
[Federal Register Volume 79, Number 131 (Wednesday, July 9, 2014)]
[Notices]
[Pages 38910-38920]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15989]


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

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: 036

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) 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: 036'' (``Recognition List Number: 036''), will assist 
manufacturers who elect to declare conformity with consensus standards 
to meet certain requirements for medical devices.

DATES: Submit either electronic or written comments concerning this 
document at any time. See section VII for the effective date of the 
recognition of standards announced in this document.

ADDRESSES: Submit written requests for single copies of the document 
entitled ``Modifications to the List of Recognized Standards, 
Recognition List Number: 036'' to the Division of Industry and Consumer 
Education, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver 
Spring,

[[Page 38911]]

MD 20993-0002. Send two self-addressed adhesive labels to assist that 
office in processing your request, or fax your request to 301-847-8149.
    Submit electronic comments on this document to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document. An electronic copy 
of Recognition List Number: 036 is available on the Internet 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: 036 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, standards@cdrh.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 204 of the Food and Drug Administration Modernization Act 
of 1997 (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 we would implement our 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 HTML and 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: 036

    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. We 
will incorporate these modifications in the list of FDA Recognized 
Consensus Standards in the Agency's searchable database. We will use 
the term ``Recognition List Number: 036'' to identify these current 
modifications.
    In table 1, we describe 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, we list 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
----------------------------------------------------------------------------------------------------------------
                              Replacement recognition
   Old  recognition  No.                No.                  Title of standard \1\               Change
----------------------------------------------------------------------------------------------------------------
                                                  A. Anesthesia
----------------------------------------------------------------------------------------------------------------
1-58......................  1-99......................  ASTM G175-13 Standard test      Withdrawn and replaced
                                                         method for evaluating the       with newer version.
                                                         ignition sensitivity and
                                                         fault tolerance of oxygen
                                                         pressure regulators used for
                                                         medical and emergency
                                                         applications.
1-77......................  1-100.....................  CGA V1:2013 Standard for        Withdrawn and replaced
                                                         compressed gas cylinder valve   with newer version.
                                                         outlet and inlet connections.
1-80......................  1-101.....................  CGA C-9:2013 Standard color     Withdrawn and replaced
                                                         marking of compressed gas       with newer version.
                                                         containers for medical use.
----------------------------------------------------------------------------------------------------------------
                                               B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-117.....................  ..........................  ANSI/AAMI/ISO 10993-3:2003/(R)  Reaffirmation.
                                                         2013 Biological evaluation of
                                                         medical devices--Part 3:
                                                         Tests for genotoxicity,
                                                         carcinogenicity, and
                                                         reproductive toxicity.
2-133.....................  ..........................  ASTM F1408-97 (Reapproved       Reaffirmation.
                                                         2013) Standard practice for
                                                         subcutaneous screening test
                                                         for implant materials.
2-136.....................  ..........................  ASTM E1262-88 (Reapproved       Reaffirmation.
                                                         2013) Standard guide for
                                                         performance of the Chinese
                                                         hamster ovary cell/
                                                         hypoxanthine guanine
                                                         phosphoribosyl transferase
                                                         gene mutation assay.
2-141.....................  ..........................  ASTM F1984-99 (Reapproved       Reaffirmation.
                                                         2013) Standard practice for
                                                         testing for whole complement
                                                         activation in serum by solid
                                                         materials.
2-145.....................  ..........................  ASTM F1439-03 (Reapproved       Reaffirmation.
                                                         2013) Standard guide for
                                                         performance of lifetime
                                                         bioassay for the tumorigenic
                                                         potential of implant
                                                         materials.
2-146.....................  2-206.....................  ASTM F2148-13 Standard          Withdrawn and replaced
                                                         practice for evaluation of      with newer version.
                                                         delayed contact
                                                         hypersensitivity using the
                                                         murine local lymph node assay
                                                         (LLNA).
2-153.....................  ..........................  ANSI/AAMI/ISO 10993-5:2009/(R)  Reaffirmation.
                                                         2014 Biological evaluation of
                                                         medical devices--Part 5:
                                                         Tests for in vitro
                                                         cytotoxicity.

[[Page 38912]]

 
2-154.....................  2-207.....................  ASTM F756-13 Standard practice  Withdrawn and replaced
                                                         for assessment of hemolytic     with newer version.
                                                         properties of materials.
2-156.....................  ..........................  ANSI/AAMI/ISO 10993-1:2009/(R)  Reaffirmation.
                                                         2013 Biological evaluation of
                                                         medical devices--Part 1:
                                                         Evaluation and testing within
                                                         a risk management process.
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.
2-199.....................  2-208.....................  USP 37-NF32:2014 <87>           Withdrawn and replaced
                                                         Biological reactivity test,     with newer version.
                                                         in vitro--direct contact test.
2-200.....................  2-209.....................  USP 37-NF32:2014 <87>           Withdrawn and replaced
                                                         Biological reactivity test,     with newer version.
                                                         in vitro--elution test.
2-201.....................  2-210.....................  USP 37-NF32:2014 <88>           Withdrawn and replaced
                                                         Biological reactivity test,     with newer version.
                                                         in vivo, procedure
                                                         preparation of sample.
2-202.....................  2-211.....................  USP 37-NF32:2014 <88>           Withdrawn and replaced
                                                         Biological reactivity test,     with newer version.
                                                         in vitro, classification of
                                                         plastics--intracutaneous test.
2-203.....................  2-212.....................  USP 37-NF32:2014 <88>           Withdrawn and replaced
                                                         Biological reactivity test,     with newer version.
                                                         in vivo, classification of
                                                         plastics--systemic injection
                                                         test.
----------------------------------------------------------------------------------------------------------------
                                                C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-42......................  ..........................  ANSI/AAMI EC13:2002/(R)2007     Withdrawn. See 3-101.
                                                         Cardiac monitors, heart rate
                                                         meters, and alarm.
3-65......................  ..........................  ANSI/AAMI EC38:2007 Medical     Withdrawn. See 3-127.
                                                         electrical equipment--Part 2-
                                                         47: Particular requirements
                                                         for the safety including
                                                         essential performance of
                                                         ambulatory
                                                         electrocardiographic systems.
3-72......................  3-129.....................  ANSI/AAMI EC53:2013 ECG trunk   Withdrawn and replaced
                                                         cables and patient lead wires.  with newer version.
3-77......................  ..........................  ANSI/AAMI PC69:2007 Active      Withdrawn. See 3-128.
                                                         implantable medical devices--
                                                         Electromagnetic
                                                         compatibility--EMC test
                                                         protocols for implantable
                                                         cardiac pacemakers and
                                                         implantable cardioverter
                                                         defibrillators.
3-78......................  3-130.....................  ANSI/AAMI/ISO 80601-2-30:2009   Withdrawn and replaced
                                                         and A1:2013 Medical             with newer version.
                                                         electrical equipment--Part 2-
                                                         30: Particular requirements
                                                         for the basic safety and
                                                         essential performance of
                                                         automated non-invasive
                                                         sphygmomanometers [Amendment
                                                         1:2013].
3-79......................  ..........................  F2070-09 (Reapproved 2013)      Reaffirmation.
                                                         Standard test method for
                                                         measuring intrinsic elastic
                                                         recoil of balloon-expandable
                                                         stents.
3-82......................  3-125.....................  ISO 5841 Third edition 2013-04- Withdrawn and replaced
                                                         15 Implants for surgery--       with newer version.
                                                         Cardiac pacemakers--Part 3:
                                                         Low-profile connectors [IS-1]
                                                         for implantable pacemakers.
3-95......................  3-126.....................  IEC 60601-2-27 Edition 3.0      Withdrawn and replaced
                                                         2011-03 Medical electrical      with newer version
                                                         equipment--Part 2-27:           including technical
                                                         Particular requirements for     corrigendum.
                                                         the basic safety and
                                                         essential performance of
                                                         electrocardiographic
                                                         monitoring equipment
                                                         [Including: Corrigendum 1
                                                         (2012)].
----------------------------------------------------------------------------------------------------------------
                                                  D. Dental/ENT
----------------------------------------------------------------------------------------------------------------
4-92......................  ..........................  ANSI/ADA Standard No. 88        Reaffirmation.
                                                         (Reaffirmed 2012) Dental
                                                         brazing alloys.
4-96......................  ..........................  ANSI/ADA Specification No. 30   Reaffirmation.
                                                         (Reaffirmed 2010) Dental zinc
                                                         oxide--eugenol and zinc
                                                         oxide--non-eugenol cements.
4-97......................  ..........................  ANSI/ADA Standard No. 57        Reaffirmation.
                                                         (Reaffirmed 2012) Endodontic
                                                         sealing materials.
4-149.....................  ..........................  ANSI/ADA Specification No. 39   Reaffirmation.
                                                         (Reaffirmed 2011) Pit and
                                                         fissure sealants.
4-160.....................  ..........................  ANSI S3.1 (Reaffirmed 2013)     Reaffirmation.
                                                         Maximum permissible ambient
                                                         noise levels for audiometric
                                                         test rooms.
4-162.....................  ..........................  ANSI S3.4-2007 (Reaffirmed      Reaffirmation.
                                                         2012) Procedure for the
                                                         computation of loudness of
                                                         steady sounds.
4-163.....................  ..........................  ANSI S3.5-1987 (Reaffirmed      Reaffirmation.
                                                         2012) American national
                                                         standard methods for
                                                         calculation of the speech
                                                         intelligibility index.
4-165.....................  ..........................  ANSI S3.13-1987 (Reaffirmed     Reaffirmation.
                                                         2012) American national
                                                         standard mechanical coupler
                                                         for measurement of bone
                                                         vibrators.
4-171.....................  ..........................  ANSI S3.37-1987 (Reaffirmed     Reaffirmation.
                                                         2012) American national
                                                         standard preferred earhook
                                                         nozzle thread for
                                                         postauricular hearing aids.
4-175.....................  4-211.....................  ANSI S3.46-2013 American        Withdrawn and replaced
                                                         national standard method of     with newer version.
                                                         measurement of real-ear
                                                         performance characteristics
                                                         of hearing aids.
4-177.....................  ..........................  ANSI S12.65-2006 (Reaffirmed    Reaffirmation.
                                                         2011) American national
                                                         standard for rating noise
                                                         with respect to speech
                                                         interference.

[[Page 38913]]

 
4-179.....................  4-212.....................  ISO 7405 Second edition 2008-   Withdrawn and replaced
                                                         12-15 Dentistry--Evaluation     with newer version
                                                         of biocompatibility of          including amendment.
                                                         medical devices used in
                                                         dentistry [Including:
                                                         Amendment 1 (2013)].
4-193.....................  ..........................  ANSI/ADA Standard No. 15        Reaffirmation.
                                                         (Reaffirmed 2013) Artificial
                                                         teeth for dental prostheses.
----------------------------------------------------------------------------------------------------------------
                             E. General I (Quality Systems/Risk Management (QS/RM))
----------------------------------------------------------------------------------------------------------------
5-22......................  ..........................  ISO 2768-l First edition 1999-  Withdrawn.
                                                         11-15 General tolerances--
                                                         Part 1: Tolerances for linear
                                                         and angular dimensions
                                                         without individual tolerance
                                                         indications.
5-23......................  ..........................  ISO 2768-2 First edition 1989-  Withdrawn.
                                                         11-15 General tolerances--
                                                         Part 2: Geometrical
                                                         tolerances for features
                                                         without individual tolerance
                                                         indications.
5-50......................  5-87......................  IEC 62366 Edition 1.1 2014-01   Withdrawn and replaced
                                                         Medical devices--Application    with newer version.
                                                         of usability engineering to
                                                         medical devices.
5-53......................  19-1......................  IEC 60601-1-2 Edition 3:2007-   Transferred to General
                                                         03 Medical electrical           II (ES/EMC).
                                                         equipment--Part 1-2: General
                                                         requirements for basic safety
                                                         and essential performance--
                                                         Collateral standard:
                                                         Electromagnetic
                                                         compatibility--Requirements
                                                         and tests.
5-54......................  19-2......................  ANSI/AAMI/IEC 60601-1-2:2007/   Transferred to General
                                                         (R)2012 Medical electrical      II (ES/EMC).
                                                         equipment--Part 1-2: General
                                                         requirements for basic safety
                                                         and essential performance--
                                                         Collateral standard:
                                                         Electromagnetic
                                                         compatibility--Requirements
                                                         and tests.
5-66......................  19-3......................  IEC 60601-1-10 Edition 1.0      Transferred to General
                                                         2007-11 Medical electrical      II (ES/EMC).
                                                         equipment--Part 1-10: General
                                                         requirements for basic safety
                                                         and essential performance--
                                                         Collateral standard:
                                                         Requirements for the
                                                         development of physiologic
                                                         closed-loop controllers.
5-77......................  19-4......................  ANSI/AAMI ES60601-1:2005/       Transferred to General
                                                         (R)2012 and A1:2012,C1:2009/    II (ES/EMC).
                                                         (R)2012 and A2:2010/(R)2012
                                                         (consolidated text) Medical
                                                         electrical equipment--Part 1:
                                                         General requirements for
                                                         basic safety and essential
                                                         performance (IEC 60601-
                                                         1:2005, mod).
5-78......................  19-5......................  ANSI/AAMI ES60601-1:2005/       Transferred to General
                                                         (R)2012 and C1:2009/(R)2012     II (ES/EMC).
                                                         and A2:2010/(R)2012
                                                         (consolidated text) Medical
                                                         electrical equipment--Part 1:
                                                         General requirements for
                                                         basic safety and essential
                                                         performance (IEC 60601-
                                                         1:2005, mod).
5-81......................  5-88......................  ISO 2859-1 First edition 1999-  Withdrawn and replaced
                                                         11-15 Sampling procedures for   with newer version
                                                         inspection by attributes--      including amendment.
                                                         Part 1: Sampling schemes
                                                         indexed by acceptance quality
                                                         limit (AQL) for lot-by-lot
                                                         inspection [Including:
                                                         Corrigendum 1 (2001),
                                                         Amendment 1 (2011)].
5-82......................  19-6......................  IEC 60601-1-11 Edition 1.0      Transferred to General
                                                         2010-04 Medical electrical      II (ES/EMC).
                                                         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 [including:
                                                         Technical corrigendum 1
                                                         (2011)].
5-83......................  19-7......................  ANSI/AAMI HA60601-1-11:2011     Transferred to General
                                                         Medical electrical equipment--  II (ES/EMC).
                                                         Part 1-11: General
                                                         requirements for basic safety
                                                         and essential performance--
                                                         Collateral standard:
                                                         Requirements for medical
                                                         electrical equipment and
                                                         medical electrical systems
                                                         used in the home healthcare
                                                         environment (IEC 60601-1-
                                                         11:2010 mod).
5-85......................  ..........................  IEC 60601-1-6 Edition 3.0 2010- Transition period added.
                                                         01 Medical electrical
                                                         equipment--Part 1-6: General
                                                         requirements for basic safety
                                                         and essential performance--
                                                         Collateral standard:
                                                         Usability.
5-73......................  5-90......................  ISO 15223-1 Second edition      Extent of recognition.
                                                         2012-07-01 Medical devices--
                                                         Symbols to be used with
                                                         medical device labels,
                                                         labeling, and information to
                                                         be supplied--Part 1: General
                                                         requirements.
5-75......................  5-91......................  AAMI/ANSI/ISO 15223-1:2012      Extent of recognition.
                                                         Medical devices--Symbols to
                                                         be used with medical devices
                                                         labels, labeling, and
                                                         information to be supplied--
                                                         Part 1: General requirements.
5-57......................  ..........................  AAMI/ANSI HE75:2009 Human       Relevant guidance.
                                                         factors engineering--Design
                                                         of medical devices.
5-67......................  ..........................  ANSI/AAMI/IEC 62366:2007/       Relevant guidance.
                                                         (R)2013 Medical devices--
                                                         Application of usability
                                                         engineering to medical
                                                         devices.
----------------------------------------------------------------------------------------------------------------
                                   F. General Hospital/General Plastic Surgery
----------------------------------------------------------------------------------------------------------------
6-180.....................  ..........................  ASTM F2407-06 (Reapproved       Reaffirmation.
                                                         2013) Standard specification
                                                         for surgical gowns intended
                                                         for use in healthcare
                                                         facilities.

[[Page 38914]]

 
6-184.....................  6-323.....................  ASTM F1862/F1862M-13 Standard   Withdrawn and replaced
                                                         test method for resistance of   with newer version.
                                                         medical face masks to
                                                         penetration by synthetic
                                                         blood (horizontal projection
                                                         of fixed volume at a known
                                                         velocity).
6-234.....................  6-324.....................  IEC 60601-2-50 Edition 2.0      Withdrawn and replaced
                                                         2009-03 Medical electrical      with newer version
                                                         equipment--Part 2-50:           including technical
                                                         Particular requirements for     corrigendum.
                                                         the basic safety and
                                                         essential performance of
                                                         infant phototherapy equipment
                                                         [Including: Technical
                                                         corrigendum 1 (2010)].
6-300.....................  6-325.....................  IEC 60601-2-21 Edition 2.0      Withdrawn and replaced
                                                         2009-02 Medical electrical      with newer version
                                                         equipment--Part 2-21:           including technical
                                                         Particular requirements for     corrigendum.
                                                         the basic safety and
                                                         essential performance of
                                                         infant radiant warmers
                                                         [Including: Technical
                                                         corrigendum 1 (2013)].
6-309.....................  6-326.....................  USP 37-NF 33:2014 Sodium        Withdrawn and replaced
                                                         chloride irrigation.            with newer version.
6-310.....................  6-327.....................  USP 37-NF 33:2014 Sodium        Withdrawn and replaced
                                                         chloride injection.             with newer version.
6-311.....................  6-328.....................  USP 37-NF 33:2014               Withdrawn and replaced
                                                         Nonabsorbable surgical suture.  with newer version.
6-312.....................  6-329.....................  USP 37-NF 33:2014 <881>         Withdrawn and replaced
                                                         Tensile strength.               with newer version.
6-313.....................  6-330.....................  USP 37-NF 33:2014 <861>         Withdrawn and replaced
                                                         Sutures--Diameter.              with newer version.
6-314.....................  6-331.....................  USP 37-NF 33:2014 <871>         Withdrawn and replaced
                                                         Sutures--Needle attachment.     with newer version.
6-315.....................  6-332.....................  USP 37-NF 33:2014 Sterile       Withdrawn and replaced
                                                         water for irrigation.           with newer version.
6-316.....................  6-333.....................  USP 37-NF 33:2014 Heparin lock  Withdrawn and replaced
                                                         flush solution.                 with newer version.
6-317.....................  6-334.....................  USP 37-NF 33:2014 Absorbable    Withdrawn and replaced
                                                         surgical suture.                with newer version.
----------------------------------------------------------------------------------------------------------------
                                             G. In Vitro Diagnostics
----------------------------------------------------------------------------------------------------------------
7-48......................  ..........................  CLSI C60-A (Formerly T/DM06-A)  Designation number.
                                                         Blood alcohol testing in the
                                                         clinical laboratory; Approved
                                                         guideline.
7-112.....................  ..........................  CLSI POCT14-A (Formerly H49-A)  Designation number.
                                                         Point-of-care monitoring of
                                                         anticoagulation therapy;
                                                         Approved guideline.
7-133.....................  7-246.....................  CLSI POCT12-A3 Point-of-care    Withdrawn and replaced
                                                         blood glucose testing in        with newer version.
                                                         acute and chronic care
                                                         facilities; Approved
                                                         guideline--Third edition.
7-142.....................  ..........................  CLSI GP43-A4 (Replaces H11-A4)  Designation number.
                                                         Procedures for the collection
                                                         of arterial blood specimens;
                                                         Approved standard--Fourth
                                                         edition.
7-162.....................  ..........................  CLSI POCT14-A (Formerly H49-A)  Designation number.
                                                         Point-of-care monitoring of
                                                         anticoagulation therapy;
                                                         Approved guideline.
7-175.....................  ..........................  CLSI C59-A (Formerly I/LA15-A)  Designation number.
                                                         Apolipoprotein immunoassays:
                                                         Development and recommended
                                                         performance characteristics;
                                                         Approved guideline.
7-201.....................  ..........................  CLSI GP41-A6 (Replaces H03-A6)  Designation number.
                                                         Procedures for the collection
                                                         of diagnostic blood specimens
                                                         by venipuncture; Approved
                                                         standard--Sixth edition.
7-203.....................  ..........................  CLSI GP42-A6 (Replaces H04-A6)  Designation number.
                                                         Procedures and devices for
                                                         the collection of diagnostic
                                                         capillary blood specimens;
                                                         Approved standard--Sixth
                                                         edition.
7-213.....................  ..........................  CLSI GP44-A4 (Replaces H18-A4)  Designation number.
                                                         Procedures for the handling
                                                         and processing of blood
                                                         specimens for common
                                                         laboratory tests; Approved
                                                         guideline--Fourth edition.
7-221.....................  ..........................  CLSI GP39-A6 (Replaces H01-A6)  Designation number.
                                                         Tubes and additives for
                                                         venous and capillary blood
                                                         specimen collection; Approved
                                                         standard--Sixth edition.
7-241.....................  7-247.....................  CLSI M100-S24 Performance       Withdrawn and replaced
                                                         standards for antimicrobial     with newer version.
                                                         susceptibility testing;
                                                         Twenty-fourth informational
                                                         supplement.
----------------------------------------------------------------------------------------------------------------
                                                  H. Materials
----------------------------------------------------------------------------------------------------------------
8-173.....................  8-371.....................  ASTM F601-13 Standard practice  Withdrawn and replaced
                                                         for fluorescent penetrant       with newer version.
                                                         inspection of metallic
                                                         surgical implants.
8-183.....................  8-372.....................  ASTM F560-13 Standard           Withdrawn and replaced
                                                         specification for unalloyed     with newer version.
                                                         tantalum for surgical implant
                                                         applications (UNS R05200, UNS
                                                         R05400).
8-193.....................  ..........................  ASTM F2754/F2754M-09            Reaffirmation.
                                                         (Reapproved 2013) Standard
                                                         test method for measurement
                                                         of camber, cast, helix, and
                                                         direction of helix of coiled
                                                         wire.

[[Page 38915]]

 
8-198.....................  8-373.....................  ASTM F2102-13 Standard guide    Withdrawn and replaced
                                                         for evaluating the extent of    with newer version.
                                                         oxidation in polyethylene
                                                         fabricated forms intended for
                                                         surgical implants.
8-199.....................  8-374.....................  ASTM F2633-13 Standard          Withdrawn and replaced
                                                         specification for wrought       with newer version.
                                                         seamless nickel-titanium
                                                         shape memory alloy tube for
                                                         medical devices and surgical
                                                         implants.
8-221.....................  8-375.....................  ASTM F2066-13 Standard          Withdrawn and replaced
                                                         specification for wrought       with newer version.
                                                         titanium-15 molybdenum alloy
                                                         for surgical implant
                                                         applications (UNS R58150).
8-224.....................  8-376.....................  ASTM F2102-13 Standard guide    Withdrawn and replaced
                                                         for evaluating the extent of    with newer version.
                                                         oxidation in polyethylene
                                                         fabricated forms intended for
                                                         surgical implants.
8-341.....................  8-377.....................  ASTM F136-13 Standard           Withdrawn and replaced
                                                         specification for wrought       with newer version.
                                                         titanium-6aluminum-4vanadium
                                                         ELI (extra low interstitial)
                                                         alloy for surgical implant
                                                         applications (UNS R56401).
8-364.....................  8-378.....................  ASTM D792-13 Standard test      Withdrawn and replaced
                                                         methods for density and         with newer version.
                                                         specific gravity (relative
                                                         density) of plastics by
                                                         displacement.
8-366.....................  8-379.....................  ISO 11542-2 First edition 1998- Withdrawn and replaced
                                                         11-15 Plastics--Ultra-high-     with newer version
                                                         molecular-weight polyethylene   including technical
                                                         (PE-UHMW) moulding and          corrigendum.
                                                         extrusion materials--Part 2:
                                                         Preparation of test specimens
                                                         and determination of
                                                         properties [Including:
                                                         Technical corrigendum 1
                                                         (2007)].
----------------------------------------------------------------------------------------------------------------
                                                I. Nanotechnology
----------------------------------------------------------------------------------------------------------------
18-2......................  ..........................  ASTM E2535-07 (Reapproved       Reaffirmation.
                                                         2013) Standard guide for
                                                         handling unbound engineered
                                                         nanoscale particles in
                                                         occupational settings.
----------------------------------------------------------------------------------------------------------------
                                                  J. Neurology
----------------------------------------------------------------------------------------------------------------
17-10.....................  ..........................  ANSI/AAMI/ISO 14708-3:2008/     Reaffirmation.
                                                         (R)2011 Implants for surgery--
                                                         Active implantable medical
                                                         devices--Part 3: Implantable
                                                         neurostimulators.
----------------------------------------------------------------------------------------------------------------
                                       K. OB-GYN/Gastroenterology/Urology
----------------------------------------------------------------------------------------------------------------
9-44......................  ..........................  ASTM F623-99 (Reapproved 2013)  Reaffirmation.
                                                         Standard performance
                                                         specification for Foley
                                                         catheter.
9-87......................  9-93......................  ISO 25841 Second edition 2014-  Withdrawn and replaced
                                                         01-15 Female condoms--          with newer version.
                                                         Requirements and test methods.
9-21......................  9-94......................  ISO 8600-4 Second edition 2014- Withdrawn and replaced
                                                         03-15 Optics and optical        with newer version.
                                                         instruments--Medical
                                                         endoscopes and certain
                                                         accessories--Part 4:
                                                         Determination of maximum
                                                         width of insertion portion.
----------------------------------------------------------------------------------------------------------------
                                                  L. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-211....................  11-276....................  ASTM F1798-13 Standard test     Withdrawn and replaced
                                                         method for evaluating the       with newer version.
                                                         static and fatigue properties
                                                         of interconnection mechanisms
                                                         and subassemblies used in
                                                         spinal arthrodesis implants.
11-237....................  11-277....................  ISO 7206-6 Second edition 2013- Withdrawn and replaced
                                                         11-15 Implants for surgery--    with newer version.
                                                         Partial and total hip joint
                                                         prostheses--Part 6: Endurance
                                                         properties testing and
                                                         performance requirements of
                                                         neck region of stemmed
                                                         femoral components.
11-255....................  11-278....................  ASTM F1717-14 Standard test     Withdrawn and replaced
                                                         methods for spinal implant      with newer version.
                                                         constructs in a vertebrectomy
                                                         model.
----------------------------------------------------------------------------------------------------------------
                                                  M. Radiology
----------------------------------------------------------------------------------------------------------------
12-23.....................  ..........................  NEMA XR 10-1986 (R1992, R1998,  Withdrawn.
                                                         R2003) Measurement of the
                                                         maximum symmetrical radiation
                                                         field from a rotating anode x-
                                                         ray tube used for medical
                                                         diagnosis.
12-24.....................  ..........................  NEMA XR 11-1993 (R1999) Test    Withdrawn.
                                                         standard for determination of
                                                         the limiting spatial
                                                         resolution of x-ray image
                                                         intensifier systems.
12-25.....................  ..........................  NEMA XR 15-1991 (R1996, R2001)  Withdrawn.
                                                         Test standard for the
                                                         determination of the visible
                                                         entrance field size of an x-
                                                         ray image intensifier system.
12-26.....................  ..........................  NEMA XR 16-1991 (R1996, R2001)  Withdrawn.
                                                         Test standard for the
                                                         determination of the system
                                                         contrast ratio and the system
                                                         veiling glare index of an x-
                                                         ray image intensifier system.
12-27.....................  ..........................  NEMA XR 17-1993 (R1999) Test    Withdrawn.
                                                         standard for the measurement
                                                         of the image signal
                                                         uniformity of an x-ray image
                                                         intensifier system.

[[Page 38916]]

 
12-28.....................  ..........................  NEMA XR 18-1993 (R1999) Test    Withdrawn.
                                                         standard for the
                                                         determination of the radial
                                                         image distortion of an x-ray
                                                         image intensifier system.
12-29.....................  ..........................  NEMA XR 19-1993 (R1999)         Withdrawn.
                                                         Electrical, thermal, and
                                                         loading characteristics of x-
                                                         ray tubes used for medical
                                                         diagnosis.
12-66.....................  12-271....................  AIUM MUS Medical ultrasound     Withdrawn and replaced
                                                         safety, third edition.          with newer version.
12-79.....................  ..........................  NEMA XR7-1995 (R2000) High-     Withdrawn.
                                                         voltage x-ray cable
                                                         assemblies and receptacles.
12-80.....................  ..........................  NEMA XR 9-1984 (R1994, R2000)   Withdrawn.
                                                         Power supply guidelines for x-
                                                         ray machines.
12-81.....................  ..........................  NEMA XR 13-1990 (R1995, R2000)  Withdrawn.
                                                         Mechanical safety standard
                                                         for power driven motions of
                                                         electromedical equipment.
12-82.....................  ..........................  NEMA XR 14-1990 (R1995, R2000)  Withdrawn.
                                                         Recommended practices for
                                                         load bearing mechanical
                                                         assemblies used in diagnostic
                                                         imaging.
12-100....................  ..........................  NEMA UD 3-2004 (R2009)          Withdrawn
                                                         Standard for real time
                                                         display of thermal and
                                                         mechanical acoustic output
                                                         indices on diagnostic
                                                         ultrasound equipment.
12-146....................  12-272....................  IEC 60601-2-17 Edition 3.0      Withdrawn and replaced
                                                         2013-11 Medical electrical      with newer version.
                                                         equipment--Part 2-17:
                                                         Particular requirements for
                                                         the basic safety and
                                                         essential performance of
                                                         automatically-controlled
                                                         brachytherapy afterloading
                                                         equipment.
12-168....................  12-273....................  IEC 60825-1 Edition 2.0 2007-   Withdrawn and replaced
                                                         03 Safety of laser products--   with newer version
                                                         Part 1: Equipment               including technical
                                                         classification and              corrigendum and
                                                         requirements [Including:        interpretation sheets.
                                                         Technical corrigendum 1
                                                         (2008), interpretation sheet
                                                         1 (2007), interpretation
                                                         sheet 2 (2007)].
12-193....................  ..........................  AIUM AOL 2008 Acoustic output   Withdrawn.
                                                         labeling standard for
                                                         diagnostic ultrasound
                                                         equipment revision 1--A
                                                         standard for how
                                                         manufacturers should specify
                                                         acoustic output data.
12-194....................  ..........................  ANSI/HPS N43.6-2007 (R2013)     Reaffirmation.
                                                         Sealed radioactive sources--
                                                         Classification.
12-201....................  12-274....................  IEC 60601-2-54 Edition 1.0      Withdrawn and replaced
                                                         2009-06 Medical electrical      with newer version
                                                         equipment--Part 2-54:           including technical
                                                         Particular requirements for     corrigendum.
                                                         the basic safety and
                                                         essential performance of x-
                                                         ray equipment for radiography
                                                         and radioscopy [Including:
                                                         Technical corrigendum 1
                                                         (2010), technical corrigendum
                                                         2 (2011)].
12-220....................  ..........................  IEC 60825-1 (Second edition-    Withdrawn. See 12-273.
                                                         2007) Safety of laser
                                                         products--Part 1: Equipment
                                                         classification and
                                                         requirements corrigendum 1.
12-239....................  ..........................  IEC 60825-1 (Second edition-    Withdrawn. See 12-273.
                                                         2007) I-SH 01 Safety of laser
                                                         products--Part 1: Equipment
                                                         classification and
                                                         requirements, interpretation
                                                         sheet 1.
12-240....................  ..........................  IEC 60825-1 (2007) Second       Withdrawn. See 12-273.
                                                         edition, I-SH 02 Safety of
                                                         laser products--Part 1:
                                                         Equipment classification and
                                                         requirements, interpretation
                                                         sheet 2.
----------------------------------------------------------------------------------------------------------------
                                             N. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-4......................  13-65.....................  ANSI/UL 1998 Third edition      Withdrawn and replaced
                                                         2013 Standard for software in   with newer version.
                                                         programmable components.
13-15.....................  ..........................  CLSI AUTO13-A2 Laboratory       New designation number.
                                                         instruments and data
                                                         management systems: Design of
                                                         software user interfaces and
                                                         end-user software systems
                                                         validation, operation, and
                                                         monitoring; Approved
                                                         guideline--second edition.
13-46.....................  ..........................  ASTM F2761-09 (2013) Medical    Reaffirmation.
                                                         devices and medical systems--
                                                         Essential safety requirements
                                                         for equipment comprising the
                                                         patient-centric integrated
                                                         clinical environment (ICE)--
                                                         Part 1: General requirements
                                                         and conceptual model.
13-58.....................  13-66.....................  ISO/IEEE 11073-10417 First      Withdrawn and replaced
                                                         edition 2014-03-01 Health       with newer version.
                                                         informatics--Personal health
                                                         device communication--Part
                                                         10417: Device specialization:
                                                         Glucose meter.
----------------------------------------------------------------------------------------------------------------
                                                  O. Sterility
----------------------------------------------------------------------------------------------------------------
14-181....................  14-432....................  ANSI/AAMI ST58:2013 Chemical    Withdrawn and replaced
                                                         sterilization and high-level    with newer version.
                                                         disinfection in health care
                                                         facilities.
14-228....................  ..........................  ANSI/AAMI/ISO 11135-1:2007      Withdrawn. See 14-452.
                                                         Sterilization of healthcare
                                                         products--Ethylene oxide--
                                                         Part 1: Requirements for the
                                                         development, validation, and
                                                         routine control of a
                                                         sterilization process for
                                                         medical devices.

[[Page 38917]]

 
14-232....................  14-433....................  ASTM F2227-13 Standard test     Withdrawn and replaced
                                                         method for non-destructive      with newer version.
                                                         detection of leaks in non-
                                                         sealed and empty packaging
                                                         trays by CO2 tracer gas
                                                         method.
14-233....................  14-434....................  ASTM F2228-13 Standard test     Withdrawn and replaced
                                                         method for non-destructive      with newer version.
                                                         detection of leaks in
                                                         packaging which incorporates
                                                         porous barrier material by
                                                         CO2 tracer gas method.
14-256....................  ..........................  ASTM F2095-07 (Reapproved       Reaffirmation.
                                                         2013) Standard test methods
                                                         for pressure decay leak test
                                                         for flexible packages with
                                                         and without restraining
                                                         plates.
14-257....................  ..........................  ASTM D3078-02 (Reapproved       Reaffirmation.
                                                         2013) Standard test method
                                                         for determination of leaks in
                                                         flexible packaging by bubble
                                                         emission.
14-259....................  14-435....................  ASTM F2251-13 Standard test     Withdrawn and replaced
                                                         method for thickness            with newer version.
                                                         measurement of flexible
                                                         packaging material.
14-261....................  ..........................  ANSI/AAMI/ISO 17665-1:2006/     Reaffirmation.
                                                         (R)2013 Sterilization of
                                                         health care products--Moist
                                                         heat--Part 1: Requirements
                                                         for the development,
                                                         validation, and routine
                                                         control of a sterilization
                                                         process for medical devices.
14-282....................  ..........................  ASTM F2338-09 (Reapproved       Reaffirmation.
                                                         2013) Standard test method
                                                         for nondestructive detection
                                                         of leaks in packages by
                                                         vacuum decay method.
14-286....................  ..........................  ANSI/AAMI ST65:2008/(R)2013     Reaffirmation.
                                                         Processing of reusable
                                                         surgical textiles for use in
                                                         health care facilities.
14-288....................  ..........................  ASTM F1886/F1886M-09            Reaffirmation.
                                                         (Reapproved 2013) Standard
                                                         test method for determining
                                                         integrity of seals for
                                                         flexible packaging by visual
                                                         inspection.
14-290....................  ..........................  ANSI/AAMI ST24:1999/(R)2013     Reaffirmation.
                                                         Automatic, general purpose
                                                         ethylene oxide sterilizers
                                                         and ethylene oxide sterilant
                                                         sources intended for use in
                                                         health care facilities.
14-291....................  ..........................  ANSI/AAMI/ISO 14937:2009/       Reaffirmation.
                                                         (R)2013 Sterilization of
                                                         healthcare products--General
                                                         requirements for
                                                         characterization of a
                                                         sterilizing agent and the
                                                         development, validation, and
                                                         routine control of a
                                                         sterilization process for
                                                         medical devices.
14-331....................  14-452....................  ISO 11135 Second edition 2014   Withdrawn and replaced
                                                         Sterilization of healthcare     with newer version.
                                                         products--Ethylene oxide--
                                                         Requirements for the
                                                         development, validation, and
                                                         routine control of a
                                                         sterilization process for
                                                         medical devices.
14-342....................  ..........................  ASTM E2628-09 (E2009) Standard  Withdrawn. See 14-436.
                                                         practice for dosimetry in
                                                         radiation.
13-343....................  ..........................  ASTM E2701-09 Standard guide    Withdrawn. See 14-437.
                                                         for performance
                                                         characterization of
                                                         dosimeters and dosimetry
                                                         systems for use in radiation
                                                         processing.
14-348....................  ..........................  ANSI/AAMI/ISO 13408-2:2003/     Reaffirmation.
                                                         (R)2013 Aseptic processing of
                                                         healthcare products--Part 2:
                                                         Filtration.
14-364....................  14-438....................  ANSI/AAMI/ISO 11137-2:2013      Withdrawn and replaced
                                                         Sterilization of health care    with newer version.
                                                         products--Radiation--Part 2:
                                                         Establishing the
                                                         sterilization dose.
14-394....................  14-439....................  ANSI/AAMI ST79:2010, A1:2010,   Withdrawn and replaced
                                                         A2:2011, A3:2012, and A4:2013   with newer version.
                                                         (consolidated text)
                                                         Comprehensive guide to steam
                                                         sterilization and sterility
                                                         assurance in health care
                                                         facilities.
14-414....................  14-440....................  USP 37NF32:2014                 Withdrawn and replaced
                                                         Microbiological examination     with newer version.
                                                         of nonsterile products:
                                                         Microbial enumeration tests.
14-415....................  14-441....................  USP 37NF32:2014 Sterility       Withdrawn and replaced
                                                         tests.                          with newer version.
14-416....................  14-442....................  USP 37NF32:2014 Bacterial       Withdrawn and replaced
                                                         endotoxins test.                with newer version.
14-417....................  14-443....................  USP 37NF32:2014 Pyrogen test    Withdrawn and replaced
                                                         (USP rabbit test).              with newer version.
14-418....................  14-444....................  USP 37NF32:2014 Transfusion     Withdrawn and replaced
                                                         and infusion assemblies and     with newer version.
                                                         similar medical devices.
14-419....................  14-445....................  USP 37NF32:2014 Biological      Withdrawn and replaced
                                                         indicator for steam             with newer version.
                                                         sterilization--Self-contained.
14-420....................  14-446....................  USP 37NF32:2014 Biological      Withdrawn and replaced
                                                         indicator for dry-heat          with newer version.
                                                         sterilization, paper carrier.
14-421....................  14-447....................  USP 37NF32:2014 Biological      Withdrawn and replaced
                                                         indicator for ethylene oxide    with newer version.
                                                         sterilization, paper carrier.
14-422....................  14-448....................  USP 37NF32:2014 Biological      Withdrawn and replaced
                                                         indicator for steam             with newer version.
                                                         sterilization, paper carrier.
14-423....................  14-449....................  USP 37NF32:2014                 Withdrawn and replaced
                                                         Microbiological examination     with newer version.
                                                         of nonsterile products: Tests
                                                         for specified microorganisms.

[[Page 38918]]

 
14-425....................  ..........................  ANSI/AAMI/ISO 13408-6:2005/     Reaffirmation.
                                                         (R)2013 and A1:2013 Aseptic
                                                         processing of healthcare
                                                         products--Part 6: Isolator
                                                         systems.
----------------------------------------------------------------------------------------------------------------
                                              P. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-21.....................  15-39.....................  ASTM F2150-13 Standard guide    Withdrawn and replaced
                                                         for characterization and        with newer version.
                                                         testing of biomaterial
                                                         scaffolds used in tissue-
                                                         engineered medical
                                                         products(TEMPs).
15-26.....................  15-40.....................  ASTM F2211-13 Standard          Withdrawn and replaced
                                                         classification for tissue-      with newer version.
                                                         engineered medical products
                                                         (TEMPs).
15-33.....................  15-41.....................  ASTM F2602-13 Standard test     Withdrawn and replaced
                                                         method for determining the      with newer version.
                                                         molar mass of chitosan and
                                                         chitosan salts by size
                                                         exclusion chromatography with
                                                         multi-angle light scattering
                                                         detection (SEC-MALS).
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.

III. Listing of New Entries

    In table 2, we provide the listing of new entries and consensus 
standards added as modifications to the list of recognized standards 
under Recognition List Number: 036.

        Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
                                                          Reference No.
       Recognition No.          Title of standard \1\        and date
------------------------------------------------------------------------
                            A. Cardiovascular
------------------------------------------------------------------------
3-127.......................  Medical electrical         ANSI/AAMI/IEC
                               equipment--Part 2-47:      60601-2-47:201
                               Particular requirements    2.
                               for the basic safety and
                               essential performance of
                               ambulatory
                               electrocardiographic
                               systems.
3-128.......................  Active implantable         ANSI/AAMI/ISO
                               medical devices--          14117:2012.
                               Electromagnetic
                               compatibility--EMC test
                               protocols for
                               implantable cardiac
                               pacemakers, implantable
                               cardioverter
                               defibrillators, and
                               cardiac
                               resynchronization
                               devices.
------------------------------------------------------------------------
          B. General I (Quality System/Risk Management (QS/RM))
------------------------------------------------------------------------
5-89........................  Medical electrical         IEC 60601-1-6
                               equipment--Part 1-6:       Edition 3.1
                               General requirements for   2013-10.
                               basic safety and
                               essential performance--
                               Collateral standard:
                               Usability.
5-92........................  Medical Electrical         ANSI/AAMI/IEC
                               Equipment--Part 1-8:       60601-1-8:2006
                               General requirements for   & A1:2012.
                               basic safety and
                               essential performance--
                               Collateral standard:
                               General requirements,
                               tests and guidance for
                               alarm systems in medical
                               electrical equipment and
                               medical electrical
                               systems.
------------------------------------------------------------------------
C. General II (Electrical Safety/Electromagnetic Compatibility (ES/EMC))
------------------------------------------------------------------------
19-1........................  Medical electrical         IEC 60601-1-2
                               equipment--Part 1-2:       Edition 3:2007-
                               General requirements for   03.
                               basic safety and
                               essential performance--
                               Collateral standard:
                               electromagnetic
                               compatibility--requireme
                               nts and tests.
19-2........................  Medical electrical         ANSI/AAMI/IEC
                               equipment--Part 1-2:       60601-1-2:2007/
                               General requirements for   (R)2012.
                               basic safety and
                               essential performance--
                               Collateral standard:
                               electromagnetic
                               compatibility--requireme
                               nts and tests.
19-3........................  Medical electrical         IEC 60601-1-10
                               equipment--Part 1-10:      Edition
                               General requirements for   1.0:2007-11.
                               basic safety and
                               essential performance--
                               Collateral standard:
                               requirements for the
                               development of
                               physiologic closed-loop
                               controllers.
19-4........................  Medical electrical         ANSI/AAMI
                               equipment--Part 1:         ES60601-1:2005/
                               General requirements for   (R)2012 and
                               basic safety and           A1:2012,C1:200
                               essential performance      9/(R)2012 and
                               (IEC 60601-1:2005, mod).   A2:2010/
                                                          (R)2012.
19-5........................  Medical electrical         ANSI/AAMI
                               equipment--Part 1:         ES60601-1:2005/
                               General requirements for   (R)2012 and
                               basic safety and           C1:2009/
                               essential performance      (R)2012 and,
                               (IEC 60601-1:2005, mod).   A2:2010/
                                                          (R)2012
                                                          (Consolidated
                                                          text).
19-6........................  Medical electrical         IEC 60601-1-11
                               equipment--Part 1-11:      Edition
                               General requirements for   1.0:2010-04.
                               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)].
19-7........................  Medical electrical         ANSI/AAMI
                               equipment--Part 1-11:      HA60601-1-11:2
                               General requirements for   011.
                               basic safety and
                               essential performance--
                               Collateral standard:
                               Requirements for medical
                               electrical equipment and
                               medical electrical
                               systems used in the home
                               healthcare environment
                               (IEC 60601-1-11:2010
                               mod).

[[Page 38919]]

 
19-8........................  Medical electrical         IEC 60601-1-2
                               equipment--Part 1-2:       Edition
                               General requirements for   4.0:2014-02.
                               basic safety and
                               essential performance--
                               Collateral standard:
                               Electromagnetic
                               disturbances--Requiremen
                               ts and tests.
19-9........................  Medical electrical         IEC 60601-1-10
                               equipment--Part 1-10:      Edition
                               General requirements for   1.1:2013-11.
                               basic safety and
                               essential performance--
                               Collateral standard:
                               Requirements for the
                               development of
                               physiologic closed-loop
                               controllers.
19-10.......................  Lithium batteries........  UL 1642 5th
                                                          Edition 2013.
19-11.......................  Household and commercial   UL 2054 2nd
                               batteries.                 Edition 2011.
------------------------------------------------------------------------
                             D. Orthopedics
------------------------------------------------------------------------
11-279......................  Standard practice for      ASTM F2996-13.
                               finite element analysis
                               (FEA) of non-modular
                               metallic orthopaedic hip
                               femoral stems.
11-280......................  Standard test method for   ASTM F2624-12.
                               static, dynamic, and
                               wear assessment of extra-
                               discal single level
                               spinal constructs.
------------------------------------------------------------------------
                              E. Radiology
------------------------------------------------------------------------
12-275......................  Ultrasonics--Power         IEC 61161
                               measurement--Radiation     Edition
                               force balances and         3.0:2013-01.
                               performance requirements.
12-276......................  Ultrasonics--Output test-- IEC TS 62462
                               Guide for the              First edition
                               maintenance of             2007-05.
                               ultrasound physiotherapy
                               systems.
12-277......................  Ultrasonics--Hydrophones-  IEC 62127-1
                               -Part 1: Measurement and   Edition
                               characterization of        1.1:2013-02.
                               medical ultrasonic
                               fields up to 40
                               megahertz (MHz).
12-278......................  Ultrasonics--Hydrophones-  IEC 62127-2
                               -Part 2: Calibration for   Edition
                               ultrasonic fields up to    1.0:2007-08.
                               40 MHz (including
                               corrigendum 1:2008 and
                               amendment 1:2013).
12-279......................  Ultrasonics--Hydrophones-  IEC 62127-3
                               -Part 3: Properties of     Edition
                               hydrophones for            1.1:2013-05.
                               ultrasonic fields up to
                               40 MHz.
12-280......................  Ultrasonics--Power         IEC 62555
                               measurement--High          Edition
                               intensity therapeutic      1.0:2013-11.
                               ultrasound (HITU)
                               transducers and systems.
12-281......................  Medical electrical         IEC 60601-2-62
                               equipment--Part 2-62:      Edition
                               Particular requirements    1.0:2013-07.
                               for the basic safety and
                               essential performance of
                               high intensity
                               therapeutic ultrasound
                               (HITU) equipment.
12-282......................  Eyewear for protection     ISO 12609-1
                               against intense light      First edition
                               sources used on humans     2013-07-15.
                               and animals for cosmetic
                               and medical
                               applications--Part 1:
                               Specification for
                               products.
12-283......................  Eyewear for protection     ISO 12609-2
                               against intense light      First edition
                               sources used on humans     2013-07-15.
                               and animals for cosmetic
                               and medical
                               applications--Part 2:
                               Guidance for use.
------------------------------------------------------------------------
                         F. Software/Informatics
------------------------------------------------------------------------
13-67.......................  Health informatics--       ISO/IEEE 11073-
                               Personal health device     10418 First
                               communication--Part        edition 2014-
                               10418: Device              03-01.
                               specialization--Internat
                               ional normalized ratio
                               (INR) monitor.
13-68.......................  Health informatics--Point- ISO 11073-90101
                               of-care medical device     First edition
                               communication--Part        2008-01-15.
                               90101: Analytical
                               instruments--Point-of-
                               care test.
13-69.......................  Health Informatics--       ISO/IEEE 11073-
                               Personal health device     10472 First
                               communication--Part        edition 2012-
                               10472: Device              11-01.
                               specialization--Medicati
                               on monitor.
------------------------------------------------------------------------
                              G. Sterility
------------------------------------------------------------------------
14-436......................  Practice for dosimetry in  ISO/ASTM 52628
                               radiation processing.      First edition
                                                          2013-11-15.
14-437......................  Guide for performance      ISO/ASTM 52701
                               characterization of        First edition
                               dosimeters and dosimetry   2013-11-15.
                               systems for use in
                               radiation processing.
14-450......................  Biological indicators--    USP 37-
                               Resistance performance     NF32:2014
                               tests.                     <55>.
14-451......................  Biological indicators for  USP 37-
                               sterilization.             NF32:2014
                                                          <1035>.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
  of the respective organizations.

IV. List of Recognized Standards

    FDA maintains the Agency's current list of FDA Recognized Consensus 
Standards in a searchable database that may be accessed directly at our 
Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. We will incorporate the modifications and 
revisions described in this notice into the database and, upon 
publication in the Federal Register, this recognition of consensus 
standards will be effective. We will announce additional modifications 
and revisions to the list of recognized consensus standards, as needed, 
in the Federal Register once a year, or more often if necessary. 
Beginning with Recognition List 033, we will no longer announce minor 
revisions to the list of recognized consensus standards such as 
technical contact person, devices affected, processes affected, Code of 
Federal Regulations citations, and product codes.

V. Recommendation of Standards for Recognition by FDA

    Any person may recommend consensus standards as candidates for

[[Page 38920]]

recognition under section 514 of the FD&C Act by submitting such 
recommendations, with reasons for the recommendation, to 
www.standards@cdrh.fda.gov. To be properly considered, such 
recommendations should contain, at a minimum, the following 
information: (1) Title of the standard, (2) any reference number and 
date, (3) name and address of the national or international standards 
development organization, (4) a proposed list of devices for which a 
declaration of conformity to this standard should routinely apply, and 
(5) a brief identification of the testing or performance or other 
characteristics of the device(s) that would be addressed by a 
declaration of conformity.

VI. Electronic Access

    You may obtain a copy of ``Guidance on the Recognition and Use of 
Consensus Standards'' by using the Internet. The Center for Devices and 
Radiological Health (CDRH) maintains a site on the Internet for easy 
access to information including text, graphics, and files that you may 
download to a personal computer with access to the Internet. Updated on 
a regular basis, the CDRH home page includes the guidance as well as 
the current list of recognized standards and other standards-related 
documents. After publication in the Federal Register, this notice 
announcing ``Modification to the List of Recognized Standards, 
Recognition List Number: 036'' will be available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. You 
may access the CDRH home page at http://www.fda.gov/MedicalDevices.
    You may access ``Guidance on the Recognition and Use of Consensus 
Standards,'' and the searchable database for ``FDA Recognized Consensus 
Standards'' at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards.

VII. Submission of Comments and Effective Date

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. FDA will consider any comments received in 
determining whether to amend the current listing of modifications to 
the list of recognized standards, Recognition List Number: 036. These 
modifications to the list of recognized standards are effective upon 
publication of this notice in the Federal Register.

    Dated: July 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15989 Filed 7-8-14; 8:45 am]
BILLING CODE 4164-01-P


