Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 034

Notice.

Citation: "79 FR 4913"

Document Number: "Docket No. FDA-2004-N-0451"

Page Number: "4913"

"Notices"

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: [email protected]. This document may also be accessed on FDA's Internet site at http://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 http://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            Replacement   Title of standard  *1           Change recognition    recognition No.            No.       A. Anesthesia  1-15                         ISO 5361-4:1987, Tracheal       Withdrawn. See                              tubes--Part 4: Cole type        1-93. 1-18           1-94          ISO 8359 Second edition 1996-   Withdrawn and                              12-15, Oxygen concentrators for replaced with                              medical use--Safety             newer version                              requirements [Including:       including                              AMENDMENT 1 2012-07-01]        amendment. 1-36           1-95          ISO 5366-3 Second edition 2001- Withdrawn and                              08-15, Anaesthetic and          replaced with                              respiratory equipment--         newer version                              Tracheostomy tubes--Part 3:     including                              Pediatric tracheostomy tubes    technical                              [Including: TECHNICAL          corrigendum.                              CORRIGENDUM 1 Published 2003-                              01-15] 1-44                         ISO 5366-1 Fourth edition 2000- Extent of                              12-15, Anaesthetic and          recognition.                              respiratory equipment--                              Tracheostomy tubes--Part 1:                              Tubes and connectors for use in                              adults 1-46                         ISO 5367 Fourth edition 2000-   Extent of                              06-01 Breathing tubes intended  recognition.                              for use with anaesthetic                              apparatus and ventilators 1-47                         AS 4259-1995 Ancillary devices  Extent of                              for expired air resuscitation   recognition. 1-56           1-97          CGA V-7.1:2011 Standard Method  Withdrawn and                              of Determining Cylinder Valve   replaced with                              Outlet Connections for Medical  newer version.                              Gases 1-57                         ASTM F1101-90 (Reapproved 2003) Extent of                              &egr;1, Standard Specification  recognition.                              for Ventilators Intended for                              Use During Anesthesia 1-58                         ASTM G175-03 (Reapproved 2011), Extent of                              Standard Test Method for        recognition.                              Evaluating the Ignition                              Sensitivity and Fault Tolerance                              of Oxygen Regulators Used for                              Medical and Emergency                              Applications 1-65                         ISO 21647:2004 Medical          Withdrawn. See                              electrical equipment--          1-96.                              Particular requirements for the                              basic safety and essential                              performance of respiratory gas                              monitors 1-69                         ASTM F1464-93 (Reapproved 2005) Extent of                              Standard Specification for      recognition.                              Oxygen Concentrators for                              Domiciliary Use 1-70                         ASTM F1246-91 (Reapproved 2005) Extent of                              Standard Specification for      recognition.                              Electrically Powered Home Care                              Ventilators, Part 1--Positive-                              Pressure Ventilators and                              Ventilator Circuits 1-78                         ASME PVHO-1-2007 Safety         Extent of                              Standard for Pressure Vessels   recognition.                              for Human Occupancy 1-81                         CGA V-5:2008 (Reaffirmed 2013), Reaffirmation.                              Diameter-Index Safety System                              (Noninterchangeable Low                              Pressure Connections for                              Medical Gas Applications) 1-83                         ISO 21647:2004 TECHNICAL        Withdrawn. See                              CORRIGENDUM 1, Medical          1-96.                              electrical equipment--                              Particular requirements for the                              basic safety and essential                              performance of respiratory gas                              monitors 1-84                         ISO 5366-3:2001 Anaesthetic and Withdrawn. See                              Respiratory Equipment--         1-95.                              Tracheostomy Tubes--Part 3:                              Pediatric Tracheostomy Tubes                              TECHNICAL CORRIGENDUM 1 1-86                         ISO 8185 Third edition 2007-07- Extent of                              01 Corrected versions 2008-06-  recognition.                              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                              2011-04-15 Medical electrical   replaced with                              equipment--Part 2-12:           newer version                              Particular requirements for the including                              safety of lung ventilators--    technical                              Critical care ventilators       corrigendum.                              [Including: TECHNICAL                              CORRIGENDUM 1 Published 2011-                              10-15] 1-89                         ISO 80601-2-12 TECHNICAL        Withdrawn. See                              CORRIGENDUM 1 Medical           1-98.                              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                              12-15 AMENDMENT 1 2012-07-01    1-94.                              Oxygen concentrators for                              medical use--Safety                              requirements 1-92                         ISO 17510-2 Second Edition      Extent of                              2007-10-01, Sleep apnoea        recognition.                              breathing therapy--Part 2:                              Masks and application                              accessories 1-93           ISO 5361      Second edition 2012-10-01       Extent of                              Anaesthetic and respiratory     recognition.                              equipment--Tracheal tubes and                              connectors       B. Biocompatibility  2-123          2-204         ASTM F720-13 Standard Practice  Withdrawn and                              for Testing Guinea Pigs for     replaced with                              Contact Allergens: Guinea Pig   newer version.                              Maximization Test 2-182          2-205         ISO 14155 Second edition 2011-  Withdrawn and                              02-01 Clinical investigations   replaced with                              of medical devices for human    newer version                              subjects--Good clinical         including                              practices [Including TECHNICAL technical                              CORRIGENDUM 1:2011]            corrigendum. 2-183                        ISO 14155:2011 and TECHNICAL    Withdrawn. See                              CORRIGENDUM 1 Published 2011-   2-205.                              07-15 Clinical investigation of                              medical devices for human                              subjects--Good clinical                              practice 2-93                         ASTM F763-04 (Reapproved 2010), Extent of                              Standard Practice for Short-    recognition.                              Term Screening of Implant                              Materials 2-94                         ASTM F981-04 (Reapproved 2010)  Extent of                              Standard Practice for           recognition.                              Assessment of Compatibility of                              Biomaterials for Surgical                              Implants with Respect to Effect                              of Materials on Muscle and Bone 2-114                        ASTM F1877-05 (Reapproved 2010) Extent of                              Standard Practice for           recognition.                              Characterization of Particles 2-118                        ANSI/AAMI/ISO 10993-11:2006/(R) Extent of                              2010 Biological evaluation of   recognition.                              medical devices--Part 11: Tests                              for systemic toxicity 2-120                        ANSI/AAMI/ISO 10993-6:2007/(R)  Extent of                              2010 Biological evaluation of   recognition.                              medical devices--Part 06: Tests                              for local effects after                              implantation 2-126                        ASTM F748-06 (Reapproved 2010)  Extent of                              Standard Practice for Selecting recognition.                              Generic Biological Test Methods                              for Materials and Devices 2-133                        ASTM F1408-97 (Reapproved 2008) Extent of                              Standard Practice for           recognition.                              Subcutaneous Screening Test for                              Implant Materials 2-134                        ASTM F2065-00 (Reapproved 2010) Extent of                              Standard Practice for Testing   recognition.                              for Alternative Pathway                              Complement Activation in Serum                              by Solid Materials 2-136                        ASTM E1262-88 (Reapproved 2008) Extent of                              Standard Guide for Performance  recognition.                              of the Chinese Hamster Ovary                              Cell/Hypoxanthine Guanine                              Phosphoribosyl Transferase Gene                              Mutation Assay 2-137                        ASTM E1263-97 (Reapproved 2008) Withdrawn.                              Standard Guide for Conduct of                              Micronucleus Assays in                              Mammalian Bone Marrow                              Erythrocytes 2-138                        ASTM E1280-97 (Reapproved 2008) Withdrawn.                              Standard Guide for Performing                              the Mouse Lymphoma Assay for                              Mammalian Cell Mutagenicity 2-139                        ASTM E1397-91 (Reapproved 2008) Withdrawn.                              Standard Practice for the In                              Vitro Rat Hepatocyte DNA Repair                              Assay 2-140                        ASTM E1398-91 (Reapproved 2008) Withdrawn.                              Standard Practice for the In                              Vivo Rat Hepatocyte DNA Repair                              Assay 2-141                        ASTM F1984-99 (Reapproved 2008) Extent of                              Standard Practice for Testing   recognition.                              for Whole Complement Activation                              in Serum by Solid Materials 2-142                        ASTM F1983-99 (Reapproved 2008) Extent of                              Standard Practice for           recognition.                              Assessment of Compatibility of                              Absorbable/Resorbable                              Biomaterials for Implant                              Application 2-143                        ASTM F1904-98 (Reapproved 2008) Extent of                              Standard Practice for Testing   recognition.                              the Biological Responses to                              Particles in vivo 2-144                        ASTMF619-03 (Reapproved 2008)   Extent of                              Standard Practice for           recognition.                              Extraction of Medical Plastics 2-145                        ASTM F1439-03 (Reapproved 2008) Extent of                              Standard Guide for Performance  recognition.                              of Lifetime Bioassay for the                              Tumorigenic Potential of                              Implant Materials 2-153                        ANSI/AAMI/ISO 10993-5:2009,     Extent of                              Biological evaluation of        recognition.                              medical devices--Part 5: Tests                              for In Vitro cytotoxicity 2-154                        ASTM F756-08 Standard Practice  Extent of                              for Assessment of Hemolytic     recognition.                              Properties of Materials 2-155                        ASTM F2147-01 (Reapproved 2010) Extent of                              Standard Practice for Guinea    recognition.                              Pig: Split Adjuvant and Closed                              Patch Testing for Contact                              Allergens 2-156                        ANSI/AAMI/ISO 10993-1:2009      Extent of                              Biological evaluation of        recognition.                              medical devices--Part 1:                              Evaluation and testing within a                              risk management 2-162                        ASTM F1903-10 Standard Practice Extent of                              for Testing for Biological      recognition.                              Responses to Particles in vitro 2-163                        ANSI/AAMI/ISO 10993-9:2009      Extent of                              Biological evaluation of        recognition.                              medical devices--Part 9:                              Framework for identification                              and quantification of potential                              degradation products 2-165                        ANSI/AAMI/ISO 10993-14:2001/(R) Extent of                              2011 Biological evaluation of   recognition.                              medical devices--Part 14:                              Identification and                              quantification of degradation                              products from ceramics 2-167                        ISO/TS 10993-19 First edition   Extent of                              2006-06-01 Biological           recognition.                              evaluation of medical devices--                              Part 19: Physico-chemical,                              morphological, and                              topographical characterization                              of materials 2-168                        ISO 10993-9 Second edition      Extent of                              2009-12-15 Biological           recognition.                              evaluation of medical devices--                              Part 9: Framework for                              identification and                              quantification of potential                              degradation products 2-169                        ISO 10993-13 Second edition     Extent of                              2010-06-15 Biological           recognition.                              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                              2001-11-15 Biological           recognition.                              evaluation of medical devices--                              Part 14: Identification and                              quantification of degradation                              products from ceramics 2-171                        ISO 10993-16 Second edition     Extent of                              2010-02-15 Biological           recognition.                              evaluation of medical devices--                              Part 16: Toxicokinetic study                              design for degradation products                              and leachables 2-172                        ANSI/AAMI/ISO TIR 10993-19:2006 Extent of                              Biological evaluation of        recognition.                              medical devices--Part 19:                              Physicochemical, morphological,                              and topographical                              characterization of materials 2-173                        ANSI/AAMI/ISO 10993-10:2010     Extent of                              Biological evaluation of        recognition.                              medical devices--Part 10: Tests                              for irritation and skin                              sensitization 2-174                        ISO 10993-10:2010 Biological    Extent of                              evaluation of medical devices-- recognition.                              Part 10: Tests for irritation                              and skin sensitization 2-175                        ISO 10993-3 Second edition      Extent of                              2003-10-15 Biological           recognition.                              evaluation of medical devices                              Part 3: Tests for genotoxicity,                              carcinogenicity and                              reproductive toxicity 2-176                        ISO 10993-11 Second edition     Extent of                              2006-08-15 Biological           recognition.                              evaluation of medical devices--                              Part 11: Tests for systemic                              toxicity 2-177                        ISO 10993-06 Second edition     Extent of                              2007-04-15 Biological           recognition.                              evaluation of medical devices--                              Part 6: Tests for local effects                              after implantation 2-179                        ISO 10993-1 Fourth edition      Extent of                              2009-10-15 Biological           recognition.                              evaluation of medical devices--                              Part 1: Evaluation and testing                              within a risk management                              process 2-181                        ANSI/AAMI/ISO 14155:2011,       Extent of                              Clinical investigation of       recognition.                              medical devices for human                              subjects--Good clinical                              practice 2-189                        ASTM F895-11, Standard Test     Extent of                              Method for Agar Diffusion Cell  recognition.                              Culture Screening for                              Cytotoxicity 2-190                        ANSI/AAMI/ISO 10993-13:2010,    Extent of                              Biological evaluation of        recognition.                              medical devices--Part 13:                              Identification and                              quantification of degradation                              products from polymeric medical                              devices 2-191                        ISO 10993-12 Fourth edition     Extent of                              2012-07-01, Biological          recognition.                              evaluation of medical devices--                              Part 12: Sample preparation and                              reference materials       C. Cardiovascular  3-41                         ANSI/AAMI EC11:1991/(R)2007     Withdrawn. See                              Diagnostic electrocardiographic 3-106.                              devices 3-52                         ANSI/AAMIEC12:2000/(R)2010      Extent of                              Disposable ECG electrodes       recognition. 3-54                         ANSI/AAMI/ISO                   Extent of                              7198:1998/2001/(R)2010          recognition.                              Cardiovascular implants--                              Tubular vascular prostheses 3-58                         ANSI/AAMI/ISO 5840:2005/(R)2010 Extent of                              Cardiovascular implants--       recognition.                              Cardiac valve prostheses 3-63                         ISO 11318 Second edition 2002-  Extent of                              08-01 Cardiac Defibrillators--  recognition.                              Connector assembly DF-1 for                              implantable defibrillators--                              Dimensions and test                              requirements 3-72                         ANSI/AAMI EC53:1995/(R) 2008    Extent of                              ECG cables and leadwires        recognition. 3-73           3-118         ANSI/AAMI EC57:2012 Testing and Withdrawn and                              reporting performance results   replaced with                              of cardiac rhythm and ST-       newer version.                              segment measurement algorithms 3-75                         ANSI/AAMI SP10:2002/(R) 2008 &  Withdrawn. See                              ANSI/AAMI SP10:2002/A1:2003,    3-80, 3-122 and                              Manual, electronic or automated 3-123.                              sphygmomanometers 3-76                         ASTM F2129-08 Standard Test     Extent of                              Method for Conducting Cyclic    recognition.                              Potentiodynamic Polarization                              Measurements to Determine the                              Corrosion Susceptibility of                              Small Implant Devices 3-78                         ANSI/AAMI/IEC 80601-2-30:2009   Extent of                              Medical electrical equipment--  recognition.                              Part 2-30: Particular                              requirements for the basic                              safety and essential                              performance of automated                              noninvasive sphygmomanometers 3-80                         ANSI/AAMI/ISO 81060-1:2007/(R)  Reaffirmation.                              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                              Implants for surgery--Active    recognition.                              implantable medical devices--                              Part 5: Circulatory support                              devices 3-85           3-120         ANSI/AAMI/ISO 25539-2:2012      Withdrawn and                              Cardiovascular implants--       replaced with                              Endovascular devices--Part 2:   newer version.                              Vascular stents 3-88                         ASTM F2514-08 Standard Guide    Extent of                              for Finite Element Analysis     recognition.                              (FEA) of Metallic Vascular                              Stents Subjected to Uniform                              Radial 3-90                         ISO 7198 First edition 1998-08- Extent of                              01 Cardiovascular implants--    recognition.                              Tubular vascular prostheses 3-93                         ISO 25539-1:2003 First edition  Withdrawn. See                              2001-11-13 AMENDMENT 1 2005-07- 3-121.                              15 Cardiovascular implants--                              Endovascular devices--Part 1:                              Endovascular prostheses                              Amendment 1: Test methods 3-97           3-122         ISO 81060-2 Second edition      Withdrawn and                              2013-05-01 Non-invasive         replace with                              sphygmomanometers--Part 2:      newer version.                              Clinical validation of                              automated measurement type 3-98                         ISO 81060-2:2009 TECHNICAL      Withdrawn. See                              CORRIGENDUM Published 2011-02-  3-122.                              15 Non-invasive                              sphygmomanometers--Part 2:                              Clinical validation of                              automated measurement type 3-100                        ANSI/AAMI/IEC 60601-2-27:2011   Withdrawn. See                              Medical electrical equipment--  3-101.                              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                              2013-07 Medical electrical      replaced with                              equipment--Part 2-30:           newer version.                              Particular requirements for the                              basic safety and essential                              performance of automated non-                              invasive sphygmomanometers 3-108                        IEC 80601-2-30 (First edition   Withdrawn. See                              2009) Medical electrical        3-123.                              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                              04-15 Cardiovascular implants   replaced with                              and artificial organs--Blood-   newer version                              gas exchangers (oxygenators)    including                              [Including: AMENDMENT 1        amendment.                              (2012)] 3-114          3-119         ISO 5841-3 Third edition 2013-  Withdrawn and                              40-15 Implants for surgery--    replace with                              Cardiac pacemakers--Part 3:     newer version.                              Low-profile connectors (IS-1)                              for implantable pacemakers       D. Dental/ENT  4-50                         ADA Specification No.18:1992    Extent of                              Alginate Impression Materials   recognition. 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. 38   Extent of                              2000 (Reaffirmed 2010), Metal-  recognition.                              Ceramic Dental Restorative                              Systems 4-89                         ANSI/ADA Specification No. 53:  Extent of                              1999 (Reaffirmed 2008) Polymer- recognition.                              Based Crowns and Bridge                              Materials 4-91                         ANSI/ADA Specification No.      Reaffirmation                              80/ISO 7491:2000 (Reaffirmed    and extent of                              2013) Dental Materials--        recognition.                              Determination of Color                              Stability 4-92                         ANSI/ADA Specification No.      Reaffirmation                              88:2000 (Reaffirmed 2010)       and extent of                              Dental Brazing Alloys           recognition. 4-96                         ANSI/ADA Specification No.      Reaffirmation                              30:2000 (Reaffirmed 2012)       and extent of                              Dental Zinc Oxide-Eugenol and   recognition.                              Zinc Oxide Non-Eugenol Cements 4-97                         ANSI/ADA Specification No. 57:  Extent of                              (Reaffirmed 2012) Endodontic    recognition.                              Sealing Materials 4-105                        ANSI/ADA Specification No.      Extent of                              75:1997 (Reapproved 2003)       recognition.                              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 2004-  Extent of                              10-01 Dentistry--Polymer-based  recognition.                              crown and bridge materials 4-130                        ADA Specification No. 17:1983   Extent of                              (Reaffirmed 2006) Denture Base  recognition.                              Temporary Relining Resins 4-134          4-207         ISO 7494-1 Second edition 2011- Withdrawn and                              08-15 Dentistry--Dental units-- replaced with                              Part 1: General requirements    newer version.                              and test methods 4-135          4-213         ISO 10139-1 Second edition      Withdrawn and                              2005-02-15 Dentistry--Soft      replaced with                              lining materials for removable  newer version                              dentures--Part 1: Materials for including                              short-term use [Including:     technical                              TECHNICAL CORRIGENDUM 1         corrigendum.                              (2006)] 4-137                        ISO 6877 Second edition 2006-   Extent of                              04-01 Dentistry--Root-canal     recognition.                              obturating points 4-139                        ANSI/ADA Specification No. 48   Reaffirmation                              (Reaffirmed 2009) Visible Light and extent of                              Curing Units                    recognition. 4-143          4-208         ANSI/ADA Specification No.      Withdrawn and                              96:2012 Dental-Water-Based      replaced with                              Cements                         newer version. 4-144          4-209         ISO 24234 First edition 2004-   Withdrawn and                              10-15 Dentistry--Mercury and    replaced with                              alloys for dental amalgam       newer version                              [Including: AMENDMENT 1        including                              (2011)]                        amendment. 4-146                        ISO 22674 First edition 2006-   Extent of                              11-15 Dentistry--Metallic       recognition.                              materials for fixed and                              removable restorations and                              appliances 4-149                        ANSI/ADA Specification No.      Reaffirmation                              39/ISO 6874:2005 (Reaffirmed    and extent of                              2011) Pit and Fissure Sealants  recognition. 4-150                        ANSI/ADA Specification No.      Extent of                              19:2004/ISO 4823:2000 Dental--  recognition.                              Elastometric Impression                              Materials 4-151                        ISO 22112 First edition 2005-   Extent of                              11-01 Dentistry--Artificial     recognition.                              teeth for dental prostheses 4-153                        ISO 9917-1 Second edition 2007- Extent of                              10-01 Dentistry--Water-based    recognition.                              cements--Part 1: Powder/liquid                              acid-base cements 4-154          4-210         ISO 4823 Third edition 2000-12- Withdrawn and                              15 Dentistry--Elastometric      replaced with                              impression materials            newer version                              [Including: AMENDMENT 1 (2000) including                              TECHNICAL CORRIGENDUM 1(2004)] amendment and                                                              technical                                                              corrigendum. 4-155                        ISO 4823: Technical Corrigendum Withdrawn. See                              1 Published 2004-07-15--        4-210.                              Dentistry--Elastometric                              impression materials--Third                              Edition 4-156                        ISO 4823 Third edition 2000-12- Withdrawn. See                              15 Amendment 1 2007-07-01       4-210.                              Dentistry--Elastometric                              impression materials--Third                              Edition 4-157                        ISO 3107 Third edition 2004-10- Withdrawn. See                              01 Dentistry--Zinc              4-198.                              oxide/Eugenol and zinc                              oxide/non-eugenol cements--                              Third edition 4-159          4-211         ANSI/IEEE C63.19:2007 American  Withdrawn and                              National Standard Methods of    replaced with                              Measurement of Compatibility    newer version.                              between Wireless Communications                              Devices and Hearing Aids 4-170          4-212         ANSI/ASA S3.36-2012 American    Withdrawn and                              National Standard Specification replaced with                              for a Manikin for Simulated in  newer version.                              situ Airborne Acoustic                              Measurements 4-178                        ISO 6872 Third edition 2008-09- Extent of                              01 Dentistry--Ceramic materials recognition. 4-179                        ISO 7405 Second edition 2008-   Extent of                              12-15 Dentistry--Evaluation of  recognition.                              biocompatibility of medical                              devices used in dentistry 4-180                        ISO 9168 Third edition 2009-07- Extent of                              15 Dentistry--Hose connectors   recognition.                              for air driven dental                              handpieces 4-181                        ISO 4049 Fourth edition 2009-   Extent of                              10-01 Dentistry--Polymer-based  recognition.                              restorative materials 4-182                        ISO 10139-2 Second edition      Extent of                              2009-08-01 Dentistry--Soft      recognition.                              lining materials for removable                              dentures--Part 2: Materials for                              long-term use 4-188                        ISO 9917-2 Second edition 2010- Extent of                              04-15 Dentistry--Water-based    recognition.                              cements--Part 2: Resin-modified                              cements 4-189                        ISO 10139-1:2005 TECHNICAL      Withdrawn. See                              CORRIGENDUM 1 2006-03-01        4-213.                              Dentistry--Soft lining                              materials for removable                              dentures--Part 1: Materials for                              short-term use 4-195                        ISO 14801 Second edition 2007-  Extent of                              11-15 Dentistry--Implants-      recognition.                              Dynamic fatigue test for                              endosseous dental implants 4-196                        ANSI/ADA Specification          Extent of                              No.69:2010/ISO 6872:2008 Dental recognition.                              Ceramic 4-198                        ISO 3107 Fourth edition 2011-   Extent of                              03-01 Dentistry--Zinc           recognition.                              oxide/eugenol and zinc                              oxide/non-eugenol cements 4-199                        ISO 6876 Third edition 2012-06- Extent of                              01 Dentistry--Root Canal        recognition.                              Sealing Materials 4-200                        ISO 24234 First edition 2004-   Withdrawn. See                              10-15 Dentistry--Mercury and    4-209.                              alloys for dental amalgam                              AMENDMENT 1 4-201                        ISO 9693-2012 Dentistry--       Extent of                              Compatibility testing--Metal-   recognition.                              ceramic systems 4-205                        ISO 14457 First edition 2012-   Withdrawn. See                              09-15 Dentistry--Handpieces and 4-206.                              motors       E. General  5-22                         ISO 2768-1 First edition 1989-  Extent of                              11-15 General tolerances--Part  recognition.                              1: Tolerances for linear and                              angular dimensions without                              individual tolerance                              indications 5-23                         ISO 2768-2 First edition 1989-  Extent of                              11-15 General Tolerances--Part  recognition.                              2: Geometrical tolerances for                              features without individual                              tolerance indications 5-36                         ISO/TR 16142 Second edition     Extent of                              2006-01-15 Medical devices--    recognition.                              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 1999- Withdrawn and                              11-15 Sampling procedures for   replaced with                              inspection by attributes--Part  newer version                              1: Sampling schemes indexed by  including                              acceptance quality limit (AQL)  technical                              for lot-by-lot inspection       corrigendum.                              [Including: TECHNICAL                              CORRIGENDUM 1 (2001)] 5-43                         ANSI/ESD S20.20-2007 For the    Extent of                              Development of an Electrostatic recognition.                              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 Practice Withdrawn and                              for Performance Testing of      replaced with                              Packages for Single Parcel      new version.                              Delivery Systems 5-46                         ISO 2859-1:1999/Cor 1:2001      Withdrawn. See                              Sampling procedures for         5-81.                              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                              01-15 Measurement management    recognition.                              systems--Requirements for                              measurement processes and                              measuring equipment 5-50                         IEC 62366 Edition 1.0 2007-10   Extent of                              Medical devices--Application of recognition.                              usability engineering to                              medical devices 5-51           5-80          ASTM D-4332-13 Standard         Withdrawn and                              Practice for Conditioning       replaced with                              Containers, Packages, or        new version.                              Packaging Components for                              Testing 5-53                         IEC 60601-1-2 Edition 3.0 2007- Relevant                              03 Medical electrical           guidance.                              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-          Reaffirmation                              2:2007/(R)2012 Medical          and relevant                              electrical equipment--Part 1-2: guidance.                              General requirements for basic                              safety and essential                              performance--Collateral                              standard: Electromagnetic                              compatibility--Requirements and                              tests 5-57                         ANSI/AAMI HE75:2009 Human       Extent of                              factors engineering--Design of  recognition.                              medical devices 5-58           5-82          IEC 60601-1-11 Edition 1.0:2010 Withdrawn and                              Medical electrical equipment--  replaced with                              Part 1-11: General requirements newer version                              for basic safety and essential  including                              performance--Collateral         technical                              Standard: Requirements for      corrigendum.                              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                              Procedures and Tables for       recognition.                              Inspection by Attributes 5-66                         IEC 60601-1-10 Edition 1.0:     Extent of                              2007-11 Medical electrical      recognition.                              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                   Reaffirmation                              62366:2007/(R)2013 Medical      and extent of                              devices--Application of         recognition.                              usability engineering to                              medical devices 5-69                         IEC 60601-1-11 (First edition   Withdrawn. See                              2010) April 2011 Medical        5-82.                              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 2011) Extent of                              Standard Specification for      recognition.                              Blood/Intravenous                              Fluid/Irrigation Fluid Warmers 6-142                        ANSI/AAMI II36:2004 Medical     Withdrawn. See                              electrical equipment--Part 2:   6-230.                              Particular requirements for                              safety of baby incubators 6-143                        ANSI/AAMI II51:2004 Medical     Withdrawn. See                              electrical equipment--Part 2:   6-231.                              Particular requirements for                              safety of transport incubators 6-150                        ASTM D7161-05 (Reapproved 2010) Withdrawn.                              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                              2013-06-15 Corrected version    replaced with                              2013-07-01 Intravascular        newer version.                              catheters--Sterile and single-                              use catheters--Part 1: General                              requirements 6-163                        ISO 9626 First edition 1991-09- Withdrawn. See                              01 AMENDMENT 1 2001-06-01       6-302.                              Stainless steel needle tubing                              for the manufacture of medical                              devices 6-164          6-303         ISO 10555-5 Second edition      Withdrawn and                              2013-06-15 Intravascular        replaced with                              catheters--Sterile and single-  newer version.                              use catheters--Part 5: Over-                              needle peripheral catheters 6-170          6-304         ISO 7886-1 First edition 1993-  Withdrawn and                              10-01 Sterile hypodermic        replaced with                              syringes for single use--Part   newer version                              1: Syringes for manual use      including                              [Including: TECHNICAL          technical                              CORRIGENDUM 1 Published 1995-   corrigendum.                              11-01] 6-171          6-305         ISO 10555-3 Second edition      Withdrawn and                              2013-06-15 Intravascular        replaced with                              catheters--Sterile and single-  newer version.                              use catheters--Part 3: Central                              venous catheters 6-176                        ASTM D7103-06 (Reapproved 2013) Extent of                              Standard Guide for Assessment   recognition.                              of Medical Gloves 6-187          6-306         ASTM F1671/F1671M-13 Standard   Withdrawn and                              Test Method for Resistance of   replaced with                              Materials Used in Protective    newer version.                              Clothing to Penetration by                              Blood-Borne Pathogens Using                              Phi-X174 Bacteriophage                              Penetration as a Test System 6-233                        IEC 60601-2-52 Edition 1.0      Withdrawn. See                              2009-12 Medical electrical      6-321.                              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                              2008-10 Medical Electrical      replaced with                              Equipment--Part 2-59:           newer version                              Particular requirements for the including                              basic safety and essential      technical                              performance of screening        corrigendum.                              thermographs for human febrile                              temperature screening                              [Including: CORRIGENDUM 1                              (April 2009)] 6-237                        IEC 80601-2-59 (First edition   Withdrawn. See                              2008) Medical Electrical        6-307.                              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                              2009-10 Medical electrical      replaced with                              equipment--Part 2-35:           newer version                              Particular requirements for the including                              basic safety and essential      technical                              performance of heating devices  corrigendum.                              using blankets, pads or                              mattresses and intended for                              heating in medical use                              [Including: CORRIGENDUM 1                              (March 2012)] 6-245                        ISO 8536-4 Fifth edition 2010-  Withdrawn. See                              10-01 Infusion equipment for    6-318.                              medical use--Part 4: Infusion                              sets for single use, gravity                              feed 6-253                        ISO 10535 Second edition 2006-  Extent of                              12-15 Hoists for the transfer   recognition.                              of disabled persons--                              Requirements and test methods 6-264                        ISO 10555-1 First edition 1995- Withdrawn. See                              06-15 AMENDMENT 1 1999-07-15    6-301.                              Sterile, single-use                              intravascular catheters--Part                              1: General requirements 6-265                        ISO 10555-1 First edition 1995- Withdrawn. See                              06-5 AMENDMENT 2 2004-05-15     6-301.                              Sterile, single-use                              intravascular catheters--Part                              1: General requirements 6-266                        ISO 10555-5 First edition 1996- Withdrawn. See                              06-15 AMENDMENT 1 Sterile,      6-303.                              single-use intravascular                              catheters--Part 5: Over-needle                              peripheral catheters 6-267                        ISO 10555-5 1996 TECHNICAL      Withdrawn. See                              CORRIGENDUM 1 Published 2002-   6-303.                              06-15 Sterile, single-use                              intravascular catheters--Part                              5: Over-needle peripheral                              catheters 6-273                        ISO 23908 First edition 2011-   Extent of                              06-11 Sharps injury             recognition.                              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 Edition  Withdrawn. See                              2009) Medical electrical        6-319.                              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 edition  Withdrawn. See                              2009) Medical electrical        6-320.                              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 edition  Withdrawn. See                              2009) Medical electrical        6-308.                              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                              Chloride Irrigation             replaced with                                                              newer version. 6-284          6-310         USP 36-NF31:2013 Sodium         Withdrawn and                              Chloride Injection              replaced with                                                              newer version. 6-285          6-311         USP 36-NF31:2013 Nonabsorbable  Withdrawn and                              Surgical Suture                 replaced with                                                              newer version. 6-286          3-312         USP 36-NF31:2013 <881> Tensile  Withdrawn and                              Strength                        replaced with                                                              newer version. 6-287          6-313         USP 36-NF31:2013 <861>          Withdrawn and                              Sutures--Diameter               replaced with                                                              newer version. 6-288          6-314         USP 36-NF 31:2013 <871>         Withdrawn and                              Sutures--Needle Attachment      replaced with                                                              newer version. 6-289          6-315         USP 36-NF31:2013 Sterile Water  Withdrawn and                              for Irrigation                  replaced with                                                              newer version. 6-290          6-316         USP 36-NF31:2013 Heparin Lock   Withdrawn and                              Flush Solution                  replaced with                                                              newer version. 6-291          6-317         USP 36-NF31:2013 Absorbable     Withdrawn and                              Surgical Suture                 replaced with                                                              newer version. 6-292                        ISO 7886-1:1993 TECHNICAL       Withdrawn. See                              CORRIGENDUM 1 Published 1995-   6-304.                              11-01 Sterile hypodermic                              syringes for single-use--Part                              1: Syringes for manual use 6-298          6-319         IEC 60601-2-19 Edition 2.0      Withdrawn and                              2009-02 Medical electrical      replaced with                              equipment--Part 2-19:           newer version                              Particular requirements for the including                              basic safety and essential      technical                              performance of infant           corrigendum.                              incubators [Including:                              CORRIGENDUM 1 (2012)] 6-299                        IEC 60601-2-20 Edition 2.0      Withdrawn. See                              2009-02 Medical electrical      6-320.                              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 Collection  Withdrawn and                              on Filter Paper for Newborn     replaced with                              Screening Programs; Approved    newer version.                              Standard--Sixth Edition 7-239                        CLSI EP32-R (Formerly X05-R)    Designation                              Metrological Traceability and   number.                              Its Implementation; A Report 7-226                        CLSI QMS01-A4 (Formerly GP26-   Designation                              A4) Quality Management System:  number.                              A Model for Laboratory                              Services; Approved Guideline--                              Fourth Edition 7-224                        CLSI EP28-A3c (Formerly C28-    Designation                              A3c) Defining, Establishing,    number.                              and Verifying Reference                              Intervals in the Clinical                              Laboratory; Approved                              Guideline--Third Edition 7-223                        CLSI QSM06-A3 (Formerly GP22-   Designation                              A3) Quality Management System:  number.                              Continual Improvement; Approved                              Guideline--Third Edition 7-92           7-245         CLSI EP09-A3 Measurement        Withdrawn and                              Procedure Comparison and Bias   replaced with                              Estimation Using Patient        newer version.                              Samples; Approved Guideline--                              Third Edition 7-210                        CLSI H26-A2 Validation,         Extent of                              Verification, and Quality       recognition.                              Assurance of Automated                              Hematology Analyzers; Approved                              Standard--Second Edition 7-152                        CLSI EP12-A2 User Protocol for  Extent of                              Evaluation of Qualitative Test  recognition.                              Performance; Approved                              Guideline--Second Edition 7-174                        CLSI EP21-A Estimation of Total Extent of                              Analytical Error for Clinical   recognition.                              Laboratory Methods; Approved                              Guideline 7-178                        CLSI M22-A3 Quality Control for Extent of                              Commercially Prepared           recognition.                              Microbiological Culture Media;                              Approved Standard--Third                              Edition 7-193                        CLSI EP06-A Evaluation of the   Extent of                              Linearity of Quantitative       recognition.                              Measurement Procedures: A                              Statistical Approach; Approved                              Guideline 7-220                        CLSI H59-A Quantitative D-dimer Extent of                              for the Exclusion of Venous     recognition.                              Thromboembolic Disease;                              Approved Guideline       H. Materials  8-67           8-344         ISO 7153-1 Second edition 1991- Withdrawn and                              04-01 Surgical instruments--    replaced with                              Metallic materials--Part 1:     newer version                              Stainless steel [Including:    including                              AMENDMENT 1(1999)]             amendment. 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                              Specification for Wrought       replaced with                              Nitrogen Strengthened 22        newer version.                              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                              Specification for Wrought       replaced with                              Titanium-12 Molybdenum-6        newer version.                              Zirconium-2 Iron Alloy for                              Surgical Implant (UNS R58120) 8-141          8-347         ASTM F2146-13 Standard          Withdrawn and                              Specification for Wrought       replaced with                              Titanium-3 Aluminum-2.5         newer version.                              Vanadium Alloy Seamless Tubing                              for Surgical Implant                              Applications (UNS R56320) 8-169          8-348         ASTM F138-13 Standard           Withdrawn and                              Specification for Wrought 18    replaced with                              Chromium-14 Nickel-2.5          newer version.                              Molybendum Stainless Steel Bar                              and Wire for Surgical Implants                              (UNS S31673) 8-176          8-349         ASTM F2503-13 Standard Practice Withdrawn and                              for Marking Medical Devices and replaced with                              Other Items for Safety in the   newer version.                              Magnetic Resonance Environment 8-149          8-350         ISO 5832-1 Fourth edition 2007- Withdrawn and                              06-15 Implants for surgery--    replaced with                              Metallic materials--Part 1:     newer version                              Wrought stainless steel         including                              [Including: TECHNICAL          technical                              CORRIGENDUM 1(2008)]           corrigendum. 8-196                        ISO 5832-1: 2007 Implants for   Withdrawn. See                              surgery--Metallic materials--   8-350.                              Part 1: Wrought stainless steel                              TECHNICAL CORRIGENDUM 1 8-151          8-351         ISO 5832-12 Second edition      Withdrawn and                              2007-05-01 Implants for         replaced with                              surgery--Metallic materials--   newer version                              Part 12: Wrought cobalt-        including                              chromium-molybdenum alloy       technical                              [Including: TECHNICAL          corrigendum.                              CORRIGENDUM 1 2008] 8-197                        ISO 5832-12:2007 TECHNICAL      Withdrawn. See                              CORRIGENDUM 1 2008-09-05,       8-351.                              Implants for surgery--Metallic                              materials--Part 12: Wrought                              cobalt-chromium-molybdenum                              alloy TECHNICAL CORRIGENDUM 1 8-211          8-352         ISO 5834-1 Third edition 2005-  Withdrawn and                              06-01 Implants for surgery--    replaced with                              Ultra-high-molecular-weight     newer version                              polyethylene--Part 1: Powder    including                              form [Including: TECHNICAL     technical                              CORRIGENDUM 1 2007]            corrigendum. 8-212                        ISO 5834-1:2005 Technical       Withdrawn. See                              Corrigendum 1 Published 2007-   8-352.                              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 Practice   Withdrawn and                              for Surface Preparation and     replaced with                              Marking of Metallic Surgical    newer version.                              Implants 8-175          8-354         ASTM F1377-13 Standard          Withdrawn and                              Specification for Cobalt-28     replaced with                              Chromium-6 Molybdenum Powder    newer version.                              for Coating of Orthopedic                              Implants (UNS R30075) 8-163          8-355         ASTM F1586/F 1586M-13&egr;1     Withdrawn and                              Standard Specification for      replaced with                              Wrought Nitrogen Strengthened   newer version.                              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                              Specification for Unalloyed     replaced with                              Titanium, for Surgical Implant  newer version.                              Applications (UNS R50250, UNS                              R50400, UNS R50550, UNS R50700) 8-208          8-357         ASTM F648-13 Standard           Withdrawn and                              Specification for Ultra-High-   replaced with                              Molecular-Weight Polyethylene   newer version.                              Powder and Fabricated Form for                              Surgical Implants 8-103                        ASTM F1801-97 (Reapproved 2009) Extent of                              &egr;1 Standard Practice for    recognition.                              Corrosion Fatigue Testing of                              Metallic Implant Materials 8-107                        ASTM F746-04 (Reapproved 2009)  Extent of                              &egr;1 Standard Test Method for recognition.                              Pitting or Crevice Corrosion of                              Metallic Surgical Implant                              Materials 8-111                        ASTM F1160-05 (Reapproved 2011) Extent of                              &egr;1 Standard Test Method for recognition.                              Shear and Bending Fatigue                              Testing of Calcium Phosphate                              and Metallic Medical and                              Composite Calcium                              Phosphate/Metallic Coatings 8-112                        ASTM F1044-05 (Reapproved 2011) Extent of                              &egr;1 Standard Test Method for recognition.                              Shear Testing of Calcium                              Phosphate Coatings and Metallic                              Coatings 8-113                        ASTM F1147-05 (Reapproved 2011) Extent of                              Standard Test Method for        recognition.                              Tension Testing of Calcium                              Phosphate and Metal Coatings 8-114                        ASTM F2255 (Reapproved 2010)    Extent of                              Standard Test Method for        recognition.                              Strength Properties of Tissue                              Adhesives in Lap Shear by                              Tension Loading 8-115                        ASTM F2256-05 (Reapproved 2010) Extent of                              Standard Test Method for        recognition.                              Strength Properties of Tissue                              Adhesives in T-Peel by Tension                              Loading 8-116                        ASTM F2258-05 (Reapproved 2010) Extent of                              Standard Test Method for        recognition.                              Strength Properties of Tissue                              Adhesives in Tension 8-121                        ASTM F2005-05 (Reapproved 2010) Extent of                              Standard Terminology for        recognition.                              Nickel-Titanium Shape Memory                              Alloys 8-123                        ISO 5832-5 Third edition 2005-  Extent of                              10-15 Implants for surgery--    recognition.                              Metallic materials--Part 5:                              Wrought cobalt-chromium-                              tungsten-nickel alloy 8-124                        ASTM F2052-06 &egr; Standard    Extent of                              Test Method for Measurement of  recognition.                              Magnetically Induced                              Displacement Force on Medical                              Devices in the Magnetic                              Resonance Environment 8-125                        ASTM F2004-05 (Reapproved 2010) Extent of                              Standard Test Method for        recognition.                              Transformation Temperature of                              Nickel-Titanium Alloys by                              Thermal Analysis 8-126          8-370         ASTM F561-13 Standard Practice  Withdrawn and                              for Retrieval and Analysis of   replaced with                              Medical Devices, and Associated newer version.                              Tissues and Fluids 8-128                        ASTM F2213-06 (Reapproved 2011) Extent of                              Standard Test Method for        recognition.                              Measurement of Magnetically                              Induced Torque on Medical                              Devices in the Magnetic                              Resonance Environment 8-132                        ASTM F1088-04a (Reapproved      Extent of                              2010) Standard Specification    recognition.                              for Beta-Tricalcium Phosphate                              for Surgical Implantation 8-134                        ASTM F2082-06 Standard Test     Extent of                              Method for Determination of     recognition.                              Transformation Temperature of                              Nickel-Titanium Shape Memory                              Alloys by Bend and Free                              Recovery 8-135                        ASTM F2392-04 (Reapproved 2010) Extent of                              Standard Test Method for Burst  recognition.                              Strength of Surgical Sealants 8-136                        ASTM F2458-05 (Reapproved 2010) Extent of                              Standard Test Method for Wound  recognition.                              Closure Strength of Tissue                              Adhesives and Sealants 8-150                        ISO 5832-9 Second edition 2007- Extent of                              06-15 Implants for surgery--    recognition.                              Metallic materials--Part 9:                              Wrought high nitrogen stainless                              steel 8-157                        ISO 9583 First edition 1993-10- Extent of                              15 Implants for surgery--Non-   recognition.                              destructive testing--Liquid                              penetrant inspection of                              metallic surgical implants 8-159                        ISO 9584 First edition 1993-10- Extent of                              15 Implants for surgery--Non-   recognition.                              destructive testing--                              Radiographic examination of                              cast metallic surgical implants 8-165                        ASTM F1058-08&egr;1 Standard    Extent of                              Specification for Wrought 40    recognition.                              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                              Specification for Wrought 18    recognition.                              Chromium-14 Nickel-2.5                              Molybdenum Stainless Steel                              Surgical Fixation Wire (UNS                              S31673) 8-168                        ASTM F1472-08&egr;1 Standard    Extent of                              Specification for Wrought       recognition.                              Titanium-6 Aluminum-4 Vanadium                              Alloy for Surgical Implant                              Applications (UNS R56400) 8-170                        ASTM F961-08 Standard           Extent of                              Specification for 35 Cobalt-35  recognition.                              Nickel-20 Chromium-10                              Molybdenum Alloy Forgings for                              Surgical Implants (UNS R30035) 8-171                        ASTM F1609-08 Standard          Extent of                              Specification for Calcium       recognition.                              Phosphate Coatings for                              Implantable Materials 8-173                        ASTM F601-03 (Reapproved 2008)  Extent of                              Standard Practice for           recognition.                              Fluorescent Penetrant                              Inspection of Metallic Surgical                              Implants 8-177                        ASTM F2129-08 Standard Test     Extent of                              Method for Conducting Cyclic    recognition.                              Potentiodynamic Polarization                              Measurements to Determine the                              Corrosion Susceptibility of                              Small Implant Devices 8-179                        ASTM F754-08 Standard           Extent of                              Specification for Implantable   recognition.                              Polytetrafluoroethylene (PTFE)                              Sheet, Tube, and Rod Shapes                              Fabricated from Granular                              Molding Powders 8-183                        ASTM F560-08 Standard           Extent of                              Specification for Unalloyed     recognition.                              Tantalum for Surgical Implant                              Applications (UNS R05200, UNS                              R05400) 8-184                        ASTM F2516-07&egr;2 Standard    Extent of                              Test Method for Tension Testing recognition.                              of Nickel-Titanium Superelastic                              Materials 8-185                        ASTM F451-08 Standard           Extent of                              Specification for Acrylic Bone  recognition.                              Cement 8-187                        ISO 13779-1 Second edition      Extent of                              2008-10-01 Implants for         recognition.                              surgery--Hydroxyapatite--Part                              1: Ceramic hydroxyapatite 8-188                        ISO 13779-2 Second edition      Extent of                              2008-10-01 Implants for         recognition.                              surgery--Hydroxyapatite--Part                              2: Coatings of hydroxyapatite 8-189                        ASTM F 1108-04 (Reapproved      Extent of                              2009) Standard Specification    recognition.                              for Titanium-6 Aluminum-4                              Vanadium Alloy Castings for                              Surgical Implants (UNS R56406) 8-190                        ASTM F 90-09 Standard           Extent of                              Specification for Wrought       recognition.                              Cobalt-20 Chromium-15 Tungsten-                              10 Nickel Alloy for Surgical                              Implant Applications (UNS                              R30605) 8-192                        ASTM F1854-09 Standard Test     Extent of                              Method for Stereological        recognition.                              Evaluation of Porous Coatings                              on Medical Implants 8-193                        ASTM F2754/F 2754M-09 Standard  Extent of                              Test Method for Measurement of  recognition.                              Camber, Cast, Helix and                              Direction of Helix of Coiled                              Wire 8-194                        ISO 6474-1 First edition 2010-  Extent of                              02-15 Implants for surgery--    recognition.                              Ceramic materials--Part 1:                              Ceramic materials based on high                              purity alumina 8-195                        ASTM F2024-10 Standard Practice Extent of                              for X-Ray Diffraction           recognition.                              Determination of Phase Content                              of Plasma-Sprayed                              Hydroxyapatite Coatings 8-199                        ASTM F2633-07 Standard          Extent of                              Specification for Wrought       recognition.                              Seamless Nickel-Titanium Shape                              Memory Alloy Tube for Medical                              Devices and Surgical Implants                              ASTM F2118-10 Standard Test     Extent of 8-204                        Method for Constant Amplitude   recognition.                              of Force Controlled Fatigue                              Testing of Acrylic Bone Cement                              Materials 8-205                        ASTM F1635-11 Standard Test     Extent of                              Method for In Vitro Degradation recognition.                              Testing of Hydrolytically                              Degradable Polymer Resins and                              Fabricated Forms for Surgical                              Implants 8-206                        ASTM F688-10 Standard           Extent of                              Specification for Wrought       recognition.                              Cobalt-35 Nickel-20 Chromium-10                              Molybdenum Alloy Plate, Sheet,                              and Foil for Surgical Implants                              (UNS R30035) 8-207                        ASTM F1926/F1926M-10 Standard   Extent of                              Test Method for Evaluation of   recognition.                              the Environmental Stability of                              Calcium Phosphate Granules,                              Fabricated Forms, and Coatings 8-213                        ISO 5834-3 First edition 2005-  Extent of                              07-15 Implants for surgery--    recognition.                              Ultra-high-molecular-weight                              polyethylene--Part 3:                              Accelerated ageing methods 8-214                        ISO 5834-4 First edition 2005-  Extent of                              05-01 Implants for surgery--    recognition.                              Ultra-high-molecular-weight                              polyethylene--Part 4: Oxidation                              index measurement method 8-215                        ISO 5834-5 First edition 2005-  Extent of                              06-01 Implants for surgery--    recognition.                              Ultra-high-molecular-weight                              polyethylene--Part 5:                              Morphology assessment method 8-216                        ASTM F1295-11 Standard          Extent of                              Specification for Wrought       recognition.                              Titanium-6 Aluminum-7 Niobium                              Alloy for Surgical Implant                              Applications (UNS R56700) 8-217                        ASTM F620-11 Standard           Extent of                              Specification for Alpha Plus    recognition.                              Beta Titanium Alloy Forgings                              for Surgical Implants 8-218                        ASTM F799-11 Standard           Extent of                              Specification for Cobalt-28     recognition.                              Chromium-6 Molybdenum Alloy                              Forgings for Surgical Implants                              (UNS R31537, R31538, R31539) 8-220                        ASTM F629-11 Standard Practice  Extent of                              for Radiography of Cast         recognition.                              Metallic Surgical Implants 8-221                        ASTM F2066-11 Standard          Extent of                              Specification for Wrought       recognition.                              Titanium-15 Molybdenum Alloy                              for Surgical Implant                              Applications (UNS R58150) 8-224                        ASTM F2102-06&egr;1 Standard    Extent of                              Guide for Evaluating the Extent recognition.                              of Oxidation in Ultra-High-                              Molecular-Weight Polyethylene                              Fabricated Forms Intended for                              Surgical Implants 8-225                        ASTM F2003-02 (Reapproved 2008) Extent of                              Standard Practice for           recognition.                              Accelerated Aging of Ultra-High                              Molecular Weight Polyethylene                              after Gamma Irradiation in Air 8-226                        ASTM F603-12 Standard           Extent of                              Specification for High-Purity   recognition.                              Dense Aluminum Oxide for                              Medical Application 8-229                        ASTM F75-12 Standard            Extent of                              Specification for Cobalt-28     recognition.                              Chromium-6 Molybdenum Alloy                              Castings and Casting Alloy for                              Surgical Implants (UNS R30075) 8-330                        ASTM F1978-12 Standard Test     Extent of                              Method for Measuring Abrasion   recognition.                              Resistance of Metallic Thermal                              Spray Coatings by Using the                              Taber Abraser 8-331                        ASTM F1580-12 Standard          Extent of                              Specification for Titanium and  recognition.                              Titanium-6 Aluminum-4 Vanadium                              Alloy Powders for Coatings of                              Surgical Implants 8-333                        ASTM F2393-12 Standard          Extent of                              Specification for High-Purity   recognition.                              Dense Magnesia Partially                              Stabilized Zirconia (Mg-PSZ)                              for Surgical Implant                              Applications 8-334                        ASTM F2459-12 Standard Test     Extent of                              Method for Extracting Residue   recognition.                              from Metallic Medical                              Components and Quantifying via                              Gravimetric Analysis       I.Nanotechnology  18-1                         ASTM E2490-09 Standard Guide    Extent of                              for Measurement of Particle     recognition.                              Size Distribution of                              Nanomaterials in Suspension by                              Photon Correlation Spectroscopy                              (PCS) 18-2                         ASTM E2535-07 (Reapproved 2013) Reaffirmation                              Standard Guide for Handling     and extent of                              Unbound Engineered Nanoscale    recognition.                              Particles in Occupational                              Settings       J. Neurology  17-3           17-12         ISO 7197 Third edition 2006-06- Withdrawn and                              01 Neurosurgical Implants--     replaced with                              Sterile, single-use             newer version                              hydrocephalus shunts and        including                              components [Including          technical                              TECHNICAL CORRIGENDUM 1         corrigendum.                              (2007)] 17-7                         ISO 7197: 2006 Neurosurgical    Withdrawn. See                              implants--Sterile, single-use   17-12.                              hydrocephalus shunts and                              components TECHNICAL                              CORRIGENDUM 1 17-1                         ANSI/AAMI NS28:1988/(R) 2010    Extent of                              Intracranial pressure           recognition.                              monitoring devices 17-4                         ASTM F647-94 (Reapproved 2006)  Extent of                              Standard Practice for           recognition.                              Evaluating and Specifying                              Implantable Shunt Assemblies                              for Neurosurgical Application 17-9                         ASTM F2129-08 Standard Test     Extent of                              Method for Conducting Cyclic    recognition.                              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 2002-02- Withdrawn and                              15 Corrected version 2002-12-01 replaced with                              Natural latex rubber condoms--  newer version                              Requirements and test methods   including                              [Including TECHNICAL           technical                              CORRIGENDUM 1 (2002), TECHNICAL corrigendum.                              CORRIGENDUM 2 (2002)] 9-57                         ISO 4074:2002 TECHNICAL         Withdrawn. See                              CORRIGENDUM 2, Natural latex    9-82.                              rubber condoms--Requirements                              and test methods TECHNICAL                              CORRIGENDUM 2 9-75           9-84          ISO 8600-3 First edition 1997-  Withdrawn and                              07-01 Optics and Optical        replaced with                              instruments--Medical endoscopes newer version                              and endoscopic accessories--    including                              Part 3: Determination of field  amendment.                              of view and direction of view                              of endoscopes with optics                              [Including AMENDMENT 1                              (2003)] 9-36           9-90          ISO 8009 First edition 2004-10- Withdrawn and                              01 Mechanical contraceptives--  replaced with                              Reusable natural and silicone   newer version                              rubber contraceptive            including                              diaphragms--Requirements and    amendment.                              tests [Including AMENDMENT                              1(2012)] 9-37           9-83          ISO 8600-1 Third edition 2013-  Withdrawn and                              03-01 Endoscopes--Medical       replaced with                              endoscopes and endotherapy      newer version.                              devices--Part 1: General                              requirements 9-38                         ISO 8600-3 First edition 1997-  Withdrawn. See                              07-01 AMENDMENT 1, Optics and   9-84.                              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 2006)  Extent of                              Standard Performance            recognition.                              Specification for Foley                              Catheter 9-54           9-85          ASTM D6976-13 Standard          Withdrawn and                              Specification for Rubber        replaced with a                              Contraceptives--Vaginal         newer version.                              Diaphragms 9-56                         ASTM D3492-08 Standard          Extent of                              Specification for Rubber        recognition.                              Contraceptives (Male Condoms) 9-65           9-91          ANSI/AAMI/ISO 8637:2010         Withdrawn and                              Cardiovascular implants and     replaced with                              extracorporeal systems--        newer version                              Hemodialyzers, hemodiafilters,  including                              hemofilters, and                amendment.                              hemoconcentrators [Including                              AMENDMENT 1 (2013)] 9-66                         ANSI/AAMI/ISO 8638:2010         Extent of                              Cardiovascular implants and     recognition.                              Extracorporeal blood circuit                              for hemodialyzers,                              hemodiafilters, and hemofilters 9-67                         ASTM D7661-10 Standard Test     Extent of                              Method for Determining          recognition.                              Compatibility of Personal                              Lubricants with Natural Rubber                              Latex Condoms 9-68                         ISO 23409 First edition 2011-   Extent of                              02-15 Male Condoms--            recognition.                              Requirements and test methods                              for condoms made from synthetic                              materials 9-73                         ANSI/AAMI/ISO 13958:2009        Extent of                              Concentrates for hemodialysis   recognition.                              and related therapies 9-74                         ISO 13958 Second edition 2009-  Extent of                              04-15 Concentrates for          recognition.                              haemodialysis and related                              therapies 9-79                         ISO 26722 First edition 2009-   Extent of                              04-15 Water treatment equipment recognition.                              for haemodialysis applications                              and related therapies       L. Ophthalmic  10-41          10-81         ISO 11979-7 Second edition      Withdrawn and                              2006-05-01 Ophthalmic           replaced with                              implants--Intraocular lenses--  newer version                              Part 7: Clinical investigations including                              [Including Amendment 1:2012]  amendment. 10-75                        ISO 11979-7/Amendment 1:2012    Withdrawn. See                              Ophthalmic implants--           10-81.                              Intraocular lenses--Part 7:                              Clinical investigations 10-42          10-82         ISO 11979-2 First edition 1999- Withdrawn and                              12-15 Ophthalmic implants--     replaced with                              Intraocular lenses--Part 2:     newer version                              Optical properties and test     including                              methods [Including TECHNICAL   technical                              CORRIGENDUM 1 (2003)]          corrigendum. 10-53          10-83         ISO 18369-1 First edition 2006- Withdrawn and                              08-15 Ophthalmic optics--       replaced with                              Contact lenses--Part 1:         newer version                              Vocabulary, classification      including                              system and recommendations for  amendment.                              labeling specifications                              [Including AMENDMENT 1 2009] 10-61                        ISO 18369-1:2006 Ophthalmic     Withdrawn. See                              optics--Contact lenses Part 1:  10-83.                              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                              National Standard for           replaced with                              Ophthalmics--Laser Systems for  newer version.                              Corneal Reshaping 10-59          10-85         ISO 11980 Third edition 2012-   Withdrawn and                              11-15 Corrected version 2013-   replaced with                              12-01 Ophthalmic optics--       newer version.                              Contact lenses and contact lens                              care products--Guidance for                              clinical investigations 10-71          10-86         ISO 14729 First edition 2001-   Withdrawn and                              04-15 Ophthalmic optics--       replaced with                              Contact lens care products--    newer version                              Microbiological requirements    including                              and test methods for products   amendment.                              and regimens for hygienic                              management of contact lenses                              [Including: AMENDMENT 1 2010] 10-43                        ISO 11979-8 Second edition      Extent of                              2006-07-01 Ophthalmic           recognition.                              implants--Intraocular lenses--                              Part 8: Fundamental                              requirements 10-54                        ISO 18369-4 First edition 2006- Extent of                              08-15 Ophthalmic optics--       recognition.                              contact lenses--Part 4:                              Physicochemical properties of                              contact lens materials 10-55                        ISO 11979-6 Second edition      Extent of                              2007-07-15 Ophthalmic           recognition.                              implants--Intraocular lenses--                              Part 6: Shelf-life and                              transport stability 10-56                        ANSI Z80.12-2007 (R2012)        Reaffirmation                              American National Standard for  and extent of                              Ophthalmics--Multifocal         recognition.                              Intraocular Lenses 10-57                        ANSI Z80.13-2007 (R2012)        Reaffirmation                              American National Standard for  and extent of                              Ophthalmics--Phakic Intraocular recognition.                              Lenses 10-60                        ISO 11981 Second edition 2009-  Extent of                              07-01 Ophthalmic optics--       recognition.                              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                              Instruments--Tonometers         recognition. 10-64          10-89         ANSI Z80.7-2013 Ophthalmics--   Withdrawn and                              Intraocular Lenses              replaced with                                                              newer version. 10-68                        ISO 13212 Second edition 2011-  Extent of                              05-15 Ophthalmic optics--       recognition.                              Contact lens care products--                              Guidelines for determination of                              shelf-life 10-69                        ANSI Z80.18-2010 American       Extent of                              National Standard for           recognition.                              Ophthalmics--Contact Lens Care                              Products--Vocabulary,                              Performance Specifications and                              Test Methodology 10-74                        ISO 10940 Second edition 2009-  Extent of                              08-01 Ophthalmic instruments--  recognition.                              Fundus Cameras       M. Orthopedic  11-190         11-256        ISO 14243-3 First edition 2004- Withdrawn and                              09-15 Implants for surgery--    replaced with                              Wear of total knee-joint        newer version                              prostheses--Part 3: Loading and including                              displacement parameters for     technical                              wear-testing machines with      corrigendum.                              displacement control and                              corresponding environmental                              conditions for test                              [Including: TECHNICAL                              CORRIGENDUM 1(2006)] 11-218                       ISO 14243-3:2004 TECHNICAL      Withdrawn. See                              CORRIGENDUM 1 Implants for      11-256.                              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                              Specification and Test Methods  replaced with a                              for Metallic Medical Bone       newer version.                              Screws 11-212                       ASTM F1440-92 (Reapproved 2008) Withdrawn.                              Standard Practice for Cyclic                              Fatigue Testing of Metallic                              Stemmed Hip Arthroplasty                              Femoral Components Without                              Torsion 11-241                       ASTM F543-07 Standard           Withdrawn                              Specification and Test Methods  duplicate.                              for Metallic Medical Bone       See 11-257.                              Screws 11-244         11-258        ASTM F2083-12 Standard          Withdrawn and                              Specification for Knee          replaced with a                              Replacement Prosthesis          newer version. 11-74                        ISO 5838-2 First edition 1991-  Extent of                              01-15 Implants for surgery--    recognition.                              Skeletal pins and wires--Part                              2: Steinmann skeletal pins--                              Dimensions 11-75                        ISO 5838-3 First edition 1993-  Extent of                              09-15 Implants for surgery--    recognition.                              Skeletal pins and wires--Part                              3: Kirschner skeletal wires 11-80                        ISO 8828 First edition 1988-10- Extent of                              15 Implants for surgery--       recognition.                              Guidance on care and handling                              of orthopaedic implants 11-83                        ISO 13402 First edition 1995-   Extent of                              08-01 Surgical and dental hand  recognition.                              instruments--Determination of                              resistance against autoclaving,                              corrosion and thermal exposure 11-168                       ASTM F1781-03 (Reapproved 2009) Extent of                              Standard Specification for      recognition.                              Elastomeric Flexible Hinge                              Finger Total Joint Implants 11-171                       ASTM F1814-97a (Reapproved      Extent of                              2009) Standard Guide for        recognition.                              Evaluating Modular Hip and Knee                              Joint Components 11-183                       ASTM F1875-98 (Reapproved 2009) Extent of                              Standard Practice for Fretting  recognition.                              Corrosion Testing of Modular                              Implant Interfaces: Hip Femoral                              Head-bore and Cone Taper                              Interface 11-184                       ISO 8827 First edition 1988-10- Extent of                              15 Implants for surgery--       recognition.                              Staples with parallel legs for                              orthopaedic use--General                              requirements 11-185                       ASTM F2267-04 (Reapproved 2011) Extent of                              Standard Test Method for        recognition.                              Measuring Load Induced                              Subsidence of Intervertebral                              Body Fusion Device Under Static                              Axial Compression 11-191                       ISO 14879-1 First edition 2000- Extent of                              06-01 Implants for surgery--    recognition.                              Total knee-joint prostheses--                              Part 1: Determination of                              endurance properties of knee                              tibial trays 11-196                       ASTM F1672-95 (Reapproved 2011) Extent of                              Standard Specification for      recognition.                              Resurfacing Patellar Prosthesis 11-197                       ASTM F983-86 (Reapproved 2013)  Reaffirmation                              Standard Practice for Permanent and extent of                              Marking of Orthopaedic Implant  recognition.                              Components 11-199                       ASTM F565-04 (Reapproved 2013)  Reaffirmation                              Standard Practice for Care and  and extent of                              Handling of Orthopedic Implants recognition.                              and Instruments 11-203                       ASTM F1541-02 (Reapproved 2011) Extent of                               *1 Standard Specification and  recognition.                              Test Methods for External                              Skeletal Fixation Devices 11-207                       ASTM F2193-02 (Reapproved 2007) Extent of                              Standard Specifications and     recognition.                              Test Methods for Components                              Used in the Surgical Fixation                              of the Spinal Skeletal System 11-211                       ASTM F1798-97 (Reapproved 2008) Extent of                              Standard Guide for Evaluating   recognition.                              the Static and Fatigue                              Properties of Interconnection                              Mechanisms and Subassemblies                              Used in Spinal Arthrodesis                              Implants 11-214                       ASTM F382-99 (Reapproved 2008)  Extent of                               *1 Standard Specification and  recognition.                              Test Method for Metallic Bone                              Plates 11-216                       ASTM F1264-03 (Reapproved 2012) Extent of                              Standard Specification and Test recognition.                              Methods for Intramedullary                              Fixation Devices 11-220                       ASTM F2068-09 Standard          Extent of                              Specification for Femoral       recognition.                              Prostheses--Metallic Implants 11-222                       ISO 14243-1 Second edition      Extent of                              2009-11-15 Implants for         recognition.                              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                              2009-11-15 Implants for         recognition.                              surgery--Wear of total knee-                              joint prostheses--Part 2:                              Methods of measurement 11-224                       ASTM F2706-08 Standard Test     Extent of                              Methods for Occipital-Cervical  recognition.                              and Occipital-Cervical-Thoracic                              Spinal Implant Constructs in a                              Vertebrectomy Model 11-225                       ISO 7206-4 Third edition 2010-  Extent of                              06-15 Implants for surgery--    recognition.                              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                              Method for Corrosion of         recognition.                              Surgical Instruments 11-227                       ASTM F366-10 Standard           Extent of                              Specification for Fixation Pins recognition.                              and Wires 11-228                       ASTM F564-10 Standard           Extent of                              Specification and Test Methods  recognition                              for Metallic Bone Staples 11-231                       ISO 7207-2 Second edition 2011- Extent of                              07-01 Implants for surgery--    recognition.                              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 2007-  Extent of                              02-01 Implants for surgery--    recognition.                              Components for partial and                              total knee joint prostheses--                              Part 1: Classification,                              definitions and designation of                              dimensions 11-234                       ASTM F732-00 (Reapproved 2011)  Extent of                              Standard Test Method for Wear   recognition.                              Testing of Polymeric Materials                              Used in Total Joint Prostheses 11-235                       ASTM F2077-11 Test Methods for  Extent of                              Intervertebral Body Fusion      recognition.                              Devices 11-237                       ISO 7206-6 First edition 1992-  Extent of                              03-15 Implants for surgery--    recognition.                              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                              Specification for Total Hip     recognition.                              Joint Prosthesis and Hip                              Endoprosthesis Bearing Surfaces                              Made of Metallic, Ceramic, and                              Polymeric Materials 11-239                       ASTM F 2345-03 (Reapproved      Extent of                              2013) Standard Test Methods for recognition.                              Determination of Static and     Reaffirmation.                              Cyclic Fatigue Strength of                              Ceramic Modular Femoral Heads 11-240                       ASTM F382-99 (Reapproved 2008)  Extent of                               *1 Standard Specification and  recognition.                              Test Method for Metallic Bone                              Plates                              ASTM F2346-05 (Reapproved 2011) Extent of 11-243                       Standard Test Methods for       recognition.                              Static and Dynamic                              Characterization of Spinal                              Artificial Discs 11-245                       ASTM F384-12 Standard           Extent of                              Specifications and Test Methods recognition.                              for Metallic Angled Orthopedic                              Fracture Fixation Devices 11-247                       ASTM F2789-10 Standard Guide    Extent of                              for Mechanical and Functional   recognition.                              Characterization of Nucleus                              Devices 11-248                       ISO 14242-1 Second edition      Extent of                              2012-01-15 Implants for         recognition.                              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 2000- Extent of                              09-15 Implants for surgery--    recognition.                              Wear of total hip-joint                              prostheses--Part 2: Methods of                              measurement 11-250                       ISO 14242-3 First edition 2009- Extent of                              03-15 Implants for surgery--    recognition.                              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 1989- Extent of                              08-01 Wheelchairs--Part 13:     recognition.                              Determination of coefficient of                              friction of test surfaces 16-27                        ISO 7176-15 First edition 1996- Extent of                              11-15 Wheelchairs--Part 15:     recognition.                              Requirements for information                              disclosure, documentation and                              labeling 16-29                        ISO 7176-6 Second edition 2001- Extent of                              10-01 Wheelchairs--Part 6:      recognition.                              Determination of maximum speed,                              acceleration and deceleration                              of electric wheelchairs 16-158                       ISO 7176-1 Second edition 1999- Extent of                              10-01 Wheelchairs--Part 1:      recognition.                              Determination of static                              stability 16-159                       ISO 7176-2 Second edition 2001- Extent of                              06-15 Wheelchairs--Part 2:      recognition.                              Determination of dynamic                              stability of electric                              wheelchairs 16-162                       ISO 7176-4 Third edition 2008-  Extent of                              10-01 Wheelchairs--Part 4:      recognition.                              Energy consumption of electric                              wheelchairs and scooters for                              determination of theoretical                              distance range 16-163                       ISO 7176-5 Second edition 2008- Extent of                              06-01 Wheelchairs--Part 5:      recognition.                              Determination of overall                              dimensions, mass and                              manoeuvring space 16-164                       ISO 7176-10 Second edition      Extent of                              2008-11-01 Wheelchairs--Part    recognition.                              10: Determination of obstacle-                              climbing ability of                              electrically powered                              wheelchairs 16-165                       ISO 7176-14 Second edition      Extent of                              2008-02-15 Wheelchairs--Part    recognition.                              14: Power and control systems                              for electrically powered                              wheelchairs and scooters--                              Requirements and test methods 16-166                       ISO 7176-21 Second edition      Extent of                              2009-04-01 Wheelchairs--Part    recognition.                              21: Requirements and test                              methods for electromagnetic                              compatibility of electrically                              powered wheelchairs and                              scooters, and battery chargers 16-167                       ISO 7176-9: Third edition 2009- Extent of                              11-15 Wheelchairs--Part 9:      recognition.                              Climatic tests for electric                              wheelchairs 16-168                       ANSI/RESNA WC-1:2009 American   Extent of                              National Standard for           recognition.                              Wheelchairs--Volume 1:                              Requirements and Test Methods                              for Wheelchairs (including                              Scooters) Section 1:                              Determination of static                              stability 16-169                       ANSI/RESNA WC-2:2009 American   Extent of                              National Standard for           recognition.                              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 American   Extent of                              National Standard for           recognition.                              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 4: Extent of                              Energy consumption of           recognition.                              electrically powered                              wheelchairs and scooters for                              determination of theoretical                              distance range 16-172                       ANSI/RESNA WC-1:2009 American   Extent of                              National Standard for           recognition.                              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 American   Extent of                              National Standard for           recognition.                              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 American   Extent of                              National Standard for           recognition.                              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 American   Extent of                              National Standard for           recognition.                              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 American   Extent of                              National Standard for           recognition.                              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 American   Extent of                              National Standard for           recognition.                              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 American   Extent of                              National Standard for           recognition.                              Wheelchairs--Volume 1:                              Requirements and Test Methods                              for Wheelchairs (including                              Scooters) Section 11: Test                              dummies 16-179                       ANSI/RESNA WC-1:2009 American   Extent of                              National Standard for           recognition.                              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 American   Extent of                              National Standard for           recognition.                              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 American   Extent of                              National Standard for           recognition.                              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 American   Extent of                              National Standard for           recognition.                              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 American   Extent of                              National Standard for           recognition                              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 American   Extent of                              National Standard for           recognition.                              Wheelchairs--Volume 1:                              Requirements and Test Methods                              for Wheelchairs (including                              Scooters) Section 22: Set-up                              procedures 16-185                       ANSI/RESNA WC-2:2009,American   Extent of                              National Standard for           recognition.                              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 American   Extent of                              National Standard for           recognition.                              Wheelchairs--Volume 1:                              Requirements and Test Methods                              for Wheelchairs (including                              Scooters) Section 26:                              Vocabulary       O. Radiology  12-53          12-257        ISO 2919 Third edition 2012-02- Withdrawn and                              15 Radiological protection--    replaced with                              Sealed radioactive sources--    newer version.                              General requirements and                              classification 12-59                        IEC 61168 First edition 1993-12 Extent of                              Radiotherapy simulators--       recognition.                              Functional performance                              characteristics 12-66                        AIUM MUS, Medical Ultrasound    Extent of                              Safety                          recognition. 12-139                       AIUM AOMS-2004, Acoustic Output Extent of                              Measurement Standard for        recognition.                              Diagnostic Ultrasound Equipment 12-140                       AIUM RTD2-2004 Standard for     Withdrawn. See                              Real-Time Display of Thermal    12-209 and 12-                              and Mechanical Acoustic Output  258.                              Indices on Diagnostic                              Ultrasound Equipment Revision 2 12-145         12-259        IEC 61674 Edition 2.0 2012-11   Withdrawn and                              Medical electrical equipment--  replaced with                              Dosimeters with ionization      newer version.                              chambers and/or semiconductor                              detectors as used in X-ray                              diagnostic imaging 12-149         12-260        IEC 60336 Fourth edition 2005-  Withdrawn and                              04 Medical electrical           replaced with                              equipment--X-ray tube           newer version                              assemblies for medical          including                              diagnosis--Characteristics of   technical                              focal spots [Including:        corrigendum.                              Technical Corrigendum 1                              (2006)] 12-150                       ISO/IEC 10918-1:1994 TECHNICAL  Withdrawn. See                              CORRIGENDUM 1:2005 Information  12-261.                              technology--Digital compression                              and coding of continuous-tone                              still image--Part 1:                              Requirements and guidelines 12-156                       ISO 11670:2003 TECHNICAL        Withdrawn. See                              CORRIGENDUM 1:2004 Lasers and   12-262.                              laser-related equipment--Test                              methods for laser beam                              parameters--Beam positional                              stability 12-157                       ISO 13694:2000 TECHNICAL        Withdrawn. See                              CORRIGENDUM 1:2005 Optics and   12-263.                              optical instruments--Lasers and                              laser-related equipment--Test                              methods for laser beam power                              (energy) density distribution 12-159         12-264        NEMA MS 11-2010 Determination   Withdrawn and                              of Gradient-Induced Electric    replaced with                              Fields In Diagnostic Magnetic   newer version.                              Resonance Imaging 12-167         12-265        NEMA NU 2-2012 Performance      Withdrawn and                              Measurements of Positron        replaced with                              Emission Tomographs (PETs)      newer version. 12-179                       ANSI/IESNA RP-27.3-2007,        Extent of                              Recommended Practice for        recognition.                              Photobiological Safety for                              Lamps--Risk Group                              Classification and Labeling 12-180         12-266        IEC 61689 Edition 3.0 2013-02   Withdrawn and                              Ultrasonic-Physiotherapy        replaced with                              systems--Field specifications   newer version.                              and methods of measurement in                              the frequency range 0. 5 MHz to                              5 MHz 12-190         12-267        IEC 61217 Edition 2.0 2011-12   Withdrawn and                              Radiotherapy equipment--        replaced with                              Coordinates, movements and      newer version.                              scales 12-194                       ANSI/HPS N43.6-2007, Sealed     Extent of                              Radioactive Sources--           recognition.                              Classification 12-207         12-271        IEC 60601-2-33 Edition 3.1      Withdrawn and                              2013-04 Medical electrical      replaced with                              equipment--Part 2-33:           newer version.                              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                              2012-10 Medical electrical      replaced with                              equipment--Part 2-22:           newer version.                              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 2013- Withdrawn and                              04 Medical electrical           replaced with                              equipment--Part 1-3: General    newer version.                              requirements for basic safety                              and essential performance--                              Collateral Standard: Radiation                              protection in diagnostic X-ray                              equipment 12-219                       IEC 60336 (2005) Medical        Withdrawn. See                              electrical equipment--X-ray     12-260.                              tube assemblies for medical                              diagnosis--Characteristics of                              focal spots 12-222         12-270        IEC 61223-3-5 First edition     Withdrawn and                              2004-08 Evaluation and routine  replaced with                              testing in medical imaging      newer version                              departments--Part 3-5:          including                              Acceptance tests--Imaging       technical                              performance of computed         corrigendum.                              tomography X-ray equipment                              [Including: TECHNICAL                              CORRIGENDUM 1 (2006)] 12-223                       IEC 61223-3-5 (First edition    Withdrawn. See                              2004) Evaluation and routine    12-270.                              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 2006- Extent of                              07 Ultrasonics--Pulse-echo      recognition.                              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 2010-01 Extent of                              Ultrasonics--Pulse-echo         recognition.                              scanners--Part 2: Measurement                              of maximum depth of penetration                              and local dynamic range 12-233         12-262        ISO 11670 Second edition 2003-  Withdrawn and                              04-01 Lasers and laser-related  replaced with                              equipment--Test methods for     newer version                              laser beam parameters--Beam     including                              positional stability            technical                              [Including: TECHNICAL          corrigendum.                              CORRIGENDUM 1 (2004)] 12-237         12-258        IEC 62359 Edition 2.0 2010-10   Withdrawn and                              Ultrasonics--Field              replaced with                              characterization--Test methods  newer version                              for the determination of        including                              thermal and mechanical indices  technical                              related to medical diagnostic   corrigendum.                              ultrasonic fields [Including                              TECHNICAL CORRIGENDUM 1                              (2011)] 12-243         12-263        ISO 13694 First edition 2000-   Withdrawn and                              04-01 Optics and optical        replaced with                              instruments--Lasers and laser-  newer version                              related equipment--Test methods including                              for laser beam power [energy] technical                              density distribution            corrigendum.                              [Including: TECHNICAL                              CORRIGENDUM 1 (2005)] 12-244                       IEC 62359 (Second edition 2010) Withdrawn. See                              March 2011 Ultrasonics--Field   12-258.                              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 2011- Extent of                              08-01, Lasers and laser-related recognition.                              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                              Safety Software in Programmable recognition.                              Components, Second Edition.                              [This Standard contains                              revisions through and including                              October 28, 2008.]       Q. Sterility  14-143         14-395        ISO 14698-2 First edition 2003- Withdrawn and                              09-15 Cleanrooms and associated replaced with                              controlled environments--       newer version                              Biocontamination control--Part  including                              2: Evaluation and               technical                              interpretation of               corrigendum.                              biocontamination data.                              [Including: TECHNICAL                              CORRIGENDUM 1 Published 2004-                              11-01] 14-193                       ANSI/AAMI/ISO 11607-            Extent of                              1:2006/(R)2010 Packaging for    recognition and                              terminally sterilized medical   relevant                              devices--Part 1: Requirements   guidance.                              for materials, sterile barrier                              systems and packaging systems 14-194                       ANSI/AAMI/ISO 11607-            Extent of                              2:2006/(R)2010 Packaging for    recognition and                              terminally sterilized medical   relevant                              devices--Part 2: Validation     guidance.                              requirements for forming,                              sealing and assembly processes 14-195                       ANSI/AAMI/ISO 11140-            Extent of                              1:2005(R)2010 Sterilization of  recognition.                              health care products--Chemical                              indicators--Part 1: General                              requirements 14-201         14-396        ANSI/AAMI ST77:2013 Containment Withdrawn and                              devices for reusable medical    replaced with                              device sterilization            newer version. 14-214         14-397        AOAC 6.2.04:2013 Official       Withdrawn and                              Method 955.15 Testing           replaced with                              Disinfectants Against           newer version.                              Staphylococcus aureus, Use-                              Dilution Method 14-218         14-398        AOAC 6.3.05:2013 Official       Withdrawn and                              Method 966.04 Sporicidal        replaced with                              Activity of Disinfectants       newer version.                              Method I 14-219         14-399        AOAC 6.3.06:2012 Official       Withdrawn and                              Method 965.12 Tuberculocidal    replaced with                              Activity of Disinfectants       newer version. 14-230         14-400        ASTM F2203-13 Standard Test     Withdrawn and                              Method for Linear Measurement   replaced with                              Using Precision Steel Rule      newer version. 14-231         14-401        ASTM F2217/F2217M-13 Standard   Withdrawn and                              Practice for Coating/Adhesive   replaced with                              Weight Determination            newer version. 14-235         14-402        ASTM F1140/F1140M-13 Standard   Withdrawn and                              Test Methods for Internal       replaced with                              Pressurization Failure          newer version.                              Resistance of Unrestrained                              Packages 14-236         14-403        ASTM F2054/F2054M-13 Standard   Withdrawn and                              Test Method for Burst Testing   replaced with                              of Flexible Package Seals Using newer version.                              Internal Air Pressurization                              Within Restraining Plates 14-241         14-424        ISO 13408-6 First edition 2005- Withdrawn and                              06-15 Aseptic processing of     replaced with                              health care products--Part 6:   newer version                              Isolator systems [Including    including                              AMENDMENT 1 (2013)]            amendment. 14-258         14-404        ASTM F2250-13 Standard Practice Withdrawn and                              for Evaluation of Chemical      replaced with                              Resistance of Printed Inks and  newer version.                              Coatings on Flexible Packaging                              Materials 14-260         14-405        ASTM F2252/F2252M-13&egr;1      Withdrawn and                              Standard Practice for           replaced with                              Evaluating Ink or Coating       newer version.                              Adhesion to Flexible Packaging                              Materials Using Tape 14-264         14-406        ANSI/AAMI ST8:2013 Hospital     Withdrawn and                              steam sterilizers               replaced with                                                              newer version. 14-274                       ANSI/AAMI/ISO 15882:2008        Extent of                              Sterilization of health care    recognition and                              products--Chemical indicators-- relevant                              Guidance for selection, use,    guidance.                              and interpretation of results 14-285                       ANSI/AAMI/ISO 14161:2009        Extent of                              Sterilization of health care    recognition.                              products--Biological                              indicators--Guidance for the                              selection, use and                              interpretation of results 14-289                       ISO 14698-2:2003 TECHNICAL      Withdrawn. See                              CORRIGENDUM Cleanrooms and      14-395.                              associated controlled                              environments--Biocontamination                              control--Part 2: Evaluation and                              interpretation of                              biocontamination data 14-296                       ANSI/AAMI/ISO 11138-            Relevant                              1:2006/(R)2010, Sterilization   guidance.                              of health care products--                              Biological indicators--Part 1:                              General requirements 14-300                       ASTM D4169-09 Standard Practice Extent of                              for Performance Testing of      recognition.                              Shipping Containers and Systems 14-326         14-407        ISO 11737-1 Second edition      Withdrawn and                              2006-04-01, Sterilization of    replaced with                              medical devices--               newer version                              Microbiological methods--Part   including                              1: Determination of a           technical                              population of microorganisms on corrigendum.                              products [Including: TECHNICAL                              CORRIGENDUM 1 Published 2007-                              05-15] 14-328         14-428        ISO 11137-1 First edition 2006- Withdrawn and                              04-15 Sterilization of health   replaced with                              care products--Radiation--Part  newer version                              1: Requirements for             including                              development, validation and     amendment.                              routine control of a                              sterilization process for                              medical devices [Including                              AMENDMENT 1 (2013)] 14-334                       ISO 15882 Second edition 2008-  Extent of                              09-01 Sterilization of health   recognition,                              care products--Chemical         title.                              indicators--Guidance for                              selection, use and                              interpretation of results 14-335         14-408        ISO 10993-7 Second edition      Withdrawn and                              2008-10-15 Biological           replaced with                              evaluation of medical devices-- newer version                              Part 7: Ethylene oxide          including                              sterilization residuals         technical                              [Including: TECHNICAL          corrigendum.                              CORRIGENDUM 1 Published 2009-                              11-15] 14-336                       ISO 14161 Second edition 2009-  Extent of                              09-15 Sterilization of health   recognition.                              care products--Biological                              indicators--Guidance for the                              selection, use and                              interpretation of results 14-338                       ISO 11138-1 Second edition      Relevant                              2006-07-01, Sterilization of    guidance.                              health care products--                              Biological indicators--Part 1:                              General requirements 14-352         14-425        ANSI/AAMI/ISO 13408-6:2005      Withdrawn and                              Aseptic processing of health    replaced with                              care products--Part 6: Isolator newer version                              systems [Including AMENDMENT 1 including                              (2013)]                        amendment. 14-353                       ISO 11140-1 Second edition      Extent of                              2005-07-15 Sterilization of     recognition.                              health care products--Chemical                              indicators--Part 1: General                              requirements 14-355                       ISO 11607-1 First edition 2006- Extent of                              04-15 Packaging for terminally  recognition and                              sterilized medical devices--    relevant                              Part 1: Requirements for        guidance.                              materials, sterile barrier                              systems and packaging systems 14-356                       ISO 11607-2 First edition 2006- Extent of                              04-15 Packaging for terminally  recognition.                              sterilized medical devices--                              Part 2: Validation requirements                              for forming, sealing and                              assembly processes 14-357                       ISO 11737-1:2006 TECHNICAL      Withdrawn. See                              CORRIGENDUM 1 Published 2007-   14-407.                              05-15 Sterilization of medical                              devices--Microbiological                              methods--Part 1: Determination                              of a population of                              microorganisms on products 14-360                       ANSI/AAMI ST72:2011, Bacterial  Relevant                              endotoxins--Test methods,       guidance.                              routine monitoring, and                              alternatives to batch testing 14-362         14-412        AOAC 6.2.01:2013 Official       Withdrawn and                              Method 955.14, Testing          replaced with                              Disinfectants Against           newer version.                              Salmonella choleraesuis, Use-                              Dilution Method 14-363         14-413        AOAC 6.2.06:2013 Official       Withdrawn and                              Method 964.02, Testing          replaced with                              Disinfectants Against           newer version.                              Pseudomonas aeruginosa, Use-                              Dilution Method 14-365         14-409        ISO 11137-2 Third edition 2013- Withdrawn and                              06-01 Sterilization of health   replaced with                              care products--Radiation--Part  newer version.                              2: Establishing the                              sterilization dose 14-366         14-414        USP 36-NF31:2013 <61>           Withdrawn and                              Microbiological Examination of  replaced with                              Nonsterile Products: Microbial  newer version.                              Enumeration Tests 14-367         14-415        USP 36-NF31:2013 <71> Sterility Withdrawn and                              Tests                           replaced with                                                              newer version. 14-368         14-416        USP 36-NF31:2013 <85> Bacterial Withdrawn and                              Endotoxins Test                 replaced with                                                              newer version. 14-369         14-417        USP 36-NF31:2013 <151> Pyrogen  Withdrawn and                              Test (USP Rabbit Test)          replaced with                                                              newer version. 14-370         14-418        USP 36-NF31:2013 <161>          Withdrawn and                              Transfusion and Infusion        replaced with                              Assemblies and Similar Medical  newer version.                              Devices 14-371         14-419        USP 36-NF31:2013 Biological     Withdrawn and                              Indicator for Steam             replaced with                              Sterilization, Self-Contained   newer version. 14-372         14-420        USP 36-NF31:2013 Biological     Withdrawn and                              Indicator for Dry-Heat          replaced with                              Sterilization, Paper Carrier    newer version. 14-373         14-421        USP 36-NF31:2013 Biological     Withdrawn and                              Indicator for Ethylene Oxide    replaced with                              Sterilization, Paper Carrier    newer version. 14-374         14-422        USP 36-NF31:2013 Biological     Withdrawn and                              Indicator for Steam             replaced with                              Sterilization, Paper Carrier    newer version. 14-375         14-423        USP 36-NF31:2013 <62>           Withdrawn and                              Microbiological Examination of  replaced with                              Nonsterile Products: Tests for  newer version.                              Specified Microorganisms 14-380         14-410        ASTM F17-13 Standard            Withdrawn and                              Terminology Relating to         replaced with                              Flexible Barrier Packaging      newer version. 14-384                       ISO 10993-7:2008 TECHNICAL      Withdrawn. See                              CORRIGENDUM 1, Published 2009-  14-408.                              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                              (R2011) Aseptic processing of   replaced with                              health care products--Part 1:   newer version                              General requirements            including                              [Including AMENDMENT 1         amendment.                              (2013)] 14-386         14-427        ISO 13408-1 Second edition      Withdrawn and                              2008-06-15 Aseptic processing   replaced with                              of health care products--Part   newer version                              1: General requirements         including                              [Including AMENDMENT 1         amendment.                              (2013)] 14-393         14-411        ISO/ASTM 51818 Third edition    Withdrawn and                              2013-06-01 Practice for         replaced with                              dosimetry in an electron beam   newer version.                              facility for radiation                              processing at energies between                              80 and 300 keV  

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  Recognition No.       Title of standard  *1             Reference No. and                                                         date       A. Anesthesia  1-96                  Medical electrical equipment--    ISO 80601-2-55 First                       Part 2-55: Particular             edition 2011-12-15.                       requirements for the basic safety                       and essential performance of                       respiratory gas monitors       B. Cardiovascular  3-121                 Cardiovascular implants--         ISO 25539-1 First                       Endovascular devices--Part 1:     edition 2003-03-01.                       Endovascular prostheses                       [Including: Amendment 1 (2005)] 5-83                  MEDICAL ELECTRICAL EQUIPMENT--    ANSI/AAMI HA60601-1-                       Part 1-11: General requirements   1:2011.                       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 equipment--    IEC 60601-1-6 Edition                       Part 1-6: General requirements    3.0 2010-01.                       for basic safety and essential                       performance--Collateral standard:                       Usability 5-86                  Medical electrical equipment--    IEC 60601-1-8 Edition                       Part 1-8: General requirements    2.0 2006-10.                       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 tubing for ISO 9626 First                       the manufacture of medical        edition 1991-09-01.                       devices [Including: AMENDMENT 1                       2001-06-01] 6-318                 Infusion equipment for medical    ISO 8536-4 Fifth                       use--Part 4: Infusion sets for    edition 2010-10-01.                       single use, gravity feed                       [Including: AMENDMENT 1 2013-03-                       01] 6-320                 Medical electrical equipment--    IEC 60601-2-20                       Part 2-20: Particular             Edition 2.0 2009-02.                       requirements 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 equipment--    IEC 60601-2-52                       Part 2-52: Particular             Edition 1.0 2009-12.                       requirements for basic safety and                       essential performance of medical                       beds [Including: CORRIGENDUM 1                       (September 2010)] 6-322                 Intravascular catheters--Sterile  ISO 10555-4 Second                       and single-use catheters--Part 4: edition 2013-06-15.                       Balloon dilatation catheters 8-358                 Standard Specification for        ASTM F1855-00                       Polyoxymethylene (Acetal) for     (Reapproved 2011).                       Medical Applications 8-359                 Standard Guide for Silicone       ASTM F2038-00                       Elastomers, Gels, and Foams Used  (Reapproved 2011).                       in Medical Applications Part I--                       Formulations and Uncured                       Materials 8-360                 Standard Guide for Silicone       ASTM F2042-00                       Elastomers, Gels, and Foams Used  (Reapproved 2011).                       in Medical Applications Part II--                       Cross-Linking and Fabrication 8-361                 Standard Specification for        ASTM F755-99                       Selection of Porous Polyethylene  (Reapproved 2011).                       for Use in Surgical Implants 8-362                 Standard Specification for Metal  ASTM F2989-13.                       Injection Molded Unalloyed                       Titanium Components for Surgical                       Implant Applications 8-363                 Standard Test Method for Tensile  ASTM D638-10.                       Properties of Plastics 8-364                 Standard Test Methods for Density ASTM D792-08.                       and Specific Gravity (Relative                       Density) of Plastics by                       Displacement 8-365                 Standard Test Method for Density  ASTM D1505-10.                       of Plastics by the Density-                       Gradient Technique 8-366                 Ultra-high-molecular-weight       ISO 11542-2 First                       polyethylene (PE-UHMW) moulding   edition 1998-11-15.                       and 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 Accelerated ASTM F2003-02                       Aging of Ultra-High Molecular     (Reapproved 2008).                       Weight Polyethylene after Gamma                       Irradiation in Air       F. OB-GYN/Gastroenterology/Urology  9-86                  Rubber condoms for clinical       ISO 16037 First                       trials--Measurement of physical   Edition 2002-05-15.                       properties Including [AMENDMENT                       1 2011-02-15)] 9-87                  Female condoms--Requirements and  ISO 25841 First                       test methods                      Edition 2011-07-15. 9-88                  Prophylactic dams--Requirements   ISO 29942 First                       and test methods                  Edition 2011-07-01. 9-89                  Cardiovascular implants and       ISO 8638 Third                       extracorporeal blood circuit for  edition 2010-07-01.                       haemodialysers, haemodiafilters,                       and haemofilters 9-92                  Cardiovascular implants and       ISO 8637 Third                       extracorporeal systems--          edition 2010-07-01.                       Haemodialysers, haemodiafilters,                       haemofilters and                       haemoconcentrators Including                       [AMENDMENT 1 2013-04-01)] 10-87                 Standard Test Method for Tensile  ASTM D882-12.                       Properties of Thin Plastic                       Sheeting 10-88                 Standard Test Methods for         ASTM D790-10.                       Flexural Properties of                       Unreinforced and Reinforced                       Plastics and Electrical                       Insulating Materials 11-259                Standard Specification For Total  ASTM F2887-12.                       Elbow Prostheses 11-260                Standard Guide for Presentation   ASTM F2943-13.                       of End User Labeling Information                       for Orthopedic Implants Used in                       Joint Arthroplasty 11-261                Standard Specification for        ASTM F1378-12                       Shoulder Prostheses 11-262                Standard Specification for        ASTM F2091-01                       Acetabular Prostheses             (Reapproved 2012). 11-263                Standard Test Methods for Dynamic ASTM F2028-08                       Evaluation of Glenoid Loosening   (Reapproved 2012)  *1                       or Disassociation                 . 11-264                Standard Test Method for          ASTM F1820-13.                       Determining the Forces for                       Disassembly of Modular Acetabular                       Devices 11-265                Standard Practice for Evaluation  ASTM F2580-13.                       of Modular Connection of                       Proximally Fixed Femoral Hip                       Prosthesis 11-266                Standard Specification for Total  ASTM F2665-09.                       Ankle Replacement Prosthesis 11-267                Standard Test Method for          ASTM F2009-00                       Determining the Axial Disassembly (Reapproved 2011).                       Force of Taper Connections of                       Modular Prostheses 11-268                Standard Test Method for Static   ASTM F1829-98                       Evaluation of Glenoid Locking     (Reapproved 2009).                       Mechanism in Shear 11-269                Standard Guide for Functional,    ASTM F2423-11.                       Kinematic, and Wear Assessment of                       Total Disc Prostheses 11-270                Standard Specification and Test   ASTM F2502-11.                       Methods for Absorbable Plates and                       Screws for Internal Fixation                       Implants 11-271                Standard Specification for        ASTM F2180-02                       Metallic Implantable Strands and  (Reapproved 2011).                       Cables 11-272                Standard Guide for Gravimetric    ASTM F1714-96                       Wear Assessment of Prosthetic Hip (Reapproved 2013).                       Designs in Simulator Devices 11-273                Implants for surgery--Wear of     ISO 18192-1 Second                       total intervertebral spinal disc  edition 2011-03-01.                       prostheses--Part 1 Loading and                       displacement parameters for wear                       testing and corresponding                       environmental conditions for test 11-274                Implants for surgery--Wear of     ISO 18192-2 First                       total intervertebral spinal disc  edition 2010-06-15.                       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       I. Radiology  12-261                Information technology--Digital   ISO/IEC 10918-1 First                       compression and coding of         edition 1994-02-15.                       continuous-tone still images:                       Requirements and guidelines                       [Including: TECHNICAL                       CORRIGENDUM 1 (2005)]       J. Software/Informatics  13-63                 Application of risk management    IEC/TR 80001-2-4                       for IT-networks incorporating     Edition 1.0 2012-11.                       medical devices--Part 2-4:                       Application guidance--General                       implementation guidance for                       healthcare delivery organizations 13-64                 Application of risk management    ANSI/AAMI/IEC                       for IT-networks incorporating     TIR80001-2-4:2012.                       medical devices--Part 2-4:                       General implementation guidance                       for healthcare delivery                       organizations 14-429                Practice for use of a             ISO/ASTM 51275 Third                       radiochromic film dosimetry       edition 2013-06-01.                       system 14-430                Practice for use of an alanine-   ISO/ASTM 51607 Third                       EPR dosimetry system              edition 2013-06-01. 14-431                Guide for estimating              ISO/ASTM 51707 Second                       uncertainties in dosimetry for    edition 2005-05-15.                       radiation 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 http://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 http://www.fda.gov/MedicalDevices.

   You may access "Guidance on the Recognition and Use of Consensus Standards," and the searchable database for "FDA Recognized Consensus Standards" at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards.

   This Federal Register document on modifications in FDA's recognition of consensus standards is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.

VII. Submission of Comments and Effective Date

   Interested persons may submit to the contact person (see FOR FURTHER INFORMATION CONTACT) either electronic or written comments regarding this document. It is only necessary to send one set of comments. 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]

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