Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 034, 4913-4935 [2014-01847]
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[Federal Register Volume 79, Number 20 (Thursday, January 30, 2014)] [Notices] [Pages 4913-4935] From the Federal Register Online via the Government Printing Office [www.gpo.gov] [FR Doc No: 2014-01847] [[Page 4913]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2004-N-0451] Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 034 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: 034'' (Recognition List Number: 034), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. DATES: Submit written or electronic comments concerning this document at any time. See section VII for the effective date of the recognition of standards announced in this document. ADDRESSES: Submit written requests for single copies of ``Modifications to the List of Recognized Standards, Recognition List Number: 034'' to the Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993. Send two self-addressed adhesive labels to assist that office in processing your requests, or fax your request to 301-847-8149. Submit written comments concerning this document, or recommendations for additional standards for recognition, to the contact person (see FOR FURTHER INFORMATION CONTACT). Submit electronic comments by email: standards@cdrh.fda.gov. This document may also be accessed on FDA's Internet site at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section VI for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 034 modifications and other standards related information. FOR FURTHER INFORMATION CONTACT: Scott A. Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3632, Silver Spring, MD 20993, 301-796- 6287. I. Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements. In a notice published in the Federal Register of February 25, 1998 (63 FR 9561), FDA announced the availability of a guidance entitled ``Recognition and Use of Consensus Standards.'' The notice described how FDA would implement its standard recognition program and provided the initial list of recognized standards. Modifications to the initial list of recognized standards, as published in the Federal Register, can be accessed at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The Agency maintains hypertext markup language (HTML) and portable document format (PDF) versions of the list of FDA Recognized Consensus Standards. Both versions are publicly accessible at the Agency's Internet site. See section VI for electronic access information. Interested persons should review the supplementary information sheet for the standard to understand fully the extent to which FDA recognizes the standard. II. Modifications to the List of Recognized Standards, Recognition List Number: 034 FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the Agency will recognize for use in premarket submissions and other requirements for devices. FDA will incorporate these modifications in the list of FDA Recognized Consensus Standards in the Agency's searchable database. FDA will use the term ``Recognition List Number: 034'' to identify these current modifications. In table 1 of this document, FDA describes the following modifications: (1) The withdrawal of standards and their replacement by others, if applicable; (2) the correction of errors made by FDA in listing previously recognized standards; and (3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards. In section III of this document, FDA lists modifications the Agency is making that involve the initial addition of standards not previously recognized by FDA. Table 1--Modifications to the List of Recognized Standards ---------------------------------------------------------------------------------------------------------------- Old recognition No. Replacement recognition No. Title of standard \1\ Change ---------------------------------------------------------------------------------------------------------------- A. Anesthesia ---------------------------------------------------------------------------------------------------------------- 1-15........................ ............................ ISO 5361-4:1987, Tracheal Withdrawn. See 1-93. tubes--Part 4: Cole type. 1-18........................ 1-94........................ ISO 8359 Second edition 1996- Withdrawn and replaced 12-15, Oxygen concentrators with newer version for medical use--Safety including amendment. requirements [Including: AMENDMENT 1 2012-07-01]. 1-36........................ 1-95........................ ISO 5366-3 Second edition Withdrawn and replaced 2001-08-15, Anaesthetic and with newer version respiratory equipment-- including technical Tracheostomy tubes--Part 3: corrigendum. Pediatric tracheostomy tubes [Including: TECHNICAL CORRIGENDUM 1 Published 2003-01-15]. 1-44........................ ............................ ISO 5366-1 Fourth edition Extent of recognition. 2000-12-15, Anaesthetic and respiratory equipment-- Tracheostomy tubes--Part 1: Tubes and connectors for use in adults. [[Page 4914]] 1-46........................ ............................ ISO 5367 Fourth edition 2000- Extent of recognition. 06-01 Breathing tubes intended for use with anaesthetic apparatus and ventilators. 1-47........................ ............................ AS 4259-1995 Ancillary Extent of recognition. devices for expired air resuscitation. 1-56........................ 1-97........................ CGA V-7.1:2011 Standard Withdrawn and replaced Method of Determining with newer version. Cylinder Valve Outlet Connections for Medical Gases. 1-57........................ ............................ ASTM F1101-90 (Reapproved Extent of recognition. 2003) [egr]1, Standard Specification for Ventilators Intended for Use During Anesthesia. 1-58........................ ............................ ASTM G175-03 (Reapproved Extent of recognition. 2011), Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications. 1-65........................ ............................ ISO 21647:2004 Medical Withdrawn. See 1-96. electrical equipment-- Particular requirements for the basic safety and essential performance of respiratory gas monitors. 1-69........................ ............................ ASTM F1464-93 (Reapproved Extent of recognition. 2005) Standard Specification for Oxygen Concentrators for Domiciliary Use. 1-70........................ ............................ ASTM F1246-91 (Reapproved Extent of recognition. 2005) Standard Specification for Electrically Powered Home Care Ventilators, Part 1-- Positive-Pressure Ventilators and Ventilator Circuits. 1-78........................ ............................ ASME PVHO-1-2007 Safety Extent of recognition. Standard for Pressure Vessels for Human Occupancy. 1-81........................ ............................ CGA V-5:2008 (Reaffirmed Reaffirmation. 2013), Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications). 1-83........................ ............................ ISO 21647:2004 TECHNICAL Withdrawn. See 1-96. CORRIGENDUM 1, Medical electrical equipment-- Particular requirements for the basic safety and essential performance of respiratory gas monitors. 1-84........................ ............................ ISO 5366-3:2001 Anaesthetic Withdrawn. See 1-95. and Respiratory Equipment-- Tracheostomy Tubes--Part 3: Pediatric Tracheostomy Tubes TECHNICAL CORRIGENDUM 1. 1-86........................ ............................ ISO 8185 Third edition 2007- Extent of recognition. 07-01 Corrected versions 2008-06-15 Respiratory tract humidifiers for medical use--Particular requirements for respiratory humidification systems. 1-88........................ 1-98........................ ISO 80601-2-12 First edition Withdrawn and replaced 2011-04-15 Medical with newer version electrical equipment--Part including technical 2-12: Particular corrigendum. requirements for the safety of lung ventilators-- Critical care ventilators [Including: TECHNICAL CORRIGENDUM 1 Published 2011-10-15]. 1-89........................ ............................ ISO 80601-2-12 TECHNICAL Withdrawn. See 1-98. CORRIGENDUM 1 Medical electrical equipment Part 2- 12: Particular requirements for basic safety and essential performance of critical care ventilators. 1-90........................ ............................ ISO 8359 Second edition 1996- Withdrawn. See 1-94. 12-15 AMENDMENT 1 2012-07- 01 Oxygen concentrators for medical use--Safety requirements. 1-92........................ ............................ ISO 17510-2 Second Edition Extent of recognition. 2007-10-01, Sleep apnoea breathing therapy--Part 2: Masks and application accessories. 1-93........................ ISO 5361................... Second edition 2012-10-01 Extent of recognition. Anaesthetic and respiratory equipment--Tracheal tubes and connectors. ---------------------------------------------------------------------------------------------------------------- B. Biocompatibility ---------------------------------------------------------------------------------------------------------------- 2-123....................... 2-204....................... ASTM F720-13 Standard Withdrawn and replaced Practice for Testing Guinea with newer version. Pigs for Contact Allergens: Guinea Pig Maximization Test. 2-182....................... 2-205....................... ISO 14155 Second edition Withdrawn and replaced 2011-02-01 Clinical with newer version investigations of medical including technical devices for human subjects-- corrigendum. Good clinical practices [Including TECHNICAL CORRIGENDUM 1:2011]. 2-183....................... ............................ ISO 14155:2011 and TECHNICAL Withdrawn. See 2-205. CORRIGENDUM 1 Published 2011-07-15 Clinical investigation of medical devices for human subjects-- Good clinical practice. 2-93........................ ............................ ASTM F763-04 (Reapproved Extent of recognition. 2010), Standard Practice for Short-Term Screening of Implant Materials. 2-94........................ ............................ ASTM F981-04 (Reapproved Extent of recognition. 2010) Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone. 2-114....................... ............................ ASTM F1877-05 (Reapproved Extent of recognition. 2010) Standard Practice for Characterization of Particles. 2-118....................... ............................ ANSI/AAMI/ISO 10993-11:2006/ Extent of recognition. (R) 2010 Biological evaluation of medical devices--Part 11: Tests for systemic toxicity. 2-120....................... ............................ ANSI/AAMI/ISO 10993-6:2007/ Extent of recognition. (R) 2010 Biological evaluation of medical devices--Part 06: Tests for local effects after implantation. 2-126....................... ............................ ASTM F748-06 (Reapproved Extent of recognition. 2010) Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices. [[Page 4915]] 2-133....................... ............................ ASTM F1408-97 (Reapproved Extent of recognition. 2008) Standard Practice for Subcutaneous Screening Test for Implant Materials. 2-134....................... ............................ ASTM F2065-00 (Reapproved Extent of recognition. 2010) Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials. 2-136....................... ............................ ASTM E1262-88 (Reapproved Extent of recognition. 2008) Standard Guide for Performance of the Chinese Hamster Ovary Cell/ Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay. 2-137....................... ............................ ASTM E1263-97 (Reapproved Withdrawn. 2008) Standard Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow Erythrocytes. 2-138....................... ............................ ASTM E1280-97 (Reapproved Withdrawn. 2008) Standard Guide for Performing the Mouse Lymphoma Assay for Mammalian Cell Mutagenicity. 2-139....................... ............................ ASTM E1397-91 (Reapproved Withdrawn. 2008) Standard Practice for the In Vitro Rat Hepatocyte DNA Repair Assay. 2-140....................... ............................ ASTM E1398-91 (Reapproved Withdrawn. 2008) Standard Practice for the In Vivo Rat Hepatocyte DNA Repair Assay. 2-141....................... ............................ ASTM F1984-99 (Reapproved Extent of recognition. 2008) Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials. 2-142....................... ............................ ASTM F1983-99 (Reapproved Extent of recognition. 2008) Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Application. 2-143....................... ............................ ASTM F1904-98 (Reapproved Extent of recognition. 2008) Standard Practice for Testing the Biological Responses to Particles in vivo. 2-144....................... ............................ ASTMF619-03 (Reapproved Extent of recognition. 2008) Standard Practice for Extraction of Medical Plastics. 2-145....................... ............................ ASTM F1439-03 (Reapproved Extent of recognition. 2008) Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials. 2-153....................... ............................ ANSI/AAMI/ISO 10993-5:2009, Extent of recognition. Biological evaluation of medical devices--Part 5: Tests for In Vitro cytotoxicity. 2-154....................... ............................ ASTM F756-08 Standard Extent of recognition. Practice for Assessment of Hemolytic Properties of Materials. 2-155....................... ............................ ASTM F2147-01 (Reapproved Extent of recognition. 2010) Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens. 2-156....................... ............................ ANSI/AAMI/ISO 10993-1:2009 Extent of recognition. Biological evaluation of medical devices--Part 1: Evaluation and testing within a risk management. 2-162....................... ............................ ASTM F1903-10 Standard Extent of recognition. Practice for Testing for Biological Responses to Particles in vitro. 2-163....................... ............................ ANSI/AAMI/ISO 10993-9:2009 Extent of recognition. Biological evaluation of medical devices--Part 9: Framework for identification and quantification of potential degradation products. 2-165....................... ............................ ANSI/AAMI/ISO 10993-14:2001/ Extent of recognition. (R) 2011 Biological evaluation of medical devices--Part 14: Identification and quantification of degradation products from ceramics. 2-167....................... ............................ ISO/TS 10993-19 First Extent of recognition. edition 2006-06-01 Biological evaluation of medical devices--Part 19: Physico-chemical, morphological, and topographical characterization of materials. 2-168....................... ............................ ISO 10993-9 Second edition Extent of recognition. 2009-12-15 Biological evaluation of medical devices--Part 9: Framework for identification and quantification of potential degradation products. 2-169....................... ............................ ISO 10993-13 Second edition Extent of recognition. 2010-06-15 Biological evaluation of medical devices--Part 13: Identification and quantification of degradation products from polymeric medical devices. 2-170....................... ............................ ISO 10993-14 First edition Extent of recognition. 2001-11-15 Biological evaluation of medical devices--Part 14: Identification and quantification of degradation products from ceramics. 2-171....................... ............................ ISO 10993-16 Second edition Extent of recognition. 2010-02-15 Biological evaluation of medical devices--Part 16: Toxicokinetic study design for degradation products and leachables. 2-172....................... ............................ ANSI/AAMI/ISO TIR 10993- Extent of recognition. 19:2006 Biological evaluation of medical devices--Part 19: Physicochemical, morphological, and topographical characterization of materials. 2-173....................... ............................ ANSI/AAMI/ISO 10993-10:2010 Extent of recognition. Biological evaluation of medical devices--Part 10: Tests for irritation and skin sensitization. 2-174....................... ............................ ISO 10993-10:2010 Biological Extent of recognition. evaluation of medical devices--Part 10: Tests for irritation and skin sensitization. 2-175....................... ............................ ISO 10993-3 Second edition Extent of recognition. 2003-10-15 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity. [[Page 4916]] 2-176....................... ............................ ISO 10993-11 Second edition Extent of recognition. 2006-08-15 Biological evaluation of medical devices--Part 11: Tests for systemic toxicity. 2-177....................... ............................ ISO 10993-06 Second edition Extent of recognition. 2007-04-15 Biological evaluation of medical devices--Part 6: Tests for local effects after implantation. 2-179....................... ............................ ISO 10993-1 Fourth edition Extent of recognition. 2009-10-15 Biological evaluation of medical devices--Part 1: Evaluation and testing within a risk management process. 2-181....................... ............................ ANSI/AAMI/ISO 14155:2011, Extent of recognition. Clinical investigation of medical devices for human subjects--Good clinical practice. 2-189....................... ............................ ASTM F895-11, Standard Test Extent of recognition. Method for Agar Diffusion Cell Culture Screening for Cytotoxicity. 2-190....................... ............................ ANSI/AAMI/ISO 10993-13:2010, Extent of recognition. Biological evaluation of medical devices--Part 13: Identification and quantification of degradation products from polymeric medical devices. 2-191....................... ............................ ISO 10993-12 Fourth edition Extent of recognition. 2012-07-01, Biological evaluation of medical devices--Part 12: Sample preparation and reference materials. ---------------------------------------------------------------------------------------------------------------- C. Cardiovascular ---------------------------------------------------------------------------------------------------------------- 3-41........................ ............................ ANSI/AAMI EC11:1991/(R)2007 Withdrawn. See 3-106. Diagnostic electrocardiographic devices. 3-52........................ ............................ ANSI/AAMIEC12:2000/(R)2010 Extent of recognition. Disposable ECG electrodes. 3-54........................ ............................ ANSI/AAMI/ISO 7198:1998/2001/ Extent of recognition. (R)2010 Cardiovascular implants--Tubular vascular prostheses. 3-58........................ ............................ ANSI/AAMI/ISO 5840:2005/ Extent of recognition. (R)2010 Cardiovascular implants--Cardiac valve prostheses. 3-63........................ ............................ ISO 11318 Second edition Extent of recognition. 2002-08-01 Cardiac Defibrillators--Connector assembly DF-1 for implantable defibrillators-- Dimensions and test requirements. 3-72........................ ............................ ANSI/AAMI EC53:1995/(R) 2008 Extent of recognition. ECG cables and leadwires. 3-73........................ 3-118....................... ANSI/AAMI EC57:2012 Testing Withdrawn and replaced and reporting performance with newer version. results of cardiac rhythm and ST-segment measurement algorithms. 3-75........................ ............................ ANSI/AAMI SP10:2002/(R) 2008 Withdrawn. See 3-80, 3- & ANSI/AAMI SP10:2002/ 122 and 3-123. A1:2003, Manual, electronic or automated sphygmomanometers. 3-76........................ ............................ ASTM F2129-08 Standard Test Extent of recognition. Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices. 3-78........................ ............................ ANSI/AAMI/IEC 80601-2- Extent of recognition. 30:2009 Medical electrical equipment--Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers. 3-80........................ ............................ ANSI/AAMI/ISO 81060-1:2007/ Reaffirmation. (R) 2013 Non-invasive sphygmomanometers--Part 1: Requirements and test methods for non-automated measurement type. 3-83........................ ............................ ANSI/AAMI/ISO 14708-5:2010 Extent of recognition. Implants for surgery-- Active implantable medical devices--Part 5: Circulatory support devices. 3-85........................ 3-120....................... ANSI/AAMI/ISO 25539-2:2012 Withdrawn and replaced Cardiovascular implants-- with newer version. Endovascular devices--Part 2: Vascular stents. 3-88........................ ............................ ASTM F2514-08 Standard Guide Extent of recognition. for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial. 3-90........................ ............................ ISO 7198 First edition 1998- Extent of recognition. 08-01 Cardiovascular implants--Tubular vascular prostheses. 3-93........................ ............................ ISO 25539-1:2003 First Withdrawn. See 3-121. edition 2001-11-13 AMENDMENT 1 2005-07-15 Cardiovascular implants-- Endovascular devices--Part 1: Endovascular prostheses Amendment 1: Test methods. 3-97........................ 3-122....................... ISO 81060-2 Second edition Withdrawn and replace 2013-05-01 Non-invasive with newer version. sphygmomanometers--Part 2: Clinical validation of automated measurement type. 3-98........................ ............................ ISO 81060-2:2009 TECHNICAL Withdrawn. See 3-122. CORRIGENDUM Published 2011- 02-15 Non-invasive sphygmomanometers--Part 2: Clinical validation of automated measurement type. 3-100....................... ............................ ANSI/AAMI/IEC 60601-2- Withdrawn. See 3-101. 27:2011 Medical electrical equipment--Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment. 3-107....................... 3-123....................... IEC 80601-2-30 Edition 1.1 Withdrawn and replaced 2013-07 Medical electrical with newer version. equipment--Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers. [[Page 4917]] 3-108....................... ............................ IEC 80601-2-30 (First Withdrawn. See 3-123. edition 2009) Medical electrical equipment--Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers CORRIGENDUM 1. 3-113....................... 3-124....................... ISO 7199 Second edition 2009- Withdrawn and replaced 04-15 Cardiovascular with newer version implants and artificial including amendment. organs--Blood-gas exchangers (oxygenators) [Including: AMENDMENT 1 (2012)]. 3-114....................... 3-119....................... ISO 5841-3 Third edition Withdrawn and replace 2013-40-15 Implants for with newer version. surgery--Cardiac pacemakers--Part 3: Low- profile connectors (IS-1) for implantable pacemakers. ---------------------------------------------------------------------------------------------------------------- D. Dental/ENT ---------------------------------------------------------------------------------------------------------------- 4-50........................ ............................ ADA Specification No.18:1992 Extent of recognition. Alginate Impression Materials. 4-62........................ ............................ ISO 1563 Second edition 1990- Withdrawn. 09-01 Dental alginate impression material. 4-63........................ ............................ ISO 1564 Second edition 1995- Withdrawn. 11-01 Dental aqueous impression materials based on agar. 4-86........................ ............................ ANSI/ADA Specification No. Extent of recognition. 38 2000 (Reaffirmed 2010), Metal-Ceramic Dental Restorative Systems. 4-89........................ ............................ ANSI/ADA Specification No. Extent of recognition. 53: 1999 (Reaffirmed 2008) Polymer-Based Crowns and Bridge Materials. 4-91........................ ............................ ANSI/ADA Specification No. Reaffirmation and 80/ISO 7491:2000 extent of (Reaffirmed 2013) Dental recognition. Materials--Determination of Color Stability. 4-92........................ ............................ ANSI/ADA Specification No. Reaffirmation and 88:2000 (Reaffirmed 2010) extent of Dental Brazing Alloys. recognition. 4-96........................ ............................ ANSI/ADA Specification No. Reaffirmation and 30:2000 (Reaffirmed 2012) extent of Dental Zinc Oxide-Eugenol recognition. and Zinc Oxide Non-Eugenol Cements. 4-97........................ ............................ ANSI/ADA Specification No. Extent of recognition. 57: (Reaffirmed 2012) Endodontic Sealing Materials. 4-105....................... ............................ ANSI/ADA Specification No. Extent of recognition. 75:1997 (Reapproved 2003) Resilient Lining Materials for Removable Dentures-- Part 1: Short-Term Materials. 4-109....................... ............................ ISO 13716 First edition 1999- Withdrawn. 05-01 Dentistry--reversible- irreversible hydrocolloid impression material system. 4-126....................... ............................ ISO 10477 Second edition Extent of recognition. 2004-10-01 Dentistry-- Polymer-based crown and bridge materials. 4-130....................... ............................ ADA Specification No. Extent of recognition. 17:1983 (Reaffirmed 2006) Denture Base Temporary Relining Resins. 4-134....................... 4-207....................... ISO 7494-1 Second edition Withdrawn and replaced 2011-08-15 Dentistry-- with newer version. Dental units--Part 1: General requirements and test methods. 4-135....................... 4-213....................... ISO 10139-1 Second edition Withdrawn and replaced 2005-02-15 Dentistry--Soft with newer version lining materials for including technical removable dentures--Part 1: corrigendum. Materials for short-term use [Including: TECHNICAL CORRIGENDUM 1 (2006)]. 4-137....................... ............................ ISO 6877 Second edition 2006- Extent of recognition. 04-01 Dentistry--Root-canal obturating points. 4-139....................... ............................ ANSI/ADA Specification No. Reaffirmation and 48 (Reaffirmed 2009) extent of Visible Light Curing Units. recognition. 4-143....................... 4-208....................... ANSI/ADA Specification No. Withdrawn and replaced 96:2012 Dental-Water-Based with newer version. Cements. 4-144....................... 4-209....................... ISO 24234 First edition 2004- Withdrawn and replaced 10-15 Dentistry--Mercury with newer version and alloys for dental including amendment. amalgam [Including: AMENDMENT 1 (2011)]. 4-146....................... ............................ ISO 22674 First edition 2006- Extent of recognition. 11-15 Dentistry--Metallic materials for fixed and removable restorations and appliances. 4-149....................... ............................ ANSI/ADA Specification No. Reaffirmation and 39/ISO 6874:2005 extent of (Reaffirmed 2011) Pit and recognition. Fissure Sealants. 4-150....................... ............................ ANSI/ADA Specification No. Extent of recognition. 19:2004/ISO 4823:2000 Dental--Elastometric Impression Materials. 4-151....................... ............................ ISO 22112 First edition 2005- Extent of recognition. 11-01 Dentistry--Artificial teeth for dental prostheses. 4-153....................... ............................ ISO 9917-1 Second edition Extent of recognition. 2007-10-01 Dentistry--Water- based cements--Part 1: Powder/liquid acid-base cements. 4-154....................... 4-210....................... ISO 4823 Third edition 2000- Withdrawn and replaced 12-15 Dentistry-- with newer version Elastometric impression including amendment materials [Including: and technical AMENDMENT 1 (2000) corrigendum. TECHNICAL CORRIGENDUM 1(2004)]. 4-155....................... ............................ ISO 4823: Technical Withdrawn. See 4-210. Corrigendum 1 Published 2004-07-15--Dentistry--Elas tometric impression materials--Third Edition. [[Page 4918]] 4-156....................... ............................ ISO 4823 Third edition 2000- Withdrawn. See 4-210. 12-15 Amendment 1 2007-07- 01 Dentistry--Elastometric impression materials--Third Edition. 4-157....................... ............................ ISO 3107 Third edition 2004- Withdrawn. See 4-198. 10-01 Dentistry--Zinc oxide/ Eugenol and zinc oxide/non- eugenol cements--Third edition. 4-159....................... 4-211....................... ANSI/IEEE C63.19:2007 Withdrawn and replaced American National Standard with newer version. Methods of Measurement of Compatibility between Wireless Communications Devices and Hearing Aids. 4-170....................... 4-212....................... ANSI/ASA S3.36-2012 American Withdrawn and replaced National Standard with newer version. Specification for a Manikin for Simulated in situ Airborne Acoustic Measurements. 4-178....................... ............................ ISO 6872 Third edition 2008- Extent of recognition. 09-01 Dentistry--Ceramic materials. 4-179....................... ............................ ISO 7405 Second edition 2008- Extent of recognition. 12-15 Dentistry--Evaluation of biocompatibility of medical devices used in dentistry. 4-180....................... ............................ ISO 9168 Third edition 2009- Extent of recognition. 07-15 Dentistry--Hose connectors for air driven dental handpieces. 4-181....................... ............................ ISO 4049 Fourth edition 2009- Extent of recognition. 10-01 Dentistry--Polymer- based restorative materials. 4-182....................... ............................ ISO 10139-2 Second edition Extent of recognition. 2009-08-01 Dentistry--Soft lining materials for removable dentures--Part 2: Materials for long-term use. 4-188....................... ............................ ISO 9917-2 Second edition Extent of recognition. 2010-04-15 Dentistry--Water- based cements--Part 2: Resin-modified cements. 4-189....................... ............................ ISO 10139-1:2005 TECHNICAL Withdrawn. See 4-213. CORRIGENDUM 1 2006-03-01 Dentistry--Soft lining materials for removable dentures--Part 1: Materials for short-term use. 4-195....................... ............................ ISO 14801 Second edition Extent of recognition. 2007-11-15 Dentistry-- Implants-Dynamic fatigue test for endosseous dental implants. 4-196....................... ............................ ANSI/ADA Specification Extent of recognition. No.69:2010/ISO 6872:2008 Dental Ceramic. 4-198....................... ............................ ISO 3107 Fourth edition 2011- Extent of recognition. 03-01 Dentistry--Zinc oxide/ eugenol and zinc oxide/non- eugenol cements. 4-199....................... ............................ ISO 6876 Third edition 2012- Extent of recognition. 06-01 Dentistry--Root Canal Sealing Materials. 4-200....................... ............................ ISO 24234 First edition 2004- Withdrawn. See 4-209. 10-15 Dentistry--Mercury and alloys for dental amalgam AMENDMENT 1. 4-201....................... ............................ ISO 9693-2012 Dentistry-- Extent of recognition. Compatibility testing-- Metal-ceramic systems. 4-205....................... ............................ ISO 14457 First edition 2012- Withdrawn. See 4-206. 09-15 Dentistry--Handpieces and motors. ---------------------------------------------------------------------------------------------------------------- E. General ---------------------------------------------------------------------------------------------------------------- 5-22........................ ............................ ISO 2768-1 First edition Extent of recognition. 1989-11-15 General tolerances--Part 1: Tolerances for linear and angular dimensions without individual tolerance indications. 5-23........................ ............................ ISO 2768-2 First edition Extent of recognition. 1989-11-15 General Tolerances--Part 2: Geometrical tolerances for features without individual tolerance indications. 5-36........................ ............................ ISO/TR 16142 Second edition Extent of recognition. 2006-01-15 Medical devices-- Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices. 5-37........................ 5-81........................ ISO 2859-1 Second edition Withdrawn and replaced 1999-11-15 Sampling with newer version procedures for inspection including technical by attributes--Part 1: corrigendum. Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection [Including: TECHNICAL CORRIGENDUM 1 (2001)]. 5-43........................ ............................ ANSI/ESD S20.20-2007 For the Extent of recognition. Development of an Electrostatic Discharge Control Program for Protection of Electrical and Electronic Parts, Assemblies and Equipment (Excluding Electrically Initiated Explosive Devices). 5-45........................ 5-79........................ ASTM D7386-12 Standard Withdrawn and replaced Practice for Performance with new version. Testing of Packages for Single Parcel Delivery Systems. 5-46........................ ............................ ISO 2859-1:1999/Cor 1:2001 Withdrawn. See 5-81. Sampling procedures for inspection by attributes-- Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot- by-lot inspection. 5-47........................ ............................ ISO 10012 First edition 2003- Extent of recognition. 01-15 Measurement management systems-- Requirements for measurement processes and measuring equipment. 5-50........................ ............................ IEC 62366 Edition 1.0 2007- Extent of recognition. 10 Medical devices-- Application of usability engineering to medical devices. [[Page 4919]] 5-51........................ 5-80........................ ASTM D-4332-13 Standard Withdrawn and replaced Practice for Conditioning with new version. Containers, Packages, or Packaging Components for Testing. 5-53........................ ............................ IEC 60601-1-2 Edition 3.0 Relevant guidance. 2007-03 Medical electrical equipment--Part 1-2: General requirements for basic safety and essential performance--Collateral standard: Electromagnetic compatibility--Requirements and tests. 5-54........................ ............................ ANSI/AAMI/IEC 60601-1-2:2007/ Reaffirmation and (R)2012 Medical electrical relevant guidance. equipment--Part 1-2: General requirements for basic safety and essential performance--Collateral standard: Electromagnetic compatibility--Requirements and tests. 5-57........................ ............................ ANSI/AAMI HE75:2009 Human Extent of recognition. factors engineering--Design of medical devices. 5-58........................ 5-82........................ IEC 60601-1-11 Edition Withdrawn and replaced 1.0:2010 Medical electrical with newer version equipment--Part 1-11: including technical General requirements for corrigendum. basic safety and essential performance--Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment [Including: TECHNICAL CORRIGENDUM 1 (2011)]. 5-62........................ ............................ ANSI/ASQ Z1.4-2008 Sampling Extent of recognition. Procedures and Tables for Inspection by Attributes. 5-66........................ ............................ IEC 60601-1-10 Edition 1.0: Extent of recognition. 2007-11 Medical electrical equipment--Part 1-10: General requirements for basic safety and essential performance--Collateral Standard: Requirements for the development of physiologic closed-loop controllers. 5-67........................ ............................ ANSI/AAMI/IEC 62366:2007/ Reaffirmation and (R)2013 Medical devices-- extent of Application of usability recognition. engineering to medical devices. 5-69........................ ............................ IEC 60601-1-11 (First Withdrawn. See 5-82. edition 2010) April 2011 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 CORRIGENDUM 1. ---------------------------------------------------------------------------------------------------------------- F. General Hospital/General Plastic Surgery ---------------------------------------------------------------------------------------------------------------- 6-13........................ ............................ ISO 595-1 First edition 1986- Withdrawn. 12-15 Reusable all-glass or metal-and-glass syringes for medical use--Part 1: Dimensions. 6-14........................ ............................ ISO 595-2 First edition 1987- Withdrawn. 12-15 Reusable all-glass or metal-and-glass syringes for medical use--Part 2: Design, performance requirements and tests. 6-117....................... ............................ ASTM F2172-02 (Reapproved Extent of recognition. 2011) Standard Specification for Blood/ Intravenous Fluid/ Irrigation Fluid Warmers. 6-142....................... ............................ ANSI/AAMI II36:2004 Medical Withdrawn. See 6-230. electrical equipment--Part 2: Particular requirements for safety of baby incubators. 6-143....................... ............................ ANSI/AAMI II51:2004 Medical Withdrawn. See 6-231. electrical equipment--Part 2: Particular requirements for safety of transport incubators. 6-150....................... ............................ ASTM D7161-05 (Reapproved Withdrawn. 2010) Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions. 6-161....................... 6-301....................... ISO 10555-1 Second edition Withdrawn and replaced 2013-06-15 Corrected with newer version. version 2013-07-01 Intravascular catheters-- Sterile and single-use catheters--Part 1: General requirements. 6-163....................... ............................ ISO 9626 First edition 1991- Withdrawn. See 6-302. 09-01 AMENDMENT 1 2001-06- 01 Stainless steel needle tubing for the manufacture of medical devices. 6-164....................... 6-303....................... ISO 10555-5 Second edition Withdrawn and replaced 2013-06-15 Intravascular with newer version. catheters--Sterile and single-use catheters--Part 5: Over-needle peripheral catheters. 6-170....................... 6-304....................... ISO 7886-1 First edition Withdrawn and replaced 1993-10-01 Sterile with newer version hypodermic syringes for including technical single use--Part 1: corrigendum. Syringes for manual use [Including: TECHNICAL CORRIGENDUM 1 Published 1995-11-01]. 6-171....................... 6-305....................... ISO 10555-3 Second edition Withdrawn and replaced 2013-06-15 Intravascular with newer version. catheters--Sterile and single-use catheters--Part 3: Central venous catheters. 6-176....................... ............................ ASTM D7103-06 (Reapproved Extent of recognition. 2013) Standard Guide for Assessment of Medical Gloves. 6-187....................... 6-306....................... ASTM F1671/F1671M-13 Withdrawn and replaced Standard Test Method for with newer version. Resistance of Materials Used in Protective Clothing to Penetration by Blood- Borne Pathogens Using Phi- X174 Bacteriophage Penetration as a Test System. [[Page 4920]] 6-233....................... ............................ IEC 60601-2-52 Edition 1.0 Withdrawn. See 6-321. 2009-12 Medical electrical equipment--Part 2-52: Particular requirements for basic safety and essential performance of medical beds. 6-236....................... 6-307....................... IEC 80601-2-59 Edition 1.0 Withdrawn and replaced 2008-10 Medical Electrical with newer version Equipment--Part 2-59: including technical Particular requirements for corrigendum. the basic safety and essential performance of screening thermographs for human febrile temperature screening [Including: CORRIGENDUM 1 (April 2009)]. 6-237....................... ............................ IEC 80601-2-59 (First Withdrawn. See 6-307. edition 2008) Medical Electrical Equipment--Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening CORRIGENDUM 1. 6-238....................... 6-308....................... IEC 80601-2-35 Edition 2.0 Withdrawn and replaced 2009-10 Medical electrical with newer version equipment--Part 2-35: including technical Particular requirements for corrigendum. the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use [Including: CORRIGENDUM 1 (March 2012)]. 6-245....................... ............................ ISO 8536-4 Fifth edition Withdrawn. See 6-318. 2010-10-01 Infusion equipment for medical use-- Part 4: Infusion sets for single use, gravity feed. 6-253....................... ............................ ISO 10535 Second edition Extent of recognition. 2006-12-15 Hoists for the transfer of disabled persons--Requirements and test methods. 6-264....................... ............................ ISO 10555-1 First edition Withdrawn. See 6-301. 1995-06-15 AMENDMENT 1 1999- 07-15 Sterile, single-use intravascular catheters-- Part 1: General requirements. 6-265....................... ............................ ISO 10555-1 First edition Withdrawn. See 6-301. 1995-06-5 AMENDMENT 2 2004- 05-15 Sterile, single-use intravascular catheters-- Part 1: General requirements. 6-266....................... ............................ ISO 10555-5 First edition Withdrawn. See 6-303. 1996-06-15 AMENDMENT 1 Sterile, single-use intravascular catheters-- Part 5: Over-needle peripheral catheters. 6-267....................... ............................ ISO 10555-5 1996 TECHNICAL Withdrawn. See 6-303. CORRIGENDUM 1 Published 2002-06-15 Sterile, single- use intravascular catheters--Part 5: Over- needle peripheral catheters. 6-273....................... ............................ ISO 23908 First edition 2011- Extent of recognition. 06-11 Sharps injury protection--Requirements and test methods--Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling. 6-279....................... ............................ IEC 60601-2-19 (Second Withdrawn. See 6-319. Edition 2009) Medical electrical equipment--Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators CORRIGENDUM 1. 6-280....................... ............................ IEC 60601-2-20 (Second Withdrawn. See 6-320. edition 2009) Medical electrical equipment--Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators CORRIGENDUM 1. 6-281....................... ............................ IEC 80601-2-35 (Second Withdrawn. See 6-308. edition 2009) Medical electrical equipment--Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use CORRIGENDUM 1. 6-283....................... 6-309....................... USP 36-NF31:2013 Sodium Withdrawn and replaced Chloride Irrigation. with newer version. 6-284....................... 6-310....................... USP 36-NF31:2013 Sodium Withdrawn and replaced Chloride Injection. with newer version. 6-285....................... 6-311....................... USP 36-NF31:2013 Withdrawn and replaced Nonabsorbable Surgical with newer version. Suture. 6-286....................... 3-312....................... USP 36-NF31:2013 <881> Withdrawn and replaced Tensile Strength. with newer version. 6-287....................... 6-313....................... USP 36-NF31:2013 <861> Withdrawn and replaced Sutures--Diameter. with newer version. 6-288....................... 6-314....................... USP 36-NF 31:2013 <871> Withdrawn and replaced Sutures--Needle Attachment. with newer version. 6-289....................... 6-315....................... USP 36-NF31:2013 Sterile Withdrawn and replaced Water for Irrigation. with newer version. 6-290....................... 6-316....................... USP 36-NF31:2013 Heparin Withdrawn and replaced Lock Flush Solution. with newer version. 6-291....................... 6-317....................... USP 36-NF31:2013 Absorbable Withdrawn and replaced Surgical Suture. with newer version. 6-292....................... ............................ ISO 7886-1:1993 TECHNICAL Withdrawn. See 6-304. CORRIGENDUM 1 Published 1995-11-01 Sterile hypodermic syringes for single-use--Part 1: Syringes for manual use. [[Page 4921]] 6-298....................... 6-319....................... IEC 60601-2-19 Edition 2.0 Withdrawn and replaced 2009-02 Medical electrical with newer version equipment--Part 2-19: including technical Particular requirements for corrigendum. the basic safety and essential performance of infant incubators [Including: CORRIGENDUM 1 (2012)]. 6-299....................... ............................ IEC 60601-2-20 Edition 2.0 Withdrawn. See 6-320. 2009-02 Medical electrical equipment--Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators. ---------------------------------------------------------------------------------------------------------------- G. In Vitro Diagnostics ---------------------------------------------------------------------------------------------------------------- 7-100....................... ............................ ISO 15197 First edition 2003- Withdrawn. 05-01 In Vitro diagnostic test systems--Requirements for blood-glucose monitoring systems for self- testing in managing diabetes mellitus. 7-137....................... 7-244....................... CLSI NBS01-A6 Blood Withdrawn and replaced Collection on Filter Paper with newer version. for Newborn Screening Programs; Approved Standard--Sixth Edition. 7-239....................... ............................ CLSI EP32-R (Formerly X05-R) Designation number. Metrological Traceability and Its Implementation; A Report. 7-226....................... ............................ CLSI QMS01-A4 (Formerly GP26- Designation number. A4) Quality Management System: A Model for Laboratory Services; Approved Guideline--Fourth Edition. 7-224....................... ............................ CLSI EP28-A3c (Formerly C28- Designation number. A3c) Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline--Third Edition. 7-223....................... ............................ CLSI QSM06-A3 (Formerly GP22- Designation number. A3) Quality Management System: Continual Improvement; Approved Guideline--Third Edition. 7-92........................ 7-245....................... CLSI EP09-A3 Measurement Withdrawn and replaced Procedure Comparison and with newer version. Bias Estimation Using Patient Samples; Approved Guideline--Third Edition. 7-210....................... ............................ CLSI H26-A2 Validation, Extent of recognition. Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard--Second Edition. 7-152....................... ............................ CLSI EP12-A2 User Protocol Extent of recognition. for Evaluation of Qualitative Test Performance; Approved Guideline--Second Edition. 7-174....................... ............................ CLSI EP21-A Estimation of Extent of recognition. Total Analytical Error for Clinical Laboratory Methods; Approved Guideline. 7-178....................... ............................ CLSI M22-A3 Quality Control Extent of recognition. for Commercially Prepared Microbiological Culture Media; Approved Standard-- Third Edition. 7-193....................... ............................ CLSI EP06-A Evaluation of Extent of recognition. the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. 7-220....................... ............................ CLSI H59-A Quantitative D- Extent of recognition. dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline. ---------------------------------------------------------------------------------------------------------------- H. Materials ---------------------------------------------------------------------------------------------------------------- 8-67........................ 8-344....................... ISO 7153-1 Second edition Withdrawn and replaced 1991-04-01 Surgical with newer version instruments--Metallic including amendment. materials--Part 1: Stainless steel [Including: AMENDMENT 1(1999)]. 8-138....................... ............................ ASTM F745-07 Standard Withdrawn. Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution- Annealed Surgical Implant Applications. 8-139....................... 8-345....................... ASTM F1314-13 Standard Withdrawn and replaced Specification for Wrought with newer version. Nitrogen Strengthened 22 Chromium-13 Nickel-5 Manganese-2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910). 8-140....................... 8-346....................... ASTM F1813-13 Standard Withdrawn and replaced Specification for Wrought with newer version. Titanium-12 Molybdenum-6 Zirconium-2 Iron Alloy for Surgical Implant (UNS R58120). 8-141....................... 8-347....................... ASTM F2146-13 Standard Withdrawn and replaced Specification for Wrought with newer version. Titanium-3 Aluminum-2.5 Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320). 8-169....................... 8-348....................... ASTM F138-13 Standard Withdrawn and replaced Specification for Wrought with newer version. 18 Chromium-14 Nickel-2.5 Molybendum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673). 8-176....................... 8-349....................... ASTM F2503-13 Standard Withdrawn and replaced Practice for Marking with newer version. Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. 8-149....................... 8-350....................... ISO 5832-1 Fourth edition Withdrawn and replaced 2007-06-15 Implants for with newer version surgery--Metallic including technical materials--Part 1: Wrought corrigendum. stainless steel [Including: TECHNICAL CORRIGENDUM 1(2008)]. [[Page 4922]] 8-196....................... ............................ ISO 5832-1: 2007 Implants Withdrawn. See 8-350. for surgery--Metallic materials--Part 1: Wrought stainless steel TECHNICAL CORRIGENDUM 1. 8-151....................... 8-351....................... ISO 5832-12 Second edition Withdrawn and replaced 2007-05-01 Implants for with newer version surgery--Metallic including technical materials--Part 12: Wrought corrigendum. cobalt-chromium-molybdenum alloy [Including: TECHNICAL CORRIGENDUM 1 2008]. 8-197....................... ............................ ISO 5832-12:2007 TECHNICAL Withdrawn. See 8-351. CORRIGENDUM 1 2008-09-05, Implants for surgery-- Metallic materials--Part 12: Wrought cobalt-chromium- molybdenum alloy TECHNICAL CORRIGENDUM 1. 8-211....................... 8-352....................... ISO 5834-1 Third edition Withdrawn and replaced 2005-06-01 Implants for with newer version surgery--Ultra-high- including technical molecular-weight corrigendum. polyethylene--Part 1: Powder form [Including: TECHNICAL CORRIGENDUM 1 2007]. 8-212....................... ............................ ISO 5834-1:2005 Technical Withdrawn. See 8-352. Corrigendum 1 Published 2007-05-01 Implants for surgery--Ultra-high- molecular-weight polyethylene--Part 1: Powder form TECHNICAL CORRIGENDUM 1. 8-228....................... 8-353....................... ASTM F86-13 Standard Withdrawn and replaced Practice for Surface with newer version. Preparation and Marking of Metallic Surgical Implants. 8-175....................... 8-354....................... ASTM F1377-13 Standard Withdrawn and replaced Specification for Cobalt-28 with newer version. Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075). 8-163....................... 8-355....................... ASTM F1586/F 1586M-13[egr]1 Withdrawn and replaced Standard Specification for with newer version. Wrought Nitrogen Strengthened 21 Chromium-10 Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675). 8-129....................... 8-356....................... ASTM F67-13 Standard Withdrawn and replaced Specification for Unalloyed with newer version. Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700). 8-208....................... 8-357....................... ASTM F648-13 Standard Withdrawn and replaced Specification for Ultra- with newer version. High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants. 8-103....................... ............................ ASTM F1801-97 (Reapproved Extent of recognition. 2009) [egr]1 Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials. 8-107....................... ............................ ASTM F746-04 (Reapproved Extent of recognition. 2009) [egr]1 Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials. 8-111....................... ............................ ASTM F1160-05 (Reapproved Extent of recognition. 2011) [egr]1 Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/ Metallic Coatings. 8-112....................... ............................ ASTM F1044-05 (Reapproved Extent of recognition. 2011) [egr]1 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings. 8-113....................... ............................ ASTM F1147-05 (Reapproved Extent of recognition. 2011) Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coatings. 8-114....................... ............................ ASTM F2255 (Reapproved 2010) Extent of recognition. Standard Test Method for Strength Properties of Tissue Adhesives in Lap Shear by Tension Loading. 8-115....................... ............................ ASTM F2256-05 (Reapproved Extent of recognition. 2010) Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading. 8-116....................... ............................ ASTM F2258-05 (Reapproved Extent of recognition. 2010) Standard Test Method for Strength Properties of Tissue Adhesives in Tension. 8-121....................... ............................ ASTM F2005-05 (Reapproved Extent of recognition. 2010) Standard Terminology for Nickel-Titanium Shape Memory Alloys. 8-123....................... ............................ ISO 5832-5 Third edition Extent of recognition. 2005-10-15 Implants for surgery--Metallic materials--Part 5: Wrought cobalt-chromium-tungsten- nickel alloy. 8-124....................... ............................ ASTM F2052-06 [egr] Standard Extent of recognition. Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment. 8-125....................... ............................ ASTM F2004-05 (Reapproved Extent of recognition. 2010) Standard Test Method for Transformation Temperature of Nickel- Titanium Alloys by Thermal Analysis. 8-126....................... 8-370....................... ASTM F561-13 Standard Withdrawn and replaced Practice for Retrieval and with newer version. Analysis of Medical Devices, and Associated Tissues and Fluids. 8-128....................... ............................ ASTM F2213-06 (Reapproved Extent of recognition. 2011) Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment. 8-132....................... ............................ ASTM F1088-04a (Reapproved Extent of recognition. 2010) Standard Specification for Beta- Tricalcium Phosphate for Surgical Implantation. [[Page 4923]] 8-134....................... ............................ ASTM F2082-06 Standard Test Extent of recognition. Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery. 8-135....................... ............................ ASTM F2392-04 (Reapproved Extent of recognition. 2010) Standard Test Method for Burst Strength of Surgical Sealants. 8-136....................... ............................ ASTM F2458-05 (Reapproved Extent of recognition. 2010) Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants. 8-150....................... ............................ ISO 5832-9 Second edition Extent of recognition. 2007-06-15 Implants for surgery--Metallic materials--Part 9: Wrought high nitrogen stainless steel. 8-157....................... ............................ ISO 9583 First edition 1993- Extent of recognition. 10-15 Implants for surgery-- Non-destructive testing-- Liquid penetrant inspection of metallic surgical implants. 8-159....................... ............................ ISO 9584 First edition 1993- Extent of recognition. 10-15 Implants for surgery-- Non-destructive testing-- Radiographic examination of cast metallic surgical implants. 8-165....................... ............................ ASTM F1058-08[egr]1 Standard Extent of recognition. Specification for Wrought 40 Cobalt-20 Chromium-16 Iron-15 Nickel-7 Molybdenum Alloy Wire and Strip for Surgical Implant Applications (UNS R30003 and UNS R30008). 8-167....................... ............................ ASTM F1350-08 Standard Extent of recognition. Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673). 8-168....................... ............................ ASTM F1472-08[egr]1 Standard Extent of recognition. Specification for Wrought Titanium-6 Aluminum-4 Vanadium Alloy for Surgical Implant Applications (UNS R56400). 8-170....................... ............................ ASTM F961-08 Standard Extent of recognition. Specification for 35 Cobalt- 35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants (UNS R30035). 8-171....................... ............................ ASTM F1609-08 Standard Extent of recognition. Specification for Calcium Phosphate Coatings for Implantable Materials. 8-173....................... ............................ ASTM F601-03 (Reapproved Extent of recognition. 2008) Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants. 8-177....................... ............................ ASTM F2129-08 Standard Test Extent of recognition. Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices. 8-179....................... ............................ ASTM F754-08 Standard Extent of recognition. Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders. 8-183....................... ............................ ASTM F560-08 Standard Extent of recognition. Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400). 8-184....................... ............................ ASTM F2516-07[egr]2 Standard Extent of recognition. Test Method for Tension Testing of Nickel-Titanium Superelastic Materials. 8-185....................... ............................ ASTM F451-08 Standard Extent of recognition. Specification for Acrylic Bone Cement. 8-187....................... ............................ ISO 13779-1 Second edition Extent of recognition. 2008-10-01 Implants for surgery--Hydroxyapatite--Pa rt 1: Ceramic hydroxyapatite. 8-188....................... ............................ ISO 13779-2 Second edition Extent of recognition. 2008-10-01 Implants for surgery--Hydroxyapatite--Pa rt 2: Coatings of hydroxyapatite. 8-189....................... ............................ ASTM F 1108-04 (Reapproved Extent of recognition. 2009) Standard Specification for Titanium- 6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants (UNS R56406). 8-190....................... ............................ ASTM F 90-09 Standard Extent of recognition. Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605). 8-192....................... ............................ ASTM F1854-09 Standard Test Extent of recognition. Method for Stereological Evaluation of Porous Coatings on Medical Implants. 8-193....................... ............................ ASTM F2754/F 2754M-09 Extent of recognition. Standard Test Method for Measurement of Camber, Cast, Helix and Direction of Helix of Coiled Wire. 8-194....................... ............................ ISO 6474-1 First edition Extent of recognition. 2010-02-15 Implants for surgery--Ceramic materials-- Part 1: Ceramic materials based on high purity alumina. 8-195....................... ............................ ASTM F2024-10 Standard Extent of recognition. Practice for X-Ray Diffraction Determination of Phase Content of Plasma- Sprayed Hydroxyapatite Coatings. 8-199....................... ............................ ASTM F2633-07 Standard Extent of recognition. Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants. 8-204....................... ............................ ASTM F2118-10 Standard Test Extent of recognition. Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials. 8-205....................... ............................ ASTM F1635-11 Standard Test Extent of recognition. Method for In Vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants. [[Page 4924]] 8-206....................... ............................ ASTM F688-10 Standard Extent of recognition. Specification for Wrought Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035). 8-207....................... ............................ ASTM F1926/F1926M-10 Extent of recognition. Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Granules, Fabricated Forms, and Coatings. 8-213....................... ............................ ISO 5834-3 First edition Extent of recognition. 2005-07-15 Implants for surgery--Ultra-high- molecular-weight polyethylene--Part 3: Accelerated ageing methods. 8-214....................... ............................ ISO 5834-4 First edition Extent of recognition. 2005-05-01 Implants for surgery--Ultra-high- molecular-weight polyethylene--Part 4: Oxidation index measurement method. 8-215....................... ............................ ISO 5834-5 First edition Extent of recognition. 2005-06-01 Implants for surgery--Ultra-high- molecular-weight polyethylene--Part 5: Morphology assessment method. 8-216....................... ............................ ASTM F1295-11 Standard Extent of recognition. Specification for Wrought Titanium-6 Aluminum-7 Niobium Alloy for Surgical Implant Applications (UNS R56700). 8-217....................... ............................ ASTM F620-11 Standard Extent of recognition. Specification for Alpha Plus Beta Titanium Alloy Forgings for Surgical Implants. 8-218....................... ............................ ASTM F799-11 Standard Extent of recognition. Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539). 8-220....................... ............................ ASTM F629-11 Standard Extent of recognition. Practice for Radiography of Cast Metallic Surgical Implants. 8-221....................... ............................ ASTM F2066-11 Standard Extent of recognition. Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150). 8-224....................... ............................ ASTM F2102-06[egr]1 Standard Extent of recognition. Guide for Evaluating the Extent of Oxidation in Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants. 8-225....................... ............................ ASTM F2003-02 (Reapproved Extent of recognition. 2008) Standard Practice for Accelerated Aging of Ultra- High Molecular Weight Polyethylene after Gamma Irradiation in Air. 8-226....................... ............................ ASTM F603-12 Standard Extent of recognition. Specification for High- Purity Dense Aluminum Oxide for Medical Application. 8-229....................... ............................ ASTM F75-12 Standard Extent of recognition. Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075). 8-330....................... ............................ ASTM F1978-12 Standard Test Extent of recognition. Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser. 8-331....................... ............................ ASTM F1580-12 Standard Extent of recognition. Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants. 8-333....................... ............................ ASTM F2393-12 Standard Extent of recognition. Specification for High- Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications. 8-334....................... ............................ ASTM F2459-12 Standard Test Extent of recognition. Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis. ---------------------------------------------------------------------------------------------------------------- I. Nanotechnology ---------------------------------------------------------------------------------------------------------------- 18-1........................ ............................ ASTM E2490-09 Standard Guide Extent of recognition. for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS). 18-2........................ ............................ ASTM E2535-07 (Reapproved Reaffirmation and 2013) Standard Guide for extent of Handling Unbound Engineered recognition. Nanoscale Particles in Occupational Settings. ---------------------------------------------------------------------------------------------------------------- J. Neurology ---------------------------------------------------------------------------------------------------------------- 17-3........................ 17-12....................... ISO 7197 Third edition 2006- Withdrawn and replaced 06-01 Neurosurgical with newer version Implants--Sterile, single- including technical use hydrocephalus shunts corrigendum. and components [Including TECHNICAL CORRIGENDUM 1 (2007)]. 17-7........................ ............................ ISO 7197: 2006 Neurosurgical Withdrawn. See 17-12. implants--Sterile, single- use hydrocephalus shunts and components TECHNICAL CORRIGENDUM 1. 17-1........................ ............................ ANSI/AAMI NS28:1988/(R) 2010 Extent of recognition. Intracranial pressure monitoring devices. [[Page 4925]] 17-4........................ ............................ ASTM F647-94 (Reapproved Extent of recognition. 2006) Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application. 17-9........................ ............................ ASTM F2129-08 Standard Test Extent of recognition. Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices. ---------------------------------------------------------------------------------------------------------------- K. OB-GYN/Gastroenterology/Urology ---------------------------------------------------------------------------------------------------------------- 9-34........................ 9-82........................ ISO 4074 First edition 2002- Withdrawn and replaced 02-15 Corrected version with newer version 2002-12-01 Natural latex including technical rubber condoms-- corrigendum. Requirements and test methods [Including TECHNICAL CORRIGENDUM 1 (2002), TECHNICAL CORRIGENDUM 2 (2002)]. 9-57........................ ............................ ISO 4074:2002 TECHNICAL Withdrawn. See 9-82. CORRIGENDUM 2, Natural latex rubber condoms-- Requirements and test methods TECHNICAL CORRIGENDUM 2. 9-75........................ 9-84........................ ISO 8600-3 First edition Withdrawn and replaced 1997-07-01 Optics and with newer version Optical instruments-- including amendment. Medical endoscopes and endoscopic accessories-- Part 3: Determination of field of view and direction of view of endoscopes with optics [Including AMENDMENT 1 (2003)]. 9-36........................ 9-90........................ ISO 8009 First edition 2004- Withdrawn and replaced 10-01 Mechanical with newer version contraceptives--Reusable including amendment. natural and silicone rubber contraceptive diaphragms-- Requirements and tests [Including AMENDMENT 1(2012)]. 9-37........................ 9-83........................ ISO 8600-1 Third edition Withdrawn and replaced 2013-03-01 Endoscopes-- with newer version. Medical endoscopes and endotherapy devices--Part 1: General requirements. 9-38........................ ............................ ISO 8600-3 First edition Withdrawn. See 9-84. 1997-07-01 AMENDMENT 1, Optics and optical instruments--Medical endoscopes and endoscopic accessories Part 3: Determination of field of view and direction of view of endoscopes with optics. 9-44........................ ............................ ASTM F623-99 (Reapproved Extent of recognition. 2006) Standard Performance Specification for Foley Catheter. 9-54........................ 9-85........................ ASTM D6976-13 Standard Withdrawn and replaced Specification for Rubber with a newer version. Contraceptives--Vaginal Diaphragms. 9-56........................ ............................ ASTM D3492-08 Standard Extent of recognition. Specification for Rubber Contraceptives (Male Condoms). 9-65........................ 9-91........................ ANSI/AAMI/ISO 8637:2010 Withdrawn and replaced Cardiovascular implants and with newer version extracorporeal systems-- including amendment. Hemodialyzers, hemodiafilters, hemofilters, and hemoconcentrators [Including AMENDMENT 1 (2013)]. 9-66........................ ............................ ANSI/AAMI/ISO 8638:2010 Extent of recognition. Cardiovascular implants and Extracorporeal blood circuit for hemodialyzers, hemodiafilters, and hemofilters. 9-67........................ ............................ ASTM D7661-10 Standard Test Extent of recognition. Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. 9-68........................ ............................ ISO 23409 First edition 2011- Extent of recognition. 02-15 Male Condoms-- Requirements and test methods for condoms made from synthetic materials. 9-73........................ ............................ ANSI/AAMI/ISO 13958:2009 Extent of recognition. Concentrates for hemodialysis and related therapies. 9-74........................ ............................ ISO 13958 Second edition Extent of recognition. 2009-04-15 Concentrates for haemodialysis and related therapies. 9-79........................ ............................ ISO 26722 First edition 2009- Extent of recognition. 04-15 Water treatment equipment for haemodialysis applications and related therapies. ---------------------------------------------------------------------------------------------------------------- L. Ophthalmic ---------------------------------------------------------------------------------------------------------------- 10-41....................... 10-81....................... ISO 11979-7 Second edition Withdrawn and replaced 2006-05-01 Ophthalmic with newer version implants--Intraocular including amendment. lenses--Part 7: Clinical investigations [Including Amendment 1:2012]. 10-75....................... ............................ ISO 11979-7/Amendment 1:2012 Withdrawn. See 10-81. Ophthalmic implants-- Intraocular lenses--Part 7: Clinical investigations. 10-42....................... 10-82....................... ISO 11979-2 First edition Withdrawn and replaced 1999-12-15 Ophthalmic with newer version implants--Intraocular including technical lenses--Part 2: Optical corrigendum. properties and test methods [Including TECHNICAL CORRIGENDUM 1 (2003)]. 10-53....................... 10-83....................... ISO 18369-1 First edition Withdrawn and replaced 2006-08-15 Ophthalmic with newer version optics--Contact lenses-- including amendment. Part 1: Vocabulary, classification system and recommendations for labeling specifications [Including AMENDMENT 1 2009]. [[Page 4926]] 10-61....................... ............................ ISO 18369-1:2006 Ophthalmic Withdrawn. See 10-83. optics--Contact lenses Part 1: Vocabulary, classification system and recommendations for labeling specifications. ISO 18369-1 First edition 2006-08-05 AMENDMENT 1 2009- 02-15. 10-58....................... 10-84....................... ANSI Z80.11-2012 American Withdrawn and replaced National Standard for with newer version. Ophthalmics--Laser Systems for Corneal Reshaping. 10-59....................... 10-85....................... ISO 11980 Third edition 2012- Withdrawn and replaced 11-15 Corrected version with newer version. 2013-12-01 Ophthalmic optics--Contact lenses and contact lens care products-- Guidance for clinical investigations. 10-71....................... 10-86....................... ISO 14729 First edition 2001- Withdrawn and replaced 04-15 Ophthalmic optics-- with newer version Contact lens care products-- including amendment. Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses [Including: AMENDMENT 1 2010]. 10-43....................... ............................ ISO 11979-8 Second edition Extent of recognition. 2006-07-01 Ophthalmic implants--Intraocular lenses--Part 8: Fundamental requirements. 10-54....................... ............................ ISO 18369-4 First edition Extent of recognition. 2006-08-15 Ophthalmic optics--contact lenses-- Part 4: Physicochemical properties of contact lens materials. 10-55....................... ............................ ISO 11979-6 Second edition Extent of recognition. 2007-07-15 Ophthalmic implants--Intraocular lenses--Part 6: Shelf-life and transport stability. 10-56....................... ............................ ANSI Z80.12-2007 (R2012) Reaffirmation and American National Standard extent of for Ophthalmics--Multifocal recognition. Intraocular Lenses. 10-57....................... ............................ ANSI Z80.13-2007 (R2012) Reaffirmation and American National Standard extent of for Ophthalmics--Phakic recognition. Intraocular Lenses. 10-60....................... ............................ ISO 11981 Second edition Extent of recognition. 2009-07-01 Ophthalmic optics--Contact lenses and contact lens care products-- Determination of physical compatibility of contact lens care products with contact lenses. 10-62....................... ............................ ANSI Z80.10-2009 Ophthalmic Extent of recognition. Instruments--Tonometers. 10-64....................... 10-89....................... ANSI Z80.7-2013 Ophthalmics-- Withdrawn and replaced Intraocular Lenses. with newer version. 10-68....................... ............................ ISO 13212 Second edition Extent of recognition. 2011-05-15 Ophthalmic optics--Contact lens care products--Guidelines for determination of shelf-life. 10-69....................... ............................ ANSI Z80.18-2010 American Extent of recognition. National Standard for Ophthalmics--Contact Lens Care Products--Vocabulary, Performance Specifications and Test Methodology. 10-74....................... ............................ ISO 10940 Second edition Extent of recognition. 2009-08-01 Ophthalmic instruments--Fundus Cameras. ---------------------------------------------------------------------------------------------------------------- M. Orthopedic ---------------------------------------------------------------------------------------------------------------- 11-190...................... 11-256...................... ISO 14243-3 First edition Withdrawn and replaced 2004-09-15 Implants for with newer version surgery--Wear of total knee- including technical joint prostheses--Part 3: corrigendum. Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test [Including: TECHNICAL CORRIGENDUM 1(2006)]. 11-218...................... ............................ ISO 14243-3:2004 TECHNICAL Withdrawn. See 11-256. CORRIGENDUM 1 Implants for surgery--Wear of total knee- joint prostheses--Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test. 11-210...................... 11-257...................... ASTM F543-13 Standard Withdrawn and replaced Specification and Test with a newer version. Methods for Metallic Medical Bone Screws. 11-212...................... ............................ ASTM F1440-92 (Reapproved Withdrawn. 2008) Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components Without Torsion. 11-241...................... ............................ ASTM F543-07 Standard Withdrawn duplicate. Specification and Test See 11-257. Methods for Metallic Medical Bone Screws. 11-244...................... 11-258...................... ASTM F2083-12 Standard Withdrawn and replaced Specification for Knee with a newer version. Replacement Prosthesis. 11-74....................... ............................ ISO 5838-2 First edition Extent of recognition. 1991-01-15 Implants for surgery--Skeletal pins and wires--Part 2: Steinmann skeletal pins--Dimensions. 11-75....................... ............................ ISO 5838-3 First edition Extent of recognition. 1993-09-15 Implants for surgery--Skeletal pins and wires--Part 3: Kirschner skeletal wires. 11-80....................... ............................ ISO 8828 First edition 1988- Extent of recognition. 10-15 Implants for surgery-- Guidance on care and handling of orthopaedic implants. 11-83....................... ............................ ISO 13402 First edition 1995- Extent of recognition. 08-01 Surgical and dental hand instruments-- Determination of resistance against autoclaving, corrosion and thermal exposure. 11-168...................... ............................ ASTM F1781-03 (Reapproved Extent of recognition. 2009) Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants. [[Page 4927]] 11-171...................... ............................ ASTM F1814-97a (Reapproved Extent of recognition. 2009) Standard Guide for Evaluating Modular Hip and Knee Joint Components. 11-183...................... ............................ ASTM F1875-98 (Reapproved Extent of recognition. 2009) Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-bore and Cone Taper Interface. 11-184...................... ............................ ISO 8827 First edition 1988- Extent of recognition. 10-15 Implants for surgery-- Staples with parallel legs for orthopaedic use-- General requirements. 11-185...................... ............................ ASTM F2267-04 (Reapproved Extent of recognition. 2011) Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression. 11-191...................... ............................ ISO 14879-1 First edition Extent of recognition. 2000-06-01 Implants for surgery--Total knee-joint prostheses--Part 1: Determination of endurance properties of knee tibial trays. 11-196...................... ............................ ASTM F1672-95 (Reapproved Extent of recognition. 2011) Standard Specification for Resurfacing Patellar Prosthesis. 11-197...................... ............................ ASTM F983-86 (Reapproved Reaffirmation and 2013) Standard Practice for extent of Permanent Marking of recognition. Orthopaedic Implant Components. 11-199...................... ............................ ASTM F565-04 (Reapproved Reaffirmation and 2013) Standard Practice for extent of Care and Handling of recognition. Orthopedic Implants and Instruments. 11-203...................... ............................ ASTM F1541-02 (Reapproved Extent of recognition. 2011) 1 Standard Specification and Test Methods for External Skeletal Fixation Devices. 11-207...................... ............................ ASTM F2193-02 (Reapproved Extent of recognition. 2007) Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System. 11-211...................... ............................ ASTM F1798-97 (Reapproved Extent of recognition. 2008) Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants. 11-214...................... ............................ ASTM F382-99 (Reapproved Extent of recognition. 2008) \1\ Standard Specification and Test Method for Metallic Bone Plates. 11-216...................... ............................ ASTM F1264-03 (Reapproved Extent of recognition. 2012) Standard Specification and Test Methods for Intramedullary Fixation Devices. 11-220...................... ............................ ASTM F2068-09 Standard Extent of recognition. Specification for Femoral Prostheses--Metallic Implants. 11-222...................... ............................ ISO 14243-1 Second edition Extent of recognition. 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. 11-223...................... ............................ ISO 14243-2 Second edition Extent of recognition. 2009-11-15 Implants for surgery--Wear of total knee- joint prostheses--Part 2: Methods of measurement. 11-224...................... ............................ ASTM F2706-08 Standard Test Extent of recognition. Methods for Occipital- Cervical and Occipital- Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model. 11-225...................... ............................ ISO 7206-4 Third edition Extent of recognition. 2010-06-15 Implants for surgery--Partial and total hip-joint prostheses--Part 4: Determination of endurance properties and performance of stemmed femoral components. 11-226...................... ............................ ASTM F1089-10 Standard Test Extent of recognition. Method for Corrosion of Surgical Instruments. 11-227...................... ............................ ASTM F366-10 Standard Extent of recognition. Specification for Fixation Pins and Wires. 11-228...................... ............................ ASTM F564-10 Standard Extent of recognition Specification and Test Methods for Metallic Bone Staples. 11-231...................... ............................ ISO 7207-2 Second edition Extent of recognition. 2011-07-01 Implants for surgery--Components for partial and total knee joint prostheses--Part 2: Articulating surfaces made of metal, ceramic and plastics materials. 11-232...................... ............................ ISO 7207-1 Third edition Extent of recognition. 2007-02-01 Implants for surgery--Components for partial and total knee joint prostheses--Part 1: Classification, definitions and designation of dimensions. 11-234...................... ............................ ASTM F732-00 (Reapproved Extent of recognition. 2011) Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses. 11-235...................... ............................ ASTM F2077-11 Test Methods Extent of recognition. for Intervertebral Body Fusion Devices. 11-237...................... ............................ ISO 7206-6 First edition Extent of recognition. 1992-03-15 Implants for surgery--Partial and total hip joint prostheses--Part 6: Determination of endurance properties of head and neck region of stemmed femoral components. 11-238...................... ............................ ASTM F2033-12 Standard Extent of recognition. Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials. [[Page 4928]] 11-239...................... ............................ ASTM F 2345-03 (Reapproved Extent of recognition. 2013) Standard Test Methods Reaffirmation. for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads. 11-240...................... ............................ ASTM F382-99 (Reapproved Extent of recognition. 2008) \1\ Standard Specification and Test Method for Metallic Bone Plates. 11-243...................... ............................ ASTM F2346-05 (Reapproved Extent of recognition. 2011) Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs. 11-245...................... ............................ ASTM F384-12 Standard Extent of recognition. Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices. 11-247...................... ............................ ASTM F2789-10 Standard Guide Extent of recognition. for Mechanical and Functional Characterization of Nucleus Devices. 11-248...................... ............................ ISO 14242-1 Second edition Extent of recognition. 2012-01-15 Implants for surgery--Wear of total hip- joint prostheses--Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test. 11-249...................... ............................ ISO 14242-2 First edition Extent of recognition. 2000-09-15 Implants for surgery--Wear of total hip- joint prostheses--Part 2: Methods of measurement. 11-250...................... ............................ ISO 14242-3 First edition Extent of recognition. 2009-03-15 Implants for surgery--Wear of total hip- joint prostheses--Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test. ---------------------------------------------------------------------------------------------------------------- N. Physical Medicine ---------------------------------------------------------------------------------------------------------------- 16-25....................... ............................ ISO 7176-13 First edition Extent of recognition. 1989-08-01 Wheelchairs-- Part 13: Determination of coefficient of friction of test surfaces. 16-27....................... ............................ ISO 7176-15 First edition Extent of recognition. 1996-11-15 Wheelchairs-- Part 15: Requirements for information disclosure, documentation and labeling. 16-29....................... ............................ ISO 7176-6 Second edition Extent of recognition. 2001-10-01 Wheelchairs-- Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs. 16-158...................... ............................ ISO 7176-1 Second edition Extent of recognition. 1999-10-01 Wheelchairs-- Part 1: Determination of static stability. 16-159...................... ............................ ISO 7176-2 Second edition Extent of recognition. 2001-06-15 Wheelchairs-- Part 2: Determination of dynamic stability of electric wheelchairs. 16-162...................... ............................ ISO 7176-4 Third edition Extent of recognition. 2008-10-01 Wheelchairs-- Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range. 16-163...................... ............................ ISO 7176-5 Second edition Extent of recognition. 2008-06-01 Wheelchairs-- Part 5: Determination of overall dimensions, mass and manoeuvring space. 16-164...................... ............................ ISO 7176-10 Second edition Extent of recognition. 2008-11-01 Wheelchairs-- Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs. 16-165...................... ............................ ISO 7176-14 Second edition Extent of recognition. 2008-02-15 Wheelchairs-- Part 14: Power and control systems for electrically powered wheelchairs and scooters--Requirements and test methods. 16-166...................... ............................ ISO 7176-21 Second edition Extent of recognition. 2009-04-01 Wheelchairs-- Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers. 16-167...................... ............................ ISO 7176-9: Third edition Extent of recognition. 2009-11-15 Wheelchairs-- Part 9: Climatic tests for electric wheelchairs. 16-168...................... ............................ ANSI/RESNA WC-1:2009 Extent of recognition. American National Standard for Wheelchairs--Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 1: Determination of static stability. 16-169...................... ............................ ANSI/RESNA WC-2:2009 Extent of recognition. American National Standard for Wheelchairs--Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 2: Determination of dynamic stability of electrically powered wheelchairs. 16-170...................... ............................ ANSI/RESNA WC-2:2009 Extent of recognition. American National Standard for Wheelchairs--Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 3: Determination of effectiveness of brakes. 16-171...................... ............................ ANSI/RESNA WC-2:2009 Section Extent of recognition. 4: Energy consumption of electrically powered wheelchairs and scooters for determination of theoretical distance range. [[Page 4929]] 16-172...................... ............................ ANSI/RESNA WC-1:2009 Extent of recognition. American National Standard for Wheelchairs--Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 5: Determination of dimensions, mass and maneuvering space. 16-173...................... ............................ ANSI/RESNA WC-2:2009 Extent of recognition. American National Standard for Wheelchairs--Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 6: Determination of maximum speed, acceleration and deceleration of electrically powered wheelchairs. 16-174...................... ............................ ANSI/RESNA WC-1:2009 Extent of recognition. American National Standard for Wheelchairs Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 7: Method of Measurement of Seating and Wheel Dimensions. 16-175...................... ............................ ANSI/RESNA WC-1:2009 Extent of recognition. American National Standard for Wheelchairs--Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 8: Requirements and test methods for static, impact and fatigue strengths. 16-176...................... ............................ ANSI/RESNA WC-2:2009 Extent of recognition. American National Standard for Wheelchairs--Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 9: Climatic tests for electrically powered wheelchairs. 16-177...................... ............................ ANSI/RESNA WC-2:2009 Extent of recognition. American National Standard for Wheelchairs--Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 10: Determination of obstacle- climbing ability of electrically powered wheelchairs. 16-178...................... ............................ ANSI/RESNA WC-1:2009 Extent of recognition. American National Standard for Wheelchairs--Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 11: Test dummies. 16-179...................... ............................ ANSI/RESNA WC-1:2009 Extent of recognition. American National Standard for Wheelchairs--Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 13: Determination of coefficient of friction of test surfaces. 16-180...................... ............................ ANSI/RESNA WC-2:2009 Extent of recognition. American National Standard for Wheelchairs--Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 14: Power and control systems for electrically powered wheelchairs--Requirements and test methods. 16-181...................... ............................ ANSI/RESNA WC-1:2009 Extent of recognition. American National Standard for Wheelchairs--Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 15: Requirements for information disclosure, documentation and labeling. 16-182...................... ............................ ANSI/RESNA WC-1:2009 Extent of recognition. American National Standard for Wheelchairs--Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 16: Resistance to ignition of upholstered parts--Requirements and test methods. 16-183...................... ............................ ANSI/RESNA WC-1:2009 Extent of recognition American National Standard for Wheelchairs--Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 20: Determination of the performance of stand- up type wheelchairs. 16-184...................... ............................ ANSI/RESNA WC-1:2009 Extent of recognition. American National Standard for Wheelchairs--Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 22: Set-up procedures. 16-185...................... ............................ ANSI/RESNA WC- Extent of recognition. 2:2009,American National Standard for Wheelchairs-- Volume 2, Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters. 16-187...................... ............................ ANSI/RESNA WC-1:2009 Extent of recognition. American National Standard for Wheelchairs--Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 26: Vocabulary. ---------------------------------------------------------------------------------------------------------------- O. Radiology ---------------------------------------------------------------------------------------------------------------- 12-53....................... 12-257...................... ISO 2919 Third edition 2012- Withdrawn and replaced 02-15 Radiological with newer version. protection--Sealed radioactive sources-- General requirements and classification. 12-59....................... ............................ IEC 61168 First edition 1993- Extent of recognition. 12 Radiotherapy simulators-- Functional performance characteristics. 12-66....................... ............................ AIUM MUS, Medical Ultrasound Extent of recognition. Safety. [[Page 4930]] 12-139...................... ............................ AIUM AOMS-2004, Acoustic Extent of recognition. Output Measurement Standard for Diagnostic Ultrasound Equipment. 12-140...................... ............................ AIUM RTD2-2004 Standard for Withdrawn. See 12-209 Real-Time Display of and 12-258. Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Revision 2. 12-145...................... 12-259...................... IEC 61674 Edition 2.0 2012- Withdrawn and replaced 11 Medical electrical with newer version. equipment--Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging. 12-149...................... 12-260...................... IEC 60336 Fourth edition Withdrawn and replaced 2005-04 Medical electrical with newer version equipment--X-ray tube including technical assemblies for medical corrigendum. diagnosis--Characteristics of focal spots [Including: Technical Corrigendum 1 (2006)]. 12-150...................... ............................ ISO/IEC 10918-1:1994 Withdrawn. See 12-261. TECHNICAL CORRIGENDUM 1:2005 Information technology--Digital compression and coding of continuous-tone still image--Part 1: Requirements and guidelines. 12-156...................... ............................ ISO 11670:2003 TECHNICAL Withdrawn. See 12-262. CORRIGENDUM 1:2004 Lasers and laser-related equipment--Test methods for laser beam parameters--Beam positional stability. 12-157...................... ............................ ISO 13694:2000 TECHNICAL Withdrawn. See 12-263. CORRIGENDUM 1:2005 Optics and optical instruments-- Lasers and laser-related equipment--Test methods for laser beam power (energy) density distribution. 12-159...................... 12-264...................... NEMA MS 11-2010 Withdrawn and replaced Determination of Gradient- with newer version. Induced Electric Fields In Diagnostic Magnetic Resonance Imaging. 12-167...................... 12-265...................... NEMA NU 2-2012 Performance Withdrawn and replaced Measurements of Positron with newer version. Emission Tomographs (PETs). 12-179...................... ............................ ANSI/IESNA RP-27.3-2007, Extent of recognition. Recommended Practice for Photobiological Safety for Lamps--Risk Group Classification and Labeling. 12-180...................... 12-266...................... IEC 61689 Edition 3.0 2013- Withdrawn and replaced 02 Ultrasonic-Physiotherapy with newer version. systems--Field specifications and methods of measurement in the frequency range 0. 5 MHz to 5 MHz. 12-190...................... 12-267...................... IEC 61217 Edition 2.0 2011- Withdrawn and replaced 12 Radiotherapy equipment-- with newer version. Coordinates, movements and scales. 12-194...................... ............................ ANSI/HPS N43.6-2007, Sealed Extent of recognition. Radioactive Sources-- Classification. 12-207...................... 12-271...................... IEC 60601-2-33 Edition 3.1 Withdrawn and replaced 2013-04 Medical electrical with newer version. equipment--Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis. 12-208...................... 12-268...................... IEC 60601-2-22 Edition 3.1 Withdrawn and replaced 2012-10 Medical electrical with newer version. equipment--Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment. 12-210...................... 12-269...................... IEC 60601-1-3 Edition 2.1 Withdrawn and replaced 2013-04 Medical electrical with newer version. equipment--Part 1-3: General requirements for basic safety and essential performance--Collateral Standard: Radiation protection in diagnostic X- ray equipment. 12-219...................... ............................ IEC 60336 (2005) Medical Withdrawn. See 12-260. electrical equipment--X-ray tube assemblies for medical diagnosis--Characteristics of focal spots. 12-222...................... 12-270...................... IEC 61223-3-5 First edition Withdrawn and replaced 2004-08 Evaluation and with newer version routine testing in medical including technical imaging departments--Part 3- corrigendum. 5: Acceptance tests-- Imaging performance of computed tomography X-ray equipment [Including: TECHNICAL CORRIGENDUM 1 (2006)]. 12-223...................... ............................ IEC 61223-3-5 (First edition Withdrawn. See 12-270. 2004) Evaluation and routine testing in medical imaging departments--Part 3- 5: Acceptance tests-- Imaging performance of computed tomography X-ray equipment CORRIGENDUM 1. 12-227...................... ............................ IEC 61391-1 First edition Extent of recognition. 2006-07 Ultrasonics--Pulse- echo scanners--Part 1: Techniques for calibrating spatial measurement systems and measurement of system point-spread function response. 12-228...................... ............................ IEC 61391-2 Edition 1.0 2010- Extent of recognition. 01 Ultrasonics--Pulse-echo scanners--Part 2: Measurement of maximum depth of penetration and local dynamic range. 12-233...................... 12-262...................... ISO 11670 Second edition Withdrawn and replaced 2003-04-01 Lasers and laser- with newer version related equipment--Test including technical methods for laser beam corrigendum. parameters--Beam positional stability [Including: TECHNICAL CORRIGENDUM 1 (2004)]. 12-237...................... 12-258...................... IEC 62359 Edition 2.0 2010- Withdrawn and replaced 10 Ultrasonics--Field with newer version characterization--Test including technical methods for the corrigendum. determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields [Including TECHNICAL CORRIGENDUM 1 (2011)]. [[Page 4931]] 12-243...................... 12-263...................... ISO 13694 First edition 2000- Withdrawn and replaced 04-01 Optics and optical with newer version instruments--Lasers and including technical laser-related equipment-- corrigendum. Test methods for laser beam power [energy] density distribution [Including: TECHNICAL CORRIGENDUM 1 (2005)]. 12-244...................... ............................ IEC 62359 (Second edition Withdrawn. See 12-258. 2010) March 2011 Ultrasonics--Field characterization--Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields CORRIGENDUM 1. 12-247...................... ............................ ISO 11990-1 First edition Extent of recognition. 2011-08-01, Lasers and laser-related equipment-- Determination of laser resistance of tracheal tubes--Part 1: Tracheal tube shaft. ---------------------------------------------------------------------------------------------------------------- P. Software/Informatics ---------------------------------------------------------------------------------------------------------------- 13-4........................ ............................ ANSI/UL 1998 Standards for Extent of recognition. Safety Software in Programmable Components, Second Edition. [This Standard contains revisions through and including October 28, 2008.] ---------------------------------------------------------------------------------------------------------------- Q. Sterility ---------------------------------------------------------------------------------------------------------------- 14-143...................... 14-395...................... ISO 14698-2 First edition Withdrawn and replaced 2003-09-15 Cleanrooms and with newer version associated controlled including technical environments--Biocontaminat corrigendum. ion control--Part 2: Evaluation and interpretation of biocontamination data. [Including: TECHNICAL CORRIGENDUM 1 Published 2004-11-01]. 14-193...................... ............................ ANSI/AAMI/ISO 11607-1:2006/ Extent of recognition (R)2010 Packaging for and relevant terminally sterilized guidance. medical devices--Part 1: Requirements for materials, sterile barrier systems and packaging systems. 14-194...................... ............................ ANSI/AAMI/ISO 11607-2:2006/ Extent of recognition (R)2010 Packaging for and relevant terminally sterilized guidance. medical devices--Part 2: Validation requirements for forming, sealing and assembly processes. 14-195...................... ............................ ANSI/AAMI/ISO 11140- Extent of recognition. 1:2005(R)2010 Sterilization of health care products-- Chemical indicators--Part 1: General requirements. 14-201...................... 14-396...................... ANSI/AAMI ST77:2013 Withdrawn and replaced Containment devices for with newer version. reusable medical device sterilization. 14-214...................... 14-397...................... AOAC 6.2.04:2013 Official Withdrawn and replaced Method 955.15 Testing with newer version. Disinfectants Against Staphylococcus aureus, Use- Dilution Method. 14-218...................... 14-398...................... AOAC 6.3.05:2013 Official Withdrawn and replaced Method 966.04 Sporicidal with newer version. Activity of Disinfectants Method I. 14-219...................... 14-399...................... AOAC 6.3.06:2012 Official Withdrawn and replaced Method 965.12 with newer version. Tuberculocidal Activity of Disinfectants. 14-230...................... 14-400...................... ASTM F2203-13 Standard Test Withdrawn and replaced Method for Linear with newer version. Measurement Using Precision Steel Rule. 14-231...................... 14-401...................... ASTM F2217/F2217M-13 Withdrawn and replaced Standard Practice for with newer version. Coating/Adhesive Weight Determination. 14-235...................... 14-402...................... ASTM F1140/F1140M-13 Withdrawn and replaced Standard Test Methods for with newer version. Internal Pressurization Failure Resistance of Unrestrained Packages. 14-236...................... 14-403...................... ASTM F2054/F2054M-13 Withdrawn and replaced Standard Test Method for with newer version. Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates. 14-241...................... 14-424...................... ISO 13408-6 First edition Withdrawn and replaced 2005-06-15 Aseptic with newer version processing of health care including amendment. products--Part 6: Isolator systems [Including AMENDMENT 1 (2013)]. 14-258...................... 14-404...................... ASTM F2250-13 Standard Withdrawn and replaced Practice for Evaluation of with newer version. Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials. 14-260...................... 14-405...................... ASTM F2252/F2252M-13[egr]1 Withdrawn and replaced Standard Practice for with newer version. Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape. 14-264...................... 14-406...................... ANSI/AAMI ST8:2013 Hospital Withdrawn and replaced steam sterilizers. with newer version. 14-274...................... ............................ ANSI/AAMI/ISO 15882:2008 Extent of recognition Sterilization of health and relevant care products--Chemical guidance. indicators--Guidance for selection, use, and interpretation of results. 14-285...................... ............................ ANSI/AAMI/ISO 14161:2009 Extent of recognition. Sterilization of health care products--Biological indicators--Guidance for the selection, use and interpretation of results. 14-289...................... ............................ ISO 14698-2:2003 TECHNICAL Withdrawn. See 14-395. CORRIGENDUM Cleanrooms and associated controlled environments--Biocontaminat ion control--Part 2: Evaluation and interpretation of biocontamination data. [[Page 4932]] 14-296...................... ............................ ANSI/AAMI/ISO 11138-1:2006/ Relevant guidance. (R)2010, Sterilization of health care products-- Biological indicators--Part 1: General requirements. 14-300...................... ............................ ASTM D4169-09 Standard Extent of recognition. Practice for Performance Testing of Shipping Containers and Systems. 14-326...................... 14-407...................... ISO 11737-1 Second edition Withdrawn and replaced 2006-04-01, Sterilization with newer version of medical devices-- including technical Microbiological methods-- corrigendum. Part 1: Determination of a population of microorganisms on products [Including: TECHNICAL CORRIGENDUM 1 Published 2007-05-15]. 14-328...................... 14-428...................... ISO 11137-1 First edition Withdrawn and replaced 2006-04-15 Sterilization of with newer version health care products-- including amendment. Radiation--Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including AMENDMENT 1 (2013)]. 14-334...................... ............................ ISO 15882 Second edition Extent of recognition, 2008-09-01 Sterilization of title. health care products-- Chemical indicators-- Guidance for selection, use and interpretation of results. 14-335...................... 14-408...................... ISO 10993-7 Second edition Withdrawn and replaced 2008-10-15 Biological with newer version evaluation of medical including technical devices--Part 7: Ethylene corrigendum. oxide sterilization residuals [Including: TECHNICAL CORRIGENDUM 1 Published 2009-11-15]. 14-336...................... ............................ ISO 14161 Second edition Extent of recognition. 2009-09-15 Sterilization of health care products-- Biological indicators-- Guidance for the selection, use and interpretation of results. 14-338...................... ............................ ISO 11138-1 Second edition Relevant guidance. 2006-07-01, Sterilization of health care products-- Biological indicators--Part 1: General requirements. 14-352...................... 14-425...................... ANSI/AAMI/ISO 13408-6:2005 Withdrawn and replaced Aseptic processing of with newer version health care products--Part including amendment. 6: Isolator systems [Including AMENDMENT 1 (2013)]. 14-353...................... ............................ ISO 11140-1 Second edition Extent of recognition. 2005-07-15 Sterilization of health care products-- Chemical indicators--Part 1: General requirements. 14-355...................... ............................ ISO 11607-1 First edition Extent of recognition 2006-04-15 Packaging for and relevant terminally sterilized guidance. medical devices--Part 1: Requirements for materials, sterile barrier systems and packaging systems. 14-356...................... ............................ ISO 11607-2 First edition Extent of recognition. 2006-04-15 Packaging for terminally sterilized medical devices--Part 2: Validation requirements for forming, sealing and assembly processes. 14-357...................... ............................ ISO 11737-1:2006 TECHNICAL Withdrawn. See 14-407. CORRIGENDUM 1 Published 2007-05-15 Sterilization of medical devices-- Microbiological methods-- Part 1: Determination of a population of microorganisms on products. 14-360...................... ............................ ANSI/AAMI ST72:2011, Relevant guidance. Bacterial endotoxins--Test methods, routine monitoring, and alternatives to batch testing. 14-362...................... 14-412...................... AOAC 6.2.01:2013 Official Withdrawn and replaced Method 955.14, Testing with newer version. Disinfectants Against Salmonella choleraesuis, Use-Dilution Method. 14-363...................... 14-413...................... AOAC 6.2.06:2013 Official Withdrawn and replaced Method 964.02, Testing with newer version. Disinfectants Against Pseudomonas aeruginosa, Use- Dilution Method. 14-365...................... 14-409...................... ISO 11137-2 Third edition Withdrawn and replaced 2013-06-01 Sterilization of with newer version. health care products-- Radiation--Part 2: Establishing the sterilization dose. 14-366...................... 14-414...................... USP 36-NF31:2013 <61> Withdrawn and replaced Microbiological Examination with newer version. of Nonsterile Products: Microbial Enumeration Tests. 14-367...................... 14-415...................... USP 36-NF31:2013 <71> Withdrawn and replaced Sterility Tests. with newer version. 14-368...................... 14-416...................... USP 36-NF31:2013 <85> Withdrawn and replaced Bacterial Endotoxins Test. with newer version. 14-369...................... 14-417...................... USP 36-NF31:2013 <151> Withdrawn and replaced Pyrogen Test (USP Rabbit with newer version. Test). 14-370...................... 14-418...................... USP 36-NF31:2013 <161> Withdrawn and replaced Transfusion and Infusion with newer version. Assemblies and Similar Medical Devices. 14-371...................... 14-419...................... USP 36-NF31:2013 Biological Withdrawn and replaced Indicator for Steam with newer version. Sterilization, Self- Contained. 14-372...................... 14-420...................... USP 36-NF31:2013 Biological Withdrawn and replaced Indicator for Dry-Heat with newer version. Sterilization, Paper Carrier. 14-373...................... 14-421...................... USP 36-NF31:2013 Biological Withdrawn and replaced Indicator for Ethylene with newer version. Oxide Sterilization, Paper Carrier. 14-374...................... 14-422...................... USP 36-NF31:2013 Biological Withdrawn and replaced Indicator for Steam with newer version. Sterilization, Paper Carrier. 14-375...................... 14-423...................... USP 36-NF31:2013 <62> Withdrawn and replaced Microbiological Examination with newer version. of Nonsterile Products: Tests for Specified Microorganisms. 14-380...................... 14-410...................... ASTM F17-13 Standard Withdrawn and replaced Terminology Relating to with newer version. Flexible Barrier Packaging. [[Page 4933]] 14-384...................... ............................ ISO 10993-7:2008 TECHNICAL Withdrawn. See 14-408. CORRIGENDUM 1, Published 2009-11-15 Biological evaluation of medical devices--Part 7: Ethylene oxide sterilization residuals. 14-385...................... 14-426...................... ANSI/AAMI/ISO 13408-1:2008 Withdrawn and replaced (R2011) Aseptic processing with newer version of health care products-- including amendment. Part 1: General requirements [Including AMENDMENT 1 (2013)]. 14-386...................... 14-427...................... ISO 13408-1 Second edition Withdrawn and replaced 2008-06-15 Aseptic with newer version processing of health care including amendment. products--Part 1: General requirements [Including AMENDMENT 1 (2013)]. 14-393...................... 14-411...................... ISO/ASTM 51818 Third edition Withdrawn and replaced 2013-06-01 Practice for with newer version. dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV. ---------------------------------------------------------------------------------------------------------------- \1\ All standard titles in this table conform to the style requirements of the respective organizations. III. Listing of New Entries In table 2 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: 034. Table 2.--New Entries to the List of Recognized Standards ------------------------------------------------------------------------ Reference No. and Recognition No. Title of standard \1\ date ------------------------------------------------------------------------ A. Anesthesia ------------------------------------------------------------------------ 1-96..................... Medical electrical ISO 80601-2-55 equipment--Part 2-55: First edition 2011- Particular requirements 12-15. for the basic safety and essential performance of respiratory gas monitors. ------------------------------------------------------------------------ B. Cardiovascular ------------------------------------------------------------------------ 3-121.................... Cardiovascular implants-- ISO 25539-1 First Endovascular devices-- edition 2003-03- Part 1: Endovascular 01. prostheses [Including: Amendment 1 (2005)]. ------------------------------------------------------------------------ C. General ------------------------------------------------------------------------ 5-83..................... MEDICAL ELECTRICAL ANSI/AAMI HA60601-1- EQUIPMENT--Part 1-11: 1:2011. 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- 1-11:2010, MOD). 5-84..................... Design of training and AAMI TIR49:2013. instructional materials for medical devices used in non-clinical environments. 5-85..................... Medical electrical IEC 60601-1-6 equipment--Part 1-6: Edition 3.0 2010- General requirements 01. for basic safety and essential performance-- Collateral standard: Usability. 5-86..................... Medical electrical IEC 60601-1-8 equipment--Part 1-8: Edition 2.0 2006- General requirements 10. for basic safety and essential performance-- Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. ------------------------------------------------------------------------ D. General Hospital/General Plastic Surgery ------------------------------------------------------------------------ 6-302.................... Stainless steel needle ISO 9626 First tubing for the edition 1991-09- manufacture of medical 01. devices [Including: AMENDMENT 1 2001-06-01]. 6-318.................... Infusion equipment for ISO 8536-4 Fifth medical use--Part 4: edition 2010-10- Infusion sets for 01. single use, gravity feed [Including: AMENDMENT 1 2013-03-01]. 6-320.................... Medical electrical IEC 60601-2-20 equipment--Part 2-20: Edition 2.0 2009- Particular requirements 02. for the basic safety and essential performance of infant transport incubators [Including: CORRIGENDUM 1 (February 2012) and CORRIGENDUM 2 (February 2013)]. 6-321.................... Medical electrical IEC 60601-2-52 equipment--Part 2-52: Edition 1.0 2009- Particular requirements 12. for basic safety and essential performance of medical beds [Including: CORRIGENDUM 1 (September 2010)]. 6-322.................... Intravascular catheters-- ISO 10555-4 Second Sterile and single-use edition 2013-06- catheters--Part 4: 15. Balloon dilatation catheters. ------------------------------------------------------------------------ E. Material ------------------------------------------------------------------------ 8-358.................... Standard Specification ASTM F1855-00 for Polyoxymethylene (Reapproved 2011). (Acetal) for Medical Applications. 8-359.................... Standard Guide for ASTM F2038-00 Silicone Elastomers, (Reapproved 2011). Gels, and Foams Used in Medical Applications Part I--Formulations and Uncured Materials. [[Page 4934]] 8-360.................... Standard Guide for ASTM F2042-00 Silicone Elastomers, (Reapproved 2011). Gels, and Foams Used in Medical Applications Part II--Cross-Linking and Fabrication. 8-361.................... Standard Specification ASTM F755-99 for Selection of Porous (Reapproved 2011). Polyethylene for Use in Surgical Implants. 8-362.................... Standard Specification ASTM F2989-13. for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications. 8-363.................... Standard Test Method for ASTM D638-10. Tensile Properties of Plastics. 8-364.................... Standard Test Methods ASTM D792-08. for Density and Specific Gravity (Relative Density) of Plastics by Displacement. 8-365.................... Standard Test Method for ASTM D1505-10. Density of Plastics by the Density-Gradient Technique. 8-366.................... Ultra-high-molecular- ISO 11542-2 First weight polyethylene (PE- edition 1998-11- UHMW) moulding and 15. extrusion materials-- Part 2: Preparation of test specimens and determination of properties. 8-367.................... Standard Test Method for ASTM E647-13[egr]1. Measurement of Fatigue Crack Growth Rates. 8-368.................... Standard Test Method for ASTM F2625-10. Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra- High-Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry. 8-369.................... Standard Practice for ASTM F2003-02 Accelerated Aging of (Reapproved 2008). Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air. ------------------------------------------------------------------------ F. OB-GYN/Gastroenterology/Urology ------------------------------------------------------------------------ 9-86..................... Rubber condoms for ISO 16037 First clinical trials-- Edition 2002-05- Measurement of physical 15. properties Including [AMENDMENT 1 2011-02- 15)]. 9-87..................... Female condoms-- ISO 25841 First Requirements and test Edition 2011-07- methods. 15. 9-88..................... Prophylactic dams-- ISO 29942 First Requirements and test Edition 2011-07- methods. 01. 9-89..................... Cardiovascular implants ISO 8638 Third and extracorporeal edition 2010-07- blood circuit for 01. haemodialysers, haemodiafilters, and haemofilters. 9-92..................... Cardiovascular implants ISO 8637 Third and extracorporeal edition 2010-07- systems--Haemodialysers 01. , haemodiafilters, haemofilters and haemoconcentrators Including [AMENDMENT 1 2013-04-01)]. ------------------------------------------------------------------------ G. Ophthalmics ------------------------------------------------------------------------ 10-87.................... Standard Test Method for ASTM D882-12. Tensile Properties of Thin Plastic Sheeting. 10-88.................... Standard Test Methods ASTM D790-10. for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials. ------------------------------------------------------------------------ H. Orthopedics ------------------------------------------------------------------------ 11-259................... Standard Specification ASTM F2887-12. For Total Elbow Prostheses. 11-260................... Standard Guide for ASTM F2943-13. Presentation of End User Labeling Information for Orthopedic Implants Used in Joint Arthroplasty. 11-261................... Standard Specification ASTM F1378-12 for Shoulder Prostheses. 11-262................... Standard Specification ASTM F2091-01 for Acetabular (Reapproved 2012). Prostheses. 11-263................... Standard Test Methods ASTM F2028-08 for Dynamic Evaluation (Reapproved 2012) of Glenoid Loosening or \1\. Disassociation. 11-264................... Standard Test Method for ASTM F1820-13. Determining the Forces for Disassembly of Modular Acetabular Devices. 11-265................... Standard Practice for ASTM F2580-13. Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis. 11-266................... Standard Specification ASTM F2665-09. for Total Ankle Replacement Prosthesis. 11-267................... Standard Test Method for ASTM F2009-00 Determining the Axial (Reapproved 2011). Disassembly Force of Taper Connections of Modular Prostheses. 11-268................... Standard Test Method for ASTM F1829-98 Static Evaluation of (Reapproved 2009). Glenoid Locking Mechanism in Shear. 11-269................... Standard Guide for ASTM F2423-11. Functional, Kinematic, and Wear Assessment of Total Disc Prostheses. 11-270................... Standard Specification ASTM F2502-11. and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants. 11-271................... Standard Specification ASTM F2180-02 for Metallic (Reapproved 2011). Implantable Strands and Cables. 11-272................... Standard Guide for ASTM F1714-96 Gravimetric Wear (Reapproved 2013). Assessment of Prosthetic Hip Designs in Simulator Devices. 11-273................... Implants for surgery-- ISO 18192-1 Second Wear of total edition 2011-03- intervertebral spinal 01. disc prostheses--Part 1 Loading and displacement parameters for wear testing and corresponding environmental conditions for test. 11-274................... Implants for surgery-- ISO 18192-2 First Wear of total edition 2010-06- intervertebral spinal 15. disc prostheses--Part 2: Nucleus replacements. 11-275................... Standard Test Method for ASTM F2381-10. Evaluating Trans- Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy. ------------------------------------------------------------------------ [[Page 4935]] I. Radiology ------------------------------------------------------------------------ 12-261................... Information technology-- ISO/IEC 10918-1 Digital compression and First edition 1994- coding of continuous- 02-15. tone still images: Requirements and guidelines [Including: TECHNICAL CORRIGENDUM 1 (2005)]. ------------------------------------------------------------------------ J. Software/Informatics ------------------------------------------------------------------------ 13-63.................... Application of risk IEC/TR 80001-2-4 management for IT- Edition 1.0 2012- networks incorporating 11. medical devices--Part 2- 4: Application guidance--General implementation guidance for healthcare delivery organizations. 13-64.................... Application of risk ANSI/AAMI/IEC management for IT- TIR80001-2-4:2012. networks incorporating medical devices--Part 2- 4: General implementation guidance for healthcare delivery organizations. ------------------------------------------------------------------------ K. Sterility ------------------------------------------------------------------------ 14-429................... Practice for use of a ISO/ASTM 51275 radiochromic film Third edition 2013- dosimetry system. 06-01. 14-430................... Practice for use of an ISO/ASTM 51607 alanine-EPR dosimetry Third edition 2013- system. 06-01. 14-431................... Guide for estimating ISO/ASTM 51707 uncertainties in Second edition dosimetry for radiation 2005-05-15. processing. ------------------------------------------------------------------------ \1\ All standard titles in this table conform to the style requirements of the respective organizations. IV. List of Recognized Standards FDA maintains the Agency's current list of FDA recognized consensus standards in a searchable database that may be accessed directly at FDA's Internet site at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA will incorporate the modifications and revisions described in this notice into the database and, upon publication in the Federal Register, this recognition of consensus standards will be effective. FDA will announce additional modifications and revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often, if necessary. Beginning with recognition list 033, FDA no longer announces minor revisions to the list of recognized consensus standards such as technical contact person, relevant guidance, processes affected, CFR citations, and product codes. V. Recommendation of Standards for Recognition by FDA Any person may recommend consensus standards as candidates for recognition under section 514 of the FD&C Act by submitting such recommendations, with reasons for the recommendation, to the contact person (see FOR FURTHER INFORMATION CONTACT). To be properly considered, such recommendations should contain, at a minimum, the following information: (1) The title of the standard, (2) any reference number and date, (3) the name and address of the national or international standards development organization, (4) a proposed list of devices for which a declaration of conformity to this standard should routinely apply, and (5) a brief identification of the testing or performance or other characteristics of the device(s) that would be addressed by a declaration of conformity. VI. Electronic Access You may obtain a copy of ``Guidance on the Recognition and Use of Consensus Standards'' by using the Internet. The Center for Devices and Radiological Health (CDRH) maintains a site on the Internet for easy access to information including text, graphics, and files that you may download to a personal computer with access to the Internet. Updated on a regular basis, the CDRH home page includes the guidance as well as the current list of recognized standards and other standards-related documents. After publication in the Federal Register, this notice announcing ``Modification to the List of Recognized Standards, Recognition List Number: 034'' will be available on the CDRH home page. You may access the CDRH home page at https://www.fda.gov/MedicalDevices. You may access ``Guidance on the Recognition and Use of Consensus Standards,'' and the searchable database for ``FDA Recognized Consensus Standards'' at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards. This Federal Register document on modifications in FDA's recognition of consensus standards is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. VII. Submission of Comments and Effective Date Interested persons may submit to the contact person (see FOR FURTHER INFORMATION CONTACT) either electronic or written comments regarding this document. It is only necessary to send one set of comments. Comments are to be identified with the docket number found in brackets in the heading of this document. FDA will consider any comments received in determining whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 034. These modifications to the list of recognized standards are effective upon publication of this notice in the Federal Register. Dated: January 23, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014-01847 Filed 1-29-14; 8:45 am] BILLING CODE 4160-01-P
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