Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 031, 47703-47712 [2013-19019]

Download as PDF Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Notices sanitation control records (§ 123.11(c)) at 280 records per processor for a total of 4,200,000 records. We estimate the burden for the preparation of each record to be 0.10 hours for a total burden of 420,000 hours. We estimate that all importers (4,100 importers) will maintain records that verify that the fish and fishery products they offer for import into the United States were processed in accordance with the HACCP and sanitation provisions set forth in § 123.12(c). FDA estimates that 80 records will be prepared per importer for a total of 328,000 records. FDA estimates the burden for the preparation of each record to be 0.10 hours for a total burden of 32,800 hours. We estimate that 1 percent of all importers (41 importers) will require new written verification procedures to verify compliance of imports (§ 123.12(a)(2)). We estimate the burden for preparing the new procedures to be 4 hours per importer for a total burden of 164 hours. Dated: July 31, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–18837 Filed 8–5–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2004–N–0451] (formerly 2004N–0226) Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 031 AGENCY: Food and Drug Administration, HHS. ACTION: I. Background 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: 031’’ (Recognition List Number: 031), will assist manufacturers tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 19:47 Aug 05, 2013 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: 031’’ 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 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: 031 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. SUPPLEMENTARY INFORMATION: Jkt 229001 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. PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 47703 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: 031 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: 031’’ to identify these current modifications. In table 1, 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, FDA lists modifications the Agency is making that involve the initial addition of standards not previously recognized by FDA. E:\FR\FM\06AUN1.SGM 06AUN1 47704 Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS Old recognition No. Replacement recognition No. Title of standard 1 Change ISO 5360 Third edition 2012–01–15 Anaesthetic vaporizers—Agentspecific filling systems. ISO 5361 Second edition 2012–10–01 Anaesthetic and respiratory equipment—Tracheal tubes and connectors. IEC 60601–2–13 Edition 3.1 2009–08 Medical electrical equipment— Part 2–13: Particular requirements for the safety and essential performance of anaesthetic systems. ISO 80601–2–12 Medical electrical equipment—Part 2–12: Particular requirements for the safety of lung ventilators—Critical care ventilators. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Transition period extended. A. Anesthesia 1–74 .......... 1–91 .................... 1–35 .......... 1–93 .................... 1–82 .......... 1–88 .......... Transition period extended. B. Biocompatibility 2–119 ........ 2–122 ........ 2–123 ........ 2–124 ........ 2–125 ........ 2–197 .................. 2–135 ........ 2–198 .................. 2–146 ........ 2–152 ........ 2–192 ........ 2–199 .................. 2–193 ........ 2–200 .................. 2–194 ........ 2–201 .................. 2–195 ........ 2–202 .................. 2–196 ........ 2–203 .................. ASTM F813–07 (Reapproved 2012) Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices. ASTM F719–81 (Reapproved 2012) Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation. ASTM F720–81 (Reapproved 2012) Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test. ASTM F750–87 (Reapproved 2012) Standard Practice for Evaluating Materials Extracts by Systemic Injection in the Mouse. ASTM F749–13 Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit. ANSI/AAMI/ISO 10993–12:2012 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials. ASTM F2148–07 (Reapproved 2012) Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA). ISO 10993–10:2002/Amd.1:2006(E) Biological evaluation of medical devices—Part 10: Tests for irritation and delayed-type hypersensitivity AMENDMENT 1. USP 36–NF31:2013 <87> Biological Reactivity Test, In Vitro—Direct Contact Test. USP 36–NF31:2013Biological Tests <87> Biological Reactivity Tests, In Vitro—Elution Test. USP 36–NF31:2013 Biological Tests <88> Biological Reactivity Tests, In Vivo Procedure Preparation of Sample. USP 36–NF31:2013 Biological Tests <88> Biological Reactivity Tests, In Vitro Classification of Plastics—Intracutaneous Test. USP 36–NF31:2013 Biological Tests <88> Biological Reactivity Tests, In Vivo Classification of Plastics—Systemic Injection Test. Reaffirmation. Reaffirmation. Reaffirmation. Reaffirmation. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Reaffirmation. Withdrawn, see 2–174. 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 C. Cardiovascular 3–38 .......... 3–115 .................. 3–55 .......... 3–56 .......... 3–66 .......... 3–79 .......... 3–86 .......... tkelley on DSK3SPTVN1PROD with NOTICES 3–87 .......... 3–81 .......... 3–117 .................. 3–94 .......... 3–116 .................. VerDate Mar<15>2010 19:47 Aug 05, 2013 IEC 60601–2–34 Edition 3.0 2011–05 Medical Electrical Equipment— Part 2–34: Particular Requirements for the Basic Safety and Essential Performance of Invasive Blood Pressure Monitoring Equipment. ASTM F1830–97 (Reapproved 2013) Standard Practice for Selection of Blood for In Vitro Evaluation of Blood Pumps. ASTM F1841–97 (Reapproved 2013) Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps. ASTM F2081–06 (Reapproved 2013) Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents. ASTM F2079–09 (Reapproved 2013) Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents. ASTM F2394–07 (Reapproved 2013) Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System. ASTM F2477–07 (Reapproved 2013) Standard Test Methods for in vitro Pulsatile Durability. ANSI/AAMI/ISO 81060–2 Second edition 2013–05–01, Non-Invasive Sphygmomanometers—Part 2: Clinical Validation of Automated Measurement Type. ISO 25539–2 Second edition 2012–12–01 Cardiovascular Implants— Endovascular Devices—Part 2: Vascular Stents Part 2: Vascular Stent. Jkt 229001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\06AUN1.SGM Newer version with transition period. Reaffirmation. Reaffirmation. Reaffirmation. Reaffirmation. Reaffirmation. Reaffirmation. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. 06AUN1 47705 Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. Title of standard 1 Change D. Dental/ENT 4–75 .......... 4–76 .......... 4–83 .......... 4–84 .......... 4–90 .......... 4–119 ........ 4–123 ........ 4–203 .................. 4–167 ........ 4–172 ........ 4–204 .................. 4–187 ........ ISO 7785–1 Second edition 1997–08–01 Dental Handpieces—Part 1: High-Speed Air Turbine Handpieces. ISO 7785–2 Second edition 1995–08–0 Dental Handpieces—Part 2: Straight and Geared Angle Handpieces. ISO 11498 First edition 1997–02–15 Dental Handpieces: Dental LowVoltage Electrical Motors. ISO 13294 First edition 1997–05–01 Dental Handpieces—Dental AirMotors. ANSI S3.39:1987 (Reaffirmed by ANSI June 15, 2012) American National Standard Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance). ANSI/ADA Specification No. 82:1998/ISO 13716:1999 Reaffirmed by ANSI: January 2009 Dental Reversible/Irreversible Hydrocolloid Impression Material Systems. ANSI/ASA S3.6–2010 (Revision of ANSI S3.6–2004) Specification for Audiometers. ANSI/ASA S3.21–2004 (R2009) Methods for Manual Pure-Tone Threshold Audiometry. ANSI/ASA S3.42–2012/Part 2/IEC 60118–15:2012 American National Standard Testing Hearing Aids—Part 2: Methods for characterizing signal processing in hearing aids with a speech-like signal (a nationally adopted international standard). 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. Withdrawn, see 4–206. Withdrawn, see 4–206. Withdrawn, see 4–206. Withdrawn, see 4–206. Reaffirmation. Reaffirmation. Withdrawn and replaced with newer version. Reaffirmation. Withdrawn and replaced with newer version. Transition period extended. E. General 5–53 .......... 5–54 .......... 5–55 .......... 5–76 .................... 5–71 .......... 5–77 .................... 5–74 .......... 5–77 .................... 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. IEC 60601–1–8 Edition 2.1 2012–11 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 ES60601–1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text), Medical electrical equipment—Part 1: General requirements for basic safety and essential performance (IEC 60601–1:2005, MOD). ANSI/AAMI ES60601–1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text), Medical electrical equipment—Part 1: General requirements for basic safety and essential performance (IEC 60601–1:2005, MOD). Transition period extended. Reaffirmation and transition period extended. Withdrawn and replaced with newer version. Transition period extended. Withdrawn and replaced with new version. Withdrawn and replaced with new version. F. General Hospital/General Plastic Surgery 6–300 .................. 6–29 .......... 6–298 .................. 6–32 .......... tkelley on DSK3SPTVN1PROD with NOTICES 6–9 ............ 6–299 .................. 6–116 ........ 6–294 .................. 6–119 ........ 6–295 .................. 6–147 ........ VerDate Mar<15>2010 IEC 60601–2–21 Edition 2.0 2009–02 Medical electrical equipment— Part 2–21: Particular requirements for the basic safety and essential performance of infant radiant warmers. IEC 60601–2–19 Edition 2.0 2009–02 Medical electrical equipment— Part 2–19: Particulars for the basic safety and essential performance of infant incubators. 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 radiant warmers. ISO 11608–3 Second edition 2012–10–01 Needle-based injection systems for medical use—Requirements and test methods—Part 3: Finished containers. ANSI/AAMI BF7:2012 Blood transfusion microfilters ................................ ASTM D6978—05 (Reapproved 2013) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. 19:47 Aug 05, 2013 Jkt 229001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\06AUN1.SGM Newer version with transition period. Newer version with transition period. Newer version with transition period. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Reaffirmation. 06AUN1 47706 Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. 6–174 ........ 6–179 ........ 6–112 ........ 6–296 .................. 6–214 ........ 6–216 ........ 6–227 ........ 6–228 ........ 6–229 ........ 6–230 ........ 6–231 ........ 6–233 ........ 6–234 ........ 6–235 ........ 6–239 ........ 6–240 ........ 6–241 ........ 6–297 .................. 6–274 ........ 6–275 ........ 6–276 ........ Title of standard 1 Change ISO 11608–4 First edition 2006–03–15 Pen-injectors for medical use— Part 4: Requirements and test methods for electronic and electromechanical pen-injectors. ISO 21649 First edition 2006–06–01, Needle-free injectors for medical use—Requirements and test methods. ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. ASTM D6355—07 (Reapproved 2012) Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves. ISO 8536–7 Third edition 2009–01–15 Infusion equipment for medical use—Part 7: Caps made of aluminium-plastics combinations for infusion bottles. ANSI/AAMI/IEC 60601–2–21:2009, Medical electrical equipment—Part 2–21: Particular requirements for the basic safety and essential performance of infant radiant warmers. IEC 60601–2–2 Edition 5.0 2009–02, Medical Electrical Equipment— Part 2–2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories. ANSI/AAMI/IEC 60601–2–2:2009, Medical electrical equipment—Part 2–2: Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories. ANSI/AAMI/IEC 60601–2–19:2009, Medical Electrical Equipment—Part 2–19: Particular requirements for the basic safety and essential performance of infant incubators. ANSI/AAMI/IEC 60601–2–20:2009, Medical Electrical Equipment—Part 2–20: Particular requirements for the basic safety and essential performance of infant transport incubators. 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 60601–2–50 Edition 2.0 2009–03 Medical electrical equipment— Part 2–50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment. ANSI/AAMI/IEC 60601–2–50:2009 Medical Electrical Equipment—Part 2–50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment. ISO 8536–6 Second edition 2009–11–15 Infusion equipment for medical use—Part 6: Freeze drying closures for infusion bottles. ISO 8536–3 Third edition 2009–06–01 Infusion equipment for medical use—Part 3: Aluminum caps for infusion bottles. ISO 1135–4 Fifth edition 2012–03–01 Transfusion equipment for medical use—Part 4: Transfusion sets for single use. ISO 11608–1 Second edition 2012–04–01 Needle-based injection systems for medical use—Requirements and test methods—Part 1: Needle-based injection systems. ISO 11608–2 Second edition 2012–04–01 Needle-based injection systems for medical use—Requirements and test methods—Part 2: Needles. ISO 8536–1 Fourth edition 2011–09–01 Infusion equipment for medical use—Part 1: Infusion glass bottles. Contact person. Contact person. Withdrawn and replaced with newer version. Reaffirmation. Contact person. Transition period extended. Transition period extended. Transition period extended. Transition period extended. Transition period extended. Transition period extended. Contact person. Contact person. Contact person. Contact person. Withdrawn and replaced with newer version. Contact person. Contact person. Contact person. G. In Vitro Diagnostics 7–3 ............ CLSI/NCCLS GP10–A 1995, Assessment of the Clinical Accuracy of Laboratory Tests Using Receiver Operating Characteristic (ROC) Plots; Approved Guideline. CLSI/NCCLS GP14–A 1996, Labeling of Home-Use In Vitro Testing Products; Approved Guideline. NCCLS I/LA6–A, Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Specimen Handling, and Use of Test Products in the Clinical Laboratory; Approved Guideline. NCCLS I/LA19–A, Primary Reference Preparations Used to Standardize Calibration of Immunochemical Assays for Serum Prostate Specific Antigen (PSA); Approved Guideline (1997). CLSI MM02–A2, Immunoglobulin and T-Cell Receptor Gene Rearrangement Assays. 7–4 ............ tkelley on DSK3SPTVN1PROD with NOTICES 7–37 .......... 7–41 .......... 7–154 ........ VerDate Mar<15>2010 19:47 Aug 05, 2013 Jkt 229001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\06AUN1.SGM Withdrawn, see 7–234. Withdrawn. Withdrawn. Withdrawn. Withdrawn. 06AUN1 47707 Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. 7–171 ........ 7–178 ........ 7–179 ........ 7–240 .................. 7–200 ........ 7–206 ........ 7–215 ........ 7–217 ........ 7–218 ........ 7–222 ........ 7–228 ........ 7–229 ........ 7–230 ........ 7–231 ........ 7–241 .................. 7–234 ........ Title of standard 1 Change CLSI M38–A2, Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi; Approved Standard—Second Edition. CLSI M22–A3, Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard—Third Edition. CLSI M27–S4, Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Fourth Informational Supplement. CLSI M48–A, Laboratory Detection and Identification of Mycobacteria; Approved Guideline. CLSI I/LA 20–A2 Analytical Performance Characteristics and Clinical Utility of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies and Defined Allergen Specificities; Approved Guideline— Second Edition. CLSI M44–A2, Method for Antifungal Disk Diffusion Susceptibility Testing of Yeast; Approved Guideline—Second Edition.. CLSI M44–S3, Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Third Informational Supplement. CLSI M45–A2, Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline—Second Edition. CLSI M24–A2, Susceptibility Testing of Mycobacteria, Nocardiae and other Aerobic Actinomycetes; Approved Standards—Second Edition. Extent of recognition, process affected, and contact person. CLSI M11–A8, Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard—Eighth Edition. CLSI M02–A11, Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard—Eleventh Edition. CLSI M07–A9, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard—Ninth Edition. CLSI M100–S23, Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Third Informational Supplement. CLSI EP24–A2, Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline—Second Edition. Extent of recognition, process affected, and contact person. Withdrawn and replaced with newer version. Extent of recognition, type of standard, and process affected. Relevant guidance. Extent of recognition, process affected, and contact person. Extent of recognition, process affected, and contact person. Extent of recognition and process affected. Extent of recognition, process affected, contact person, and title and type of standard. Extent of recognition, process affected, and contact person. Extent of recognition, process affected, and contact person. Extent of recognition, process affected, and contact person. Withdrawn and replaced with newer version. Extent of recognition. H. Materials 8–122 ........ 8–335 .................. 8–147 ........ 8–336 .................. 8–153 ........ 8–154 ........ 8–337 .................. 8–156 ........ 8–338 .................. 8–158 ........ 8–339 .................. 8–203 ........ 8–340 .................. 8–219 ........ tkelley on DSK3SPTVN1PROD with NOTICES 8–166 ........ 8–341 .................. 8–222 ........ 8–342 .................. 8–332 ........ 8–343 .................. VerDate Mar<15>2010 19:47 Aug 05, 2013 ASTM F2063–12 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants. ASTM F562–13 Standard Specification for Wrought 35Cobalt-35Nickel20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035). ASTM F2119–07 (Reapproved 2013) Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants. ASTM F621–12 Standard Specification for Stainless Steel Forgings for Surgical Implants. ASTM F139–12 Standard Specification for Wrought 18Chromium14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673). ASTM F1713–08 (Reapproved 2013) Standard Specification for Wrought Titanium-13Niobium-13 Zirconium Alloy for Surgical Implant Applications (UNS R58130). ASTM F1091–12 Standard Specification for Wrought Cobalt20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605). ASTM F2026–12 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications. ASTM F136–12a Standard Specification for Wrought Titanium6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). ASTM F1537–11 Standard Specification for Wrought Cobalt28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539). ASTM F899–12b Standard Specification for Wrought Stainless Steels for Surgical Instruments. Jkt 229001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\06AUN1.SGM Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Reaffirmation. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Reaffirmation. 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. 06AUN1 47708 Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. Title of standard 1 Change I. OB–GYN/Gastroenterology 9–31 .......... 9–60 .......... 9–61 .......... 9–72 .......... 9–81 .................... 9–62 .......... 9–63 .......... 9–64 .......... 9–80 .......... ANSI/AAMI ID54:1996/(R)2012 Enteral feeding set adapters and connectors. IEC 60601–2–16 Edition 3.0 2008–04 Medical electrical equipment— Part 2–16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration. 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. ANSI/AAMI/IEC 60601–2–16:2012 Medical electrical equipment—Part 2–16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment. IEC 60601–2–2 Edition 5.0 2009–02 Medical electrical equipment—Part 2–2: Particular requirements for the basic safety and essential performance of frequency surgical equipment and high frequency surgical accessories. IEC 60601–2–16 (Third edition—2008), Medical electrical equipment— Part 2–16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment CORRIGENDUM 1. ANSI/AAMI/IEC 60601–2–2:2009 Medical electrical equipment—Part 2– 2: Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories. IEC 60601–2–16 Edition 4.0 2012–03 Medical electrical equipment— Part 2–16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment. Reaffirmation. Withdrawn, see 9–80. Transition period extended. Newer version with transition period. Transition period extended. Withdrawn, see 9–80. Transition period extended. Transition period extended. J. Ophthalmic 10–15 ........ 10–77 .................. 10–36 ........ 10–78 .................. 10–40 ........ 10–79 .................. 10–45 ........ 10–80 .................. 10–56 ........ 10–57 ........ 10–76 ........ ISO 9394 Third edition 2012–10–01 Ophthalmic optics—Contact lenses and contact lens care products—Determination of biocompatibility by ocular study with rabbit eyes. ISO 11979–3 Third edition 2012–12–01 Ophthalmic implants—Intraocular lenses—Part 3: Mechanical properties and test methods. ISO 11979–1 Third edition 2012–09–15 Ophthalmic implants—Intraocular lenses—Part 1: Vocabulary. ISO 18369–2 Second edition 2012–12–01 Ophthalmic optics—Contact lenses—Part 2: Tolerances. 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 11979–8 Second edition 2006–07–01 AMENDMENT 1 2011–05– 15 Ophthalmic implants—Intraocular lenses—Part 8: Fundamental requirements. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Reaffirmation. Reaffirmation. Withdrawn. K. Orthopedics 11–73 ........ 11–252 ................ 11–206 ...... 11–253 ................ 11–208 ...... 11–254 ................ 11–213 ...... 11–215 ...... tkelley on DSK3SPTVN1PROD with NOTICES 11–242 ...... 11–246 ...... 11–255 ................ ISO 5838–1 Third edition 2013–03–01 Implants for surgery—Metallic skeletal pins and wires—Part 1: General requirements. ASTM F1800–12 Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements. ISO 14630 Fourth edition 2012–12–01 Non-active surgical implants— General requirements. ASTM F1223–08 (Reapproved 2012) Standard Test Method for Determination of Total Knee Replacement Constraint. ASTM F897–02 (Reapproved 2013) Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws. ASTM F1839–08 (Reapproved 2012) Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments. ASTM F1717–13 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model. Withdrawn and replaced with a newer version. Withdrawn and replaced with a newer version. Withdrawn and replaced with a newer version. Reaffirmation. Reaffirmation. Reaffirmation. Withdrawn and replaced with a newer version. L. Physical Medicine 16–24 ........ VerDate Mar<15>2010 16–190 ................ 19:47 Aug 05, 2013 ISO 7176–11 Second edition 2012–12–01 Wheelchairs—Part 11: Test dummies. Jkt 229001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\06AUN1.SGM Withdrawn and replaced with a newer version. 06AUN1 47709 Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. Title of standard 1 Change 16–28 ........ 16–191 ................ 16–50 ........ 16–192 ................ ISO 7176–16 Second edition 2012–12–01 Wheelchairs—Part 16: Resistance to ignition of postural support devices. ISO 7176–3 Third edition 2012–12–15 Wheelchairs—Part 3: Determination of effectiveness of brakes. Withdrawn and replaced with a newer version. Withdrawn and replaced with a newer version. M. Radiology 12–34 ........ 12–201 ................ 12–54 ........ 12–254 ................ 12–127 ...... 12–201 ................ 12–133 ...... 12–255 ................ 12–202 ...... 12–203 ...... 12–256 ................ 12–204 ...... 12–205 ...... 12–206 ...... 12–207 ...... 12–208 ...... 12–209 ...... 12–210 ...... 12–211 ...... 12–224 ...... 12–236 ...... tkelley on DSK3SPTVN1PROD with NOTICES 12–250 ...... IEC 60601–2–54 Edition 1.0 2009–06 Medical electrical equipment— Part 2–54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy. IEC 60601–2–8 Edition 2.0 2010–11 Medical electrical equipment—Part 2–8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV. IEC 60601–2–54 Edition 1.0 2009–06 Medical electrical equipment— Part 2–54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy. IEC 60601–2–11 Edition 3.0 2013–01 Medical electrical equipment— Part 2–11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment. IEC 60601–2–43 Edition 2.0 2010–03 Medical electrical equipment— Part 2–43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures. IEC 60601–2–44 Edition 3.1 2012–09 Medical electrical equipment— Part 2–44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography. IEC 60601–2–28 Edition 2.0 2010–03 Medical electrical equipment— Part 2–28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis. IEC 60601–2–5 Edition 3.0 2009–07 Medical electrical equipment—Part 2–5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment. IEC 60601–2–1 Edition 3.0 2009–10 Medical electrical equipment—Part 2–1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV. IEC 60601–2–33 Edition 3.0 2010–03 Medical electrical equipment— Part 2–33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnostic. IEC 60601–2–22 Third Edition 2007–05 Medical electrical equipment— Part 2–22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment. IEC 60601–2–37 Edition 2.0 2007–08 Medical electrical equipment— Part 2–37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. IEC 60601–1–3 Edition 2.0 2008–01 Medical electrical equipment—Part 1–3: General requirements for basic safety and essential performance—Collateral Standard: Radiation protection in diagnostic X-ray equipment. IEC 60601–2–29 Edition 3.0 2008–06 Medical electrical equipment Part 2–29: Particular requirements for the basic safety and essential performance of radiotherapy simulators. IEC 60601–2–44 (Third edition -2009) Medical electrical equipment— Part 2–44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography CORRIGENDUM 1. IEC 60601–2–45 Edition 3.0 2011–02 Medical electrical equipment— Part 2–45: Particular requirements for the safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices. IEC 60601–2–44 Edition 3.0 2012–08 Amendment 1 Medical electrical equipment—Part 2–44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography. Newer version with transition period. Newer version with extended transition period. Newer version with transition period. Newer version with transition period. Transition period extended. Newer version with extended transition period. Transition period extended. Transition period extended. Transition period extended. Transition period extended. Transition period extended. Transition period extended. Transition period extended. Transition period extended. Withdrawn, see 12–256. Transition period extended. Withdrawn, see 12–256. N. Sterility 14–64 ........ VerDate Mar<15>2010 14–378 ................ 19:47 Aug 05, 2013 ASTM F1929–12 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration. Jkt 229001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\06AUN1.SGM Withdrawn and replaced with newer version. 06AUN1 47710 Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. 14–230 ...... 14–231 ...... 14–235 ...... 14–236 ...... 14–244 ...... 14–379 ................ 14–264 ...... 14–275 ...... 14–281 ...... 14–380 ................ 14–295 ...... 14–311 ...... 14–312 ...... 14–394 ................ 14–341 ...... 14–345 ...... 14–381 ................ 14–346 ...... 14–382 ................ 14–347 ...... 14–383 ................ 14–349 ...... 14–350 ...... 14–351 ...... Title of standard 1 Change ASTM F2203–02 (Reapproved 2012) Standard Test Method for Linear Measurement Using Precision Steel Rule. ASTM F2217–02 (Reapproved 2012) Standard Practice for Coating/Adhesive Weight Determination. ASTM F1140 -07 (Reapproved 2012) Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages. ASTM F2054–07 (Reapproved 2012) Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates. ISO 14644–8 Second edition 2013–02–15 Cleanrooms and associated controlled environments—Part 8: Classification of air cleanliness by chemical concentration (ACC). ANSI/AAMI ST8:2008 Hospital steam sterilizers ...................................... ANSI/AAMI ST41:2008/(R)2012 Ethylene oxide sterilization in health care facilities: Safety and effectiveness. ASTM F17–12 Standard Terminology Relating to Flexible Barrier Packaging. ANSI/AAMI ST81:2004/(R)2010 Sterilization of medical devices—Information to be provided by the manufacturer for the processing of resterilizable medical devices. ANSI/AAMI ST55:2010 Table-top steam sterilizers .................................. ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 (Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ASTM E2303–11 Ö1 Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities. ISO/ASTM 51261 Second edition 2013–04–15 Practice for calibration of routine dosimetry systems for radiation processing. ISO/ASTM 51276 Third edition 2012–07–15 Practice for use of a polymethylmethacrylate dosimetry system. ISO/ASTM 51702 Third edition 2013–04–15 Practice for dosimetry in a gamma facility for radiation processing. ANSI/AAMI/ISO 13408–3:2006/(R)2012 Aseptic processing of health care products—Part 3: Lyophilization. ANSI/AAMI/ISO 13408–4:2005/(R)2012 Aseptic processing of health care products—Part 4: Clean-in-place technologies. ANSI/AAMI/ISO 13408–5:2006/(R)2012 Aseptic processing of health care products—Part 5: Sterilization in place. Reaffirmation. Reaffirmation. Reaffirmation. Reaffirmation. Withdrawn and replaced with newer version. Contact person. Reaffirmation. Withdrawn and replaced with newer version. Relevant guidance. Contact person Withdrawn and replaced with newer version. Editorial change. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Reaffirmation. Reaffirmation. Reaffirmation. O. Tissue Engineering 15–5 .......... 15–37 .................. 15–14 ........ 15–29 ........ 15–32 ........ 1 All ASTM F2347—11 Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications. ASTM F2603 ¥06 (Reapproved 2012) Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds. ASTM F2259 ¥10 (Reapproved 2012) Ö1 Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy. ASTM F2260 ¥03 (Reapproved 2012) Ö1 Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy. Withdrawn and replaced with newer version. Reaffirmation. Reaffirmation. Reaffirmation. standard titles in this table conform to the style requirements of the respective organizations. III. Listing of New Entries In table 2, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 031. tkelley on DSK3SPTVN1PROD with NOTICES TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS Recognition No. Title of standard 1 Reference No. and Date A. Anesthesia 1–90 ......... VerDate Mar<15>2010 Oxygen concentrators for medical use—Safety requirements ........................................ 19:47 Aug 05, 2013 Jkt 229001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 ISO 8359 Second edition 1996–12–15 Amendment 1 2012–07–01 E:\FR\FM\06AUN1.SGM 06AUN1 Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Notices 47711 TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued Recognition No. Title of standard 1 Reference No. and Date 1–92 ......... Sleep apnoea breathing therapy—Part 2: Masks and application accessories ............. ISO 17510–2 Second edition 2007–10–01 B. Dental/ENT 4–205 ....... Dentistry—Handpieces and motors ................................................................................. ISO 14457 First edition 2012–09–15 C. General 5–75 ......... Medical devices—Symbols to be used with medical device labels, labeling, and information to be supplied—Part 1: General requirements. ANSI/AAMI/ISO 15223–1 2012 D. In Vitro Diagnostics 7–242 ....... 7–243 ....... Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis; Approved Guideline. Method for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi; Approved Guideline. CLSI C56–A CLSI M51–A E. Neurology 17–11 ....... Medical electrical equipment—Part 2–10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators. IEC 60601–2–10 Edition 2.0 2012–06 F. Radiology 12–251 ..... 12–252 ..... 12–253 ..... Medical electrical equipment—Part 2–63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment. Medical electrical equipment—Part 2–65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment. Medical electrical equipment—Medical electron accelerators—Functional performance characteristics. IEC 60601–2–63 Edition 1.0 2012–09 IEC 60601–2–65 Edition 1.0 2012–09 IEC 60976 Edition 2.0 2007–10 G. Software/Informatics 13–37 ....... Laboratory Automation: Data Content for Specimen Identification; Approved Standard NCCLS AUTO7–A H. Sterility 14–384 ..... Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals 14–385 ..... 14–386 ..... 14–387 ..... Aseptic processing of health care products—Part 1: General requirements .................. Aseptic processing of health care products—Part 1: General requirements .................. Aseptic processing of health care products—Part 7: Alternate processes for medical devices and combination products. Aseptic processing of health care products—Part 7: Alternate processes for medical devices and combination products. Cleanrooms and associated controlled environments—Part 9: Classification of surface cleanliness by particle concentration. Cleanrooms and associated controlled environments—Part 10: Classification of surface cleanliness by chemical concentration. Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing .... 14–388 ..... 14–389 ..... 14–390 ..... 14–391 ..... 14–392 ..... 14–393 ..... Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV. Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV. ISO 10993–7:2008 TECHNICAL CORRIGENDUM 1 Published 2009–11–15 ANSI/AAMI/ISO 13408–1:2008/(R2011) ISO 13408–1 Second edition 2008–06–15 ANSI/AAMI/ISO 13408–7:2012 ISO 13408–7 First edition 2012–08–01 ISO 14644–9 First edition 2012–08–15 ISO 14644–10 First edition 2013–03–01 ISO/ASTM 51608 Second edition 2005– 05–15 ISO/ASTM 51649 Second edition 2005– 05–15 ISO/ASTM 51818 Second edition 2009– 06–15 I. Tissue Engineering 15–38 ....... tkelley on DSK3SPTVN1PROD with NOTICES 1 All Standard Guide for Characterization of Ceramic and Mineral Based Scaffolds used for Tissue-Engineered Medical Products (TEMPs) and as Device for Surgical Implant Applications. ATSM F2883—11 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 VerDate Mar<15>2010 19:47 Aug 05, 2013 Jkt 229001 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 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 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 E:\FR\FM\06AUN1.SGM 06AUN1 47712 Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Notices recognized consensus standards, as needed, in the Federal Register once a year, or more often, if necessary. Beginning with Recognition List Number: 033, FDA will no longer be announcing minor revisions to the list of recognized consensus standards such as technical contact person, relevant guidance, processes affected, CFR citations, and product codes. tkelley on DSK3SPTVN1PROD with NOTICES 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: 031’’ 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 VerDate Mar<15>2010 19:47 Aug 05, 2013 Jkt 229001 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: 031. These modifications to the list of recognized standards are effective upon publication of this notice in the Federal Register. Dated: July 31, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–19019 Filed 8–5–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2004–N–0451] (formerly 2004N–0226) Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 032 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). Specifically, this publication announces the addition of a list of recognized standards that are relevant to interoperability of medical devices. This publication, entitled ‘‘Modifications to the List of Recognized Standards, Recognition List Number: 032’’ (Recognition List Number: 032), 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 SUMMARY: PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 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: 032’’ 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 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: 032 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. SUPPLEMENTARY INFORMATION: 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/ E:\FR\FM\06AUN1.SGM 06AUN1

Agencies

[Federal Register Volume 78, Number 151 (Tuesday, August 6, 2013)]
[Notices]
[Pages 47703-47712]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-19019]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0451] (formerly 2004N-0226)

Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 031

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: 031'' (Recognition List Number: 031), 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: 031'' 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:
031 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.

SUPPLEMENTARY INFORMATION:

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: 031

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: 031'' to identify these current
modifications.
In table 1, 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, FDA lists modifications the Agency is making that
involve the initial addition of standards not previously recognized by
FDA.

[[Page 47704]]

Table 1--Modifications to the List of Recognized Standards
------------------------------------------------------------------------
Old
recognition Replacement Title of standard \1\ Change
No. recognition No.
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
1-74.......... 1-91............ ISO 5360 Third Withdrawn and
edition 2012-01-15 replaced with
Anaesthetic newer version.
vaporizers--Agent-
specific filling
systems.
1-35.......... 1-93............ ISO 5361 Second Withdrawn and
edition 2012-10-01 replaced with
Anaesthetic and newer version.
respiratory
equipment--Tracheal
tubes and connectors.
1-82.......... IEC 60601-2-13 Transition
Edition 3.1 2009-08 period
Medical electrical extended.
equipment--Part 2-
13: Particular
requirements for the
safety and essential
performance of
anaesthetic systems.
1-88.......... ISO 80601-2-12 Transition
Medical electrical period
equipment--Part 2- extended.
12: Particular
requirements for the
safety of lung
ventilators--Critica
l care ventilators.
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
2-119......... ASTM F813-07 Reaffirmation.
(Reapproved 2012)
Standard Practice
for Direct Contact
Cell Culture
Evaluation of
Materials for
Medical Devices.
2-122......... ASTM F719-81 Reaffirmation.
(Reapproved 2012)
Standard Practice
for Testing
Biomaterials in
Rabbits for Primary
Skin Irritation.
2-123......... ASTM F720-81 Reaffirmation.
(Reapproved 2012)
Standard Practice
for Testing Guinea
Pigs for Contact
Allergens: Guinea
Pig Maximization
Test.
2-124......... ASTM F750-87 Reaffirmation.
(Reapproved 2012)
Standard Practice
for Evaluating
Materials Extracts
by Systemic
Injection in the
Mouse.
2-125......... 2-197........... ASTM F749-13 Standard Withdrawn and
Practice for replaced with
Evaluating Material newer version.
Extracts by
Intracutaneous
Injection in the
Rabbit.
2-135......... 2-198........... ANSI/AAMI/ISO 10993- Withdrawn and
12:2012 Biological replaced with
evaluation of newer version.
medical devices--
Part 12:Sample
preparation and
reference materials.
2-146......... ASTM F2148-07 Reaffirmation.
(Reapproved 2012)
Standard Practice
for Evaluation of
Delayed Contact
Hypersensitivity
Using the Murine
Local Lymph Node
Assay (LLNA).
2-152......... ISO 10993-10:2002/ Withdrawn, see
Amd.1:2006(E) 2-174.
Biological
evaluation of
medical devices--
Part 10: Tests for
irritation and
delayed-type
hypersensitivity
AMENDMENT 1.
2-192......... 2-199........... USP 36-NF31:2013 <87> Withdrawn and
Biological replaced with
Reactivity Test, In newer version.
Vitro--Direct
Contact Test.
2-193......... 2-200........... USP 36- Withdrawn and
NF31:2013Biological replaced with
Tests <87> newer version.
Biological
Reactivity Tests, In
Vitro--Elution Test.
2-194......... 2-201........... USP 36-NF31:2013 Withdrawn and
Biological Tests replaced with
<88> Biological newer version.
Reactivity Tests, In
Vivo Procedure
Preparation of
Sample.
2-195......... 2-202........... USP 36-NF31:2013 Withdrawn and
Biological Tests replaced with
<88> Biological newer version.
Reactivity Tests, In
Vitro Classification
of Plastics--
Intracutaneous Test.
2-196......... 2-203........... USP 36-NF31:2013 Withdrawn and
Biological Tests replaced with
<88> Biological newer version.
Reactivity Tests, In
Vivo Classification
of Plastics--
Systemic Injection
Test.
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
3-38.......... 3-115........... IEC 60601-2-34 Newer version
Edition 3.0 2011-05 with
Medical Electrical transition
Equipment--Part 2- period.
34: Particular
Requirements for the
Basic Safety and
Essential
Performance of
Invasive Blood
Pressure Monitoring
Equipment.
3-55.......... ASTM F1830-97 Reaffirmation.
(Reapproved 2013)
Standard Practice
for Selection of
Blood for In Vitro
Evaluation of Blood
Pumps.
3-56.......... ASTM F1841-97 Reaffirmation.
(Reapproved 2013)
Standard Practice
for Assessment of
Hemolysis in
Continuous Flow
Blood Pumps.
3-66.......... ASTM F2081-06 Reaffirmation.
(Reapproved 2013)
Standard Guide for
Characterization and
Presentation of the
Dimensional
Attributes of
Vascular Stents.
3-79.......... ASTM F2079-09 Reaffirmation.
(Reapproved 2013)
Standard Test Method
for Measuring
Intrinsic Elastic
Recoil of Balloon-
Expandable Stents.
3-86.......... ASTM F2394-07 Reaffirmation.
(Reapproved 2013)
Standard Guide for
Measuring Securement
of Balloon
Expandable Vascular
Stent Mounted on
Delivery System.
3-87.......... ASTM F2477-07 Reaffirmation.
(Reapproved 2013)
Standard Test
Methods for in vitro
Pulsatile Durability.
3-81.......... 3-117........... ANSI/AAMI/ISO 81060-2 Withdrawn and
Second edition 2013- replaced with
05-01, Non-Invasive newer version.
Sphygmomanometers--P
art 2: Clinical
Validation of
Automated
Measurement Type.
3-94.......... 3-116........... ISO 25539-2 Second Withdrawn and
edition 2012-12-01 replaced with
Cardiovascular newer version.
Implants--Endovascul
ar Devices--Part 2:
Vascular Stents Part
2: Vascular Stent.
------------------------------------------------------------------------

[[Page 47705]]

D. Dental/ENT
------------------------------------------------------------------------
4-75.......... ISO 7785-1 Second Withdrawn, see
edition 1997-08-01 4-206.
Dental Handpieces--
Part 1: High-Speed
Air Turbine
Handpieces.
4-76.......... ISO 7785-2 Second Withdrawn, see
edition 1995-08-0 4-206.
Dental Handpieces--
Part 2: Straight and
Geared Angle
Handpieces.
4-83.......... ISO 11498 First Withdrawn, see
edition 1997-02-15 4-206.
Dental Handpieces:
Dental Low-Voltage
Electrical Motors.
4-84.......... ISO 13294 First Withdrawn, see
edition 1997-05-01 4-206.
Dental Handpieces--
Dental Air-Motors.
4-90.......... ANSI S3.39:1987 Reaffirmation.
(Reaffirmed by ANSI
June 15, 2012)
American National
Standard
Specifications for
Instruments to
Measure Aural
Acoustic Impedance
and Admittance
(Aural Acoustic
Immittance).
4-119......... ANSI/ADA Reaffirmation.
Specification No.
82:1998/ISO
13716:1999
Reaffirmed by ANSI:
January 2009 Dental
Reversible/
Irreversible
Hydrocolloid
Impression Material
Systems.
4-123......... 4-203........... ANSI/ASA S3.6-2010 Withdrawn and
(Revision of ANSI replaced with
S3.6-2004) newer version.
Specification for
Audiometers.
4-167......... ANSI/ASA S3.21-2004 Reaffirmation.
(R2009) Methods for
Manual Pure-Tone
Threshold Audiometry.
4-172......... 4-204........... ANSI/ASA S3.42-2012/ Withdrawn and
Part 2/IEC 60118- replaced with
15:2012 American newer version.
National Standard
Testing Hearing
Aids--Part 2:
Methods for
characterizing
signal processing in
hearing aids with a
speech-like signal
(a nationally
adopted
international
standard).
4-187......... IEC 60601-2-18 Transition
Edition 3.0 2009-08 period
Medical electrical extended.
equipment--Part 2-
18: Particular
requirements for the
basic safety and
essential
performance of
endoscopic equipment.
------------------------------------------------------------------------
E. General
------------------------------------------------------------------------
5-53.......... IEC 60601-1-2 Edition Transition
3.0 2007-03 Medical period
electrical extended.
equipment--Part 1-2:
General requirements
for basic safety and
essential
performance--Collate
ral standard:
Electromagnetic
compatibility--Requi
rements and tests.
5-54.......... ANSI/AAMI/IEC 60601-1- Reaffirmation
2:2007/(R)2012 and transition
Medical electrical period
equipment--Part 1-2: extended.
General requirements
for basic safety and
essential
performance--Collate
ral standard:
Electromagnetic
compatibility--Requi
rements and tests.
5-55.......... 5-76............ IEC 60601-1-8 Edition Withdrawn and
2.1 2012-11 Medical replaced with
electrical newer version.
equipment--Part 1-8: Transition
General requirements period
for basic safety and extended.
essential
performance--Collate
ral standard:
General
requirements, tests,
and guidance for
alarm systems in
medical electrical
equipment and
medical electrical
systems.
5-71.......... 5-77............ ANSI/AAMI ES60601- Withdrawn and
1:2005/(R)2012 and replaced with
A1:2012, C1:2009/ new version.
(R)2012 and A2:2010/
(R)2012
(Consolidated Text),
Medical electrical
equipment--Part 1:
General requirements
for basic safety and
essential
performance (IEC
60601-1:2005, MOD).
5-74.......... 5-77............ ANSI/AAMI ES60601- Withdrawn and
1:2005/(R)2012 and replaced with
A1:2012, C1:2009/ new version.
(R)2012 and A2:2010/
(R)2012
(Consolidated Text),
Medical electrical
equipment--Part 1:
General requirements
for basic safety and
essential
performance (IEC
60601-1:2005, MOD).
------------------------------------------------------------------------
F. General Hospital/General Plastic Surgery
------------------------------------------------------------------------
6-9........... 6-300........... IEC 60601-2-21 Newer version
Edition 2.0 2009-02 with
Medical electrical transition
equipment--Part 2- period.
21: Particular
requirements for the
basic safety and
essential
performance of
infant radiant
warmers.
6-29.......... 6-298........... IEC 60601-2-19 Newer version
Edition 2.0 2009-02 with
Medical electrical transition
equipment--Part 2- period.
19: Particulars for
the basic safety and
essential
performance of
infant incubators.
6-32.......... 6-299........... IEC 60601-2-20 Newer version
Edition 2.0 2009-02 with
Medical electrical transition
equipment--Part 2- period.
20: Particular
requirements for the
basic safety and
essential
performance of
infant radiant
warmers.
6-116......... 6-294........... ISO 11608-3 Second Withdrawn and
edition 2012-10-01 replaced with
Needle-based newer version.
injection systems
for medical use--
Requirements and
test methods--Part
3: Finished
containers.
6-119......... 6-295........... ANSI/AAMI BF7:2012 Withdrawn and
Blood transfusion replaced with
microfilters. newer version.
6-147......... ASTM D6978--05 Reaffirmation.
(Reapproved 2013)
Standard Practice
for Assessment of
Resistance of
Medical Gloves to
Permeation by
Chemotherapy Drugs.

[[Page 47706]]

6-174......... ISO 11608-4 First Contact person.
edition 2006-03-15
Pen-injectors for
medical use--Part 4:
Requirements and
test methods for
electronic and
electromechanical
pen-injectors.
6-179......... ISO 21649 First Contact person.
edition 2006-06-01,
Needle-free
injectors for
medical use--
Requirements and
test methods.
6-112......... 6-296........... ANSI/AAMI PB70:2012 Withdrawn and
Liquid barrier replaced with
performance and newer version.
classification of
protective apparel
and drapes intended
for use in health
care facilities.
6-214......... ASTM D6355--07 Reaffirmation.
(Reapproved 2012)
Standard Test Method
for Human Repeat
Insult Patch Testing
of Medical Gloves.
6-216......... ISO 8536-7 Third Contact person.
edition 2009-01-15
Infusion equipment
for medical use--
Part 7: Caps made of
aluminium-plastics
combinations for
infusion bottles.
6-227......... ANSI/AAMI/IEC 60601-2- Transition
21:2009, Medical period
electrical extended.
equipment--Part 2-
21: Particular
requirements for the
basic safety and
essential
performance of
infant radiant
warmers.
6-228......... IEC 60601-2-2 Edition Transition
5.0 2009-02, Medical period
Electrical extended.
Equipment--Part 2-2:
Particular
requirements for the
basic safety and
essential
performance of high
frequency surgical
equipment and high
frequency surgical
accessories.
6-229......... ANSI/AAMI/IEC 60601-2- Transition
2:2009, Medical period
electrical extended.
equipment--Part 2-2:
Particular
requirements for the
basic safety and
essential
performance of high
frequency surgery
equipment and high
frequency surgical
accessories.
6-230......... ANSI/AAMI/IEC 60601-2- Transition
19:2009, Medical period
Electrical extended.
Equipment--Part 2-
19: Particular
requirements for the
basic safety and
essential
performance of
infant incubators.
6-231......... ANSI/AAMI/IEC 60601-2- Transition
20:2009, Medical period
Electrical extended.
Equipment--Part 2-
20: Particular
requirements for the
basic safety and
essential
performance of
infant transport
incubators.
6-233......... IEC 60601-2-52 Transition
Edition 1.0 2009-12 period
Medical electrical extended.
equipment--Part 2-
52: Particular
requirements for
basic safety and
essential
performance of
medical beds.
6-234......... IEC 60601-2-50 Contact person.
Edition 2.0 2009-03
Medical electrical
equipment--Part 2-
50: Particular
requirements for the
basic safety and
essential
performance of
infant phototherapy
equipment.
6-235......... ANSI/AAMI/IEC 60601-2- Contact person.
50:2009 Medical
Electrical
Equipment--Part 2-
50: Particular
requirements for the
basic safety and
essential
performance of
infant phototherapy
equipment.
6-239......... ISO 8536-6 Second Contact person.
edition 2009-11-15
Infusion equipment
for medical use--
Part 6: Freeze
drying closures for
infusion bottles.
6-240......... ISO 8536-3 Third Contact person.
edition 2009-06-01
Infusion equipment
for medical use--
Part 3: Aluminum
caps for infusion
bottles.
6-241......... 6-297........... ISO 1135-4 Fifth Withdrawn and
edition 2012-03-01 replaced with
Transfusion newer version.
equipment for
medical use--Part 4:
Transfusion sets for
single use.
6-274......... ISO 11608-1 Second Contact person.
edition 2012-04-01
Needle-based
injection systems
for medical use--
Requirements and
test methods--Part
1: Needle-based
injection systems.
6-275......... ISO 11608-2 Second Contact person.
edition 2012-04-01
Needle-based
injection systems
for medical use--
Requirements and
test methods--Part
2: Needles.
6-276......... ISO 8536-1 Fourth Contact person.
edition 2011-09-01
Infusion equipment
for medical use--
Part 1: Infusion
glass bottles.
------------------------------------------------------------------------
G. In Vitro Diagnostics
------------------------------------------------------------------------
7-3........... CLSI/NCCLS GP10-A Withdrawn, see
1995, Assessment of 7-234.
the Clinical
Accuracy of
Laboratory Tests
Using Receiver
Operating
Characteristic (ROC)
Plots; Approved
Guideline.
7-4........... CLSI/NCCLS GP14-A Withdrawn.
1996, Labeling of
Home-Use In Vitro
Testing Products;
Approved Guideline.
7-37.......... NCCLS I/LA6-A, Withdrawn.
Detection and
Quantitation of
Rubella IgG
Antibody: Evaluation
and Performance
Criteria for
Multiple Component
Test Products,
Specimen Handling,
and Use of Test
Products in the
Clinical Laboratory;
Approved Guideline.
7-41.......... NCCLS I/LA19-A, Withdrawn.
Primary Reference
Preparations Used to
Standardize
Calibration of
Immunochemical
Assays for Serum
Prostate Specific
Antigen (PSA);
Approved Guideline
(1997).
7-154......... CLSI MM02-A2, Withdrawn.
Immunoglobulin and T-
Cell Receptor Gene
Rearrangement Assays.

[[Page 47707]]

7-171......... CLSI M38-A2, Extent of
Reference Method for recognition,
Broth Dilution process
Antifungal affected, and
Susceptibility contact
Testing of person.
Filamentous Fungi;
Approved Standard--
Second Edition.
7-178......... CLSI M22-A3, Quality Extent of
Control for recognition,
Commercially process
Prepared affected, and
Microbiological contact
Culture Media; person.
Approved Standard--
Third Edition.
7-179......... 7-240........... CLSI M27-S4, Withdrawn and
Reference Method for replaced with
Broth Dilution newer version.
Antifungal
Susceptibility
Testing of Yeasts;
Fourth Informational
Supplement.
7-200......... CLSI M48-A, Extent of
Laboratory Detection recognition,
and Identification type of
of Mycobacteria; standard, and
Approved Guideline. process
affected.
7-206......... CLSI I/LA 20-A2 Relevant
Analytical guidance.
Performance
Characteristics and
Clinical Utility of
Immunological Assays
for Human
Immunoglobulin E
(IgE) Antibodies and
Defined Allergen
Specificities;
Approved Guideline--
Second Edition.
7-215......... CLSI M44-A2, Method Extent of
for Antifungal Disk recognition,
Diffusion process
Susceptibility affected, and
Testing of Yeast; contact
Approved Guideline-- person.
Second Edition..
7-217......... CLSI M44-S3, Zone Extent of
Diameter recognition,
Interpretive process
Standards, affected, and
Corresponding contact
Minimal Inhibitory person.
Concentration (MIC)
Interpretive
Breakpoints, and
Quality Control
Limits for
Antifungal Disk
Diffusion
Susceptibility
Testing of Yeasts;
Third Informational
Supplement.
7-218......... CLSI M45-A2, Methods Extent of
for Antimicrobial recognition
Dilution and Disk and process
Susceptibility affected.
Testing of
Infrequently
Isolated or
Fastidious Bacteria;
Approved Guideline--
Second Edition.
7-222......... CLSI M24-A2, Extent of
Susceptibility recognition,
Testing of process
Mycobacteria, affected,
Nocardiae and other contact
Aerobic person, and
Actinomycetes; title and type
Approved Standards-- of standard.
Second Edition.
7-228......... CLSI M11-A8, Methods Extent of
for Antimicrobial recognition,
Susceptibility process
Testing of Anaerobic affected, and
Bacteria; Approved contact
Standard--Eighth person.
Edition.
7-229......... CLSI M02-A11, Extent of
Performance recognition,
Standards for process
Antimicrobial Disk affected, and
Susceptibility contact
Tests; Approved person.
Standard--Eleventh
Edition.
7-230......... CLSI M07-A9, Methods Extent of
for Dilution recognition,
Antimicrobial process
Susceptibility Tests affected, and
for Bacteria That contact
Grow Aerobically; person.
Approved Standard--
Ninth Edition.
7-231......... 7-241........... CLSI M100-S23, Withdrawn and
Performance replaced with
Standards for newer version.
Antimicrobial
Susceptibility
Testing; Twenty-
Third Informational
Supplement.
7-234......... CLSI EP24-A2, Extent of
Assessment of the recognition.
Diagnostic Accuracy
of Laboratory Tests
Using Receiver
Operating
Characteristic
Curves; Approved
Guideline--Second
Edition.
------------------------------------------------------------------------
H. Materials
------------------------------------------------------------------------
8-122......... 8-335........... ASTM F2063-12 Withdrawn and
Standard replaced with
Specification for newer version.
Wrought Nickel-
Titanium Shape
Memory Alloys for
Medical Devices and
Surgical Implants.
8-147......... 8-336........... ASTM F562-13 Standard Withdrawn and
Specification for replaced with
Wrought 35Cobalt- newer version.
35Nickel-20Chromium-
10Molybdenum Alloy
for Surgical Implant
Applications (UNS
R30035).
8-153......... ASTM F2119-07 Reaffirmation.
(Reapproved 2013)
Standard Test Method
for Evaluation of MR
Image Artifacts from
Passive Implants.
8-154......... 8-337........... ASTM F621-12 Standard Withdrawn and
Specification for replaced with
Stainless Steel newer version.
Forgings for
Surgical Implants.
8-156......... 8-338........... ASTM F139-12 Standard Withdrawn and
Specification for replaced with
Wrought 18Chromium- newer version.
14Nickel-
2.5Molybdenum
Stainless Steel
Sheet and Strip for
Surgical Implants
(UNS S31673).
8-158......... ASTM F1713-08 Reaffirmation.
(Reapproved 2013)
Standard
Specification for
Wrought Titanium-
13Niobium-13
Zirconium Alloy for
Surgical Implant
Applications (UNS
R58130).
8-166......... 8-339........... ASTM F1091-12 Withdrawn and
Standard replaced with
Specification for newer version.
Wrought Cobalt-
20Chromium-
15Tungsten-10Nickel
Alloy Surgical
Fixation Wire (UNS
R30605).
8-203......... 8-340........... ASTM F2026-12 Withdrawn and
Standard replaced with
Specification for newer version.
Polyetheretherketone
(PEEK) Polymers for
Surgical Implant
Applications.
8-219......... 8-341........... ASTM F136-12a Withdrawn and
Standard replaced with
Specification for newer version.
Wrought Titanium-
6Aluminum-4Vanadium
ELI (Extra Low
Interstitial) Alloy
for Surgical Implant
Applications (UNS
R56401).
8-222......... 8-342........... ASTM F1537-11 Withdrawn and
Standard replaced with
Specification for newer version.
Wrought Cobalt-
28Chromium-
6Molybdenum Alloys
for Surgical
Implants (UNS
R31537, UNS R31538,
and UNS R31539).
8-332......... 8-343........... ASTM F899-12b Withdrawn and
Standard replaced with
Specification for newer version.
Wrought Stainless
Steels for Surgical
Instruments.
------------------------------------------------------------------------

[[Page 47708]]

I. OB-GYN/Gastroenterology
------------------------------------------------------------------------
9-31.......... ANSI/AAMI ID54:1996/ Reaffirmation.
(R)2012 Enteral
feeding set adapters
and connectors.
9-60.......... IEC 60601-2-16 Withdrawn, see
Edition 3.0 2008-04 9-80.
Medical electrical
equipment--Part 2-
16: Particular
requirements for
basic safety and
essential
performance of
haemodialysis,
haemodiafiltration
and haemofiltration.
9-61.......... IEC 60601-2-18 Transition
Edition 3.0 2009-08 period
Medical electrical extended.
equipment--Part 2-
18: Particular
requirements for the
basic safety and
essential
performance of
endoscopic equipment.
9-72.......... 9-81............ ANSI/AAMI/IEC 60601-2- Newer version
16:2012 Medical with
electrical transition
equipment--Part 2- period.
16: Particular
requirements for
basic safety and
essential
performance of
hemodialysis,
hemodiafiltration
and hemofiltration
equipment.
9-62.......... IEC 60601-2-2 Edition Transition
5.0 2009-02 Medical period
electrical extended.
equipment--Part 2-2:
Particular
requirements for the
basic safety and
essential
performance of
frequency surgical
equipment and high
frequency surgical
accessories.
9-63.......... IEC 60601-2-16 (Third Withdrawn, see
edition--2008), 9-80.
Medical electrical
equipment--Part 2-
16: Particular
requirements for
basic safety and
essential
performance of
haemodialysis,
haemodiafiltration
and haemofiltration
equipment
CORRIGENDUM 1.
9-64.......... ANSI/AAMI/IEC 60601-2- Transition
2:2009 Medical period
electrical extended.
equipment--Part 2-2:
Particular
requirements for the
basic safety and
essential
performance of high
frequency surgery
equipment and high
frequency surgical
accessories.
9-80.......... IEC 60601-2-16 Transition
Edition 4.0 2012-03 period
Medical electrical extended.
equipment--Part 2-
16: Particular
requirements for the
basic safety and
essential
performance of
haemodialysis,
haemodiafiltration
and haemofiltration
equipment.
------------------------------------------------------------------------
J. Ophthalmic
------------------------------------------------------------------------
10-15......... 10-77........... ISO 9394 Third Withdrawn and
edition 2012-10-01 replaced with
Ophthalmic optics-- newer version.
Contact lenses and
contact lens care
products--Determinat
ion of
biocompatibility by
ocular study with
rabbit eyes.
10-36......... 10-78........... ISO 11979-3 Third Withdrawn and
edition 2012-12-01 replaced with
Ophthalmic implants-- newer version.
Intraocular lenses--
Part 3: Mechanical
properties and test
methods.
10-40......... 10-79........... ISO 11979-1 Third Withdrawn and
edition 2012-09-15 replaced with
Ophthalmic implants-- newer version.
Intraocular lenses--
Part 1: Vocabulary.
10-45......... 10-80........... ISO 18369-2 Second Withdrawn and
edition 2012-12-01 replaced with
Ophthalmic optics-- newer version.
Contact lenses--Part
2: Tolerances.
10-56......... ANSI Z80.12-2007 Reaffirmation.
(R2012) American
National Standard
for Ophthalmics--
Multifocal
Intraocular Lenses.
10-57......... ANSI Z80.13-2007 Reaffirmation.
(R2012) American
National Standard
for Ophthalmics--
Phakic Intraocular
Lenses.
10-76......... ISO 11979-8 Second Withdrawn.
edition 2006-07-01
AMENDMENT 1 2011-05-
15 Ophthalmic
implants--Intraocula
r lenses--Part 8:
Fundamental
requirements.
------------------------------------------------------------------------
K. Orthopedics
------------------------------------------------------------------------
11-73......... 11-252.......... ISO 5838-1 Third Withdrawn and
edition 2013-03-01 replaced with
Implants for a newer
surgery--Metallic version.
skeletal pins and
wires--Part 1:
General requirements.
11-206........ 11-253.......... ASTM F1800-12 Withdrawn and
Standard Practice replaced with
for Cyclic Fatigue a newer
Testing of Metal version.
Tibial Tray
Components of Total
Knee Joint
Replacements.
11-208........ 11-254.......... ISO 14630 Fourth Withdrawn and
edition 2012-12-01 replaced with
Non-active surgical a newer
implants--General version.
requirements.
11-213........ ASTM F1223-08 Reaffirmation.
(Reapproved 2012)
Standard Test Method
for Determination of
Total Knee
Replacement
Constraint.
11-215........ ASTM F897-02 Reaffirmation.
(Reapproved 2013)
Standard Test Method
for Measuring
Fretting Corrosion
of Osteosynthesis
Plates and Screws.
11-242........ ASTM F1839-08 Reaffirmation.
(Reapproved 2012)
Standard
Specification for
Rigid Polyurethane
Foam for Use as a
Standard Material
for Testing
Orthopaedic Devices
and Instruments.
11-246........ 11-255.......... ASTM F1717-13 Withdrawn and
Standard Test replaced with
Methods for Spinal a newer
Implant Constructs version.
in a Vertebrectomy
Model.
------------------------------------------------------------------------
L. Physical Medicine
------------------------------------------------------------------------
16-24......... 16-190.......... ISO 7176-11 Second Withdrawn and
edition 2012-12-01 replaced with
Wheelchairs--Part a newer
11: Test dummies. version.

[[Page 47709]]

16-28......... 16-191.......... ISO 7176-16 Second Withdrawn and
edition 2012-12-01 replaced with
Wheelchairs--Part a newer
16: Resistance to version.
ignition of postural
support devices.
16-50......... 16-192.......... ISO 7176-3 Third Withdrawn and
edition 2012-12-15 replaced with
Wheelchairs--Part 3: a newer
Determination of version.
effectiveness of
brakes.
------------------------------------------------------------------------
M. Radiology
------------------------------------------------------------------------
12-34......... 12-201.......... IEC 60601-2-54 Newer version
Edition 1.0 2009-06 with
Medical electrical transition
equipment--Part 2- period.
54: Particular
requirements for the
basic safety and
essential
performance of X-ray
equipment for
radiography and
radioscopy.
12-54......... 12-254.......... IEC 60601-2-8 Edition Newer version
2.0 2010-11 Medical with extended
electrical transition
equipment--Part 2-8: period.
Particular
requirements for the
basic safety and
essential
performance of
therapeutic X-ray
equipment operating
in the range 10 kV
to 1 MV.
12-127........ 12-201.......... IEC 60601-2-54 Newer version
Edition 1.0 2009-06 with
Medical electrical transition
equipment--Part 2- period.
54: Particular
requirements for the
basic safety and
essential
performance of X-ray
equipment for
radiography and
radioscopy.
12-133........ 12-255.......... IEC 60601-2-11 Newer version
Edition 3.0 2013-01 with
Medical electrical transition
equipment--Part 2- period.
11: Particular
requirements for the
basic safety and
essential
performance of gamma
beam therapy
equipment.
12-202........ IEC 60601-2-43 Transition
Edition 2.0 2010-03 period
Medical electrical extended.
equipment--Part 2-
43: Particular
requirements for the
basic safety and
essential
performance of X-ray
equipment for
interventional
procedures.
12-203........ 12-256.......... IEC 60601-2-44 Newer version
Edition 3.1 2012-09 with extended
Medical electrical transition
equipment--Part 2- period.
44: Particular
requirements for the
basic safety and
essential
performance of X-ray
equipment for
computed tomography.
12-204........ IEC 60601-2-28 Transition
Edition 2.0 2010-03 period
Medical electrical extended.
equipment--Part 2-
28: Particular
requirements for the
basic safety and
essential
performance of X-ray
tube assemblies for
medical diagnosis.
12-205........ IEC 60601-2-5 Edition Transition
3.0 2009-07 Medical period
electrical extended.
equipment--Part 2-5:
Particular
requirements for the
basic safety and
essential
performance of
ultrasonic
physiotherapy
equipment.
12-206........ IEC 60601-2-1 Edition Transition
3.0 2009-10 Medical period
electrical extended.
equipment--Part 2-1:
Particular
requirements for the
basic safety and
essential
performance of
electron
accelerators in the
range 1 MeV to 50
MeV.
12-207........ IEC 60601-2-33 Transition
Edition 3.0 2010-03 period
Medical electrical extended.
equipment--Part 2-
33: Particular
requirements for the
basic safety and
essential
performance of
magnetic resonance
equipment for
medical diagnostic.
12-208........ IEC 60601-2-22 Third Transition
Edition 2007-05 period
Medical electrical extended.
equipment--Part 2-
22: Particular
requirements for
basic safety and
essential
performance of
surgical, cosmetic,
therapeutic and
diagnostic laser
equipment.
12-209........ IEC 60601-2-37 Transition
Edition 2.0 2007-08 period
Medical electrical extended.
equipment--Part 2-
37: Particular
requirements for the
basic safety and
essential
performance of
ultrasonic medical
diagnostic and
monitoring equipment.
12-210........ IEC 60601-1-3 Edition Transition
2.0 2008-01 Medical period
electrical extended.
equipment--Part 1-3:
General requirements
for basic safety and
essential
performance--Collate
ral Standard:
Radiation protection
in diagnostic X-ray
equipment.
12-211........ IEC 60601-2-29 Transition
Edition 3.0 2008-06 period
Medical electrical extended.
equipment Part 2-29:
Particular
requirements for the
basic safety and
essential
performance of
radiotherapy
simulators.
12-224........ IEC 60601-2-44 (Third Withdrawn, see
edition -2009) 12-256.
Medical electrical
equipment--Part 2-
44: Particular
requirements for the
basic safety and
essential
performance of X-ray
equipment for
computed tomography
CORRIGENDUM 1.
12-236........ IEC 60601-2-45 Transition
Edition 3.0 2011-02 period
Medical electrical extended.
equipment--Part 2-
45: Particular
requirements for the
safety and essential
performance of
mammographic X-ray
equipment and
mammographic
stereotactic devices.
12-250........ IEC 60601-2-44 Withdrawn, see
Edition 3.0 2012-08 12-256.
Amendment 1 Medical
electrical
equipment--Part 2-
44: Particular
requirements for the
basic safety and
essential
performance of X-ray
equipment for
computed tomography.
------------------------------------------------------------------------
N. Sterility
------------------------------------------------------------------------
14-64......... 14-378.......... ASTM F1929-12 Withdrawn and
Standard Test Method replaced with
for Detecting Seal newer version.
Leaks in Porous
Medical Packaging by
Dye Penetration.

[[Page 47710]]

14-230........ ASTM F2203-02 Reaffirmation.
(Reapproved 2012)
Standard Test Method
for Linear
Measurement Using
Precision Steel Rule.
14-231........ ASTM F2217-02 Reaffirmation.
(Reapproved 2012)
Standard Practice
for Coating/Adhesive
Weight Determination.
14-235........ ASTM F1140 -07 Reaffirmation.
(Reapproved 2012)
Standard Test
Methods for Internal
Pressurization
Failure Resistance
of Unrestrained
Packages.
14-236........ ASTM F2054-07 Reaffirmation.
(Reapproved 2012)
Standard Test Method
for Burst Testing of
Flexible Package
Seals Using Internal
Air Pressurization
Within Restraining
Plates.
14-244........ 14-379.......... ISO 14644-8 Second Withdrawn and
edition 2013-02-15 replaced with
Cleanrooms and newer version.
associated
controlled
environments--Part
8: Classification of
air cleanliness by
chemical
concentration (ACC).
14-264........ ANSI/AAMI ST8:2008 Contact person.
Hospital steam
sterilizers.
14-275........ ANSI/AAMI ST41:2008/ Reaffirmation.
(R)2012 Ethylene
oxide sterilization
in health care
facilities: Safety
and effectiveness.
14-281........ 14-380.......... ASTM F17-12 Standard Withdrawn and
Terminology Relating replaced with
to Flexible Barrier newer version.
Packaging.
14-295........ ANSI/AAMI ST81:2004/ Relevant
(R)2010 guidance.
Sterilization of
medical devices--
Information to be
provided by the
manufacturer for the
processing of
resterilizable
medical devices.
14-311........ ANSI/AAMI ST55:2010 Contact person
Table-top steam
sterilizers.
14-312........ 14-394.......... ANSI/AAMI ST79:2010 & Withdrawn and
A1:2010 & A2:2011 & replaced with
A3:2012 newer version.
(Consolidated Text)
Comprehensive guide
to steam
sterilization and
sterility assurance
in health care
facilities.
14-341........ ASTM E2303-11 [euro]1 Editorial
Standard Guide for change.
Absorbed-Dose
Mapping in Radiation
Processing
Facilities.
14-345........ 14-381.......... ISO/ASTM 51261 Second Withdrawn and
edition 2013-04-15 replaced with
Practice for newer version.
calibration of
routine dosimetry
systems for
radiation processing.
14-346........ 14-382.......... ISO/ASTM 51276 Third Withdrawn and
edition 2012-07-15 replaced with
Practice for use of newer version.
a
polymethylmethacryla
te dosimetry system.
14-347........ 14-383.......... ISO/ASTM 51702 Third Withdrawn and
edition 2013-04-15 replaced with
Practice for newer version.
dosimetry in a gamma
facility for
radiation processing.
14-349........ ANSI/AAMI/ISO 13408- Reaffirmation.
3:2006/(R)2012
Aseptic processing
of health care
products--Part 3:
Lyophilization.
14-350........ ANSI/AAMI/ISO 13408- Reaffirmation.
4:2005/(R)2012
Aseptic processing
of health care
products--Part 4:
Clean-in-place
technologies.
14-351........ ANSI/AAMI/ISO 13408- Reaffirmation.
5:2006/(R)2012
Aseptic processing
of health care
products--Part 5:
Sterilization in
place.
------------------------------------------------------------------------
O. Tissue Engineering
------------------------------------------------------------------------
15-5.......... 15-37........... ASTM F2347--11 Withdrawn and
Standard Guide for replaced with
Characterization and newer version.
Testing of
Hyaluronan as
Starting Materials
Intended for Use in
Biomedical and
Tissue Engineered
Medical Product
Applications.
15-14......... ASTM F2603 -06 Reaffirmation.
(Reapproved 2012)
Standard Guide for
Interpreting Images
of Polymeric Tissue
Scaffolds.
15-29......... ASTM F2259 -10 Reaffirmation.
(Reapproved 2012)
[euro]1 Standard
Test Method for
Determining the
Chemical Composition
and Sequence in
Alginate by Proton
Nuclear Magnetic
Resonance (\1\H NMR)
Spectroscopy.
15-32......... ASTM F2260 -03 Reaffirmation.
(Reapproved 2012)
[euro]1 Standard
Test Method for
Determining Degree
of Deacetylation in
Chitosan Salts by
Proton Nuclear
Magnetic Resonance
(\1\H NMR)
Spectroscopy.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
of the respective organizations.

III. Listing of New Entries

In table 2, FDA provides the listing of new entries and consensus
standards added as modifications to the list of recognized standards
under Recognition List Number: 031.

Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
Reference No. and
Recognition No. Title of standard \1\ Date
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
1-90................ Oxygen concentrators for ISO 8359 Second
medical use--Safety edition 1996-12-15
requirements. Amendment 1 2012-07-
01

[[Page 47711]]

1-92................ Sleep apnoea breathing ISO 17510-2 Second
therapy--Part 2: Masks and edition 2007-10-01
application accessories.
------------------------------------------------------------------------
B. Dental/ENT
------------------------------------------------------------------------
4-205............... Dentistry--Handpieces and ISO 14457 First
motors. edition 2012-09-15
------------------------------------------------------------------------
C. General
------------------------------------------------------------------------
5-75................ Medical devices--Symbols to ANSI/AAMI/ISO 15223-1
be used with medical 2012
device labels, labeling,
and information to be
supplied--Part 1: General
requirements.
------------------------------------------------------------------------
D. In Vitro Diagnostics
------------------------------------------------------------------------
7-242............... Hemolysis, Icterus, and CLSI C56-A
Lipemia/Turbidity Indices
as Indicators of
Interference in Clinical
Laboratory Analysis;
Approved Guideline.
7-243............... Method for Antifungal Disk CLSI M51-A
Diffusion Susceptibility
Testing of Nondermatophyte
Filamentous Fungi;
Approved Guideline.
------------------------------------------------------------------------
E. Neurology
------------------------------------------------------------------------
17-11............... Medical electrical IEC 60601-2-10
equipment--Part 2-10: Edition 2.0 2012-06
Particular requirements
for the basic safety and
essential performance of
nerve and muscle
stimulators.
------------------------------------------------------------------------
F. Radiology
------------------------------------------------------------------------
12-251.............. Medical electrical IEC 60601-2-63
equipment--Part 2-63: Edition 1.0 2012-09
Particular requirements
for the basic safety and
essential performance of
dental extra-oral X-ray
equipment.
12-252.............. Medical electrical IEC 60601-2-65
equipment--Part 2-65: Edition 1.0 2012-09
Particular requirements
for the basic safety and
essential performance of
dental intra-oral X-ray
equipment.
12-253.............. Medical electrical IEC 60976 Edition 2.0
equipment--Medical 2007-10
electron accelerators--
Functional performance
characteristics.
------------------------------------------------------------------------
G. Software/Informatics
------------------------------------------------------------------------
13-37............... Laboratory Automation: Data NCCLS AUTO7-A
Content for Specimen
Identification; Approved
Standard.
------------------------------------------------------------------------
H. Sterility
------------------------------------------------------------------------
14-384.............. Biological evaluation of ISO 10993-7:2008
medical devices--Part 7: TECHNICAL
Ethylene oxide CORRIGENDUM 1
sterilization residuals. Published 2009-11-15
14-385.............. Aseptic processing of ANSI/AAMI/ISO 13408-
health care products--Part 1:2008/(R2011)
1: General requirements.
14-386.............. Aseptic processing of ISO 13408-1 Second
health care products--Part edition 2008-06-15
1: General requirements.
14-387.............. Aseptic processing of ANSI/AAMI/ISO 13408-
health care products--Part 7:2012
7: Alternate processes for
medical devices and
combination products.
14-388.............. Aseptic processing of ISO 13408-7 First
health care products--Part edition 2012-08-01
7: Alternate processes for
medical devices and
combination products.
14-389.............. Cleanrooms and associated ISO 14644-9 First
controlled environments-- edition 2012-08-15
Part 9: Classification of
surface cleanliness by
particle concentration.
14-390.............. Cleanrooms and associated ISO 14644-10 First
controlled environments-- edition 2013-03-01
Part 10: Classification of
surface cleanliness by
chemical concentration.
14-391.............. Practice for dosimetry in ISO/ASTM 51608 Second
an X-ray (bremsstrahlung) edition 2005-05-15
facility for radiation
processing.
14-392.............. Practice for dosimetry in ISO/ASTM 51649 Second
an electron beam facility edition 2005-05-15
for radiation processing
at energies between 300
keV and 25 MeV.
14-393.............. Practice for dosimetry in ISO/ASTM 51818 Second
an electron beam facility edition 2009-06-15
for radiation processing
at energies between 80 and
300 keV.
------------------------------------------------------------------------
I. Tissue Engineering
------------------------------------------------------------------------
15-38............... Standard Guide for ATSM F2883--11
Characterization of
Ceramic and Mineral Based
Scaffolds used for Tissue-
Engineered Medical
Products (TEMPs) and as
Device for Surgical
Implant Applications.
------------------------------------------------------------------------
\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

[[Page 47712]]

recognized consensus standards, as needed, in the Federal Register once
a year, or more often, if necessary. Beginning with Recognition List
Number: 033, FDA will no longer be announcing 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) 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: 031'' 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: 031. These modifications to the list of recognized standards
are effective upon publication of this notice in the Federal Register.

Dated: July 31, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-19019 Filed 8-5-13; 8:45 am]
BILLING CODE 4160-01-P

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