[Federal Register Volume 79, Number 20 (Thursday, January 30, 2014)]
[Notices]
[Pages 4913-4935]
[FR Doc No: 2014-01847]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0451]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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<PHONE_NUMBER>. 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_ADDRESS>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 recognition  No.      Replacement recognition  No.      Title of standard \1\             Change
----------------------------------------------------------------------------------------------------------------
                                                  A. Anesthesia
----------------------------------------------------------------------------------------------------------------
1-15........................  ............................  ISO 5361-4:1987, Tracheal     Withdrawn. See 1-93.
                                                             tubes--Part 4: Cole type.
1-18........................  1-94........................  ISO 8359 Second edition 1996- Withdrawn and replaced
                                                             12-15, Oxygen concentrators   with newer version
                                                             for medical use--Safety       including amendment.
                                                             requirements [Including:
                                                             AMENDMENT 1 2012-07-01].
1-36........................  1-95........................  ISO 5366-3 Second edition     Withdrawn and replaced
                                                             2001-08-15, Anaesthetic and   with newer version
                                                             respiratory equipment--       including technical
                                                             Tracheostomy tubes--Part 3:   corrigendum.
                                                             Pediatric tracheostomy
                                                             tubes [Including: TECHNICAL
                                                             CORRIGENDUM 1 Published
                                                             2003-01-15].
1-44........................  ............................  ISO 5366-1 Fourth edition     Extent of recognition.
                                                             2000-12-15, Anaesthetic and
                                                             respiratory equipment--
                                                             Tracheostomy tubes--Part 1:
                                                             Tubes and connectors for
                                                             use in adults.

1-46........................  ............................  ISO 5367 Fourth edition 2000- Extent of recognition.
                                                             06-01 Breathing tubes
                                                             intended for use with
                                                             anaesthetic apparatus and
                                                             ventilators.
1-47........................  ............................  AS 4259-1995 Ancillary        Extent of recognition.
                                                             devices for expired air
                                                             resuscitation.
1-56........................  1-97........................  CGA V-7.1:2011 Standard       Withdrawn and replaced
                                                             Method of Determining         with newer version.
                                                             Cylinder Valve Outlet
                                                             Connections for Medical
                                                             Gases.
1-57........................  ............................  ASTM F1101-90 (Reapproved     Extent of recognition.
                                                             2003) [egr]1, Standard
                                                             Specification for
                                                             Ventilators Intended for
                                                             Use During Anesthesia.
1-58........................  ............................  ASTM G175-03 (Reapproved      Extent of recognition.
                                                             2011), Standard Test Method
                                                             for Evaluating the Ignition
                                                             Sensitivity and Fault
                                                             Tolerance of Oxygen
                                                             Regulators Used for Medical
                                                             and Emergency Applications.
1-65........................  ............................  ISO 21647:2004 Medical        Withdrawn. See 1-96.
                                                             electrical equipment--
                                                             Particular requirements for
                                                             the basic safety and
                                                             essential performance of
                                                             respiratory gas monitors.
1-69........................  ............................  ASTM F1464-93 (Reapproved     Extent of recognition.
                                                             2005) Standard
                                                             Specification for Oxygen
                                                             Concentrators for
                                                             Domiciliary Use.
1-70........................  ............................  ASTM F1246-91 (Reapproved     Extent of recognition.
                                                             2005) Standard
                                                             Specification for
                                                             Electrically Powered Home
                                                             Care Ventilators, Part 1--
                                                             Positive-Pressure
                                                             Ventilators and Ventilator
                                                             Circuits.
1-78........................  ............................  ASME PVHO-1-2007 Safety       Extent of recognition.
                                                             Standard for Pressure
                                                             Vessels for Human Occupancy.
1-81........................  ............................  CGA V-5:2008 (Reaffirmed      Reaffirmation.
                                                             2013), Diameter-Index
                                                             Safety System
                                                             (Noninterchangeable Low
                                                             Pressure Connections for
                                                             Medical Gas Applications).
1-83........................  ............................  ISO 21647:2004 TECHNICAL      Withdrawn. See 1-96.
                                                             CORRIGENDUM 1, Medical
                                                             electrical equipment--
                                                             Particular requirements for
                                                             the basic safety and
                                                             essential performance of
                                                             respiratory gas monitors.
1-84........................  ............................  ISO 5366-3:2001 Anaesthetic   Withdrawn. See 1-95.
                                                             and Respiratory Equipment--
                                                             Tracheostomy Tubes--Part 3:
                                                             Pediatric Tracheostomy
                                                             Tubes TECHNICAL CORRIGENDUM
                                                             1.
1-86........................  ............................  ISO 8185 Third edition 2007-  Extent of recognition.
                                                             07-01 Corrected versions
                                                             2008-06-15 Respiratory
                                                             tract humidifiers for
                                                             medical use--Particular
                                                             requirements for
                                                             respiratory humidification
                                                             systems.
1-88........................  1-98........................  ISO 80601-2-12 First edition  Withdrawn and replaced
                                                             2011-04-15 Medical            with newer version
                                                             electrical equipment--Part    including technical
                                                             2-12: Particular              corrigendum.
                                                             requirements for the safety
                                                             of lung ventilators--
                                                             Critical care ventilators
                                                             [Including: TECHNICAL
                                                             CORRIGENDUM 1 Published
                                                             2011-10-15].
1-89........................  ............................  ISO 80601-2-12 TECHNICAL      Withdrawn. See 1-98.
                                                             CORRIGENDUM 1 Medical
                                                             electrical equipment Part 2-
                                                             12: Particular requirements
                                                             for basic safety and
                                                             essential performance of
                                                             critical care ventilators.
1-90........................  ............................  ISO 8359 Second edition 1996- Withdrawn. See 1-94.
                                                             12-15 AMENDMENT 1 2012-07-
                                                             01 Oxygen concentrators for
                                                             medical use--Safety
                                                             requirements.
1-92........................  ............................  ISO 17510-2 Second Edition    Extent of recognition.
                                                             2007-10-01, Sleep apnoea
                                                             breathing therapy--Part 2:
                                                             Masks and application
                                                             accessories.
1-93........................   ISO 5361...................  Second edition 2012-10-01     Extent of recognition.
                                                             Anaesthetic and respiratory
                                                             equipment--Tracheal tubes
                                                             and connectors.
----------------------------------------------------------------------------------------------------------------
                                               B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-123.......................  2-204.......................  ASTM F720-13 Standard         Withdrawn and replaced
                                                             Practice for Testing Guinea   with newer version.
                                                             Pigs for Contact Allergens:
                                                             Guinea Pig Maximization
                                                             Test.
2-182.......................  2-205.......................  ISO 14155 Second edition      Withdrawn and replaced
                                                             2011-02-01 Clinical           with newer version
                                                             investigations of medical     including technical
                                                             devices for human subjects--  corrigendum.
                                                             Good clinical practices
                                                             [Including TECHNICAL
                                                             CORRIGENDUM 1:2011].
2-183.......................  ............................  ISO 14155:2011 and TECHNICAL  Withdrawn. See 2-205.
                                                             CORRIGENDUM 1 Published
                                                             2011-07-15 Clinical
                                                             investigation of medical
                                                             devices for human subjects--
                                                             Good clinical practice.
2-93........................  ............................  ASTM F763-04 (Reapproved      Extent of recognition.
                                                             2010), Standard Practice
                                                             for Short-Term Screening of
                                                             Implant Materials.
2-94........................  ............................  ASTM F981-04 (Reapproved      Extent of recognition.
                                                             2010) Standard Practice for
                                                             Assessment of Compatibility
                                                             of Biomaterials for
                                                             Surgical Implants with
                                                             Respect to Effect of
                                                             Materials on Muscle and
                                                             Bone.
2-114.......................  ............................  ASTM F1877-05 (Reapproved     Extent of recognition.
                                                             2010) Standard Practice for
                                                             Characterization of
                                                             Particles.
2-118.......................  ............................  ANSI/AAMI/ISO 10993-11:2006/  Extent of recognition.
                                                             (R) 2010 Biological
                                                             evaluation of medical
                                                             devices--Part 11: Tests for
                                                             systemic toxicity.
2-120.......................  ............................  ANSI/AAMI/ISO 10993-6:2007/   Extent of recognition.
                                                             (R) 2010 Biological
                                                             evaluation of medical
                                                             devices--Part 06: Tests for
                                                             local effects after
                                                             implantation.
2-126.......................  ............................  ASTM F748-06 (Reapproved      Extent of recognition.
                                                             2010) Standard Practice for
                                                             Selecting Generic
                                                             Biological Test Methods for
                                                             Materials and Devices.

2-133.......................  ............................  ASTM F1408-97 (Reapproved     Extent of recognition.
                                                             2008) Standard Practice for
                                                             Subcutaneous Screening Test
                                                             for Implant Materials.
2-134.......................  ............................  ASTM F2065-00 (Reapproved     Extent of recognition.
                                                             2010) Standard Practice for
                                                             Testing for Alternative
                                                             Pathway Complement
                                                             Activation in Serum by
                                                             Solid Materials.
2-136.......................  ............................  ASTM E1262-88 (Reapproved     Extent of recognition.
                                                             2008) Standard Guide for
                                                             Performance of the Chinese
                                                             Hamster Ovary Cell/
                                                             Hypoxanthine Guanine
                                                             Phosphoribosyl Transferase
                                                             Gene Mutation Assay.
2-137.......................  ............................  ASTM E1263-97 (Reapproved     Withdrawn.
                                                             2008) Standard Guide for
                                                             Conduct of Micronucleus
                                                             Assays in Mammalian Bone
                                                             Marrow Erythrocytes.
2-138.......................  ............................  ASTM E1280-97 (Reapproved     Withdrawn.
                                                             2008) Standard Guide for
                                                             Performing the Mouse
                                                             Lymphoma Assay for
                                                             Mammalian Cell Mutagenicity.
2-139.......................  ............................  ASTM E1397-91 (Reapproved     Withdrawn.
                                                             2008) Standard Practice for
                                                             the In Vitro Rat Hepatocyte
                                                             DNA Repair Assay.
2-140.......................  ............................  ASTM E1398-91 (Reapproved     Withdrawn.
                                                             2008) Standard Practice for
                                                             the In Vivo Rat Hepatocyte
                                                             DNA Repair Assay.
2-141.......................  ............................  ASTM F1984-99 (Reapproved     Extent of recognition.
                                                             2008) Standard Practice for
                                                             Testing for Whole
                                                             Complement Activation in
                                                             Serum by Solid Materials.
2-142.......................  ............................  ASTM F1983-99 (Reapproved     Extent of recognition.
                                                             2008) Standard Practice for
                                                             Assessment of Compatibility
                                                             of Absorbable/Resorbable
                                                             Biomaterials for Implant
                                                             Application.
2-143.......................  ............................  ASTM F1904-98 (Reapproved     Extent of recognition.
                                                             2008) Standard Practice for
                                                             Testing the Biological
                                                             Responses to Particles in
                                                             vivo.
2-144.......................  ............................  ASTMF619-03 (Reapproved       Extent of recognition.
                                                             2008) Standard Practice for
                                                             Extraction of Medical
                                                             Plastics.
2-145.......................  ............................  ASTM F1439-03 (Reapproved     Extent of recognition.
                                                             2008) Standard Guide for
                                                             Performance of Lifetime
                                                             Bioassay for the
                                                             Tumorigenic Potential of
                                                             Implant Materials.
2-153.......................  ............................  ANSI/AAMI/ISO 10993-5:2009,   Extent of recognition.
                                                             Biological evaluation of
                                                             medical devices--Part 5:
                                                             Tests for In Vitro
                                                             cytotoxicity.
2-154.......................  ............................  ASTM F756-08 Standard         Extent of recognition.
                                                             Practice for Assessment of
                                                             Hemolytic Properties of
                                                             Materials.
2-155.......................  ............................  ASTM F2147-01 (Reapproved     Extent of recognition.
                                                             2010) Standard Practice for
                                                             Guinea Pig: Split Adjuvant
                                                             and Closed Patch Testing
                                                             for Contact Allergens.
2-156.......................  ............................  ANSI/AAMI/ISO 10993-1:2009    Extent of recognition.
                                                             Biological evaluation of
                                                             medical devices--Part 1:
                                                             Evaluation and testing
                                                             within a risk management.
2-162.......................  ............................  ASTM F1903-10 Standard        Extent of recognition.
                                                             Practice for Testing for
                                                             Biological Responses to
                                                             Particles in vitro.
2-163.......................  ............................  ANSI/AAMI/ISO 10993-9:2009    Extent of recognition.
                                                             Biological evaluation of
                                                             medical devices--Part 9:
                                                             Framework for
                                                             identification and
                                                             quantification of potential
                                                             degradation products.
2-165.......................  ............................  ANSI/AAMI/ISO 10993-14:2001/  Extent of recognition.
                                                             (R) 2011 Biological
                                                             evaluation of medical
                                                             devices--Part 14:
                                                             Identification and
                                                             quantification of
                                                             degradation products from
                                                             ceramics.
2-167.......................  ............................  ISO/TS 10993-19 First         Extent of recognition.
                                                             edition 2006-06-01
                                                             Biological evaluation of
                                                             medical devices--Part 19:
                                                             Physico-chemical,
                                                             morphological, and
                                                             topographical
                                                             characterization of
                                                             materials.
2-168.......................  ............................  ISO 10993-9 Second edition    Extent of recognition.
                                                             2009-12-15 Biological
                                                             evaluation of medical
                                                             devices--Part 9: Framework
                                                             for identification and
                                                             quantification of potential
                                                             degradation products.
2-169.......................  ............................  ISO 10993-13 Second edition   Extent of recognition.
                                                             2010-06-15 Biological
                                                             evaluation of medical
                                                             devices--Part 13:
                                                             Identification and
                                                             quantification of
                                                             degradation products from
                                                             polymeric medical devices.
2-170.......................  ............................  ISO 10993-14 First edition    Extent of recognition.
                                                             2001-11-15 Biological
                                                             evaluation of medical
                                                             devices--Part 14:
                                                             Identification and
                                                             quantification of
                                                             degradation products from
                                                             ceramics.
2-171.......................  ............................  ISO 10993-16 Second edition   Extent of recognition.
                                                             2010-02-15 Biological
                                                             evaluation of medical
                                                             devices--Part 16:
                                                             Toxicokinetic study design
                                                             for degradation products
                                                             and leachables.
2-172.......................  ............................  ANSI/AAMI/ISO TIR 10993-      Extent of recognition.
                                                             19:2006 Biological
                                                             evaluation of medical
                                                             devices--Part 19:
                                                             Physicochemical,
                                                             morphological, and
                                                             topographical
                                                             characterization of
                                                             materials.
2-173.......................  ............................  ANSI/AAMI/ISO 10993-10:2010   Extent of recognition.
                                                             Biological evaluation of
                                                             medical devices--Part 10:
                                                             Tests for irritation and
                                                             skin sensitization.
2-174.......................  ............................  ISO 10993-10:2010 Biological  Extent of recognition.
                                                             evaluation of medical
                                                             devices--Part 10: Tests for
                                                             irritation and skin
                                                             sensitization.
2-175.......................  ............................  ISO 10993-3 Second edition    Extent of recognition.
                                                             2003-10-15 Biological
                                                             evaluation of medical
                                                             devices Part 3: Tests for
                                                             genotoxicity,
                                                             carcinogenicity and
                                                             reproductive toxicity.

2-176.......................  ............................  ISO 10993-11 Second edition   Extent of recognition.
                                                             2006-08-15 Biological
                                                             evaluation of medical
                                                             devices--Part 11: Tests for
                                                             systemic toxicity.
2-177.......................  ............................  ISO 10993-06 Second edition   Extent of recognition.
                                                             2007-04-15 Biological
                                                             evaluation of medical
                                                             devices--Part 6: Tests for
                                                             local effects after
                                                             implantation.
2-179.......................  ............................  ISO 10993-1 Fourth edition    Extent of recognition.
                                                             2009-10-15 Biological
                                                             evaluation of medical
                                                             devices--Part 1: Evaluation
                                                             and testing within a risk
                                                             management process.
2-181.......................  ............................  ANSI/AAMI/ISO 14155:2011,     Extent of recognition.
                                                             Clinical investigation of
                                                             medical devices for human
                                                             subjects--Good clinical
                                                             practice.
2-189.......................  ............................  ASTM F895-11, Standard Test   Extent of recognition.
                                                             Method for Agar Diffusion
                                                             Cell Culture Screening for
                                                             Cytotoxicity.
2-190.......................  ............................  ANSI/AAMI/ISO 10993-13:2010,  Extent of recognition.
                                                             Biological evaluation of
                                                             medical devices--Part 13:
                                                             Identification and
                                                             quantification of
                                                             degradation products from
                                                             polymeric medical devices.
2-191.......................  ............................  ISO 10993-12 Fourth edition   Extent of recognition.
                                                             2012-07-01, Biological
                                                             evaluation of medical
                                                             devices--Part 12: Sample
                                                             preparation and reference
                                                             materials.
----------------------------------------------------------------------------------------------------------------
                                                C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-41........................  ............................  ANSI/AAMI EC11:1991/(R)2007   Withdrawn. See 3-106.
                                                             Diagnostic
                                                             electrocardiographic
                                                             devices.
3-52........................  ............................  ANSI/AAMIEC12:2000/(R)2010    Extent of recognition.
                                                             Disposable ECG electrodes.
3-54........................  ............................  ANSI/AAMI/ISO 7198:1998/2001/ Extent of recognition.
                                                             (R)2010 Cardiovascular
                                                             implants--Tubular vascular
                                                             prostheses.
3-58........................  ............................  ANSI/AAMI/ISO 5840:2005/      Extent of recognition.
                                                             (R)2010 Cardiovascular
                                                             implants--Cardiac valve
                                                             prostheses.
3-63........................  ............................  ISO 11318 Second edition      Extent of recognition.
                                                             2002-08-01 Cardiac
                                                             Defibrillators--Connector
                                                             assembly DF-1 for
                                                             implantable defibrillators--
                                                             Dimensions and test
                                                             requirements.
3-72........................  ............................  ANSI/AAMI EC53:1995/(R) 2008  Extent of recognition.
                                                             ECG cables and leadwires.
3-73........................  3-118.......................  ANSI/AAMI EC57:2012 Testing   Withdrawn and replaced
                                                             and reporting performance     with newer version.
                                                             results of cardiac rhythm
                                                             and ST-segment measurement
                                                             algorithms.
3-75........................  ............................  ANSI/AAMI SP10:2002/(R) 2008  Withdrawn. See 3-80, 3-
                                                             & ANSI/AAMI SP10:2002/        122 and 3-123.
                                                             A1:2003, Manual, electronic
                                                             or automated
                                                             sphygmomanometers.
3-76........................  ............................  ASTM F2129-08 Standard Test   Extent of recognition.
                                                             Method for Conducting
                                                             Cyclic Potentiodynamic
                                                             Polarization Measurements
                                                             to Determine the Corrosion
                                                             Susceptibility of Small
                                                             Implant Devices.
3-78........................  ............................  ANSI/AAMI/IEC 80601-2-        Extent of recognition.
                                                             30:2009 Medical electrical
                                                             equipment--Part 2-30:
                                                             Particular requirements for
                                                             the basic safety and
                                                             essential performance of
                                                             automated noninvasive
                                                             sphygmomanometers.
3-80........................  ............................  ANSI/AAMI/ISO 81060-1:2007/   Reaffirmation.
                                                             (R) 2013 Non-invasive
                                                             sphygmomanometers--Part 1:
                                                             Requirements and test
                                                             methods for non-automated
                                                             measurement type.
3-83........................  ............................  ANSI/AAMI/ISO 14708-5:2010    Extent of recognition.
                                                             Implants for surgery--
                                                             Active implantable medical
                                                             devices--Part 5:
                                                             Circulatory support devices.
3-85........................  3-120.......................  ANSI/AAMI/ISO 25539-2:2012    Withdrawn and replaced
                                                             Cardiovascular implants--     with newer version.
                                                             Endovascular devices--Part
                                                             2: Vascular stents.
3-88........................  ............................  ASTM F2514-08 Standard Guide  Extent of recognition.
                                                             for Finite Element Analysis
                                                             (FEA) of Metallic Vascular
                                                             Stents Subjected to Uniform
                                                             Radial.
3-90........................  ............................  ISO 7198 First edition 1998-  Extent of recognition.
                                                             08-01 Cardiovascular
                                                             implants--Tubular vascular
                                                             prostheses.
3-93........................  ............................  ISO 25539-1:2003 First        Withdrawn. See 3-121.
                                                             edition 2001-11-13
                                                             AMENDMENT 1 2005-07-15
                                                             Cardiovascular implants--
                                                             Endovascular devices--Part
                                                             1: Endovascular prostheses
                                                             Amendment 1: Test methods.
3-97........................  3-122.......................  ISO 81060-2 Second edition    Withdrawn and replace
                                                             2013-05-01 Non-invasive       with newer version.
                                                             sphygmomanometers--Part 2:
                                                             Clinical validation of
                                                             automated measurement type.
3-98........................  ............................  ISO 81060-2:2009 TECHNICAL    Withdrawn. See 3-122.
                                                             CORRIGENDUM Published 2011-
                                                             02-15 Non-invasive
                                                             sphygmomanometers--Part 2:
                                                             Clinical validation of
                                                             automated measurement type.
3-100.......................  ............................  ANSI/AAMI/IEC 60601-2-        Withdrawn. See 3-101.
                                                             27:2011 Medical electrical
                                                             equipment--Part 2-27:
                                                             Particular requirements for
                                                             the basic safety and
                                                             essential performance of
                                                             electrocardiographic
                                                             monitoring equipment.
3-107.......................  3-123.......................  IEC 80601-2-30 Edition 1.1    Withdrawn and replaced
                                                             2013-07 Medical electrical    with newer version.
                                                             equipment--Part 2-30:
                                                             Particular requirements for
                                                             the basic safety and
                                                             essential performance of
                                                             automated non-invasive
                                                             sphygmomanometers.

3-108.......................  ............................  IEC 80601-2-30 (First         Withdrawn. See 3-123.
                                                             edition 2009) Medical
                                                             electrical equipment--Part
                                                             2-30: Particular
                                                             requirements for the basic
                                                             safety and essential
                                                             performance of automated
                                                             non-invasive
                                                             sphygmomanometers
                                                             CORRIGENDUM 1.
3-113.......................  3-124.......................  ISO 7199 Second edition 2009- Withdrawn and replaced
                                                             04-15 Cardiovascular          with newer version
                                                             implants and artificial       including amendment.
                                                             organs--Blood-gas
                                                             exchangers (oxygenators)
                                                             [Including: AMENDMENT 1
                                                             (2012)].
3-114.......................  3-119.......................  ISO 5841-3 Third edition      Withdrawn and replace
                                                             2013-40-15 Implants for       with newer version.
                                                             surgery--Cardiac
                                                             pacemakers--Part 3: Low-
                                                             profile connectors (IS-1)
                                                             for implantable pacemakers.
----------------------------------------------------------------------------------------------------------------
                                                  D. Dental/ENT
----------------------------------------------------------------------------------------------------------------
4-50........................  ............................  ADA Specification No.18:1992  Extent of recognition.
                                                             Alginate Impression
                                                             Materials.
4-62........................  ............................  ISO 1563 Second edition 1990- Withdrawn.
                                                             09-01 Dental alginate
                                                             impression material.
4-63........................  ............................  ISO 1564 Second edition 1995- Withdrawn.
                                                             11-01 Dental aqueous
                                                             impression materials based
                                                             on agar.
4-86........................  ............................  ANSI/ADA Specification No.    Extent of recognition.
                                                             38 2000 (Reaffirmed 2010),
                                                             Metal-Ceramic Dental
                                                             Restorative Systems.
4-89........................  ............................  ANSI/ADA Specification No.    Extent of recognition.
                                                             53: 1999 (Reaffirmed 2008)
                                                             Polymer-Based Crowns and
                                                             Bridge Materials.
4-91........................  ............................  ANSI/ADA Specification No.    Reaffirmation and
                                                             80/ISO 7491:2000              extent of
                                                             (Reaffirmed 2013) Dental      recognition.
                                                             Materials--Determination of
                                                             Color Stability.
4-92........................  ............................  ANSI/ADA Specification No.    Reaffirmation and
                                                             88:2000 (Reaffirmed 2010)     extent of
                                                             Dental Brazing Alloys.        recognition.
4-96........................  ............................  ANSI/ADA Specification No.    Reaffirmation and
                                                             30:2000 (Reaffirmed 2012)     extent of
                                                             Dental Zinc Oxide-Eugenol     recognition.
                                                             and Zinc Oxide Non-Eugenol
                                                             Cements.
4-97........................  ............................  ANSI/ADA Specification No.    Extent of recognition.
                                                             57: (Reaffirmed 2012)
                                                             Endodontic Sealing
                                                             Materials.
4-105.......................  ............................  ANSI/ADA Specification No.    Extent of recognition.
                                                             75:1997 (Reapproved 2003)
                                                             Resilient Lining Materials
                                                             for Removable Dentures--
                                                             Part 1: Short-Term
                                                             Materials.
4-109.......................  ............................  ISO 13716 First edition 1999- Withdrawn.
                                                             05-01 Dentistry--reversible-
                                                             irreversible hydrocolloid
                                                             impression material system.
4-126.......................  ............................  ISO 10477 Second edition      Extent of recognition.
                                                             2004-10-01 Dentistry--
                                                             Polymer-based crown and
                                                             bridge materials.
4-130.......................  ............................  ADA Specification No.         Extent of recognition.
                                                             17:1983 (Reaffirmed 2006)
                                                             Denture Base Temporary
                                                             Relining Resins.
4-134.......................  4-207.......................  ISO 7494-1 Second edition     Withdrawn and replaced
                                                             2011-08-15 Dentistry--        with newer version.
                                                             Dental units--Part 1:
                                                             General requirements and
                                                             test methods.
4-135.......................  4-213.......................  ISO 10139-1 Second edition    Withdrawn and replaced
                                                             2005-02-15 Dentistry--Soft    with newer version
                                                             lining materials for          including technical
                                                             removable dentures--Part 1:   corrigendum.
                                                             Materials for short-term
                                                             use [Including: TECHNICAL
                                                             CORRIGENDUM 1 (2006)].
4-137.......................  ............................  ISO 6877 Second edition 2006- Extent of recognition.
                                                             04-01 Dentistry--Root-canal
                                                             obturating points.
4-139.......................  ............................  ANSI/ADA Specification No.    Reaffirmation and
                                                             48 (Reaffirmed 2009)          extent of
                                                             Visible Light Curing Units.   recognition.
4-143.......................  4-208.......................  ANSI/ADA Specification No.    Withdrawn and replaced
                                                             96:2012 Dental-Water-Based    with newer version.
                                                             Cements.
4-144.......................  4-209.......................  ISO 24234 First edition 2004- Withdrawn and replaced
                                                             10-15 Dentistry--Mercury      with newer version
                                                             and alloys for dental         including amendment.
                                                             amalgam [Including:
                                                             AMENDMENT 1 (2011)].
4-146.......................  ............................  ISO 22674 First edition 2006- Extent of recognition.
                                                             11-15 Dentistry--Metallic
                                                             materials for fixed and
                                                             removable restorations and
                                                             appliances.
4-149.......................  ............................  ANSI/ADA Specification No.    Reaffirmation and
                                                             39/ISO 6874:2005              extent of
                                                             (Reaffirmed 2011) Pit and     recognition.
                                                             Fissure Sealants.
4-150.......................  ............................  ANSI/ADA Specification No.    Extent of recognition.
                                                             19:2004/ISO 4823:2000
                                                             Dental--Elastometric
                                                             Impression Materials.
4-151.......................  ............................  ISO 22112 First edition 2005- Extent of recognition.
                                                             11-01 Dentistry--Artificial
                                                             teeth for dental prostheses.
4-153.......................  ............................  ISO 9917-1 Second edition     Extent of recognition.
                                                             2007-10-01 Dentistry--Water-
                                                             based cements--Part 1:
                                                             Powder/liquid acid-base
                                                             cements.
4-154.......................  4-210.......................  ISO 4823 Third edition 2000-  Withdrawn and replaced
                                                             12-15 Dentistry--             with newer version
                                                             Elastometric impression       including amendment
                                                             materials [Including:         and technical
                                                             AMENDMENT 1 (2000)            corrigendum.
                                                             TECHNICAL CORRIGENDUM
                                                             1(2004)].
4-155.......................  ............................  ISO 4823: Technical           Withdrawn. See 4-210.
                                                             Corrigendum 1 Published
                                                             2004-07-15--Dentistry--Elas
                                                             tometric impression
                                                             materials--Third Edition.

4-156.......................  ............................  ISO 4823 Third edition 2000-  Withdrawn. See 4-210.
                                                             12-15 Amendment 1 2007-07-
                                                             01 Dentistry--Elastometric
                                                             impression materials--Third
                                                             Edition.
4-157.......................  ............................  ISO 3107 Third edition 2004-  Withdrawn. See 4-198.
                                                             10-01 Dentistry--Zinc oxide/
                                                             Eugenol and zinc oxide/non-
                                                             eugenol cements--Third
                                                             edition.
4-159.......................  4-211.......................  ANSI/IEEE C63.19:2007         Withdrawn and replaced
                                                             American National Standard    with newer version.
                                                             Methods of Measurement of
                                                             Compatibility between
                                                             Wireless Communications
                                                             Devices and Hearing Aids.
4-170.......................  4-212.......................  ANSI/ASA S3.36-2012 American  Withdrawn and replaced
                                                             National Standard             with newer version.
                                                             Specification for a Manikin
                                                             for Simulated in situ
                                                             Airborne Acoustic
                                                             Measurements.
4-178.......................  ............................  ISO 6872 Third edition 2008-  Extent of recognition.
                                                             09-01 Dentistry--Ceramic
                                                             materials.
4-179.......................  ............................  ISO 7405 Second edition 2008- Extent of recognition.
                                                             12-15 Dentistry--Evaluation
                                                             of biocompatibility of
                                                             medical devices used in
                                                             dentistry.
4-180.......................  ............................  ISO 9168 Third edition 2009-  Extent of recognition.
                                                             07-15 Dentistry--Hose
                                                             connectors for air driven
                                                             dental handpieces.
4-181.......................  ............................  ISO 4049 Fourth edition 2009- Extent of recognition.
                                                             10-01 Dentistry--Polymer-
                                                             based restorative materials.
4-182.......................  ............................  ISO 10139-2 Second edition    Extent of recognition.
                                                             2009-08-01 Dentistry--Soft
                                                             lining materials for
                                                             removable dentures--Part 2:
                                                             Materials for long-term use.
4-188.......................  ............................  ISO 9917-2 Second edition     Extent of recognition.
                                                             2010-04-15 Dentistry--Water-
                                                             based cements--Part 2:
                                                             Resin-modified cements.
4-189.......................  ............................  ISO 10139-1:2005 TECHNICAL    Withdrawn. See 4-213.
                                                             CORRIGENDUM 1 2006-03-01
                                                             Dentistry--Soft lining
                                                             materials for removable
                                                             dentures--Part 1: Materials
                                                             for short-term use.
4-195.......................  ............................  ISO 14801 Second edition      Extent of recognition.
                                                             2007-11-15 Dentistry--
                                                             Implants-Dynamic fatigue
                                                             test for endosseous dental
                                                             implants.
4-196.......................  ............................  ANSI/ADA Specification        Extent of recognition.
                                                             No.69:2010/ISO 6872:2008
                                                             Dental Ceramic.
4-198.......................  ............................  ISO 3107 Fourth edition 2011- Extent of recognition.
                                                             03-01 Dentistry--Zinc oxide/
                                                             eugenol and zinc oxide/non-
                                                             eugenol cements.
4-199.......................  ............................  ISO 6876 Third edition 2012-  Extent of recognition.
                                                             06-01 Dentistry--Root Canal
                                                             Sealing Materials.
4-200.......................  ............................  ISO 24234 First edition 2004- Withdrawn. See 4-209.
                                                             10-15 Dentistry--Mercury
                                                             and alloys for dental
                                                             amalgam AMENDMENT 1.
4-201.......................  ............................  ISO 9693-2012 Dentistry--     Extent of recognition.
                                                             Compatibility testing--
                                                             Metal-ceramic systems.
4-205.......................  ............................  ISO 14457 First edition 2012- Withdrawn. See 4-206.
                                                             09-15 Dentistry--Handpieces
                                                             and motors.
----------------------------------------------------------------------------------------------------------------
                                                   E. General
----------------------------------------------------------------------------------------------------------------
5-22........................  ............................  ISO 2768-1 First edition      Extent of recognition.
                                                             1989-11-15 General
                                                             tolerances--Part 1:
                                                             Tolerances for linear and
                                                             angular dimensions without
                                                             individual tolerance
                                                             indications.
5-23........................  ............................  ISO 2768-2 First edition      Extent of recognition.
                                                             1989-11-15 General
                                                             Tolerances--Part 2:
                                                             Geometrical tolerances for
                                                             features without individual
                                                             tolerance indications.
5-36........................  ............................  ISO/TR 16142 Second edition   Extent of recognition.
                                                             2006-01-15 Medical devices--
                                                             Guidance on the selection
                                                             of standards in support of
                                                             recognized essential
                                                             principles of safety and
                                                             performance of medical
                                                             devices.
5-37........................  5-81........................  ISO 2859-1 Second edition     Withdrawn and replaced
                                                             1999-11-15 Sampling           with newer version
                                                             procedures for inspection     including technical
                                                             by attributes--Part 1:        corrigendum.
                                                             Sampling schemes indexed by
                                                             acceptance quality limit
                                                             (AQL) for lot-by-lot
                                                             inspection [Including:
                                                             TECHNICAL CORRIGENDUM 1
                                                             (2001)].
5-43........................  ............................  ANSI/ESD S20.20-2007 For the  Extent of recognition.
                                                             Development of an
                                                             Electrostatic Discharge
                                                             Control Program for
                                                             Protection of Electrical
                                                             and Electronic Parts,
                                                             Assemblies and Equipment
                                                             (Excluding Electrically
                                                             Initiated Explosive
                                                             Devices).
5-45........................  5-79........................  ASTM D7386-12 Standard        Withdrawn and replaced
                                                             Practice for Performance      with new version.
                                                             Testing of Packages for
                                                             Single Parcel Delivery
                                                             Systems.
5-46........................  ............................  ISO 2859-1:1999/Cor 1:2001    Withdrawn. See 5-81.
                                                             Sampling procedures for
                                                             inspection by attributes--
                                                             Part 1: Sampling schemes
                                                             indexed by acceptance
                                                             quality limit (AQL) for lot-
                                                             by-lot inspection.
5-47........................  ............................  ISO 10012 First edition 2003- Extent of recognition.
                                                             01-15 Measurement
                                                             management systems--
                                                             Requirements for
                                                             measurement processes and
                                                             measuring equipment.
5-50........................  ............................  IEC 62366 Edition 1.0 2007-   Extent of recognition.
                                                             10 Medical devices--
                                                             Application of usability
                                                             engineering to medical
                                                             devices.

5-51........................  5-80........................  ASTM D-4332-13 Standard       Withdrawn and replaced
                                                             Practice for Conditioning     with new version.
                                                             Containers, Packages, or
                                                             Packaging Components for
                                                             Testing.
5-53........................  ............................  IEC 60601-1-2 Edition 3.0     Relevant guidance.
                                                             2007-03 Medical electrical
                                                             equipment--Part 1-2:
                                                             General requirements for
                                                             basic safety and essential
                                                             performance--Collateral
                                                             standard: Electromagnetic
                                                             compatibility--Requirements
                                                             and tests.
5-54........................  ............................  ANSI/AAMI/IEC 60601-1-2:2007/ Reaffirmation and
                                                             (R)2012 Medical electrical    relevant guidance.
                                                             equipment--Part 1-2:
                                                             General requirements for
                                                             basic safety and essential
                                                             performance--Collateral
                                                             standard: Electromagnetic
                                                             compatibility--Requirements
                                                             and tests.
5-57........................  ............................  ANSI/AAMI HE75:2009 Human     Extent of recognition.
                                                             factors engineering--Design
                                                             of medical devices.
5-58........................  5-82........................  IEC 60601-1-11 Edition        Withdrawn and replaced
                                                             1.0:2010 Medical electrical   with newer version
                                                             equipment--Part 1-11:         including technical
                                                             General requirements for      corrigendum.
                                                             basic safety and essential
                                                             performance--Collateral
                                                             Standard: Requirements for
                                                             medical electrical
                                                             equipment and medical
                                                             electrical systems used in
                                                             the home healthcare
                                                             environment [Including:
                                                             TECHNICAL CORRIGENDUM 1
                                                             (2011)].
5-62........................  ............................  ANSI/ASQ Z1.4-2008 Sampling   Extent of recognition.
                                                             Procedures and Tables for
                                                             Inspection by Attributes.
5-66........................  ............................  IEC 60601-1-10 Edition 1.0:   Extent of recognition.
                                                             2007-11 Medical electrical
                                                             equipment--Part 1-10:
                                                             General requirements for
                                                             basic safety and essential
                                                             performance--Collateral
                                                             Standard: Requirements for
                                                             the development of
                                                             physiologic closed-loop
                                                             controllers.
5-67........................  ............................  ANSI/AAMI/IEC 62366:2007/     Reaffirmation and
                                                             (R)2013 Medical devices--     extent of
                                                             Application of usability      recognition.
                                                             engineering to medical
                                                             devices.
5-69........................  ............................  IEC 60601-1-11 (First         Withdrawn. See 5-82.
                                                             edition 2010) April 2011
                                                             Medical electrical
                                                             equipment--Part 1-11:
                                                             General requirements for
                                                             basic safety and essential
                                                             performance--Collateral
                                                             Standard: Requirements for
                                                             medical electrical
                                                             equipment and medical
                                                             electrical systems used in
                                                             the home healthcare
                                                             environment CORRIGENDUM 1.
----------------------------------------------------------------------------------------------------------------
                                   F. General Hospital/General Plastic Surgery
----------------------------------------------------------------------------------------------------------------
6-13........................  ............................  ISO 595-1 First edition 1986- Withdrawn.
                                                             12-15 Reusable all-glass or
                                                             metal-and-glass syringes
                                                             for medical use--Part 1:
                                                             Dimensions.
6-14........................  ............................  ISO 595-2 First edition 1987- Withdrawn.
                                                             12-15 Reusable all-glass or
                                                             metal-and-glass syringes
                                                             for medical use--Part 2:
                                                             Design, performance
                                                             requirements and tests.
6-117.......................  ............................  ASTM F2172-02 (Reapproved     Extent of recognition.
                                                             2011) Standard
                                                             Specification for Blood/
                                                             Intravenous Fluid/
                                                             Irrigation Fluid Warmers.
6-142.......................  ............................  ANSI/AAMI II36:2004 Medical   Withdrawn. See 6-230.
                                                             electrical equipment--Part
                                                             2: Particular requirements
                                                             for safety of baby
                                                             incubators.
6-143.......................  ............................  ANSI/AAMI II51:2004 Medical   Withdrawn. See 6-231.
                                                             electrical equipment--Part
                                                             2: Particular requirements
                                                             for safety of transport
                                                             incubators.
6-150.......................  ............................  ASTM D7161-05 (Reapproved     Withdrawn.
                                                             2010) Standard Practice for
                                                             Determination of Real Time
                                                             Expiration Dating of Mature
                                                             Medical Gloves Stored Under
                                                             Typical Warehouse
                                                             Conditions.
6-161.......................  6-301.......................  ISO 10555-1 Second edition    Withdrawn and replaced
                                                             2013-06-15 Corrected          with newer version.
                                                             version 2013-07-01
                                                             Intravascular catheters--
                                                             Sterile and single-use
                                                             catheters--Part 1: General
                                                             requirements.
6-163.......................  ............................  ISO 9626 First edition 1991-  Withdrawn. See 6-302.
                                                             09-01 AMENDMENT 1 2001-06-
                                                             01 Stainless steel needle
                                                             tubing for the manufacture
                                                             of medical devices.
6-164.......................  6-303.......................  ISO 10555-5 Second edition    Withdrawn and replaced
                                                             2013-06-15 Intravascular      with newer version.
                                                             catheters--Sterile and
                                                             single-use catheters--Part
                                                             5: Over-needle peripheral
                                                             catheters.
6-170.......................  6-304.......................  ISO 7886-1 First edition      Withdrawn and replaced
                                                             1993-10-01 Sterile            with newer version
                                                             hypodermic syringes for       including technical
                                                             single use--Part 1:           corrigendum.
                                                             Syringes for manual use
                                                             [Including: TECHNICAL
                                                             CORRIGENDUM 1 Published
                                                             1995-11-01].
6-171.......................  6-305.......................  ISO 10555-3 Second edition    Withdrawn and replaced
                                                             2013-06-15 Intravascular      with newer version.
                                                             catheters--Sterile and
                                                             single-use catheters--Part
                                                             3: Central venous catheters.
6-176.......................  ............................  ASTM D7103-06 (Reapproved     Extent of recognition.
                                                             2013) Standard Guide for
                                                             Assessment of Medical
                                                             Gloves.
6-187.......................  6-306.......................  ASTM F1671/F1671M-13          Withdrawn and replaced
                                                             Standard Test Method for      with newer version.
                                                             Resistance of Materials
                                                             Used in Protective Clothing
                                                             to Penetration by Blood-
                                                             Borne Pathogens Using Phi-
                                                             X174 Bacteriophage
                                                             Penetration as a Test
                                                             System.

6-233.......................  ............................  IEC 60601-2-52 Edition 1.0    Withdrawn. See 6-321.
                                                             2009-12 Medical electrical
                                                             equipment--Part 2-52:
                                                             Particular requirements for
                                                             basic safety and essential
                                                             performance of medical beds.
6-236.......................  6-307.......................  IEC 80601-2-59 Edition 1.0    Withdrawn and replaced
                                                             2008-10 Medical Electrical    with newer version
                                                             Equipment--Part 2-59:         including technical
                                                             Particular requirements for   corrigendum.
                                                             the basic safety and
                                                             essential performance of
                                                             screening thermographs for
                                                             human febrile temperature
                                                             screening [Including:
                                                             CORRIGENDUM 1 (April 2009)].
6-237.......................  ............................  IEC 80601-2-59 (First         Withdrawn. See 6-307.
                                                             edition 2008) Medical
                                                             Electrical Equipment--Part
                                                             2-59: Particular
                                                             requirements for the basic
                                                             safety and essential
                                                             performance of screening
                                                             thermographs for human
                                                             febrile temperature
                                                             screening CORRIGENDUM 1.
6-238.......................  6-308.......................  IEC 80601-2-35 Edition 2.0    Withdrawn and replaced
                                                             2009-10 Medical electrical    with newer version
                                                             equipment--Part 2-35:         including technical
                                                             Particular requirements for   corrigendum.
                                                             the basic safety and
                                                             essential performance of
                                                             heating devices using
                                                             blankets, pads or
                                                             mattresses and intended for
                                                             heating in medical use
                                                             [Including: CORRIGENDUM 1
                                                             (March 2012)].
6-245.......................  ............................  ISO 8536-4 Fifth edition      Withdrawn. See 6-318.
                                                             2010-10-01 Infusion
                                                             equipment for medical use--
                                                             Part 4: Infusion sets for
                                                             single use, gravity feed.
6-253.......................  ............................  ISO 10535 Second edition      Extent of recognition.
                                                             2006-12-15 Hoists for the
                                                             transfer of disabled
                                                             persons--Requirements and
                                                             test methods.
6-264.......................  ............................  ISO 10555-1 First edition     Withdrawn. See 6-301.
                                                             1995-06-15 AMENDMENT 1 1999-
                                                             07-15 Sterile, single-use
                                                             intravascular catheters--
                                                             Part 1: General
                                                             requirements.
6-265.......................  ............................  ISO 10555-1 First edition     Withdrawn. See 6-301.
                                                             1995-06-5 AMENDMENT 2 2004-
                                                             05-15 Sterile, single-use
                                                             intravascular catheters--
                                                             Part 1: General
                                                             requirements.
6-266.......................  ............................  ISO 10555-5 First edition     Withdrawn. See 6-303.
                                                             1996-06-15 AMENDMENT 1
                                                             Sterile, single-use
                                                             intravascular catheters--
                                                             Part 5: Over-needle
                                                             peripheral catheters.
6-267.......................  ............................  ISO 10555-5 1996 TECHNICAL    Withdrawn. See 6-303.
                                                             CORRIGENDUM 1 Published
                                                             2002-06-15 Sterile, single-
                                                             use intravascular
                                                             catheters--Part 5: Over-
                                                             needle peripheral catheters.
6-273.......................  ............................  ISO 23908 First edition 2011- Extent of recognition.
                                                             06-11 Sharps injury
                                                             protection--Requirements
                                                             and test methods--Sharps
                                                             protection features for
                                                             single-use hypodermic
                                                             needles, introducers for
                                                             catheters and needles used
                                                             for blood sampling.
6-279.......................  ............................  IEC 60601-2-19 (Second        Withdrawn. See 6-319.
                                                             Edition 2009) Medical
                                                             electrical equipment--Part
                                                             2-19: Particular
                                                             requirements for the basic
                                                             safety and essential
                                                             performance of infant
                                                             incubators CORRIGENDUM 1.
6-280.......................  ............................  IEC 60601-2-20 (Second        Withdrawn. See 6-320.
                                                             edition 2009) Medical
                                                             electrical equipment--Part
                                                             2-20: Particular
                                                             requirements for the basic
                                                             safety and essential
                                                             performance of infant
                                                             transport incubators
                                                             CORRIGENDUM 1.
6-281.......................  ............................  IEC 80601-2-35 (Second        Withdrawn. See 6-308.
                                                             edition 2009) Medical
                                                             electrical equipment--Part
                                                             2-35: Particular
                                                             requirements for the basic
                                                             safety and essential
                                                             performance of heating
                                                             devices using blankets,
                                                             pads or mattresses and
                                                             intended for heating in
                                                             medical use CORRIGENDUM 1.
6-283.......................  6-309.......................  USP 36-NF31:2013 Sodium       Withdrawn and replaced
                                                             Chloride Irrigation.          with newer version.
6-284.......................  6-310.......................  USP 36-NF31:2013 Sodium       Withdrawn and replaced
                                                             Chloride Injection.           with newer version.
6-285.......................  6-311.......................  USP 36-NF31:2013              Withdrawn and replaced
                                                             Nonabsorbable Surgical        with newer version.
                                                             Suture.
6-286.......................  3-312.......................  USP 36-NF31:2013 <881>        Withdrawn and replaced
                                                             Tensile Strength.             with newer version.
6-287.......................  6-313.......................  USP 36-NF31:2013 <861>        Withdrawn and replaced
                                                             Sutures--Diameter.            with newer version.
6-288.......................  6-314.......................  USP 36-NF 31:2013 <871>       Withdrawn and replaced
                                                             Sutures--Needle Attachment.   with newer version.
6-289.......................  6-315.......................  USP 36-NF31:2013 Sterile      Withdrawn and replaced
                                                             Water for Irrigation.         with newer version.
6-290.......................  6-316.......................  USP 36-NF31:2013 Heparin      Withdrawn and replaced
                                                             Lock Flush Solution.          with newer version.
6-291.......................  6-317.......................  USP 36-NF31:2013 Absorbable   Withdrawn and replaced
                                                             Surgical Suture.              with newer version.
6-292.......................  ............................  ISO 7886-1:1993 TECHNICAL     Withdrawn. See 6-304.
                                                             CORRIGENDUM 1 Published
                                                             1995-11-01 Sterile
                                                             hypodermic syringes for
                                                             single-use--Part 1:
                                                             Syringes for manual use.

6-298.......................  6-319.......................  IEC 60601-2-19 Edition 2.0    Withdrawn and replaced
                                                             2009-02 Medical electrical    with newer version
                                                             equipment--Part 2-19:         including technical
                                                             Particular requirements for   corrigendum.
                                                             the basic safety and
                                                             essential performance of
                                                             infant incubators
                                                             [Including: CORRIGENDUM 1
                                                             (2012)].
6-299.......................  ............................  IEC 60601-2-20 Edition 2.0    Withdrawn. See 6-320.
                                                             2009-02 Medical electrical
                                                             equipment--Part 2-20:
                                                             Particular requirements for
                                                             the basic safety and
                                                             essential performance of
                                                             infant transport incubators.
----------------------------------------------------------------------------------------------------------------
                                             G. In Vitro Diagnostics
----------------------------------------------------------------------------------------------------------------
7-100.......................  ............................  ISO 15197 First edition 2003- Withdrawn.
                                                             05-01 In Vitro diagnostic
                                                             test systems--Requirements
                                                             for blood-glucose
                                                             monitoring systems for self-
                                                             testing in managing
                                                             diabetes mellitus.
7-137.......................  7-244.......................  CLSI NBS01-A6 Blood           Withdrawn and replaced
                                                             Collection on Filter Paper    with newer version.
                                                             for Newborn Screening
                                                             Programs; Approved
                                                             Standard--Sixth Edition.
7-239.......................  ............................  CLSI EP32-R (Formerly X05-R)  Designation number.
                                                             Metrological Traceability
                                                             and Its Implementation; A
                                                             Report.
7-226.......................  ............................  CLSI QMS01-A4 (Formerly GP26- Designation number.
                                                             A4) Quality Management
                                                             System: A Model for
                                                             Laboratory Services;
                                                             Approved Guideline--Fourth
                                                             Edition.
7-224.......................  ............................  CLSI EP28-A3c (Formerly C28-  Designation number.
                                                             A3c) Defining,
                                                             Establishing, and Verifying
                                                             Reference Intervals in the
                                                             Clinical Laboratory;
                                                             Approved Guideline--Third
                                                             Edition.
7-223.......................  ............................  CLSI QSM06-A3 (Formerly GP22- Designation number.
                                                             A3) Quality Management
                                                             System: Continual
                                                             Improvement; Approved
                                                             Guideline--Third Edition.
7-92........................  7-245.......................  CLSI EP09-A3 Measurement      Withdrawn and replaced
                                                             Procedure Comparison and      with newer version.
                                                             Bias Estimation Using
                                                             Patient Samples; Approved
                                                             Guideline--Third Edition.
7-210.......................  ............................  CLSI H26-A2 Validation,       Extent of recognition.
                                                             Verification, and Quality
                                                             Assurance of Automated
                                                             Hematology Analyzers;
                                                             Approved Standard--Second
                                                             Edition.
7-152.......................  ............................  CLSI EP12-A2 User Protocol    Extent of recognition.
                                                             for Evaluation of
                                                             Qualitative Test
                                                             Performance; Approved
                                                             Guideline--Second Edition.
7-174.......................  ............................  CLSI EP21-A Estimation of     Extent of recognition.
                                                             Total Analytical Error for
                                                             Clinical Laboratory
                                                             Methods; Approved Guideline.
7-178.......................  ............................  CLSI M22-A3 Quality Control   Extent of recognition.
                                                             for Commercially Prepared
                                                             Microbiological Culture
                                                             Media; Approved Standard--
                                                             Third Edition.
7-193.......................  ............................  CLSI EP06-A Evaluation of     Extent of recognition.
                                                             the Linearity of
                                                             Quantitative Measurement
                                                             Procedures: A Statistical
                                                             Approach; Approved
                                                             Guideline.
7-220.......................  ............................  CLSI H59-A Quantitative D-    Extent of recognition.
                                                             dimer for the Exclusion of
                                                             Venous Thromboembolic
                                                             Disease; Approved Guideline.
----------------------------------------------------------------------------------------------------------------
                                                  H. Materials
----------------------------------------------------------------------------------------------------------------
8-67........................  8-344.......................  ISO 7153-1 Second edition     Withdrawn and replaced
                                                             1991-04-01 Surgical           with newer version
                                                             instruments--Metallic         including amendment.
                                                             materials--Part 1:
                                                             Stainless steel [Including:
                                                             AMENDMENT 1(1999)].
8-138.......................  ............................  ASTM F745-07 Standard         Withdrawn.
                                                             Specification for 18
                                                             Chromium-12.5 Nickel-2.5
                                                             Molybdenum Stainless Steel
                                                             for Cast and Solution-
                                                             Annealed Surgical Implant
                                                             Applications.
8-139.......................  8-345.......................  ASTM F1314-13 Standard        Withdrawn and replaced
                                                             Specification for Wrought     with newer version.
                                                             Nitrogen Strengthened 22
                                                             Chromium-13 Nickel-5
                                                             Manganese-2.5 Molybdenum
                                                             Stainless Steel Alloy Bar
                                                             and Wire for Surgical
                                                             Implants (UNS S20910).
8-140.......................  8-346.......................  ASTM F1813-13 Standard        Withdrawn and replaced
                                                             Specification for Wrought     with newer version.
                                                             Titanium-12 Molybdenum-6
                                                             Zirconium-2 Iron Alloy for
                                                             Surgical Implant (UNS
                                                             R58120).
8-141.......................  8-347.......................  ASTM F2146-13 Standard        Withdrawn and replaced
                                                             Specification for Wrought     with newer version.
                                                             Titanium-3 Aluminum-2.5
                                                             Vanadium Alloy Seamless
                                                             Tubing for Surgical Implant
                                                             Applications (UNS R56320).
8-169.......................  8-348.......................  ASTM F138-13 Standard         Withdrawn and replaced
                                                             Specification for Wrought     with newer version.
                                                             18 Chromium-14 Nickel-2.5
                                                             Molybendum Stainless Steel
                                                             Bar and Wire for Surgical
                                                             Implants (UNS S31673).
8-176.......................  8-349.......................  ASTM F2503-13 Standard        Withdrawn and replaced
                                                             Practice for Marking          with newer version.
                                                             Medical Devices and Other
                                                             Items for Safety in the
                                                             Magnetic Resonance
                                                             Environment.
8-149.......................  8-350.......................  ISO 5832-1 Fourth edition     Withdrawn and replaced
                                                             2007-06-15 Implants for       with newer version
                                                             surgery--Metallic             including technical
                                                             materials--Part 1: Wrought    corrigendum.
                                                             stainless steel [Including:
                                                             TECHNICAL CORRIGENDUM
                                                             1(2008)].

8-196.......................  ............................  ISO 5832-1: 2007 Implants     Withdrawn. See 8-350.
                                                             for surgery--Metallic
                                                             materials--Part 1: Wrought
                                                             stainless steel TECHNICAL
                                                             CORRIGENDUM 1.
8-151.......................  8-351.......................  ISO 5832-12 Second edition    Withdrawn and replaced
                                                             2007-05-01 Implants for       with newer version
                                                             surgery--Metallic             including technical
                                                             materials--Part 12: Wrought   corrigendum.
                                                             cobalt-chromium-molybdenum
                                                             alloy [Including: TECHNICAL
                                                             CORRIGENDUM 1 2008].
8-197.......................  ............................  ISO 5832-12:2007 TECHNICAL    Withdrawn. See 8-351.
                                                             CORRIGENDUM 1 2008-09-05,
                                                             Implants for surgery--
                                                             Metallic materials--Part
                                                             12: Wrought cobalt-chromium-
                                                             molybdenum alloy TECHNICAL
                                                             CORRIGENDUM 1.
8-211.......................  8-352.......................  ISO 5834-1 Third edition      Withdrawn and replaced
                                                             2005-06-01 Implants for       with newer version
                                                             surgery--Ultra-high-          including technical
                                                             molecular-weight              corrigendum.
                                                             polyethylene--Part 1:
                                                             Powder form [Including:
                                                             TECHNICAL CORRIGENDUM 1
                                                             2007].
8-212.......................  ............................  ISO 5834-1:2005 Technical     Withdrawn. See 8-352.
                                                             Corrigendum 1 Published
                                                             2007-05-01 Implants for
                                                             surgery--Ultra-high-
                                                             molecular-weight
                                                             polyethylene--Part 1:
                                                             Powder form TECHNICAL
                                                             CORRIGENDUM 1.
8-228.......................  8-353.......................  ASTM F86-13 Standard          Withdrawn and replaced
                                                             Practice for Surface          with newer version.
                                                             Preparation and Marking of
                                                             Metallic Surgical Implants.
8-175.......................  8-354.......................  ASTM F1377-13 Standard        Withdrawn and replaced
                                                             Specification for Cobalt-28   with newer version.
                                                             Chromium-6 Molybdenum
                                                             Powder for Coating of
                                                             Orthopedic Implants (UNS
                                                             R30075).
8-163.......................  8-355.......................  ASTM F1586/F 1586M-13[egr]1   Withdrawn and replaced
                                                             Standard Specification for    with newer version.
                                                             Wrought Nitrogen
                                                             Strengthened 21 Chromium-10
                                                             Nickel-3 Manganese-2.5
                                                             Molybdenum Stainless Steel
                                                             Alloy Bar for Surgical
                                                             Implants (UNS S31675).
8-129.......................  8-356.......................  ASTM F67-13 Standard          Withdrawn and replaced
                                                             Specification for Unalloyed   with newer version.
                                                             Titanium, for Surgical
                                                             Implant Applications (UNS
                                                             R50250, UNS R50400, UNS
                                                             R50550, UNS R50700).
8-208.......................  8-357.......................  ASTM F648-13 Standard         Withdrawn and replaced
                                                             Specification for Ultra-      with newer version.
                                                             High-Molecular-Weight
                                                             Polyethylene Powder and
                                                             Fabricated Form for
                                                             Surgical Implants.
8-103.......................  ............................  ASTM F1801-97 (Reapproved     Extent of recognition.
                                                             2009) [egr]1 Standard
                                                             Practice for Corrosion
                                                             Fatigue Testing of Metallic
                                                             Implant Materials.
8-107.......................  ............................  ASTM F746-04 (Reapproved      Extent of recognition.
                                                             2009) [egr]1 Standard Test
                                                             Method for Pitting or
                                                             Crevice Corrosion of
                                                             Metallic Surgical Implant
                                                             Materials.
8-111.......................  ............................  ASTM F1160-05 (Reapproved     Extent of recognition.
                                                             2011) [egr]1 Standard Test
                                                             Method for Shear and
                                                             Bending Fatigue Testing of
                                                             Calcium Phosphate and
                                                             Metallic Medical and
                                                             Composite Calcium Phosphate/
                                                             Metallic Coatings.
8-112.......................  ............................  ASTM F1044-05 (Reapproved     Extent of recognition.
                                                             2011) [egr]1 Standard Test
                                                             Method for Shear Testing of
                                                             Calcium Phosphate Coatings
                                                             and Metallic Coatings.
8-113.......................  ............................  ASTM F1147-05 (Reapproved     Extent of recognition.
                                                             2011) Standard Test Method
                                                             for Tension Testing of
                                                             Calcium Phosphate and Metal
                                                             Coatings.
8-114.......................  ............................  ASTM F2255 (Reapproved 2010)  Extent of recognition.
                                                             Standard Test Method for
                                                             Strength Properties of
                                                             Tissue Adhesives in Lap
                                                             Shear by Tension Loading.
8-115.......................  ............................  ASTM F2256-05 (Reapproved     Extent of recognition.
                                                             2010) Standard Test Method
                                                             for Strength Properties of
                                                             Tissue Adhesives in T-Peel
                                                             by Tension Loading.
8-116.......................  ............................  ASTM F2258-05 (Reapproved     Extent of recognition.
                                                             2010) Standard Test Method
                                                             for Strength Properties of
                                                             Tissue Adhesives in Tension.
8-121.......................  ............................  ASTM F2005-05 (Reapproved     Extent of recognition.
                                                             2010) Standard Terminology
                                                             for Nickel-Titanium Shape
                                                             Memory Alloys.
8-123.......................  ............................  ISO 5832-5 Third edition      Extent of recognition.
                                                             2005-10-15 Implants for
                                                             surgery--Metallic
                                                             materials--Part 5: Wrought
                                                             cobalt-chromium-tungsten-
                                                             nickel alloy.
8-124.......................  ............................  ASTM F2052-06 [egr] Standard  Extent of recognition.
                                                             Test Method for Measurement
                                                             of Magnetically Induced
                                                             Displacement Force on
                                                             Medical Devices in the
                                                             Magnetic Resonance
                                                             Environment.
8-125.......................  ............................  ASTM F2004-05 (Reapproved     Extent of recognition.
                                                             2010) Standard Test Method
                                                             for Transformation
                                                             Temperature of Nickel-
                                                             Titanium Alloys by Thermal
                                                             Analysis.
8-126.......................  8-370.......................  ASTM F561-13 Standard         Withdrawn and replaced
                                                             Practice for Retrieval and    with newer version.
                                                             Analysis of Medical
                                                             Devices, and Associated
                                                             Tissues and Fluids.
8-128.......................  ............................  ASTM F2213-06 (Reapproved     Extent of recognition.
                                                             2011) Standard Test Method
                                                             for Measurement of
                                                             Magnetically Induced Torque
                                                             on Medical Devices in the
                                                             Magnetic Resonance
                                                             Environment.
8-132.......................  ............................  ASTM F1088-04a (Reapproved    Extent of recognition.
                                                             2010) Standard
                                                             Specification for Beta-
                                                             Tricalcium Phosphate for
                                                             Surgical Implantation.