# Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 025 > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2010-24788 ## Record - **Collection:** Federal Register - **Document type:** Notice - **Published:** October 4, 2010 - **Citation:** 75 FR 61148 ## Text 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 Old Recognition No. Replacement Recognition No. Title of Standard 1 Change A. Anesthesia 1-61 1-82 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 Withdrawn and replaced with newer version B. Biocompatibility 2-96 ASTM F 1903-98 (Reapproved 2003) Standard Practice for Testing For Biological Responses to Particles in vitro Type of standard and Contact person 2-98 2-156 ANSI/AAMI/ISO 10993-1:2009 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process Withdrawn and replaced with newer version 2-100 ASTM E1372-95 (2003) Standard Test Method for Conducting a 90-Day Oral Toxicity Study in Rats Withdrawn 2-115 ASTM F 895—84 (Reapproved 2006) Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity Title, Type of standard , Relevant guidance and Contact person 2-117 ANSI/AAMI/ISO 10993-3:2003/(R)2009 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity Reaffirmation, CDRH Office(s) and Division(s) associated with recognized standard and Contact person 2-118 ANSI/AAMI/ISO 10993-11:2006 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity Contact person 2-119 ASTM F 813-07 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices Title, Type of standard and Contact person 2-135 ANSI/AAMI/ISO 10993-12:2007 Biological evaluation of medical devices—Part 12: Sample preparation and reference materials Title and Contact person 2-147 2-157 USP 33—NF 28 2010 Biological Tests <87> Biological Reactivity Test, In Vitro—Direct Contact Test Withdrawn and replaced with newer version 2-148 2-158 USP 33-NF28 2010 Biological Tests <87> Biological Reactivity Test, In Vitro—Elution Test Withdrawn and replaced with newer version 2-149 2-159 USP 33-NF28 2010 Biological Tests <88> Biological Reactivity Tests, In Vivo, Procedure—Preparation of Sample Withdrawn and replaced with newer version 2-150 2-160 USP 33-NF28 2010 Biological Tests <88> Biological Reactivity Tests, In Vivo, Classification of Plastics—Intracutaneous Test Withdrawn and replaced with newer version 2-151 2-161 USP 33-NF28 2010 Biological Tests <88> Biological Reactivity Tests, In Vivo, Classification of Plastics—Systemic Injection Test Withdrawn and replaced with newer version C. Cardiology 3-74 3-79 ASTM F 2079—09 Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents Withdrawn and replaced with newer version 3-75 ANSI/AAMI SP10:2002/(R)2008 & ANSI/AAMI SP10:2002/A1:2003/(R)2008 & ANSI/AAMI SP10:2002/A2:2006/(R)2008 Manual, electronic or automated sphygmomanometers Title and Extent of recognition D. Dental/ENT 4-86 ANSI/ADA Specification No. 38 2000 (Reaffirmed 2010) Metal-Ceramic Dental Restorative Systems Reaffirmation 4-91 ANSI/ADA Specification No. 80 2001 (Reaffirmed 2007) Dental Materials—Determination of Color Stability Test Procedure Reaffirmation 4-107 4-188 ISO 9917-2 Second edition 2010-04-15 Dentistry—Water-based cements—Part 2: Resin-modified cements Withdrawn and replaced with newer version 4-117 ANSI/ADA Specification No. 12 2002 (Reaffirmed 2007) Denture Base Polymers Reaffirmation 4-119 ANSI/ADA Specification No. 82 1998 (Reaffirmed 2009)—Dental Reversible/Irreversible Hydrocolloid Impression Material Systems Reaffirmation 4-139 ANSI/ADA Specification No. 48-Visible Light Curing Units: 2004, Reaffirmed 2009 Reaffirmation 4-160 ANSI/ASA S3.1-1999 (Reaffirmed 2003) (Reaffirmed 2008) Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms Reaffirmation 4-164 ANSI/ASA S3.7-1997 (Reaffirmed 2003) (Reaffirmed 2008) Methods for Coupler Calibration of Earphones Reaffirmation 4-166 ANSI/ASA S3.20-1995 (Reaffirmed 2003) (Reaffirmed 2008) Bioacoustical Terminology Reaffirmation 4-167 ANSI/ASA S3.21-2004 (Reaffirmed 2009) Methods for Manual Pure-Tone Threshold Audiometry Reaffirmation 4-169 4-190 ANSI/ASA S3.35-2010 (Revision of ANSI S3.35-2004) Method of Measurement of Performance Characteristics of Hearing Aids Under Simulated Real-Ear Working Conditions Withdrawn and replaced with newer version E. General 5-31 ISO 15223:2000 Medical device symbols to be used with medical device labels, labeling and information to be supplied—First Edition: Amendment 1: 08/01/2002; Amendment 2: 02/15/2004 Withdrawn 5-32 CEN EN 980:1996+A1:1999+A2:2001 Graphical Symbols for Use in the Labelling of Medical Devices Withdrawn 5-38 5-62 ANSI/ASQ Z1.4-2008 Sampling Procedures and Tables for Inspection by Attributes Withdrawn and replaced with newer version F. General Hospital/General Plastic Surgery 6-62 6-239 ISO 8536-6 Second edition 2009-11-15 Infusion equipment for medical use—Part 6: Freeze drying closures for infusion bottles Withdrawn and replaced with newer version 6-64 6-240 ISO 8536-3 Third edition 2009-06-01 Infusion equipment for medical use— Part 3: Aluminum caps for infusion bottles Withdrawn and replaced with newer version 6-70 ASTM E825-98 (Reapproved 2009) Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature Reaffirmation 6-110 ASTM F 1441-03 (Reapproved 2009) Standard Specification for Soft-Tissue Expander Devices Reaffirmation 6-112 ANSI/AAMI PB70:2003/(R)2009 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities Reaffirmation 6-123 ASTM E667-98 (Reapproved 2009) Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers Reaffirmation 6-124 ASTM E1104-98 (Reapproved 2009) Standard Specification for Clinical Thermometer Probe Covers and Sheaths Reaffirmation 6-125 ASTM E1965-98 (Reapproved 2009) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature Reaffirmation 6-127 6-241 ISO 1135-4 Forth edition 2010-04-15 Transfusion equipment for medical use—Part 4: Transfusion sets for single use Withdrawn and replaced with newer version 6-173 6-242 ISO 8536-2 Third edition 2010-03-15 Infusion equipment for medical use—Part 2: Closures for infusion bottles Withdrawn and replaced with newer version G. IVD 7-49 7-210 CLSI H26-A2 Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard-Second Edition Withdrawn and replaced with newer version 7-82 7-211 CLSI C34-A3 Sweat Testing: Sample Collection and Quantitative Chloride Analysis; Approved Guideline-Third Edition Withdrawn and replaced with newer version 7-96 7-212 CLSI EP18-A2 Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline-Second Edition Withdrawn and replaced with newer version 7-100 ISO 15197 First edition 2003-05-01 In vitro diagnostic test systems—Requirements for blood-glucose monitoring systems for self testing in managing diabetes mellitus Title 7-141 7-213 CLSI H18-A4 Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline-Fourth Edition Withdrawn and replaced with newer version 7-181 7-214 CLSI M35-A2 Abbreviated Identification of Bacteria and Yeast; Approved Guideline-Second Edition Withdrawn, see 7-197 7-186 7-215 CLSI M44-A2 Method for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Approved Guideline-Second Edition Withdrawn and Replaced with newer version 7-199 7-216 CLSI M100-S20 Performance Standards for Antimicrobial Susceptibility Testing; Twentieth Informational Supplement Withdrawn and Replaced with newer version 7-208 7-217 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 Withdrawn and replaced with newer version H. Materials 8-66 8-191 ISO 6474-1 First edition Implants for surgery—Ceramic materials—Part 1: Ceramic materials based on high purity alumina Withdrawn and replaced with newer version 8-71 8-192 ASTM F2182—09 Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging Withdraw and replaced with newer version 8-85 8-193 ASTM F 1854—09 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants Withdraw and replaced with newer version 8-88 ASTM F2024-00 Standard Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings Type of standard and Contact person 8-130 ASTM F 620—06 Standard Specification for Alpha Plus Beta Titanium Alloy Forgings for Surgical Implants Type of standard 8-131 ASTM F 799—06 Standard Specification for Cobalt-28Chromium-6Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539) Type of standard 8-137 ASTM F 75—07, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075) Type of standard 8-138 ASTM F 745—07 Standard Specification for 18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications Type of standard 8-156 ASTM F 139—08 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673) Type of standard 8-183 ASTM F 560—08 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400) Type of standard I. Neurology 17-2 ASTM F1542-94 (2000) Standard Specification for the Requirements and Disclosure of Self-Closing Aneurysm Clips Withdrawn 17-6 17-9 ASTM F 2129-08 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices Withdrawn and replaced with newer version J. OB-GYN/Gastroenterology 9-23 ASTM F1518-00 Standard Practice for Cleaning and Disinfection of Flexible Fiberoptic and Video Endoscopes Used in the Examination of the Hollow Viscera Withdrawn K. Ophthalmic 10-12 10-59 ISO 11980 Second edition 2009-10-15 Ophthalmic optics—Contact lenses and contact lens care products—Guidance for clinical investigations Withdrawn and replaced with newer version 10-30 ANSI Z80.7 (2002) Ophthalmics—Intraocular Lenses Withdrawn 10-34 ANSI Z80.20 (2004) Ophthalmics—Contact lenses- Standard Terminology, Tolerances, Measurements and Physicochemical Properties Withdrawn 10-44 10-60 ISO 11981 Second edition 2009-07-01 Ophthalmic optics—Contact lenses and contact lens care products- Determination of physical compatibility of contact lens care products with contact lenses Withdrawn and replaced with newer version L. Orthopedics 11-171 ASTM F 1814—97a (Reapproved 2009) Standard Guide for Evaluating Modular Hip and Knee Joint Components Reaffirmation 11-179 11-220 ASTM F 2068—09 Standard Specification for Femoral Prostheses—Metallic Implants Withdrawn and replaced with newer version 11-180 ASTM F 366—04 (Reapproved 2009) Standard Specification for Fixation Pins and Wires Reaffirmation 11-181 11-221 ASTM F 1717—09 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model Withdrawn and replaced with newer version 11-188 11-222 ISO 14243-1 Second edition 2009-11-15 Implants for surgery—Wear of total knee-joint prostheses—Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test Withdrawn and replaced with newer version 11-189 11-223 ISO 14243-2 Second edition 2009-11-15 Implants for surgery—Wear of total knee-joint prostheses—Part 2: Methods of measurement Withdrawn and replaced with newer version 11-197 ASTM F 983—86 (Reapproved 2009) Standard Practice for Permanent Marking of Orthopaedic Implant Components Reaffirmation 11-199 ASTM F 565—04 (Reapproved 2009) e Standard Practice for Care and Handling of Orthopedic Implants and Instruments Reaffirmation 11-203 ASTM F 1541—02 (Reapproved 2007) e Standard Specification and Test Methods for External Skeletal Fixation Devices Title, Type of standard and Relevant guidance 11-210 ASTM F 543—07 e Standard Specification and Test Methods for Metallic Medical Bone Screws Title, Type of standard and Relevant guidance 11-214 ASTM F 382—99 (Reapproved 2008) e Standard Specification and Test Method for Metallic Bone Plates Title and Type of standard M. Sterility 14-54 14-287 ANSI/AAMI/ISO 11737-2:2009 Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process Withdrawn and replaced with newer version 14-55 AAMI/ANSI/ISO 14160:1998/(R)2008 Sterilization of single-use medical devices incorporating materials of animal origin—Validation and routine control of sterilization by liquid chemical Contact person 14-63 14-288 ASTM F1886/F1886M-09 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection Withdrawn and replaced with newer version 14-77 14-290 ANSI/AAMI ST:24:1999/(R)2009 Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities Withdrawn and replaced with newer version 14-88 14-291 ANSI/AAMI/ISO 14937:2009 Sterilization of health care products—General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices Withdrawn and replaced with newer version 14-116 14-292 ANSI/AAMI ST72:2002/(R)2010 Bacterial Endotoxins—Test methodologies, routine monitoring, and alternatives to batch testing Withdrawn and replaced with newer version 14-118 14-293 ANSI/AAMI ST50:2004/(R)2010 Dry heat (heated air) sterilizers Withdrawn and replaced with newer version 14-152 14-294 ANSI/AAMI ST40:2004/(R)2010 Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities Withdrawn and replaced with newer version 14-164 14-295 ANSI/AAMI ST81:2004/(R)2010 Sterilization of medical devices—Information to be provided by the manufacturer for the processing of resterilizable medical devices Withdrawn and replaced with newer version 14-181 AAMI/ANSI ST58: 2005 Chemical sterilization and high-level disinfection in health care facilities Contact person 14-197 ASTM F1608-00 (Reapproved 2009) Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) Reaffirmation 14-211 AOAC 6.2.01:2006 Official Method 955.14 Testing Disinfectants against Salmonella choleraesuis, Use-Dilution Method Contact person 14-212 AOAC 6.2.02:2006 Official Method 991.47 Testing Disinfectants against Salmonella choleraesuis, Hard Surface Carrier Test Method Contact person 14-213 AOAC 6.2.03:2006 Official Method 991.48 Testing Disinfectant against Staphylococcus aureus, Hard Surface Carrier Test Method Contact person 14-214 AOAC 6.2.04:2006 Official Method 955.15 Testing Disinfectants Against Staphylococcus aureus, Use-Dilution Method Contact person 14-215 AOAC 6.2.05:2006 Official Method 991.49 Testing Disinfectants against Pseudomonas aeruginosa, Hard Surface Carrier Test Method Contact person 14-216 AOAC 6.2.06:2006 Official Method 964.02 Testing Disinfectants against Pseudomonas aeruginosa, Use-Dilution Method Contact person 14-217 AOAC 6.3.02:2006 Official Method 955.17 Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes Contact person 14-218 AOAC 6.3.05:2006 Official Method 966.04 Sporicidal Activity of Disinfectants Method I Contact person 14-219 AOAC 6.3.06:2006 Official Method 965.12 Tuberculocidal Activity of Disinfectants Contact person 14-223 14-296 ANSI/AAMI/ISO 11138-1:2006/(R)2010 Sterilization of health care products—Biological indicators—Part 1: General requirements Withdrawn and replaced with newer version 14-224 14-297 ANSI/AAMI/ISO 11137-1:2006/(R)2010 Sterilization of health care products—Radiation—Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices Withdrawn and replaced with newer version 14-226 14-298 ANSI/AAMI/ISO 11137-3:2006/(R)2010 Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspects Withdrawn and replaced with newer version 14-234 14-299 ASTM F2097-10 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products Withdrawn and replaced with newer version 14-265 USP 32:2009 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests Contact person 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 Assemblies and Similar Medical Devices Contact person 14-270 USP 32:2009 Biological Indicator for Steam Sterilization—Self Contained Contact person 14-271 USP 32: 2009 Biological Indicator for Dry-Heat Sterilization, Paper Carrier Contact person 14-272 USP 32:2009 Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier Contact person 14-273 USP 32:2009 Biological Indicator for Steam Sterilization, Paper Carrier Contact person 14-278 USP 32:2009 <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms Contact person 14-280 AAMI/ANSI ST79:2006 and A1:2008, A2:2009 (Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities Contact person 14-284 14-300 ASTM D4169-09 Standard Practice for Performance Testing of Shipping Containers and Systems Withdrawn and replaced with newer version 14-285 AAMI/ANSI/ISO 14161:2009 Sterilization of health care products—Biological indicators—Guidance for the selection, use and interpretation of results Contact person N. Tissue Engineering 15-16 15-19 ASTM F2450-10 Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products Withdrawn and replaced with newer version 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 the basic safety and essential performance of respiratory gas monitors ISO 21647:2004 TECHNICAL CORRIGENDUM 1 B. Cardiology 3-80 Non-invasive sphygmomanometers—Part 1: Requirements and test methods for non-automated measurement type ANSI/AAMI/ISO 81060-1:2007 3-81 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type ANSI/AAMI/ISO 81060-2:2009 3-82 Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors [IS-I] for implantable pacemakers TECHNICAL CORRIGENDUM 1 IS0 5841 -3:2000 TECHNICAL CORRIGENDUM 1 C. Dental/ENT 4-189 Dentistry—Soft lining materials for removable dentures—Part 1: Materials for short-term use ISO 10139-1:2005 TECHNICAL CORRIGENDUM 1 2006-03-01 D. General 5-56 Medical devices—Symbols to be used with medical device labels, labelling, and information to be supplied—Part 2: Symbol development, selection and validation ISO 15223-2 First edition 2010-01-15 5-57 Human factors engineering—Design of medical devices ANSI/AAMI HE75:2009 5-58 Medical electrical equipment—Part 1-11: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment IEC 60601-1-11 Edition 1.0 2010-04 5-59 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied—Part 1: General requirements ISO 15223-1 First Edition 2007 5-60 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests, Interpretation Sheet IEC 60601-1-2 (2007) Third edition/I-SH 01 5-61 Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied—Part 1: General requirements ANSI/AAMI/ISO 15223-1:2007 E. Materials 8-194 Standard Test Method for Measurement of Camber, Cast, Helix and Direction of Helix of Coiled Wire ASTM F 2754/F 2754M—09 8-195 Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants ASTM F 2633-07 F. Ophthalmic 10-61 Ophthalmic optics—Contact lenses—Part 1: Vocabulary, classification system and recommendations for labelling specifications AMENDMENT 1 ISO 18369-1 First edition 2006-08-05 AMENDMENT 1 2009-02-15 G. Orthopedic 11-224 Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model ASTM F 2706—08 H. Radiology 12-212 Medical electrical equipment—Characteristics of digital X-ray imaging devices—Part 1: Determination of the detective quantum efficiency IEC 62220-1 First Edition 2003-10 12-213 Medical electrical equipment—Characteristics of digital X-ray imaging devices—Part 1-2: Determination of the detective quantum efficiency—Detectors used in mammography IEC 62220-1-2 First Edition 2007-06 12-214 Medical electrical equipment—Characteristics of digital X-ray imaging devices—Part 1-3: Determination of the detective quantum efficiency—Detectors used in dynamic imaging IEC 62220-1-3 Edition 1.0 2008-06 12-215 Medical electrical equipment—Exposure index of digital X-ray imaging systems—Part 1: Definitions and requirements for general radiography IEC 62494-1 Edition 1.0 2008-08 12-216 Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods IEC 62563-1 Edition 1.0 2009-12 I. Sterility 14-289 Cleanrooms and associated controlled environments—Biocontamination control—Part 2: Evaluation and interpretation of biocontamination data ISO 14698-2:2003 TECHNICAL CORRIGENDUM 1 J. Tissue Engineering 15-20 Standard Guide for Characterization and Testing of Raw or Starting Biomaterials for Tissue-Engineered Medical Products ASTM F 2027-08 15-21 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products ASTM F 2150-07 15-22 Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions ASTM F 2791-00 15-23 Standard Guide for Quantitating Cell Viability within Biomaterial Scaffolds ASTM F 2739-08 15-24 Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects ASTM F 2721-09 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 --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2010-24788. Public record. Not legal advice.