3–30 ............... 3–105 3–61 ............... 3–101 ............. 3–59 ............... IEC 60601–2–25 Edition 2.0 2011–10 Medical electrical equipment— Part 2–25: Particular requirements for the basic safety and essential performance of electrocardiographs. IEC 60601–2–27 Edition 3.0 2011–03 Medical electrical equipment— Part 2–27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment. ANSI/AAMI/ISO 60601–2–27 Edition 3.0 2011–03 Medical electrical equipment—Part 2–27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment. ISO 5841–3 Second edition 2000–10–15 Implants for surgery—Cardiac pacemakers—Part 3: Low-profile connectors [IS–1] for implantable pacemakers. Withdrawn and replaced with newer version. Withdrawn, see 3–95. Withdrawn, see 3–100. Title, processes impacted, related CFR citation(s) and procode(s), and relevant guidance. C. Dental/ENT 4–43 ............... 4–87 ............... 4–196 4–94 ............... 4–96 ............... 4–110 ............. 4–113 ............. 4–131 ............. 4–198 4–133 ............. 4–199 4–147 ............. 4–152 ............. 4–201 4–158 ............. srobinson on DSK4SPTVN1PROD with 4–192 ............. 4–202 ADA/ANSI Specification No. 5, Dental Casting Alloys: 1997 ............... ANSI/ADA Specification No. 69, 2010 Dental Ceramic ....................... Specification No.14, Dental Base Metal Casting Alloys: 1982 (Reaffirmed 1998). ANSI/ADA Specification No. 30, Reaffirmed by ANSI October 2010 Dental Zinc Oxide-Eugenol and Zinc Oxide Non-Eugenol Cements. ADA/ANSI ADA Specification No. 11, Agar Impression Materials: 1997. ADA/ANSI ADA Specification No. 20, Dental Duplicating Material; 1972 (Reaffirmed 1995). ISO 3107 Fourth edition 2011–03 Dentistry—Zinc oxide/Eugenol cements and zinc oxide/non-eugenol cements. ISO 6876 Third edition 2012–06–01 Dentistry—Root canal sealing materials. ADA/ANSI Specification No. 27, Resin-Based Filling Materials: 2005 ISO 9693 Second edition 1999–12–15 Metal-ceramic dental restorative systems. ISO 10139–1:2005, Dentistry—Soft lining materials for removable dentures—Part 1: Materials for short-term use Technical Corrigendum 1:2006. ANSI/ADA Specification No. 58, 2010 Root Canal Files, Type H (Hedstrom). Withdrawn, see 4–146. Withdrawn and replaced with newer version. Withdrawn, see 4–146. Reaffirmation. Withdrawn. Withdrawn. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn. Withdrawn and replaced with newer version. Withdrawn—Duplicate, see 4–189. Withdrawn and replaced with newer version. D. General 5–56 ............... VerDate Mar<15>2010 ISO 15223–2 First edition 2010–01–15 Medical devices—Symbols to Withdrawn. be used with medical devices labels, labelling, and information to be supplied—Part 2: Symbol development, selection and validation. 17:00 Jan 14, 2013 Jkt 229001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\15JAN1.SGM 15JAN1 3000 Federal Register / Vol. 78, No. 10 / Tuesday, January 15, 2013 / Notices TABLE 2—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. Title of standard 1 5–73 AAMI/ANSI/ISO 15223–2, Medical devices—Symbols to be used with medical device labels, labellings, and information to be supplied—Part 2: Symbol development, selection and validation. ISO 15223–1 Second Edition 2012–07–01 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1: General requirements. 5–68 ............... 5–72 ............... Change Withdrawn. Withdrawn and replaced with new version. E. General Hospital/General Plastic Surgery 6–13 ............... 6–255 ............. 6–283 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. ISO 7864 Third edition 1993–05–15 Sterile hypodermic needles for single use. ASTM F 882–84 (Reapproved 2002) Standard Performance and Safety Specification for Cryosurgical Medical Instruments. ISO 8536–5 Second edition 2004–02–01 Infusion equipment for medical use—Part 5: Burette infusion sets for single use, gravity feed. ISO 7886–3 First edition 2005–03–01 Sterile hypodermic syringes for single use—Part 3: Auto-disable syringes for fixed-dose immunization. ISO 7886–1 First edition 1993–10–01 Sterile hypodermic syringes for single use—Part 1: Syringes for manual use. ASTM D6499–12 Standard Test Method for The Immunological Measurement of Antigenic Protein in Natural Rubber and its Products. ISO 8537 Second edition 2007–10–01 Sterile single-use syringes, with or without needle, for insulin. USP 35–NF30:2012 Sodium Chloride Irrigation .................................. 6–256 ............. 6–284 USP 35–NF30:2012 Sodium Chloride Injection ................................... 6–257 ............. 6–285 USP 35–NF30:2012 Nonabsorbable Surgical Suture .......................... 6–258 ............. 6–286 USP 35–NF30:2012 <881> Tensile Strength ....................................... 6–259 ............. 6–287 USP 35–NF30:2012 <861> Sutures-Diameter ..................................... 6–260 ............. 6–288 USP 35–NF30:2012 <871> Sutures-Needle Attachment ..................... 6–261 ............. 6–289 USP 35–NF30:2012 Sterile Water for Irrigation ................................... 6–262 ............. 6–290 USP 35–NF30:2012 Heparin Lock Flush Solution ............................... 6–623 ............. 6–291 USP 35–NF30:2012 Absorbable Surgical Suture ................................ 6–14 ............... 6–15 ............... 6–107 ............. 6–122 ............. 6–148 ............. 6–170 ............. 6–203 ............. 6–282 6–204 ............. Contact person and title. Contact person. Contact person. Withdrawn. Contact person. Contact person. Contact person and title. Withdrawn and replaced with newer version. Contact person. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. and replaced with newer and replaced with newer and replaced with newer and replaced with newer and replaced with newer and replaced with newer and replaced with newer and replaced with newer and replaced with newer F. In Vitro Diagnostics 7–7 ............. ........................ 7–124 ............. 7–99 ............... 7–232 7–194 ............. 7–233 CLSI/NCCLS LA1–A2 1994 Assessing the Quality of Radioimmunoassay Systems—Second Edition; Approved Guideline. CLSI/NCCLS I/LA24–A Fluorescence Calibration and Quantitative Measurement of Fluorescence Intensity; Approved Guideline. CLSI MM05–A2 Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline—Second Edition. CLSI EP17–A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition. Withdrawn. Withdrawn. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. srobinson on DSK4SPTVN1PROD with G. Materials 8–117 ............. 8–228 8–124 ............. VerDate Mar<15>2010 17:00 Jan 14, 2013 ASTM F86–12 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants. ASTM F2052–06e1 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment. Jkt 229001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\15JAN1.SGM Withdrawn and replaced with a newer version. Relevant guidance. 15JAN1 3001 Federal Register / Vol. 78, No. 10 / Tuesday, January 15, 2013 / Notices TABLE 2—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Replacement recognition No. Title of standard 1 8–137 ............. 8–229 8–142 ............. 8–330 8–155 ............. 8–331 8–209 ............. 8–332 ASTM F2213–06 (Reapproved 2011) Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment. ASTM F2119–07 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants. ASTM F2503–08 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. ASTM F2182–11a Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging. 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 Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants. ASTM F899–12 Standard Specification for Wrought Stainless Steels for Surgical Instruments. Old recognition No. 8–128 ............. 8–153 ............. 8–176 ............. 8–227 ............. Change Relevant guidance. Relevant guidance. Relevant guidance. Relevant guidance . Withdrawn and replaced with a newer version. Withdrawn and replaced with a newer version. Withdrawn and replaced with a newer version. Withdrawn and replaced with a newer version. H. OB-GYN/Gastroenterology 9–21 ............... IS0 8600–4 First edition 1997–07–01 Optics and optical instruments—Medical endoscopes and certain accessories—Part 4: Determination of maximum width of insertion portion. ISO 4074 First edition 2002–02–15 Corrected version 2002–12–01 Natural latex rubber condoms—Requirements and test methods. ISO 8009 First edition 2004–10–01 Mechanical contraceptives—Reusable natural and silicone rubber contraceptive diaphragms—Requirements and tests. ISO 8600–1 Second edition 2005–05–01 Optics and photonics— Medical endoscopes and endotherapy devices—Part 1: General requirements. ISO 8600–5 First edition 2005–03–15 Optics and photonics—Medical endoscopes and endotherapy devices—Part 5: Determination of optical resolution of rigid endoscopes with optics. ISO 8600–6 First edition 2005–03–15 Optics and photonics—Medical endoscopes and endotherapy devices—Part 6: Vocabulary. ISO 16038 First edition 2005–11–01 Rubber condoms—Guidance on the use of ISO 4074 in the quality management of natural rubber latex condoms. ASTM D 3492–08 Standard Specification for Rubber Contraceptives (Male Condoms). IEC 60601–2–18 Edition 3.0 2009–08 Medical electrical equipment— Part 2–18: Particular requirements for the basic safety and essential performance of endoscopic equipment. ASTM D6324–08 Standard Test Methods for Male Condoms Made from Polyurethane. 9–34 ............... 9–36 ............... 9–37 ............... 9–39 ............... 9–40 ............... 9–43 ............... 9–56 ............... 9–61 ............... 9–58 ............... Contact person. Contact person. Contact person. Contact person. Contact person. Contact person. Contact person. Contact person. Contact person. Withdrawn. I. Ophthalmic 10–56 ............. ANSI Z80.12–2007 (R2012) American National Ophthalmics—Multifocal Intraocular Lenses. ANSI Z80.13–2007 (R2012) American National Ophthalmics—Phakic Intraocular Lenses. 10–57 ............. Standard for Reaffirmation. Standard for Reaffirmation. J. Orthopedics srobinson on DSK4SPTVN1PROD with 11–203 ........... 11–216 ........... 11–229 ........... 11–244 11–233 ........... 11–245 VerDate Mar<15>2010 17:00 Jan 14, 2013 ASTM F1541–02 (Reapproved 2011) euroi;1 Standard Specification and Test Methods for External Skeletal Fixation Devices. ASTM F1264–03 (Reapproved 2012) Standard Specification and Test Methods for Intramedullary Fixation Devices. ASTM F2083–11 Standard Specification for Total Knee Prosthesis ... ASTM F384–12 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices. Jkt 229001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\15JAN1.SGM Title. Reaffirmation. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. 15JAN1 3002 Federal Register / Vol. 78, No. 10 / Tuesday, January 15, 2013 / Notices TABLE 2—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. Title of standard 1 Change 11–236 ........... 11–246 ASTM F1717–12 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model. Withdrawn and replaced with newer version. K. Sterility 14–64 ............. 14–315 ........... 14–366 14–316 ........... 14–367 ASTM F1929–98 (Reapproved 2004) Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration. ASTM F2391–05 (Reapproved 2011) Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas. ASTM F1608–00 (Reapproved 2009) Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method). AOAC 6.2.01:2012 Official Method 955.14 Testing Disinfectants against Salmonella enterica, Use-Dilution Method. AOAC 6.2.02:2006 Official Method 991.47 Testing Disinfectants against Salmonella choleraesuis, Hard Surface Carrier Test Method. AOAC 6.2.03:2006 Official Method 991.48 Testing Disinfectants against Staphylococcus aureus, Hard Surface Carrier Test Method. AOAC 6.2.05:2006 Official Method 991.49 Testing Disinfectants against Pseudomonas aeruginosa, Hard Surface Carrier Test Method. AOAC 6.2.06:2012 Official Method 964.02 Testing Disinfectants against Pseudomonas aeruginosa, Use-Dilution Method. AOAC 6.3.02:2006 Official Method 955.17 Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes. AOAC 6.3.05:2006 Official Method 966.04 Sporicidal Activity of Disinfectants Method I. ANSI/AAMI/ISO 11137–2:2012 Sterilization of health care products— Radiation—Part 2: Establishing the sterilization dose. ASTM F1980–07 (Reapproved 2011) Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. ASTM F1140–07 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages. ASTM F2054–07 Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates. ANSI/AAMI/ISO 11140–5:2007/(R)2012 Sterilization of health care products—Chemical indicators—Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs. ASTM F2095–07e1 Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates. ASTM D3078–02 (Reapproved 2008) Ö 1 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission. ANSI/AAMI/ISO 10993–7:2008(R)2012 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals. ASTM F2338–09 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method. ASTM F88/F88M–09 Standard Test Method for Seal Strength of Flexible Barrier Materials. ASTM F1886/F1886M–09 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection. ANSI/AAMI/ISO 11138–1:2006/(R)2010 Sterilization of health care products—Biological indicators—Part 1: General requirements. ASTM F2097–10 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products. ASTM D4169–09 Standard Practice for Performance Testing of Shipping Containers and Systems. ASTM F2475–11 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials. USP 35–NF30:2012 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests. USP 35–NF30:2012 <71> Sterility Tests ............................................. 14–317 ........... 14–368 USP 35–NF30:2012 <85> Bacterial Endotoxins Test .......................... 14–318 ........... 14–369 USP 35–NF30:2012 <151> Pyrogen Test (USP Rabbit Test) ............. 14–169 ........... 14–197 ........... 14–211 ........... 14–362 14–212 ........... 14–213 ........... 14–215 ........... 14–216 ........... 14–363 14–217 ........... 14–218 ........... 14–225 ........... 14–364 14–229 ........... 14–235 ........... 14–236 ........... 14–238 ........... 14–256 ........... 14–257 ........... 14–278 ........... 14–282 ........... 14–283 ........... 14–288 ........... 14–296 ........... 14–299 ........... 14–300 ........... srobinson on DSK4SPTVN1PROD with 14–313 ........... VerDate Mar<15>2010 17:00 Jan 14, 2013 Jkt 229001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\15JAN1.SGM Relevant guidance. Relevant guidance. Relevant guidance. Withdrawn and replaced with newer version. Relevant guidance. Relevant guidance. Relevant guidance. Withdrawn and replaced with newer version. Relevant guidance. Relevant guidance. Withdrawn and replaced with newer version. Relevant guidance. Relevant guidance. Relevant guidance. Reaffirmation. Relevant guidance change. Relevant guidance change. Reaffirmation. and editorial and editorial Relevant guidance. Relevant guidance. Relevant guidance. Relevant guidance, extent of recognition and title. Relevant guidance. Relevant guidance. Relevant guidance. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. 15JAN1 and replaced with newer and replaced with newer and replaced with newer and replaced with newer 3003 Federal Register / Vol. 78, No. 10 / Tuesday, January 15, 2013 / Notices TABLE 2—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. 14–319 ........... 14–370 14–320 ........... 14–371 14–321 ........... 14–372 14–322 ........... 14–373 14–323 ........... 14–374 14–324 ........... 14–375 14–329 ........... 14–365 14–335 ........... 14–338 ........... 14–345 ........... 14–359 ........... 14–360 ........... 1 All Title of standard 1 Change USP 35–NF30:2012 <161> Transfusion and Infusion Assemblies and Similar Medical Devices. USP 35–NF30:2012 Biological Indicator for Steam Sterilization, SelfContained. USP 35–NF30:2012 Biological Indicator for Dry-Heat Sterilization, Paper Carrier. USP 35–NF30:2012 Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier. USP 35–NF30:2012 Biological Indicator for Steam Sterilization, Paper Carrier. USP 35–NF30:2012 <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms. ISO 11137–2 Second edition 2012–03–15 Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose. ISO 10993–7 Second edition 2008–10–15 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals. ISO 11138–1 Second edition 2006–07–01 Sterilization of health care products—Biological indicators—Part 1: General requirements. ISO/ASTM 51261 First edition 2002–03–15 Guide for selection and calibration of dosimetry systems for radiation processing. ASTM F2096–11 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test). ANSI/AAMI ST72:2011 Bacterial endotoxins—Test methods, routine monitoring, and alternatives to batch testing. Withdrawn and replaced with newer version Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Extent of recognition and relevant guidance. Relevant guidance and extent of recognition. Relevant guidance. Relevant guidance. Relevant guidance. standard titles in this table conform to the style requirements of the respective organizations. III. Listing of New Entries In table 3 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: 030. TABLE 3—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS Recognition No. Title of standard 1 Reference No. and date A. Cardiovascular 3–106 ............. 3–107 ............. 3–108 ............. 3–109 ............. 3–110 ............. 3–111 ............. 3–112 ............. 3–113 ............. Medical electrical equipment—Part 2–25: Particular requirements for the basic safety and essential performance of electrocardiographs. Medical electrical equipment—Part 2–30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers. Medical electrical equipment—Part 2–30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers CORRIGENDUM 1. Active implantable medical devices—Four-pole connector system for implantable cardiac rhythm management devices—Dimensional and test requirements. Active implantable medical devices—Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators. Cardiovascular implants—Endovascular devices—Part 3: Vena cava filters ............. Cardiovascular implants and artificial organs—Blood-gas exchangers (oxygenators) Cardiovascular implants and artificial organs—Blood-gas exchangers (oxygenators) ANSI/AAMI/IEC 60601–2–25:2011. IEC 80601–2–30 Edition 1.0 2009–01. IEC 80601–2–30 (First edition—2009). ANSI/AAMI/ISO 27186:2010. AAMI TIR41:2011. ANSI/AAMI/ISO 25539–3: 2011. ANSI/AAMI/ISO 7199: 2009. ISO 7199 Second edition 2009–04–15. B. Dental/ENT 4–200 ............. Dentistry—Mercury and alloys for dental amalgam AMENDMENT 1: Requirements for marking and manufacturer’s instructions concerning mercury. ISO 24234 First edition 2004–10–15 AMENDMENT 1 2011–08–15. srobinson on DSK4SPTVN1PROD with C. General 5–74 ............... Medical electrical equipment—Part 1: General requirements for basic safety and essential performance, Amendment 1. ANSI/AAMI (R)2012. ES60601–1:2005/C1:2009/ D. General Hospital/General Plastic Surgery 6–292 ............. VerDate Mar<15>2010 Sterile hypodermic syringes for single use—Part 1: Syringes for manual use ........... 17:00 Jan 14, 2013 Jkt 229001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 ISO 7886–1:1993 TECHNICAL CORRIGENDUM 1 Published 1995–11–01. E:\FR\FM\15JAN1.SGM 15JAN1 3004 Federal Register / Vol. 78, No. 10 / Tuesday, January 15, 2013 / Notices TABLE 3—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued Recognition No. Title of standard 1 6–293 ............. Sharps injury protection—Requirements and test methods—Sharps containers ....... Reference No. and date ISO 23907 First edition 2012–09–01. E. In Vitro Diagnostics 7–234 ............. 7–235 ............. 7–236 ............. 7–237 ............. 7–238 ............. 7–239 ............. Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline—Second Edition. Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline ............. Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline. Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline—Third Edition. Quantitative Molecular Methods for Infectious Diseases; Approved Guideline—Second Edition. Metrological Traceability and Its Implementation; A Report ........................................ CLSI EP24–A2. CLSI EP25–A. CLSI M43–A. CLSI MM01–A3. CLSI MM06–A2. CLSI X5–R. F. Materials 8–333 ............. 8–334 ............. Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications. Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis. ASTM F2393–12. ASTM F2459–12. G. OB–GYN/Gastroenterology 9–79 ............... 9–80 ............... 9–81 ............... Water treatment equipment for haemodialysis applications and related therapies .... Medical electrical equipment—Part 2–16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment. Mechanical contraceptives—Reusable natural and silicone rubber contraceptive diaphragms—Requirements and tests. ISO 26722 First edition 2009–04–15. IEC 60601–2–16 Edition 4.0 2012–03. ISO 8009 First edition 2004–10–01 ISO 8009: 2004/Amd. 1: 2012 (E) AMENDMENT 1 2012–02–15 H. Ophthalmic 10–75 ............. 10–76 ............. Ophthalmic implants—Intraocular lenses—Part 7: Clinical investigations AMENDMENT 1. Ophthalmic implants—Intraocular lenses—Part 8: Fundamental requirements AMENDMENT 1. ISO 11979–7 Second edition 2006–05– 01 AMENDMENT 1 2012–01–15. ISO 11979–8 Second edition 2006–07– 01 AMENDMENT 1 2011–05–15. I. Orthopedic 11–247 ........... 11–250 ........... 11–249 ........... 11–248 ........... 11–251 ........... Standard Guide for Mechanical and Functional Characterization of Nucleus Devices 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. Implants for surgery—Wear of total hip joint prostheses—Part 2: Methods of measurement. 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. Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems. ASTM F2789–10. ISO 14242–3 First edition 2009–03–15. ISO 14242–2 First edition 2000–09–15. ISO 14242–1 Second edition 2012–01– 15. ASTM F2554–10. J. Radiology 12–250 ........... 12–251 ........... Medical electrical equipment—Part 2–44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography CORRIGENDUM 1. Medical electrical equipment—Part 2–44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography. IEC 60601–2–44 (Third edition-2009). IEC 60601–2–44 Edition 3.0 2012–08 Amendment 1. K. Software/Informatics srobinson on DSK4SPTVN1PROD with 13–33 ............. 13–34 ............. 13–35 ............. 13–36 ............. VerDate Mar<15>2010 Validation of software for regulated processes ........................................................... Medical device software—Part 1: Guidance on the application of ISO 14971 to medical device software. Application of quality management system concepts to medical device data systems. Guidance on the use of AGILE practices in the development of medical device software. 17:00 Jan 14, 2013 Jkt 229001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 AAMI TIR362007. IEC/TR 80002–1 Edition 1.0 2009–09. ANSI/AAMI SW87 2012. AAMI TIR45 2012. E:\FR\FM\15JAN1.SGM 15JAN1 Federal Register / Vol. 78, No. 10 / Tuesday, January 15, 2013 / Notices 3005 TABLE 3—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued Recognition No. Title of standard 1 Reference No. and date L. Sterility 14–376 ........... 14–377 ........... 1 All Sterilization of health care products—Moist heat—Part 2: Guidance on the application of ANSI/AAMI/ISO 17665–1. Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier. ASTM F2638–12. 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 minor 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 minor revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often, if necessary. 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) Title of the standard, (2) any reference number and date, (3) 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. srobinson on DSK4SPTVN1PROD with ANSI/AAMI/ISO TIR 17665–2:2009. 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 VerDate Mar<15>2010 17:00 Jan 14, 2013 Jkt 229001 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: 030’’ 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: 030. These modifications to the list or recognized standards are effective upon publication of this notice in the Federal Register. Dated: January 9, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–00605 Filed 1–14–13; 8:45 am] BILLING CODE 4160–01–P PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–1248] Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need; Public Hearing; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of public hearing; request for comments. ACTION: The Food and Drug Administration (FDA) is announcing a public hearing to obtain input on a potential new pathway to expedite the development of drugs, including biological products, for serious or lifethreatening conditions that would address an unmet medical need. The drug’s safety and effectiveness would be studied in a smaller subpopulation of patients with more serious manifestations of a condition. Such a pathway could involve smaller and more rapid clinical trials than would occur if the drug were studied in a broader group of patients with a wide range of clinical manifestations. The labeling of drugs approved using this pathway would make clear that the drug is narrowly indicated for use in limited, well-defined subpopulations in which the drug’s benefits have been shown to outweigh its risks. The purpose of the public hearing is to obtain information and comments from the public on the need for and feasibility of this pathway and its potential advantages and disadvantages. SUMMARY: Dates and Time: The public hearing will be held on February 4 and 5, 2013, from 9 a.m. to 4 p.m. The public hearing may be extended or may end early depending on the level of public participation. Attendance, Presentations, and Comments: Individuals who wish to attend or present at the public hearing must register on or before 5 p.m. e.s.t. on January 22, 2013. To register for the DATES: E:\FR\FM\15JAN1.SGM 15JAN1

Agencies

[Federal Register Volume 78, Number 10 (Tuesday, January 15, 2013)]
[Notices]
[Pages 2998-3005]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-00605]

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

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: 030

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: 030'' (Recognition List Number: 030), 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 of this document 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: 030'' 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 of
this document for electronic access to the searchable database for the
current list of FDA recognized consensus standards, including
Recognition List Number: 030 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, are identified in table 1 of this
document.

Table 1--Previous Publications of Standard Recognition Lists
------------------------------------------------------------------------

-------------------------------------------------------------------------
February 25, 1998 (63 FR 9561)
October 16, 1998 (63 FR 55617)
July 12, 1999 (64 FR 37546)
November 15, 2000 (65 FR 69022)
May 7, 2001 (66 FR 23032)
January 14, 2002 (67 FR 1774)
October 2, 2002 (67 FR 61893)
April 28, 2003 (68 FR 22391)
March 8, 2004 (69 FR 10712)
June 18, 2004 (69 FR 34176)
October 4, 2004 (69 FR 59240)
May 27, 2005 (70 FR 30756)
November 8, 2005 (70 FR 67713)
March 31, 2006 (71 FR 16313)
June 23, 2006 (71 FR 36121)
November 3, 2006 (71 FR 64718).
May 21, 2007 (72 FR 28500).
September 12, 2007 (72 FR 52142).
December 19, 2007 (72 FR 71924).
September 9, 2008 (73 FR 52358).
March 18, 2009 (74 FR 11586).
September 8, 2009 (74 FR 46203).
May 5, 2010 (75 FR 24711).
June 10, 2010 (75 FR 32943).
October 4, 2010 (75 FR 61148).
March 14, 2011 (76 FR 13631).
August 2, 2011 (76 FR 46300).
March 16, 2012 (77 FR 15765).
August 20, 2012 (77 FR 50114).
------------------------------------------------------------------------

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 of this document 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: 030

FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the Agency will recognize for
use in satisfying premarket reviews 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: 030'' to identify these current
modifications.
In table 2 of this document, FDA describes the following
modifications: (1) The withdrawal of standards and their replacement by
others; (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

[[Page 2999]]

that involve the initial addition of standards not previously
recognized by FDA.

Table 2--Modifications to the List of Recognized Standards
--------------------------------------------------------------------------------------------------------------------------------------------------------
Replacement
Old recognition No. recognition No. Title of standard \1\ Change
--------------------------------------------------------------------------------------------------------------------------------------------------------
A. Biocompatibility
--------------------------------------------------------------------------------------------------------------------------------------------------------
2-156..................... ............... AAMI/ANSI/ISO 10993-1:2009 Biological evaluation Extent of recognition.
of medical devices--Part 1: Evaluation and
testing within a risk management process.
2-178..................... 2-191 ISO 10993-12 Fourth edition 2012-07-01 Biological Withdrawn and replaced with newer version.
evaluation of medical devices--Part 12: Sample
preparation and reference materials.
2-184..................... 2-192 USP 35-NF30:2012<87> Biological Reactivity Test, Withdrawn and replaced with newer version.
In Vitro--Direct Contact Test.
2-185..................... 2-193 USP 35-NF30:2012 Biological Tests <87> Biological Withdrawn and replaced with newer version.
Reactivity Test, In Vitro--Elution Test.
2-186..................... 2-194 USP 35-NF30:2012 Biological Tests <88> Biological Withdrawn and replaced with newer version.
Reactivity Tests, In Vivo, Procedure Preparation
of Sample.
2-187..................... 2-195 USP 35-NF30:2012 Biological Tests <88> Biological Withdrawn and replaced with newer version.
Reactivity Test, In Vitro, Classification of
Plastics--Intracutaneous Test.
2-188..................... 2-196 USP 35-NF30:2012 Biological Tests <88> Biological Withdrawn and replaced with newer version.
Reactivity Tests, In Vivo, Classification of
Plastics--Systemic Injection Test.
--------------------------------------------------------------------------------------------------------------------------------------------------------
B. Cardiovascular
--------------------------------------------------------------------------------------------------------------------------------------------------------
3-30...................... 3-105 IEC 60601-2-25 Edition 2.0 2011-10 Medical Withdrawn and replaced with newer version.
electrical equipment--Part 2-25: Particular
requirements for the basic safety and essential
performance of electrocardiographs.
3-61...................... ............... IEC 60601-2-27 Edition 3.0 2011-03 Medical Withdrawn, see 3-95.
electrical equipment--Part 2-27: Particular
requirements for the basic safety and essential
performance of electrocardiographic monitoring
equipment.
3-101..................... ............... ANSI/AAMI/ISO 60601-2-27 Edition 3.0 2011-03 Withdrawn, see 3-100.
Medical electrical equipment--Part 2-27:
Particular requirements for the basic safety and
essential performance of electrocardiographic
monitoring equipment.
3-59...................... ............... ISO 5841-3 Second edition 2000-10-15 Implants for Title, processes impacted, related CFR citation(s) and
surgery--Cardiac pacemakers--Part 3: Low-profile procode(s), and relevant guidance.
connectors [IS-1] for implantable pacemakers.
--------------------------------------------------------------------------------------------------------------------------------------------------------
C. Dental/ENT
--------------------------------------------------------------------------------------------------------------------------------------------------------
4-43...................... ............... ADA/ANSI Specification No. 5, Dental Casting Withdrawn, see 4-146.
Alloys: 1997.
4-87...................... 4-196 ANSI/ADA Specification No. 69, 2010 Dental Ceramic Withdrawn and replaced with newer version.
4-94...................... ............... Specification No.14, Dental Base Metal Casting Withdrawn, see 4-146.
Alloys: 1982 (Reaffirmed 1998).
4-96...................... ............... ANSI/ADA Specification No. 30, Reaffirmed by ANSI Reaffirmation.
October 2010 Dental Zinc Oxide-Eugenol and Zinc
Oxide Non-Eugenol Cements.
4-110..................... ............... ADA/ANSI ADA Specification No. 11, Agar Impression Withdrawn.
Materials: 1997.
4-113..................... ............... ADA/ANSI ADA Specification No. 20, Dental Withdrawn.
Duplicating Material; 1972 (Reaffirmed 1995).
4-131..................... 4-198 ISO 3107 Fourth edition 2011-03 Dentistry--Zinc Withdrawn and replaced with newer version.
oxide/Eugenol cements and zinc oxide/non-eugenol
cements.
4-133..................... 4-199 ISO 6876 Third edition 2012-06-01 Dentistry--Root Withdrawn and replaced with newer version.
canal sealing materials.
4-147..................... ............... ADA/ANSI Specification No. 27, Resin-Based Filling Withdrawn.
Materials: 2005.
4-152..................... 4-201 ISO 9693 Second edition 1999-12-15 Metal-ceramic Withdrawn and replaced with newer version.
dental restorative systems.
4-158..................... ............... ISO 10139-1:2005, Dentistry--Soft lining materials Withdrawn--Duplicate, see 4-189.
for removable dentures--Part 1: Materials for
short-term use Technical Corrigendum 1:2006.
4-192..................... 4-202 ANSI/ADA Specification No. 58, 2010 Root Canal Withdrawn and replaced with newer version.
Files, Type H (Hedstrom).
--------------------------------------------------------------------------------------------------------------------------------------------------------
D. General
--------------------------------------------------------------------------------------------------------------------------------------------------------
5-56...................... ............... ISO 15223-2 First edition 2010-01-15 Medical Withdrawn.
devices--Symbols to be used with medical devices
labels, labelling, and information to be
supplied--Part 2: Symbol development, selection
and validation.

[[Page 3000]]

5-68...................... ............... AAMI/ANSI/ISO 15223-2, Medical devices--Symbols to Withdrawn.
be used with medical device labels, labellings,
and information to be supplied--Part 2: Symbol
development, selection and validation.
5-72...................... 5-73 ISO 15223-1 Second Edition 2012-07-01 Medical Withdrawn and replaced with new version.
devices--Symbols to be used with medical device
labels, labelling and information to be supplied--
Part 1: General requirements.
--------------------------------------------------------------------------------------------------------------------------------------------------------
E. General Hospital/General Plastic Surgery
--------------------------------------------------------------------------------------------------------------------------------------------------------
6-13...................... ............... ISO 595-1 First edition 1986-12-15 Reusable all- Contact person and title.
glass or metal-and-glass syringes for medical
use--Part 1: Dimensions.
6-14...................... ............... ISO 595-2 First edition 1987-12-15 Reusable all- Contact person.
glass or metal-and-glass syringes for medical
use--Part 2: Design, performance requirements and
tests.
6-15...................... ............... ISO 7864 Third edition 1993-05-15 Sterile Contact person.
hypodermic needles for single use.
6-107..................... ............... ASTM F 882-84 (Reapproved 2002) Standard Withdrawn.
Performance and Safety Specification for
Cryosurgical Medical Instruments.
6-122..................... ............... ISO 8536-5 Second edition 2004-02-01 Infusion Contact person.
equipment for medical use--Part 5: Burette
infusion sets for single use, gravity feed.
6-148..................... ............... ISO 7886-3 First edition 2005-03-01 Sterile Contact person.
hypodermic syringes for single use--Part 3: Auto-
disable syringes for fixed-dose immunization.
6-170..................... ............... ISO 7886-1 First edition 1993-10-01 Sterile Contact person and title.
hypodermic syringes for single use--Part 1:
Syringes for manual use.
6-203..................... 6-282 ASTM D6499-12 Standard Test Method for The Withdrawn and replaced with newer version.
Immunological Measurement of Antigenic Protein in
Natural Rubber and its Products.
6-204..................... ............... ISO 8537 Second edition 2007-10-01 Sterile single- Contact person.
use syringes, with or without needle, for insulin.
6-255..................... 6-283 USP 35-NF30:2012 Sodium Chloride Irrigation....... Withdrawn and replaced with newer version.
6-256..................... 6-284 USP 35-NF30:2012 Sodium Chloride Injection........ Withdrawn and replaced with newer version.
6-257..................... 6-285 USP 35-NF30:2012 Nonabsorbable Surgical Suture.... Withdrawn and replaced with newer version.
6-258..................... 6-286 USP 35-NF30:2012 <881> Tensile Strength........... Withdrawn and replaced with newer version.
6-259..................... 6-287 USP 35-NF30:2012 <861> Sutures-Diameter........... Withdrawn and replaced with newer version.
6-260..................... 6-288 USP 35-NF30:2012 <871> Sutures-Needle Attachment.. Withdrawn and replaced with newer version.
6-261..................... 6-289 USP 35-NF30:2012 Sterile Water for Irrigation..... Withdrawn and replaced with newer version.
6-262..................... 6-290 USP 35-NF30:2012 Heparin Lock Flush Solution...... Withdrawn and replaced with newer version.
6-623..................... 6-291 USP 35-NF30:2012 Absorbable Surgical Suture....... Withdrawn and replaced with newer version.
--------------------------------------------------------------------------------------------------------------------------------------------------------
F. In Vitro Diagnostics
--------------------------------------------------------------------------------------------------------------------------------------------------------
7-7....................... ............... CLSI/NCCLS LA1-A2 1994 Assessing the Quality of Withdrawn.
Radioimmunoassay Systems--Second Edition;
Approved Guideline.
7-124..................... ............... CLSI/NCCLS I/LA24-A Fluorescence Calibration and Withdrawn.
Quantitative Measurement of Fluorescence
Intensity; Approved Guideline.
7-99...................... 7-232 CLSI MM05-A2 Nucleic Acid Amplification Assays for Withdrawn and replaced with newer version.
Molecular Hematopathology; Approved Guideline--
Second Edition.
7-194..................... 7-233 CLSI EP17-A2 Evaluation of Detection Capability Withdrawn and replaced with newer version.
for Clinical Laboratory Measurement Procedures;
Approved Guideline--Second Edition.
--------------------------------------------------------------------------------------------------------------------------------------------------------
G. Materials
--------------------------------------------------------------------------------------------------------------------------------------------------------
8-117..................... 8-228 ASTM F86-12 Standard Practice for Surface Withdrawn and replaced with a newer version.
Preparation and Marking of Metallic Surgical
Implants.
8-124..................... ............... ASTM F2052-06e1 Standard Test Method for Relevant guidance.
Measurement of Magnetically Induced Displacement
Force on Medical Devices in the Magnetic
Resonance Environment.

[[Page 3001]]

8-128..................... ............... ASTM F2213-06 (Reapproved 2011) Standard Test Relevant guidance.
Method for Measurement of Magnetically Induced
Torque on Medical Devices in the Magnetic
Resonance Environment.
8-153..................... ............... ASTM F2119-07 Standard Test Method for Evaluation Relevant guidance.
of MR Image Artifacts from Passive Implants.
8-176..................... ............... ASTM F2503-08 Standard Practice for Marking Relevant guidance.
Medical Devices and Other Items for Safety in the
Magnetic Resonance Environment.
8-227..................... ............... ASTM F2182-11a Standard Test Method for Relevant guidance .
Measurement of Radio Frequency Induced Heating On
or Near Passive Implants During Magnetic
Resonance Imaging.
8-137..................... 8-229 ASTM F75-12 Standard Specification for Cobalt-28 Withdrawn and replaced with a newer version.
Chromium-6 Molybdenum Alloy Castings and Casting
Alloy for Surgical Implants (UNS R30075).
8-142..................... 8-330 ASTM F1978-12 Standard Test Method for Measuring Withdrawn and replaced with a newer version.
Abrasion Resistance of Metallic Thermal Spray
Coatings by Using the Taber Abraser.
8-155..................... 8-331 ASTM F1580-12 Standard Specification for Titanium Withdrawn and replaced with a newer version.
and Titanium-6 Aluminum-4 Vanadium Alloy Powders
for Coatings of Surgical Implants.
8-209..................... 8-332 ASTM F899-12 Standard Specification for Wrought Withdrawn and replaced with a newer version.
Stainless Steels for Surgical Instruments.
--------------------------------------------------------------------------------------------------------------------------------------------------------
H. OB-GYN/Gastroenterology
--------------------------------------------------------------------------------------------------------------------------------------------------------
9-21...................... ............... IS0 8600-4 First edition 1997-07-01 Optics and Contact person.
optical instruments--Medical endoscopes and
certain accessories--Part 4: Determination of
maximum width of insertion portion.
9-34...................... ............... ISO 4074 First edition 2002-02-15 Corrected Contact person.
version 2002-12-01 Natural latex rubber condoms--
Requirements and test methods.
9-36...................... ............... ISO 8009 First edition 2004-10-01 Mechanical Contact person.
contraceptives--Reusable natural and silicone
rubber contraceptive diaphragms--Requirements and
tests.
9-37...................... ............... ISO 8600-1 Second edition 2005-05-01 Optics and Contact person.
photonics--Medical endoscopes and endotherapy
devices--Part 1: General requirements.
9-39...................... ............... ISO 8600-5 First edition 2005-03-15 Optics and Contact person.
photonics--Medical endoscopes and endotherapy
devices--Part 5: Determination of optical
resolution of rigid endoscopes with optics.
9-40...................... ............... ISO 8600-6 First edition 2005-03-15 Optics and Contact person.
photonics--Medical endoscopes and endotherapy
devices--Part 6: Vocabulary.
9-43...................... ............... ISO 16038 First edition 2005-11-01 Rubber condoms-- Contact person.
Guidance on the use of ISO 4074 in the quality
management of natural rubber latex condoms.
9-56...................... ............... ASTM D 3492-08 Standard Specification for Rubber Contact person.
Contraceptives (Male Condoms).
9-61...................... ............... IEC 60601-2-18 Edition 3.0 2009-08 Medical Contact person.
electrical equipment--Part 2-18: Particular
requirements for the basic safety and essential
performance of endoscopic equipment.
9-58...................... ............... ASTM D6324-08 Standard Test Methods for Male Withdrawn.
Condoms Made from Polyurethane.
--------------------------------------------------------------------------------------------------------------------------------------------------------
I. Ophthalmic
--------------------------------------------------------------------------------------------------------------------------------------------------------
10-56..................... ............... ANSI Z80.12-2007 (R2012) American National Reaffirmation.
Standard for Ophthalmics--Multifocal Intraocular
Lenses.
10-57..................... ............... ANSI Z80.13-2007 (R2012) American National Reaffirmation.
Standard for Ophthalmics--Phakic Intraocular
Lenses.
--------------------------------------------------------------------------------------------------------------------------------------------------------
J. Orthopedics
--------------------------------------------------------------------------------------------------------------------------------------------------------
11-203.................... ............... ASTM F1541-02 (Reapproved 2011) \[euroi]\1 Title.
Standard Specification and Test Methods for
External Skeletal Fixation Devices.
11-216.................... ............... ASTM F1264-03 (Reapproved 2012) Standard Reaffirmation.
Specification and Test Methods for Intramedullary
Fixation Devices.
11-229.................... 11-244 ASTM F2083-11 Standard Specification for Total Withdrawn and replaced with newer version.
Knee Prosthesis.
11-233.................... 11-245 ASTM F384-12 Standard Specifications and Test Withdrawn and replaced with newer version.
Methods for Metallic Angled Orthopedic Fracture
Fixation Devices.

[[Page 3002]]

11-236.................... 11-246 ASTM F1717-12 Standard Test Methods for Spinal Withdrawn and replaced with newer version.
Implant Constructs in a Vertebrectomy Model.
--------------------------------------------------------------------------------------------------------------------------------------------------------
K. Sterility
--------------------------------------------------------------------------------------------------------------------------------------------------------
14-64..................... ............... ASTM F1929-98 (Reapproved 2004) Standard Test Relevant guidance.
Method for Detecting Seal Leaks in Porous Medical
Packaging by Dye Penetration.
14-169.................... ............... ASTM F2391-05 (Reapproved 2011) Standard Test Relevant guidance.
Method for Measuring Package and Seal Integrity
Using Helium as the Tracer Gas.
14-197.................... ............... ASTM F1608-00 (Reapproved 2009) Standard Test Relevant guidance.
Method for Microbial Ranking of Porous Packaging
Materials (Exposure Chamber Method).
14-211.................... 14-362 AOAC 6.2.01:2012 Official Method 955.14 Testing Withdrawn and replaced with newer version.
Disinfectants against Salmonella enterica, Use-
Dilution Method.
14-212.................... ............... AOAC 6.2.02:2006 Official Method 991.47 Testing Relevant guidance.
Disinfectants against Salmonella choleraesuis,
Hard Surface Carrier Test Method.
14-213.................... ............... AOAC 6.2.03:2006 Official Method 991.48 Testing Relevant guidance.
Disinfectants against Staphylococcus aureus, Hard
Surface Carrier Test Method.
14-215.................... ............... AOAC 6.2.05:2006 Official Method 991.49 Testing Relevant guidance.
Disinfectants against Pseudomonas aeruginosa,
Hard Surface Carrier Test Method.
14-216.................... 14-363 AOAC 6.2.06:2012 Official Method 964.02 Testing Withdrawn and replaced with newer version.
Disinfectants against Pseudomonas aeruginosa, Use-
Dilution Method.
14-217.................... ............... AOAC 6.3.02:2006 Official Method 955.17 Fungicidal Relevant guidance.
Activity of Disinfectants Using Trichophyton
mentagrophytes.
14-218.................... ............... AOAC 6.3.05:2006 Official Method 966.04 Sporicidal Relevant guidance.
Activity of Disinfectants Method I.
14-225.................... 14-364 ANSI/AAMI/ISO 11137-2:2012 Sterilization of health Withdrawn and replaced with newer version.
care products--Radiation--Part 2: Establishing
the sterilization dose.
14-229.................... ............... ASTM F1980-07 (Reapproved 2011) Standard Guide for Relevant guidance.
Accelerated Aging of Sterile Barrier Systems for
Medical Devices.
14-235.................... ............... ASTM F1140-07 Standard Test Methods for Internal Relevant guidance.
Pressurization Failure Resistance of Unrestrained
Packages.
14-236.................... ............... ASTM F2054-07 Standard Test Method for Burst Relevant guidance.
Testing of Flexible Package Seals Using Internal
Air Pressurization Within Restraining Plates.
14-238.................... ............... ANSI/AAMI/ISO 11140-5:2007/(R)2012 Sterilization Reaffirmation.
of health care products--Chemical indicators--
Part 5: Class 2 indicators for Bowie and Dick air
removal test sheets and packs.
14-256.................... ............... ASTM F2095-07e1 Standard Test Methods for Pressure Relevant guidance and editorial change.
Decay Leak Test for Flexible Packages With and
Without Restraining Plates.
14-257.................... ............... ASTM D3078-02 (Reapproved 2008) [euro] 1 Standard Relevant guidance and editorial change.
Test Method for Determination of Leaks in
Flexible Packaging by Bubble Emission.
14-278.................... ............... ANSI/AAMI/ISO 10993-7:2008(R)2012 Biological Reaffirmation.
evaluation of medical devices--Part 7: Ethylene
oxide sterilization residuals.
14-282.................... ............... ASTM F2338-09 Standard Test Method for Relevant guidance.
Nondestructive Detection of Leaks in Packages by
Vacuum Decay Method.
14-283.................... ............... ASTM F88/F88M-09 Standard Test Method for Seal Relevant guidance.
Strength of Flexible Barrier Materials.
14-288.................... ............... ASTM F1886/F1886M-09 Standard Test Method for Relevant guidance.
Determining Integrity of Seals for Flexible
Packaging by Visual Inspection.
14-296.................... ............... ANSI/AAMI/ISO 11138-1:2006/(R)2010 Sterilization Relevant guidance, extent of recognition and title.
of health care products--Biological indicators--
Part 1: General requirements.
14-299.................... ............... ASTM F2097-10 Standard Guide for Design and Relevant guidance.
Evaluation of Primary Flexible Packaging for
Medical Products.
14-300.................... ............... ASTM D4169-09 Standard Practice for Performance Relevant guidance.
Testing of Shipping Containers and Systems.
14-313.................... ............... ASTM F2475-11 Standard Guide for Biocompatibility Relevant guidance.
Evaluation of Medical Device Packaging Materials.
14-315.................... 14-366 USP 35-NF30:2012 <61> Microbiological Examination Withdrawn and replaced with newer version.
of Nonsterile Products: Microbial Enumeration
Tests.
14-316.................... 14-367 USP 35-NF30:2012 <71> Sterility Tests............. Withdrawn and replaced with newer version.
14-317.................... 14-368 USP 35-NF30:2012 <85> Bacterial Endotoxins Test... Withdrawn and replaced with newer version.
14-318.................... 14-369 USP 35-NF30:2012 <151> Pyrogen Test (USP Rabbit Withdrawn and replaced with newer version.
Test).

[[Page 3003]]

14-319.................... 14-370 USP 35-NF30:2012 <161> Transfusion and Infusion Withdrawn and replaced with newer version
Assemblies and Similar Medical Devices.
14-320.................... 14-371 USP 35-NF30:2012 Biological Indicator for Steam Withdrawn and replaced with newer version.
Sterilization, Self-Contained.
14-321.................... 14-372 USP 35-NF30:2012 Biological Indicator for Dry-Heat Withdrawn and replaced with newer version.
Sterilization, Paper Carrier.
14-322.................... 14-373 USP 35-NF30:2012 Biological Indicator for Ethylene Withdrawn and replaced with newer version.
Oxide Sterilization, Paper Carrier.
14-323.................... 14-374 USP 35-NF30:2012 Biological Indicator for Steam Withdrawn and replaced with newer version.
Sterilization, Paper Carrier.
14-324.................... 14-375 USP 35-NF30:2012 <62> Microbiological Examination Withdrawn and replaced with newer version.
of Nonsterile Products: Tests for Specified
Microorganisms.
14-329.................... 14-365 ISO 11137-2 Second edition 2012-03-15 Withdrawn and replaced with newer version.
Sterilization of health care products--Radiation--
Part 2: Establishing the sterilization dose.
14-335.................... ............... ISO 10993-7 Second edition 2008-10-15 Biological Extent of recognition and relevant guidance.
evaluation of medical devices--Part 7: Ethylene
oxide sterilization residuals.
14-338.................... ............... ISO 11138-1 Second edition 2006-07-01 Relevant guidance and extent of recognition.
Sterilization of health care products--Biological
indicators--Part 1: General requirements.
14-345.................... ............... ISO/ASTM 51261 First edition 2002-03-15 Guide for Relevant guidance.
selection and calibration of dosimetry systems
for radiation processing.
14-359.................... ............... ASTM F2096-11 Standard Test Method for Detecting Relevant guidance.
Gross Leaks in Packaging by Internal
Pressurization (Bubble Test).
14-360.................... ............... ANSI/AAMI ST72:2011 Bacterial endotoxins--Test Relevant guidance.
methods, routine monitoring, and alternatives to
batch testing.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.

III. Listing of New Entries

In table 3 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: 030.

Table 3--New Entries to the List of Recognized Standards
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recognition No. Title of standard \1\ Reference No. and date
--------------------------------------------------------------------------------------------------------------------------------------------------------
A. Cardiovascular
--------------------------------------------------------------------------------------------------------------------------------------------------------
3-106...................... Medical electrical equipment--Part 2-25: Particular ANSI/AAMI/IEC 60601-2-25:2011.
requirements for the basic safety and essential performance
of electrocardiographs.
3-107...................... Medical electrical equipment--Part 2-30: Particular IEC 80601-2-30 Edition 1.0 2009-01.
requirements for the basic safety and essential performance
of automated non-invasive sphygmomanometers.
3-108...................... Medical electrical equipment--Part 2-30: Particular IEC 80601-2-30 (First edition--2009).
requirements for the basic safety and essential performance
of automated non-invasive sphygmomanometers CORRIGENDUM 1.
3-109...................... Active implantable medical devices--Four-pole connector ANSI/AAMI/ISO 27186:2010.
system for implantable cardiac rhythm management devices--
Dimensional and test requirements.
3-110...................... Active implantable medical devices--Guidance for designation AAMI TIR41:2011.
of left ventricle and implantable cardioverter defibrillator
lead connectors and pulse generator connector cavities for
implantable pacemakers and implantable cardioverter
defibrillators.
3-111...................... Cardiovascular implants--Endovascular devices--Part 3: Vena ANSI/AAMI/ISO 25539-3: 2011.
cava filters.
3-112...................... Cardiovascular implants and artificial organs--Blood-gas ANSI/AAMI/ISO 7199: 2009.
exchangers (oxygenators).
3-113...................... Cardiovascular implants and artificial organs--Blood-gas ISO 7199 Second edition 2009-04-15.
exchangers (oxygenators).
--------------------------------------------------------------------------------------------------------------------------------------------------------
B. Dental/ENT
--------------------------------------------------------------------------------------------------------------------------------------------------------
4-200...................... Dentistry--Mercury and alloys for dental amalgam AMENDMENT 1: ISO 24234 First edition 2004-10-15 AMENDMENT 1 2011-08-15.
Requirements for marking and manufacturer's instructions
concerning mercury.
--------------------------------------------------------------------------------------------------------------------------------------------------------
C. General
--------------------------------------------------------------------------------------------------------------------------------------------------------
5-74....................... Medical electrical equipment--Part 1: General requirements ANSI/AAMI ES60601-1:2005/C1:2009/(R)2012.
for basic safety and essential performance, Amendment 1.
--------------------------------------------------------------------------------------------------------------------------------------------------------
D. General Hospital/General Plastic Surgery
--------------------------------------------------------------------------------------------------------------------------------------------------------
6-292...................... Sterile hypodermic syringes for single use--Part 1: Syringes ISO 7886-1:1993 TECHNICAL CORRIGENDUM 1 Published 1995-11-
for manual use. 01.

[[Page 3004]]

6-293...................... Sharps injury protection--Requirements and test methods-- ISO 23907 First edition 2012-09-01.
Sharps containers.
--------------------------------------------------------------------------------------------------------------------------------------------------------
E. In Vitro Diagnostics
--------------------------------------------------------------------------------------------------------------------------------------------------------
7-234...................... Assessment of the Diagnostic Accuracy of Laboratory Tests CLSI EP24-A2.
Using Receiver Operating Characteristic Curves; Approved
Guideline--Second Edition.
7-235...................... Evaluation of Stability of In Vitro Diagnostic Reagents; CLSI EP25-A.
Approved Guideline.
7-236...................... Methods for Antimicrobial Susceptibility Testing for Human CLSI M43-A.
Mycoplasmas; Approved Guideline.
7-237...................... Molecular Methods for Clinical Genetics and Oncology Testing; CLSI MM01-A3.
Approved Guideline--Third Edition.
7-238...................... Quantitative Molecular Methods for Infectious Diseases; CLSI MM06-A2.
Approved Guideline--Second Edition.
7-239...................... Metrological Traceability and Its Implementation; A Report... CLSI X5-R.
--------------------------------------------------------------------------------------------------------------------------------------------------------
F. Materials
--------------------------------------------------------------------------------------------------------------------------------------------------------
8-333...................... Standard Specification for High-Purity Dense Magnesia ASTM F2393-12.
Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant
Applications.
8-334...................... Standard Test Method for Extracting Residue from Metallic ASTM F2459-12.
Medical Components and Quantifying via Gravimetric Analysis.
--------------------------------------------------------------------------------------------------------------------------------------------------------
G. OB-GYN/Gastroenterology
--------------------------------------------------------------------------------------------------------------------------------------------------------
9-79....................... Water treatment equipment for haemodialysis applications and ISO 26722 First edition 2009-04-15.
related therapies.
9-80....................... Medical electrical equipment--Part 2-16: Particular IEC 60601-2-16 Edition 4.0 2012-03.
requirements for the basic safety and essential performance
of haemodialysis, haemodiafiltration and haemofiltration
equipment.
9-81....................... Mechanical contraceptives--Reusable natural and silicone ISO 8009 First edition 2004-10-01 ISO 8009: 2004/Amd. 1:
rubber contraceptive diaphragms--Requirements and tests. 2012 (E) AMENDMENT 1 2012-02-15
--------------------------------------------------------------------------------------------------------------------------------------------------------
H. Ophthalmic
--------------------------------------------------------------------------------------------------------------------------------------------------------
10-75...................... Ophthalmic implants--Intraocular lenses--Part 7: Clinical ISO 11979-7 Second edition 2006-05-01 AMENDMENT 1 2012-01-
investigations AMENDMENT 1. 15.
10-76...................... Ophthalmic implants--Intraocular lenses--Part 8: Fundamental ISO 11979-8 Second edition 2006-07-01 AMENDMENT 1 2011-05-
requirements AMENDMENT 1. 15.
--------------------------------------------------------------------------------------------------------------------------------------------------------
I. Orthopedic
--------------------------------------------------------------------------------------------------------------------------------------------------------
11-247..................... Standard Guide for Mechanical and Functional Characterization ASTM F2789-10.
of Nucleus Devices.
11-250..................... Implants for surgery--Wear of total hip joint prostheses-- ISO 14242-3 First edition 2009-03-15.
Part 3: Loading and displacement parameters for orbital
bearing type wear testing machines and corresponding
environmental conditions for test.
11-249..................... Implants for surgery--Wear of total hip joint prostheses-- ISO 14242-2 First edition 2000-09-15.
Part 2: Methods of measurement.
11-248..................... Implants for surgery--Wear of total hip joint prostheses-- ISO 14242-1 Second edition 2012-01-15.
Part 1: Loading and displacement parameters for wear-testing
machines and corresponding environmental conditions for test.
11-251..................... Standard Practice for Measurement of Positional Accuracy of ASTM F2554-10.
Computer Assisted Surgical Systems.
--------------------------------------------------------------------------------------------------------------------------------------------------------
J. Radiology
--------------------------------------------------------------------------------------------------------------------------------------------------------
12-250..................... Medical electrical equipment--Part 2-44: Particular IEC 60601-2-44 (Third edition-2009).
requirements for the basic safety and essential performance
of X-ray equipment for computed tomography CORRIGENDUM 1.
12-251..................... Medical electrical equipment--Part 2-44: Particular IEC 60601-2-44 Edition 3.0 2012-08 Amendment 1.
requirements for the basic safety and essential performance
of X-ray equipment for computed tomography.
--------------------------------------------------------------------------------------------------------------------------------------------------------
K. Software/Informatics
--------------------------------------------------------------------------------------------------------------------------------------------------------
13-33...................... Validation of software for regulated processes............... AAMI TIR362007.
13-34...................... Medical device software--Part 1: Guidance on the application IEC/TR 80002-1 Edition 1.0 2009-09.
of ISO 14971 to medical device software.
13-35...................... Application of quality management system concepts to medical ANSI/AAMI SW87 2012.
device data systems.
13-36...................... Guidance on the use of AGILE practices in the development of AAMI TIR45 2012.
medical device software.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 3005]]

L. Sterility
--------------------------------------------------------------------------------------------------------------------------------------------------------
14-376..................... Sterilization of health care products--Moist heat--Part 2: ANSI/AAMI/ISO TIR 17665-2:2009.
Guidance on the application of ANSI/AAMI/ISO 17665-1.
14-377..................... Standard Test Method for Using Aerosol Filtration for ASTM F2638-12.
Measuring the Performance of Porous Packaging Materials as a
Surrogate Microbial Barrier.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 minor 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 minor revisions to the list of recognized consensus standards, as
needed, in the Federal Register once a year, or more often, if
necessary.

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) Title of the standard, (2) any reference
number and date, (3) 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: 030'' 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: 030. These modifications to the list or recognized standards
are effective upon publication of this notice in the Federal Register.

Dated: January 9, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-00605 Filed 1-14-13; 8:45 am]
BILLING CODE 4160-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.