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Federal Register: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 025

Mon, 10/04/2010 - 5:32am
U.S. Food & Drug Administration

[Federal Register: October 4, 2010 (Volume 75, Number 191)] [Notices] [Page 61148-61157] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr04oc10-39] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2004-N-0451] (formerly Docket No. 2004N-0226) Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 025 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: 025'' (Recognition List Number: 025), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. DATES: Submit either electronic or written comments concerning this document at any time. See section VII of this document for the effective date of the recognition of standards announced in this document. ADDRESSES: Submit written requests for single copies of ``Modifications to the List of Recognized Standards, Recognition List Number: 025'' 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 20993-0002. 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 http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/Standards/ucm123792.htm. See section VI of this document for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 025 modifications and other standards related information. FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 3632, Silver Spring, MD 20993-0002, 301- 796-6574. SUPPLEMENTARY INFORMATION: I. Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements. In a notice published in the Federal Register of February 25, 1998 (63 FR 9561), FDA announced the availability of a guidance entitled ``Recognition and Use of Consensus Standards.'' The notice described how FDA would implement its standard recognition program and provided the initial list of recognized standards. Modifications to the initial list of recognized standards, as published in the Federal Register, are identified in table 1 of this document. Table 1.--Previous Publications of Standard Recognition Lists February 25, 1998 (63 FR 9561) November 8, 2005 (70 FR 67713) ------------------------------------------------------------------------ October 16, 1998 (63 FR 55617) March 31, 2006 (71 FR 16313) ------------------------------------------------------------------------ July 12, 1999 (64 FR 37546) June 23, 2006 (71 FR 36121) ------------------------------------------------------------------------ November 15, 2000 (65 FR 69022) November 3, 2006 (71 FR 64718) ------------------------------------------------------------------------ May 7, 2001 (66 FR 23032) May 21, 2007 (72 FR 28500) ------------------------------------------------------------------------ January 14, 2002 (67 FR 1774) September 12, 2007 (72 FR 52142) ------------------------------------------------------------------------ October 2, 2002 (67 FR 61893) December 19, 2007 (72 FR 71924) ------------------------------------------------------------------------ April 28, 2003 (68 FR 22391) September 9, 2008 (73 FR 52358) ------------------------------------------------------------------------ March 8, 2004 (69 FR 10712) March, 18, 2009 (74 FR 11586) ------------------------------------------------------------------------ June 18, 2004 (69 FR 34176) September 8, 2009 (74 FR 46203) ------------------------------------------------------------------------ October 4, 2004 (69 FR 59240) May 5, 2010 (75 FR 24711) ------------------------------------------------------------------------ May 27, 2005 (70 FR 30756) June 10, 2010 (75 FR 32943) ------------------------------------------------------------------------ These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The Agency maintains ``hypertext markup language (HTML)'' and ``portable document format (PDF)'' versions of the list of ``FDA Recognized Consensus Standards.'' Both versions are publicly accessible at the Agency's Internet site. See section VI of this document for electronic access information. Interested persons should review the supplementary information sheet for the standard to understand fully the extent to which FDA recognizes the standard. II. Modifications to the List of Recognized Standards, Recognition List Number: 025 FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the Agency will recognize for use in satisfying premarket reviews and other requirements for devices. FDA will incorporate these modifications in the list of FDA Recognized Consensus Standards in the Agency's searchable database. FDA will use the term ``Recognition List Number: 025'' to identify these current modifications. In table 2 of this document, FDA describes the following modifications: (1) The withdrawal of standards and their replacement by others; (2) the correction of errors made by FDA in listing previously recognized standards; and (3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards. In section III of this document, FDA lists modifications the Agency is making that involve the initial addition of standards not previously recognized by FDA. Table 2.--Modifications to the List of Recognized Standards ---------------------------------------------------------------------------------------------------------------- Replacement Old Recognition No. Recognition No. Title of Standard\1\ Change ---------------------------------------------------------------------------------------------------------------- A. Anesthesia ---------------------------------------------------------------------------------------------------------------- 1-61 1-82 IEC 60601-2-13 Edition 3.1 2009-08 Medical Withdrawn and replaced electrical equipment--Part 2-13: with newer version Particular requirements for the safety and essential performance of anaesthetic systems ---------------------------------------------------------------------------------------------------------------- B. Biocompatibility ---------------------------------------------------------------------------------------------------------------- 2-96 ..................... ASTM F 1903-98 (Reapproved 2003) Standard Type of standard and Practice for Testing For Biological Contact person Responses to Particles in vitro ---------------------------------------------------------------------------------------------------------------- 2-98 2-156 ANSI/AAMI/ISO 10993-1:2009 Biological Withdrawn and replaced evaluation of medical devices--Part 1: with newer version Evaluation and testing within a risk management process ---------------------------------------------------------------------------------------------------------------- 2-100 ..................... ASTM E1372-95 (2003) Standard Test Method Withdrawn for Conducting a 90-Day Oral Toxicity Study in Rats ---------------------------------------------------------------------------------------------------------------- 2-115 ..................... ASTM F 895--84 (Reapproved 2006) Standard Title, Type of Test Method for Agar Diffusion Cell standard , Relevant Culture Screening for Cytotoxicity guidance and Contact person ---------------------------------------------------------------------------------------------------------------- 2-117 ..................... ANSI/AAMI/ISO 10993-3:2003/(R)2009 Reaffirmation, CDRH Biological evaluation of medical devices - Office(s) and Part 3: Tests for genotoxicity, Division(s) carcinogenicity, and reproductive associated with toxicity recognized standard and Contact person ---------------------------------------------------------------------------------------------------------------- 2-118 ..................... ANSI/AAMI/ISO 10993-11:2006 Biological Contact person evaluation of medical devices--Part 11: Tests for systemic toxicity ---------------------------------------------------------------------------------------------------------------- 2-119 ..................... ASTM F 813-07 Standard Practice for Direct Title, Type of Contact Cell Culture Evaluation of standard and Contact Materials for Medical Devices person ---------------------------------------------------------------------------------------------------------------- 2-135 ..................... ANSI/AAMI/ISO 10993-12:2007 Biological Title and Contact evaluation of medical devices--Part 12: person Sample preparation and reference materials ---------------------------------------------------------------------------------------------------------------- 2-147 2-157 USP 33--NF 28 2010 Biological Tests <87> Withdrawn and replaced Biological Reactivity Test, In Vitro-- with newer version Direct Contact Test ---------------------------------------------------------------------------------------------------------------- 2-148 2-158 USP 33-NF28 2010 Biological Tests <87> Withdrawn and replaced Biological Reactivity Test, In Vitro-- with newer version Elution Test ---------------------------------------------------------------------------------------------------------------- 2-149 2-159 USP 33-NF28 2010 Biological Tests <88> Withdrawn and replaced Biological Reactivity Tests, In Vivo, with newer version Procedure--Preparation of Sample ---------------------------------------------------------------------------------------------------------------- 2-150 2-160 USP 33-NF28 2010 Biological Tests <88> Withdrawn and replaced Biological Reactivity Tests, In Vivo, with newer version Classification of Plastics-- Intracutaneous Test ---------------------------------------------------------------------------------------------------------------- 2-151 2-161 USP 33-NF28 2010 Biological Tests <88> Withdrawn and replaced Biological Reactivity Tests, In Vivo, with newer version Classification of Plastics--Systemic Injection Test ---------------------------------------------------------------------------------------------------------------- C. Cardiology ---------------------------------------------------------------------------------------------------------------- 3-74 3-79 ASTM F 2079--09 Standard Test Method for Withdrawn and replaced Measuring Intrinsic Elastic Recoil of with newer version Balloon-Expandable Stents ---------------------------------------------------------------------------------------------------------------- 3-75 ..................... ANSI/AAMI SP10:2002/(R)2008 & ANSI/AAMI Title and Extent of SP10:2002/A1:2003/(R)2008 & ANSI/AAMI recognition SP10:2002/A2:2006/(R)2008 Manual, electronic or automated sphygmomanometers ---------------------------------------------------------------------------------------------------------------- D. Dental/ENT ---------------------------------------------------------------------------------------------------------------- 4-86 ..................... ANSI/ADA Specification No. 38 2000 Reaffirmation (Reaffirmed 2010) Metal-Ceramic Dental Restorative Systems ---------------------------------------------------------------------------------------------------------------- 4-91 ..................... ANSI/ADA Specification No. 80 2001 Reaffirmation (Reaffirmed 2007) Dental Materials-- Determination of Color Stability Test Procedure ---------------------------------------------------------------------------------------------------------------- 4-107 4-188 ISO 9917-2 Second edition 2010-04-15 Withdrawn and replaced Dentistry--Water-based cements--Part 2: with newer version Resin-modified cements ---------------------------------------------------------------------------------------------------------------- 4-117 ..................... ANSI/ADA Specification No. 12 2002 Reaffirmation (Reaffirmed 2007) Denture Base Polymers ---------------------------------------------------------------------------------------------------------------- 4-119 ..................... ANSI/ADA Specification No. 82 1998 Reaffirmation (Reaffirmed 2009)--Dental Reversible/ Irreversible Hydrocolloid Impression Material Systems ---------------------------------------------------------------------------------------------------------------- 4-139 ..................... ANSI/ADA Specification No. 48-Visible Reaffirmation Light Curing Units: 2004, Reaffirmed 2009 ---------------------------------------------------------------------------------------------------------------- 4-160 ..................... ANSI/ASA S3.1-1999 (Reaffirmed 2003) Reaffirmation (Reaffirmed 2008) Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms ---------------------------------------------------------------------------------------------------------------- 4-164 ..................... ANSI/ASA S3.7-1997 (Reaffirmed 2003) Reaffirmation (Reaffirmed 2008) Methods for Coupler Calibration of Earphones ---------------------------------------------------------------------------------------------------------------- 4-166 ..................... ANSI/ASA S3.20-1995 (Reaffirmed 2003) Reaffirmation (Reaffirmed 2008) Bioacoustical Terminology ---------------------------------------------------------------------------------------------------------------- 4-167 ..................... ANSI/ASA S3.21-2004 (Reaffirmed 2009) Reaffirmation Methods for Manual Pure-Tone Threshold Audiometry ---------------------------------------------------------------------------------------------------------------- 4-169 4-190 ANSI/ASA S3.35-2010 (Revision of ANSI Withdrawn and replaced S3.35-2004) Method of Measurement of with newer version Performance Characteristics of Hearing Aids Under Simulated Real-Ear Working Conditions ---------------------------------------------------------------------------------------------------------------- E. General ---------------------------------------------------------------------------------------------------------------- 5-31 ..................... ISO 15223:2000 Medical device symbols to Withdrawn be used with medical device labels, labeling and information to be supplied-- First Edition: Amendment 1: 08/01/2002; Amendment 2: 02/15/2004 ---------------------------------------------------------------------------------------------------------------- 5-32 ..................... CEN EN 980:1996+A1:1999+A2:2001 Graphical Withdrawn Symbols for Use in the Labelling of Medical Devices ---------------------------------------------------------------------------------------------------------------- 5-38 5-62 ANSI/ASQ Z1.4-2008 Sampling Procedures and Withdrawn and replaced Tables for Inspection by Attributes with newer version ---------------------------------------------------------------------------------------------------------------- F. General Hospital/General Plastic Surgery ---------------------------------------------------------------------------------------------------------------- 6-62 6-239 ISO 8536-6 Second edition 2009-11-15 Withdrawn and replaced Infusion equipment for medical use--Part with newer version 6: Freeze drying closures for infusion bottles ---------------------------------------------------------------------------------------------------------------- 6-64 6-240 ISO 8536-3 Third edition 2009-06-01 Withdrawn and replaced Infusion equipment for medical use-- Part with newer version 3: Aluminum caps for infusion bottles ---------------------------------------------------------------------------------------------------------------- 6-70 ..................... ASTM E825-98 (Reapproved 2009) Standard Reaffirmation Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature ---------------------------------------------------------------------------------------------------------------- 6-110 ..................... ASTM F 1441-03 (Reapproved 2009) Standard Reaffirmation Specification for Soft-Tissue Expander Devices ---------------------------------------------------------------------------------------------------------------- 6-112 ..................... ANSI/AAMI PB70:2003/(R)2009 Liquid barrier Reaffirmation performance and classification of protective apparel and drapes intended for use in health care facilities ---------------------------------------------------------------------------------------------------------------- 6-123 ..................... ASTM E667-98 (Reapproved 2009) Standard Reaffirmation Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers ---------------------------------------------------------------------------------------------------------------- 6-124 ..................... ASTM E1104-98 (Reapproved 2009) Standard Reaffirmation Specification for Clinical Thermometer Probe Covers and Sheaths ---------------------------------------------------------------------------------------------------------------- 6-125 ..................... ASTM E1965-98 (Reapproved 2009) Standard Reaffirmation Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature ---------------------------------------------------------------------------------------------------------------- 6-127 6-241 ISO 1135-4 Forth edition 2010-04-15 Withdrawn and replaced Transfusion equipment for medical use-- with newer version Part 4: Transfusion sets for single use ---------------------------------------------------------------------------------------------------------------- 6-173 6-242 ISO 8536-2 Third edition 2010-03-15 Withdrawn and replaced Infusion equipment for medical use--Part with newer version 2: Closures for infusion bottles ---------------------------------------------------------------------------------------------------------------- G. IVD ---------------------------------------------------------------------------------------------------------------- 7-49 7-210 CLSI H26-A2 Validation, Verification, and Withdrawn and replaced Quality Assurance of Automated Hematology with newer version Analyzers; Approved Standard-Second Edition ---------------------------------------------------------------------------------------------------------------- 7-82 7-211 CLSI C34-A3 Sweat Testing: Sample Withdrawn and replaced Collection and Quantitative Chloride with newer version Analysis; Approved Guideline-Third Edition ---------------------------------------------------------------------------------------------------------------- 7-96 7-212 CLSI EP18-A2 Risk Management Techniques to Withdrawn and replaced Identify and Control Laboratory Error with newer version Sources; Approved Guideline-Second Edition ---------------------------------------------------------------------------------------------------------------- 7-100 ..................... ISO 15197 First edition 2003-05-01 In Title vitro diagnostic test systems-- Requirements for blood-glucose monitoring systems for self testing in managing diabetes mellitus ---------------------------------------------------------------------------------------------------------------- 7-141 7-213 CLSI H18-A4 Procedures for the Handling Withdrawn and replaced and Processing of Blood Specimens for with newer version Common Laboratory Tests; Approved Guideline-Fourth Edition ---------------------------------------------------------------------------------------------------------------- 7-181 7-214 CLSI M35-A2 Abbreviated Identification of Withdrawn, see 7-197 Bacteria and Yeast; Approved Guideline- Second Edition ---------------------------------------------------------------------------------------------------------------- 7-186 7-215 CLSI M44-A2 Method for Antifungal Disk Withdrawn and Replaced Diffusion Susceptibility Testing of with newer version Yeasts; Approved Guideline-Second Edition ---------------------------------------------------------------------------------------------------------------- 7-199 7-216 CLSI M100-S20 Performance Standards for Withdrawn and Replaced Antimicrobial Susceptibility Testing; with newer version Twentieth Informational Supplement ---------------------------------------------------------------------------------------------------------------- 7-208 7-217 CLSI M44-S3, Zone Diameter Interpretive Withdrawn and replaced Standards, Corresponding Minimal with newer version Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Third Informational Supplement ---------------------------------------------------------------------------------------------------------------- H. Materials ---------------------------------------------------------------------------------------------------------------- 8-66 8-191 ISO 6474-1 First edition Implants for Withdrawn and replaced surgery--Ceramic materials--Part 1: with newer version Ceramic materials based on high purity alumina ---------------------------------------------------------------------------------------------------------------- 8-71 8-192 ASTM F2182--09 Standard Test Method for Withdraw and replaced Measurement of Radio Frequency Induced with newer version Heating On or Near Passive Implants During Magnetic Resonance Imaging ---------------------------------------------------------------------------------------------------------------- 8-85 8-193 ASTM F 1854--09 Standard Test Method for Withdraw and replaced Stereological Evaluation of Porous with newer version Coatings on Medical Implants ---------------------------------------------------------------------------------------------------------------- 8-88 ..................... ASTM F2024-00 Standard Practice for X-ray Type of standard and Diffraction Determination of Phase Contact person Content of Plasma-Sprayed Hydroxyapatite Coatings ---------------------------------------------------------------------------------------------------------------- 8-130 ..................... ASTM F 620--06 Standard Specification for Type of standard Alpha Plus Beta Titanium Alloy Forgings for Surgical Implants ---------------------------------------------------------------------------------------------------------------- 8-131 ..................... ASTM F 799--06 Standard Specification for Type of standard Cobalt-28Chromium-6Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539) ---------------------------------------------------------------------------------------------------------------- 8-137 ..................... ASTM F 75--07, Standard Specification for Type of standard Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075) ---------------------------------------------------------------------------------------------------------------- 8-138 ..................... ASTM F 745--07 Standard Specification for Type of standard 18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel for Cast and Solution- Annealed Surgical Implant Applications ---------------------------------------------------------------------------------------------------------------- 8-156 ..................... ASTM F 139--08 Standard Specification for Type of standard Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673) ---------------------------------------------------------------------------------------------------------------- 8-183 ..................... ASTM F 560--08 Standard Specification for Type of standard Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400) ---------------------------------------------------------------------------------------------------------------- I. Neurology ---------------------------------------------------------------------------------------------------------------- 17-2 ..................... ASTM F1542-94 (2000) Standard Withdrawn Specification for the Requirements and Disclosure of Self-Closing Aneurysm Clips ---------------------------------------------------------------------------------------------------------------- 17-6 17-9 ASTM F 2129-08 Standard Test Method for Withdrawn and replaced Conducting Cyclic Potentiodynamic with newer version Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices ---------------------------------------------------------------------------------------------------------------- J. OB-GYN/Gastroenterology ---------------------------------------------------------------------------------------------------------------- 9-23 ..................... ASTM F1518-00 Standard Practice for Withdrawn Cleaning and Disinfection of Flexible Fiberoptic and Video Endoscopes Used in the Examination of the Hollow Viscera ---------------------------------------------------------------------------------------------------------------- K. Ophthalmic ---------------------------------------------------------------------------------------------------------------- 10-12 10-59 ISO 11980 Second edition 2009-10-15 Withdrawn and replaced Ophthalmic optics--Contact lenses and with newer version contact lens care products--Guidance for clinical investigations ---------------------------------------------------------------------------------------------------------------- 10-30 ..................... ANSI Z80.7 (2002) Ophthalmics--Intraocular Withdrawn Lenses ---------------------------------------------------------------------------------------------------------------- 10-34 ..................... ANSI Z80.20 (2004) Ophthalmics--Contact Withdrawn lenses- Standard Terminology, Tolerances, Measurements and Physicochemical Properties ---------------------------------------------------------------------------------------------------------------- 10-44 10-60 ISO 11981 Second edition 2009-07-01 Withdrawn and replaced Ophthalmic optics--Contact lenses and with newer version contact lens care products- Determination of physical compatibility of contact lens care products with contact lenses ---------------------------------------------------------------------------------------------------------------- L. Orthopedics ---------------------------------------------------------------------------------------------------------------- 11-171 ..................... ASTM F 1814--97a (Reapproved 2009) Reaffirmation Standard Guide for Evaluating Modular Hip and Knee Joint Components ---------------------------------------------------------------------------------------------------------------- 11-179 11-220 ASTM F 2068--09 Standard Specification for Withdrawn and replaced Femoral Prostheses--Metallic Implants with newer version ---------------------------------------------------------------------------------------------------------------- 11-180 ..................... ASTM F 366--04 (Reapproved 2009) Standard Reaffirmation Specification for Fixation Pins and Wires ---------------------------------------------------------------------------------------------------------------- 11-181 11-221 ASTM F 1717--09 Standard Test Methods for Withdrawn and replaced Spinal Implant Constructs in a with newer version Vertebrectomy Model ---------------------------------------------------------------------------------------------------------------- 11-188 11-222 ISO 14243-1 Second edition 2009-11-15 Withdrawn and replaced Implants for surgery--Wear of total knee- with newer version joint prostheses--Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test ---------------------------------------------------------------------------------------------------------------- 11-189 11-223 ISO 14243-2 Second edition 2009-11-15 Withdrawn and replaced Implants for surgery--Wear of total knee- with newer version joint prostheses--Part 2: Methods of measurement ---------------------------------------------------------------------------------------------------------------- 11-197 ..................... ASTM F 983--86 (Reapproved 2009) Standard Reaffirmation Practice for Permanent Marking of Orthopaedic Implant Components ---------------------------------------------------------------------------------------------------------------- 11-199 ..................... ASTM F 565--04 (Reapproved 2009) e Reaffirmation Standard Practice for Care and Handling of Orthopedic Implants and Instruments ---------------------------------------------------------------------------------------------------------------- 11-203 ..................... ASTM F 1541--02 (Reapproved 2007) e Title, Type of Standard Specification and Test Methods standard and Relevant for External Skeletal Fixation Devices guidance ---------------------------------------------------------------------------------------------------------------- 11-210 ..................... ASTM F 543--07e Standard Specification and Title, Type of Test Methods for Metallic Medical Bone standard and Relevant Screws guidance ---------------------------------------------------------------------------------------------------------------- 11-214 ..................... ASTM F 382--99 (Reapproved 2008) e Title and Type of Standard Specification and Test Method standard for Metallic Bone Plates ---------------------------------------------------------------------------------------------------------------- M. Sterility ---------------------------------------------------------------------------------------------------------------- 14-54 14-287 ANSI/AAMI/ISO 11737-2:2009 Sterilization Withdrawn and replaced of medical devices--Microbiological with newer version methods--Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process ---------------------------------------------------------------------------------------------------------------- 14-55 ..................... AAMI/ANSI/ISO 14160:1998/(R)2008 Contact person Sterilization of single-use medical devices incorporating materials of animal origin--Validation and routine control of sterilization by liquid chemical ---------------------------------------------------------------------------------------------------------------- 14-63 14-288 ASTM F1886/F1886M-09 Standard Test Method Withdrawn and replaced for Determining Integrity of Seals for with newer version Flexible Packaging by Visual Inspection ---------------------------------------------------------------------------------------------------------------- 14-77 14-290 ANSI/AAMI ST:24:1999/(R)2009 Automatic, Withdrawn and replaced general purpose ethylene oxide with newer version sterilizers and ethylene oxide sterilant sources intended for use in health care facilities ---------------------------------------------------------------------------------------------------------------- 14-88 14-291 ANSI/AAMI/ISO 14937:2009 Sterilization of Withdrawn and replaced health care products--General with newer version requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices ---------------------------------------------------------------------------------------------------------------- 14-116 14-292 ANSI/AAMI ST72:2002/(R)2010 Bacterial Withdrawn and replaced Endotoxins--Test methodologies, routine with newer version monitoring, and alternatives to batch testing ---------------------------------------------------------------------------------------------------------------- 14-118 14-293 ANSI/AAMI ST50:2004/(R)2010 Dry heat Withdrawn and replaced (heated air) sterilizers with newer version ---------------------------------------------------------------------------------------------------------------- 14-152 14-294 ANSI/AAMI ST40:2004/(R)2010 Table-top dry Withdrawn and replaced heat (heated air) sterilization and with newer version sterility assurance in health care facilities ---------------------------------------------------------------------------------------------------------------- 14-164 14-295 ANSI/AAMI ST81:2004/(R)2010 Sterilization Withdrawn and replaced of medical devices--Information to be with newer version provided by the manufacturer for the processing of resterilizable medical devices ---------------------------------------------------------------------------------------------------------------- 14-181 ..................... AAMI/ANSI ST58: 2005 Chemical Contact person sterilization and high-level disinfection in health care facilities ---------------------------------------------------------------------------------------------------------------- 14-197 ..................... ASTM F1608-00 (Reapproved 2009) Standard Reaffirmation Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) ---------------------------------------------------------------------------------------------------------------- 14-211 ..................... AOAC 6.2.01:2006 Official Method 955.14 Contact person Testing Disinfectants against Salmonella choleraesuis, Use-Dilution Method ---------------------------------------------------------------------------------------------------------------- 14-212 ..................... AOAC 6.2.02:2006 Official Method 991.47 Contact person Testing Disinfectants against Salmonella choleraesuis, Hard Surface Carrier Test Method ---------------------------------------------------------------------------------------------------------------- 14-213 ..................... AOAC 6.2.03:2006 Official Method 991.48 Contact person Testing Disinfectant against Staphylococcus aureus, Hard Surface Carrier Test Method ---------------------------------------------------------------------------------------------------------------- 14-214 ..................... AOAC 6.2.04:2006 Official Method 955.15 Contact person Testing Disinfectants Against Staphylococcus aureus, Use-Dilution Method ---------------------------------------------------------------------------------------------------------------- 14-215 ..................... AOAC 6.2.05:2006 Official Method 991.49 Contact person Testing Disinfectants against Pseudomonas aeruginosa, Hard Surface Carrier Test Method ---------------------------------------------------------------------------------------------------------------- 14-216 ..................... AOAC 6.2.06:2006 Official Method 964.02 Contact person Testing Disinfectants against Pseudomonas aeruginosa, Use-Dilution Method ---------------------------------------------------------------------------------------------------------------- 14-217 ..................... AOAC 6.3.02:2006 Official Method 955.17 Contact person Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes ---------------------------------------------------------------------------------------------------------------- 14-218 ..................... AOAC 6.3.05:2006 Official Method 966.04 Contact person Sporicidal Activity of Disinfectants Method I ---------------------------------------------------------------------------------------------------------------- 14-219 ..................... AOAC 6.3.06:2006 Official Method 965.12 Contact person Tuberculocidal Activity of Disinfectants ---------------------------------------------------------------------------------------------------------------- 14-223 14-296 ANSI/AAMI/ISO 11138-1:2006/(R)2010 Withdrawn and replaced Sterilization of health care products-- with newer version Biological indicators--Part 1: General requirements ---------------------------------------------------------------------------------------------------------------- 14-224 14-297 ANSI/AAMI/ISO 11137-1:2006/(R)2010 Withdrawn and replaced Sterilization of health care products-- with newer version Radiation--Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices ---------------------------------------------------------------------------------------------------------------- 14-226 14-298 ANSI/AAMI/ISO 11137-3:2006/(R)2010 Withdrawn and replaced Sterilization of health care products-- with newer version Radiation--Part 3: Guidance on dosimetric aspects ---------------------------------------------------------------------------------------------------------------- 14-234 14-299 ASTM F2097-10 Standard Guide for Design Withdrawn and replaced and Evaluation of Primary Flexible with newer version Packaging for Medical Products ---------------------------------------------------------------------------------------------------------------- 14-265 ..................... USP 32:2009 <61> Microbiological Contact person Examination of Nonsterile Products: Microbial Enumeration Tests ---------------------------------------------------------------------------------------------------------------- 14-266 ..................... USP 32:2009 <71> Sterility Tests Contact person ---------------------------------------------------------------------------------------------------------------- 14-267 ..................... USP 32:2009 <85> Bacterial Endotoxins Test Contact person ---------------------------------------------------------------------------------------------------------------- 14-268 ..................... USP 32:2009 <151> Pyrogen Test Contact person ---------------------------------------------------------------------------------------------------------------- 14-269 ..................... USP 32:2009 <161> Transfusion and Infusion Contact person Assemblies and Similar Medical Devices ---------------------------------------------------------------------------------------------------------------- 14-270 ..................... USP 32:2009 Biological Indicator for Steam Contact person Sterilization--Self Contained ---------------------------------------------------------------------------------------------------------------- 14-271 ..................... USP 32: 2009 Biological Indicator for Dry- Contact person Heat Sterilization, Paper Carrier ---------------------------------------------------------------------------------------------------------------- 14-272 ..................... USP 32:2009 Biological Indicator for Contact person Ethylene Oxide Sterilization, Paper Carrier ---------------------------------------------------------------------------------------------------------------- 14-273 ..................... USP 32:2009 Biological Indicator for Steam Contact person Sterilization, Paper Carrier ---------------------------------------------------------------------------------------------------------------- 14-278 ..................... USP 32:2009 <62> Microbiological Contact person Examination of Nonsterile Products: Tests for Specified Microorganisms ---------------------------------------------------------------------------------------------------------------- 14-280 ..................... AAMI/ANSI ST79:2006 and A1:2008, A2:2009 Contact person (Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities ---------------------------------------------------------------------------------------------------------------- 14-284 14-300 ASTM D4169-09 Standard Practice for Withdrawn and replaced Performance Testing of Shipping with newer version Containers and Systems ---------------------------------------------------------------------------------------------------------------- 14-285 ..................... AAMI/ANSI/ISO 14161:2009 Sterilization of Contact person health care products--Biological indicators--Guidance for the selection, use and interpretation of results ---------------------------------------------------------------------------------------------------------------- N. Tissue Engineering ---------------------------------------------------------------------------------------------------------------- 15-16 15-19 ASTM F2450-10 Standard Guide for Assessing Withdrawn and replaced Microstructure of Polymeric Scaffolds for with newer version Use in Tissue-Engineered Medical Products ---------------------------------------------------------------------------------------------------------------- \1\ All standard titles in this table conform to the style requirements of the respective organizations. III. Listing of New Entries In table 3 of this document, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 025. Table 3.--New Entries to the List of Recognized Standards ---------------------------------------------------------------------------------------------------------------- Recognition No. Title of Standard\1\ Reference No. & Date ---------------------------------------------------------------------------------------------------------------- A. Anesthesia ---------------------------------------------------------------------------------------------------------------- 1-83 Medical electrical equipment--Particular requirements for ISO 21647:2004 TECHNICAL the basic safety and essential performance of respiratory CORRIGENDUM 1 gas monitors ---------------------------------------------------------------------------------------------------------------- B. Cardiology ---------------------------------------------------------------------------------------------------------------- 3-80 Non-invasive sphygmomanometers--Part 1: Requirements and ANSI/AAMI/ISO 81060-1:2007 test methods for non-automated measurement type ---------------------------------------------------------------------------------------------------------------- 3-81 Non-invasive sphygmomanometers - Part 2: Clinical validation ANSI/AAMI/ISO 81060-2:2009 of automated measurement type ---------------------------------------------------------------------------------------------------------------- 3-82 Implants for surgery - Cardiac pacemakers - Part 3: Low- IS0 5841 -3:2000 TECHNICAL profile connectors [IS-I] for implantable pacemakers CORRIGENDUM 1 TECHNICAL CORRIGENDUM 1 ---------------------------------------------------------------------------------------------------------------- C. Dental/ENT ---------------------------------------------------------------------------------------------------------------- 4-189 Dentistry--Soft lining materials for removable dentures-- ISO 10139-1:2005 TECHNICAL Part 1: Materials for short-term use CORRIGENDUM 1 2006-03-01 ---------------------------------------------------------------------------------------------------------------- D. General ---------------------------------------------------------------------------------------------------------------- 5-56 Medical devices--Symbols to be used with medical device ISO 15223-2 First edition labels, labelling, and information to be supplied--Part 2: 2010-01-15 Symbol development, selection and validation ---------------------------------------------------------------------------------------------------------------- 5-57 Human factors engineering--Design of medical devices ANSI/AAMI HE75:2009 ---------------------------------------------------------------------------------------------------------------- 5-58 Medical electrical equipment--Part 1-11: General IEC 60601-1-11 Edition 1.0 requirements for basic safety and essential performance-- 2010-04 Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment ---------------------------------------------------------------------------------------------------------------- 5-59 Medical devices - Symbols to be used with medical device ISO 15223-1 First Edition labels, labelling and information to be supplied--Part 1: 2007 General requirements ---------------------------------------------------------------------------------------------------------------- 5-60 Medical electrical equipment - Part 1-2: General IEC 60601-1-2 (2007) Third requirements for basic safety and essential performance - edition/I-SH 01 Collateral standard: Electromagnetic compatibility - Requirements and tests, Interpretation Sheet ---------------------------------------------------------------------------------------------------------------- 5-61 Medical devices - Symbols to be used with medical device ANSI/AAMI/ISO 15223-1:2007 labels, labeling, and information to be supplied--Part 1: General requirements ---------------------------------------------------------------------------------------------------------------- E. Materials ---------------------------------------------------------------------------------------------------------------- 8-194 Standard Test Method for Measurement of Camber, Cast, Helix ASTM F 2754/F 2754M--09 and Direction of Helix of Coiled Wire ---------------------------------------------------------------------------------------------------------------- 8-195 Standard Specification for Wrought Seamless Nickel-Titanium ASTM F 2633-07 Shape Memory Alloy Tube for Medical Devices and Surgical Implants ---------------------------------------------------------------------------------------------------------------- F. Ophthalmic ---------------------------------------------------------------------------------------------------------------- 10-61 Ophthalmic optics--Contact lenses--Part 1: Vocabulary, ISO 18369-1 First edition classification system and recommendations for labelling 2006-08-05 AMENDMENT 1 specifications AMENDMENT 1 2009-02-15 ---------------------------------------------------------------------------------------------------------------- G. Orthopedic ---------------------------------------------------------------------------------------------------------------- 11-224 Standard Test Methods for Occipital-Cervical and Occipital- ASTM F 2706--08 Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model ---------------------------------------------------------------------------------------------------------------- H. Radiology ---------------------------------------------------------------------------------------------------------------- 12-212 Medical electrical equipment--Characteristics of digital X- IEC 62220-1 First Edition ray imaging devices--Part 1: Determination of the detective 2003-10 quantum efficiency ---------------------------------------------------------------------------------------------------------------- 12-213 Medical electrical equipment--Characteristics of digital X- IEC 62220-1-2 First ray imaging devices--Part 1-2: Determination of the Edition 2007-06 detective quantum efficiency--Detectors used in mammography ---------------------------------------------------------------------------------------------------------------- 12-214 Medical electrical equipment--Characteristics of digital X- IEC 62220-1-3 Edition 1.0 ray imaging devices--Part 1-3: Determination of the 2008-06 detective quantum efficiency--Detectors used in dynamic imaging ---------------------------------------------------------------------------------------------------------------- 12-215 Medical electrical equipment--Exposure index of digital X- IEC 62494-1 Edition 1.0 ray imaging systems--Part 1: Definitions and requirements 2008-08 for general radiography ---------------------------------------------------------------------------------------------------------------- 12-216 Medical electrical equipment - Medical image display systems IEC 62563-1 Edition 1.0 - Part 1: Evaluation methods 2009-12 ---------------------------------------------------------------------------------------------------------------- I. Sterility ---------------------------------------------------------------------------------------------------------------- 14-289 Cleanrooms and associated controlled environments-- ISO 14698-2:2003 TECHNICAL Biocontamination control--Part 2: Evaluation and CORRIGENDUM 1 interpretation of biocontamination data ---------------------------------------------------------------------------------------------------------------- J. Tissue Engineering ---------------------------------------------------------------------------------------------------------------- 15-20 Standard Guide for Characterization and Testing of Raw or ASTM F 2027-08 Starting Biomaterials for Tissue-Engineered Medical Products ---------------------------------------------------------------------------------------------------------------- 15-21 Standard Guide for Characterization and Testing of ASTM F 2150-07 Biomaterial Scaffolds Used in Tissue-Engineered Medical Products ---------------------------------------------------------------------------------------------------------------- 15-22 Standard Guide for Assessment of Surface Texture of Non- ASTM F 2791-00 Porous Biomaterials in Two Dimensions ---------------------------------------------------------------------------------------------------------------- 15-23 Standard Guide for Quantitating Cell Viability within ASTM F 2739-08 Biomaterial Scaffolds ---------------------------------------------------------------------------------------------------------------- 15-24 Standard Guide for Pre-clinical in vivo Evaluation in ASTM F 2721-09 Critical Size Segmental Bone Defects ---------------------------------------------------------------------------------------------------------------- \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 http://www.accessdata.fda.gov/scripts/cdrh/ cfdocs/cfStandards/search.cfm. FDA will incorporate the modifications and minor revisions described in this notice into the database and, upon publication in the Federal Register, this recognition of consensus standards will be effective. FDA will announce additional modifications and minor revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often, if necessary. V. Recommendation of Standards for Recognition by FDA Any person may recommend consensus standards as candidates for recognition under the new provision of section 514 of the 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. 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: 025'' will be available on the CDRH home page. You may access the CDRH home page at http://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'' through the hyperlink at http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/Standards. This Federal Register document on modifications in FDA's recognition of consensus standards is available at http://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. It is no longer necessary to sent two copies of mailed 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: 025. These modifications to the list or recognized standards are effective upon publication of this notice in the Federal Register. Dated: September 28, 2010. Nancy K. Stade, Deputy Director for Policy, Center for Devices and Radiological Health. [FR Doc. 2010-24788 Filed 10-1-10; 8:45 am] BILLING CODE 4160-01-S

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