Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 025, 61148-61157 [2010-24788]

Download as PDF 61148 Federal Register / Vol. 75, No. 191 / Monday, October 4, 2010 / Notices • When and where they viewed the video. • Whom they recommended to view the video. • What they learned from watching the video. • What actions they may take because of the video. • Whether they plan to change behaviors and knowledge about their State’s activities. The process assessment of the State videos will be conducted using telephone interviews with the State points of contact. This interview should take 10 minutes (0.167 hours). The short form, and submit it electronically. The burden estimate is based on comments from several potential respondents who completed the online form, submitted it, and provided feedback on how long it would take them to complete it. The respondents will be employees of the State. A short survey will also be used to collect data from viewers of the State videos. An estimated 1,000 viewers will voluntarily choose to complete this online survey, which will take 10 minutes (0.167 hours) to review, complete, and submit. The viewers are expected to represent the general public. outcome assessment of the State videos will be collected using an online form that will be completed by no more than 26 respondents and will require only 1 response per respondent. It will take an average of 10 minutes (0.167 hours) to review the instructions, complete the form, and submit it electronically. Dissemination updates will be requested from each State point of contact every 6 months if there have been changes during that time period. These updates will be submitted electronically, and it should take approximately 5 minutes (0.083 hours) to review the instructions, complete the Responses per respondent Number of respondents Form name Burden per response (hrs.) Total burden Process Interview ............................................................................................ Dissemination Outcome ................................................................................... Dissemination Updates .................................................................................... Viewers Survey ................................................................................................ 26 26 26 1,000 1 1 1 1 0.167 0.167 0.083 0.167 4.34 4.34 2.16 167 Total .......................................................................................................... 1,078 ........................ ........................ 177.84 Written comments and recommendations concerning the proposed information collection should be sent by November 3, 2010 to: SAMHSA Desk Officer, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503; due to potential delays in OMB’s receipt and processing of mail sent through the U.S. Postal Service, respondents are encouraged to submit comments by fax to: 202–395– 5806. Dated: September 28, 2010. Elaine Parry Director, Office of Management Technology and Operations. [FR Doc. 2010–24849 Filed 10–1–10; 8:45 am] BILLING CODE 4162–20–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration jlentini on DSKJ8SOYB1PROD with NOTICES [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. VerDate Mar<15>2010 17:23 Oct 01, 2010 Jkt 223001 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 SUMMARY: PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 document may also be accessed on FDA’s Internet site at https:// www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ Standards/ucm123792.htm. See section VI of this document for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 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 E:\FR\FM\04OCN1.SGM 04OCN1 61149 Federal Register / Vol. 75, No. 191 / Monday, October 4, 2010 / Notices 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—Continued March 8, 2004 (69 FR 10712) March, 18, 2009 (74 FR 11586) TABLE 1.—PREVIOUS PUBLICATIONS OF STANDARD RECOGNITION LISTS June 18, 2004 (69 FR 34176) September 8, 2009 (74 FR 46203) February 25, 1998 (63 FR 9561) November 8, 2005 (70 FR 67713) October 4, 2004 (69 FR 59240) May 5, 2010 (75 FR 24711) October 16, 1998 (63 FR 55617) March 31, 2006 (71 FR 16313) May 27, 2005 (70 FR 30756) June 10, 2010 (75 FR 32943) 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) 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 Standard1 Change 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 ASTM F 1903–98 (Reapproved 2003) Standard Practice for Testing For Biological Responses to Particles in vitro Type of standard and Contact person 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 A. Anesthesia 1–61 1–82 B. Biocompatibility 2–96 jlentini on DSKJ8SOYB1PROD with NOTICES 2–98 VerDate Mar<15>2010 2–156 17:23 Oct 01, 2010 Jkt 223001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\04OCN1.SGM 04OCN1 61150 Federal Register / Vol. 75, No. 191 / Monday, October 4, 2010 / Notices TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old Recognition No. Replacement Recognition No. Title of Standard1 Change 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 3–79 ASTM F 2079—09 Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents Withdrawn and replaced with newer version 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 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 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 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 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 C. Cardiology 3–74 3–75 D. Dental/ENT 4–107 4–169 4–188 4–190 jlentini on DSKJ8SOYB1PROD with NOTICES E. General VerDate Mar<15>2010 17:23 Oct 01, 2010 Jkt 223001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\04OCN1.SGM 04OCN1 61151 Federal Register / Vol. 75, No. 191 / Monday, October 4, 2010 / Notices TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old Recognition No. 5–38 Replacement Recognition No. 5–62 Title of Standard1 Change 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-inGlass, 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 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 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 G. IVD 7–100 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 jlentini on DSKJ8SOYB1PROD with NOTICES 7–141 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 VerDate Mar<15>2010 17:23 Oct 01, 2010 Jkt 223001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\04OCN1.SGM 04OCN1 61152 Federal Register / Vol. 75, No. 191 / Monday, October 4, 2010 / Notices TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old Recognition No. Replacement Recognition No. Title of Standard1 Change 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-28Chromium6Molybdenum 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-12.5Nickel2.5Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications Type of standard 8–156 ASTM F 139—08 Standard Specification for Wrought 18Chromium14Nickel-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 ASTM F1542–94 (2000) Standard Specification for the Requirements and Disclosure of Self-Closing Aneurysm Clips Withdrawn 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 ASTM F1518–00 Standard Practice for Cleaning and Disinfection of Flexible Fiberoptic and Video Endoscopes Used in the Examination of the Hollow Viscera Withdrawn 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 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 ASTM F 1814—97a (Reapproved 2009) Standard Guide for Evaluating Modular Hip and Knee Joint Components Reaffirmation I. Neurology 17–2 17–6 17–9 J. OB-GYN/Gastroenterology 9–23 K. Ophthalmic 10–12 jlentini on DSKJ8SOYB1PROD with NOTICES 10–44 10–59 10–60 L. Orthopedics 11–171 VerDate Mar<15>2010 17:23 Oct 01, 2010 Jkt 223001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\04OCN1.SGM 04OCN1 61153 Federal Register / Vol. 75, No. 191 / Monday, October 4, 2010 / Notices TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old Recognition No. 11–179 Replacement Recognition No. 11–180 Change ASTM F 2068—09 Standard Specification for Femoral Prostheses—Metallic Implants Withdrawn and replaced with newer version ASTM F 366—04 (Reapproved 2009) Standard Specification for Fixation Pins and Wires 11–220 Title of Standard1 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) ε Standard Practice for Care and Handling of Orthopedic Implants and Instruments Reaffirmation 11–203 ASTM F 1541—02 (Reapproved 2007) ε Standard Specification and Test Methods for External Skeletal Fixation Devices Title, Type of standard and Relevant guidance 11–210 ASTM F 543—07ε 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) Method for Metallic Bone Plates ε Standard Specification and Test Title and Type of standard M. Sterility 14–54 14–287 Withdrawn and replaced with newer version 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 14–55 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 Contact person 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 jlentini on DSKJ8SOYB1PROD with NOTICES 14–63 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 AAMI/ANSI ST58: 2005 Chemical sterilization and high-level disinfection in health care facilities Contact person 14–181 VerDate Mar<15>2010 17:23 Oct 01, 2010 Jkt 223001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\04OCN1.SGM 04OCN1 61154 Federal Register / Vol. 75, No. 191 / Monday, October 4, 2010 / Notices TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old Recognition No. Replacement Recognition No. Title of Standard1 Change 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 14–296 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 jlentini on DSKJ8SOYB1PROD with NOTICES 14–223 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 VerDate Mar<15>2010 17:23 Oct 01, 2010 Jkt 223001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\04OCN1.SGM 04OCN1 61155 Federal Register / Vol. 75, No. 191 / Monday, October 4, 2010 / Notices TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old Recognition No. 14–284 Replacement Recognition No. 14–300 Title of Standard1 Change Withdrawn and replaced with newer version AAMI/ANSI/ISO 14161:2009 Sterilization of health care products—Biological indicators—Guidance for the selection, use and interpretation of results 14–285 ASTM D4169–09 Standard Practice for Performance Testing of Shipping Containers and Systems Contact person ASTM F2450–10 Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products Withdrawn and replaced with newer version N. Tissue Engineering 15–16 1 All 15–19 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 Title of Standard1 Recognition No. 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 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 Dentistry—Soft lining materials for removable dentures—Part 1: Materials for short-term use ISO 10139–1:2005 TECHNICAL CORRIGENDUM 1 2006–03–01 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 Standard Test Method for Measurement of Camber, Cast, Helix and Direction of Helix of Coiled Wire ASTM F 2754/F 2754M—09 B. Cardiology C. Dental/ENT 4–189 jlentini on DSKJ8SOYB1PROD with NOTICES D. General E. Materials 8–194 VerDate Mar<15>2010 17:23 Oct 01, 2010 Jkt 223001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\04OCN1.SGM 04OCN1 61156 Federal Register / Vol. 75, No. 191 / Monday, October 4, 2010 / Notices TABLE 3.—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued Title of Standard1 Recognition No. 8–195 Reference No. & Date Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants ASTM F 2633–07 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 Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model ASTM F 2706—08 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 Cleanrooms and associated controlled environments—Biocontamination control—Part 2: Evaluation and interpretation of biocontamination data ISO 14698–2:2003 TECHNICAL CORRIGENDUM 1 F. Ophthalmic 10–61 G. Orthopedic 11–224 H. Radiology I. Sterility 14–289 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 TissueEngineered 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 Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects ASTM F 2721–09 15–24 jlentini on DSKJ8SOYB1PROD with NOTICES 1 All standard titles in this table conform to the style requirements of the respective organizations. IV. List of Recognized Standards FDA maintains the Agency’s current list of FDA recognized consensus standards in a searchable database that may be accessed directly at FDA’s Internet site at https://www.accessdata. fda.gov/scripts/cdrh/cfdocs/ cfStandards/search.cfm. FDA will incorporate the modifications and minor revisions described in this notice into the database and, upon publication in the Federal Register, this recognition of consensus standards will be effective. FDA will announce additional modifications and minor revisions to the list of recognized consensus standards, as needed, in the Federal VerDate Mar<15>2010 17:23 Oct 01, 2010 Jkt 223001 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) PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 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 E:\FR\FM\04OCN1.SGM 04OCN1 Federal Register / Vol. 75, No. 191 / Monday, October 4, 2010 / Notices 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 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’’ through the hyperlink 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. 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 jlentini on DSKJ8SOYB1PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as VerDate Mar<15>2010 17:23 Oct 01, 2010 Jkt 223001 amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Aging Special Emphasis Panel, Relationships and Health. Date: November 16, 2010. Time: 1:30 p.m. to 5:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Suite 2C218, Bethesda, MD 20892. (Telephone Conference Call.) Contact Person: Alfonso R. Latoni, PhD, Deputy Chief and Scientific Review Officer, Scientific Review Branch, National Institute on Aging, 7201 Wisconsin Avenue, Suite 2C218, Bethesda, MD 20892. 301–402–7702. Alfonso.Latoni@nih.gov. Name of Committee: National Institute on Aging Special Emphasis Panel, Aging Bone and Muscle. Date: November 18, 2010. Time: 1 p.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Suite 2C212, Bethesda, MD 20892. (Telephone Conference Call.) Contact Person: William Cruce, PhD, Scientific Review Officer, National Institute on Aging, Scientific Review Branch, Gateway Building 2C–212, 7201 Wisconsin Ave., Bethesda, MD 20814. 301–402–7704. crucew@nia.nih.gov. Name of Committee: National Institute on Aging Special Emphasis Panel, Restless Leg Syndrome. Date: November 22, 2010. Time: 1 p.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Suite 2C212, Bethesda, MD 20892. (Telephone Conference Call.) Contact Person: William Cruce, PhD, Scientific Review Officer, National Institute on Aging, Scientific Review Branch, Gateway Building 2C–212, 7201 Wisconsin Ave., Bethesda, MD 20814. 301–402–7704. crucew@nia.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 61157 Dated: September 28, 2010. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–24784 Filed 10–1–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center For Scientific Review; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, October 19, 2010, 11 a.m. to October 19, 2010, 5 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 which was published in the Federal Register on September 17, 2010, 75 FR 57042–57043. The meeting will be two days— October 18, 2010, from 8 a.m. to October 19, 2010, 5 p.m. The meeting location remains the same. The meeting is closed to the public. Dated: September 28, 2010. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–24783 Filed 10–1–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Statement of Organization, Functions and Delegations of Authority This notice amends Part R of the Statement of Organization, Functions and Delegations of Authority of the Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA) (60 FR 56605, as amended November 6, 1995; as last amended at 75 FR 58416–58417 dated September 24, 2010). This notice reflects organizational changes to the Health Resources and Services Administration and updates the functional statement for the Bureau of Primary Health Care (RC). Specifically, this notice (1) Creates the Office of Administrative Management (RCM) and the Office of Training and Technical Assistance Coordination (RCS); (2) abolishes the Division of Health Information Technology State and Community Assistance (RCR); (3) renames the Office of Minority and Special Populations (RCG) to the Office E:\FR\FM\04OCN1.SGM 04OCN1

Agencies

[Federal Register Volume 75, Number 191 (Monday, October 4, 2010)]
[Notices]
[Pages 61148-61157]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-24788]


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

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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section VI of 
this document for electronic access to the searchable database for the 
current list of FDA recognized consensus standards, including 
Recognition List Number: 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

[[Page 61149]]

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

[[Page 61150]]

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

[[Page 61151]]

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

[[Page 61152]]

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

[[Page 61153]]

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

[[Page 61154]]

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

[[Page 61155]]

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

[[Page 61156]]

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