[Federal Register Volume 78, Number 151 (Tuesday, August 6, 2013)]
[Notices]
[Pages 47703-47712]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-19019]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0451] (formerly 2004N-0226)


Food and Drug Administration Modernization Act of 1997: 
Modifications to the List of Recognized Standards, Recognition List 
Number: 031

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a 
publication containing modifications the Agency is making to the list 
of standards FDA recognizes for use in premarket reviews (FDA 
recognized consensus standards). This publication, entitled 
``Modifications to the List of Recognized Standards, Recognition List 
Number: 031'' (Recognition List Number: 031), will assist manufacturers 
who elect to declare conformity with consensus standards to meet 
certain requirements for medical devices.

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

ADDRESSES: Submit written requests for single copies of ``Modifications 
to the List of Recognized Standards, Recognition List Number: 031'' to 
the Division of Small Manufacturers, International and Consumer 
Assistance, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 
20993. Send two self-addressed adhesive labels to assist that office in 
processing your requests, or fax your request to 301-847-8149. Submit 
written comments concerning this document, or recommendations for 
additional standards for recognition, to the contact person (see FOR 
FURTHER INFORMATION CONTACT). Submit electronic comments by email: 
[email protected]. This document may also be accessed on FDA's 
Internet site at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section VI for 
electronic access to the searchable database for the current list of 
FDA recognized consensus standards, including Recognition List Number: 
031 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.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 204 of the Food and Drug Administration Modernization Act 
of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). Amended 
section 514 allows FDA to recognize consensus standards developed by 
international and national organizations for use in satisfying portions 
of device premarket review submissions or other requirements.
    In a notice published in the Federal Register of February 25, 1998 
(63 FR 9561), FDA announced the availability of a guidance entitled 
``Recognition and Use of Consensus Standards.'' The notice described 
how FDA would implement its standard recognition program and provided 
the initial list of recognized standards.
    Modifications to the initial list of recognized standards, as 
published in the Federal Register, can be accessed at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.
    These notices describe the addition, withdrawal, and revision of 
certain standards recognized by FDA. The Agency maintains ``hypertext 
markup language (HTML)'' and ``portable document format (PDF)'' 
versions of the list of ``FDA Recognized Consensus Standards.'' Both 
versions are publicly accessible at the Agency's Internet site. See 
section VI for electronic access information. Interested persons should 
review the supplementary information sheet for the standard to 
understand fully the extent to which FDA recognizes the standard.

II. Modifications to the List of Recognized Standards, Recognition List 
Number: 031

    FDA is announcing the addition, withdrawal, correction, and 
revision of certain consensus standards the Agency will recognize for 
use in premarket submissions and other requirements for devices. FDA 
will incorporate these modifications in the list of FDA Recognized 
Consensus Standards in the Agency's searchable database. FDA will use 
the term ``Recognition List Number: 031'' to identify these current 
modifications.
    In table 1, FDA describes the following modifications: (1) The 
withdrawal of standards and their replacement by others, if applicable; 
(2) the correction of errors made by FDA in listing previously 
recognized standards; and (3) the changes to the supplementary 
information sheets of recognized standards that describe revisions to 
the applicability of the standards.
    In section III, FDA lists modifications the Agency is making that 
involve the initial addition of standards not previously recognized by 
FDA.

[[Page 47704]]



       Table 1--Modifications to the List of Recognized Standards
------------------------------------------------------------------------
      Old
  recognition      Replacement    Title of standard \1\       Change
      No.        recognition No.
------------------------------------------------------------------------
                     A. Anesthesia
------------------------------------------------------------------------
1-74..........  1-91............  ISO 5360 Third         Withdrawn and
                                   edition 2012-01-15     replaced with
                                   Anaesthetic            newer version.
                                   vaporizers--Agent-
                                   specific filling
                                   systems.
1-35..........  1-93............  ISO 5361 Second        Withdrawn and
                                   edition 2012-10-01     replaced with
                                   Anaesthetic and        newer version.
                                   respiratory
                                   equipment--Tracheal
                                   tubes and connectors.
1-82..........                    IEC 60601-2-13         Transition
                                   Edition 3.1 2009-08    period
                                   Medical electrical     extended.
                                   equipment--Part 2-
                                   13: Particular
                                   requirements for the
                                   safety and essential
                                   performance of
                                   anaesthetic systems.
1-88..........                    ISO 80601-2-12         Transition
                                   Medical electrical     period
                                   equipment--Part 2-     extended.
                                   12: Particular
                                   requirements for the
                                   safety of lung
                                   ventilators--Critica
                                   l care ventilators.
------------------------------------------------------------------------
                  B. Biocompatibility
------------------------------------------------------------------------
2-119.........                    ASTM F813-07           Reaffirmation.
                                   (Reapproved 2012)
                                   Standard Practice
                                   for Direct Contact
                                   Cell Culture
                                   Evaluation of
                                   Materials for
                                   Medical Devices.
2-122.........                    ASTM F719-81           Reaffirmation.
                                   (Reapproved 2012)
                                   Standard Practice
                                   for Testing
                                   Biomaterials in
                                   Rabbits for Primary
                                   Skin Irritation.
2-123.........                    ASTM F720-81           Reaffirmation.
                                   (Reapproved 2012)
                                   Standard Practice
                                   for Testing Guinea
                                   Pigs for Contact
                                   Allergens: Guinea
                                   Pig Maximization
                                   Test.
2-124.........                    ASTM F750-87           Reaffirmation.
                                   (Reapproved 2012)
                                   Standard Practice
                                   for Evaluating
                                   Materials Extracts
                                   by Systemic
                                   Injection in the
                                   Mouse.
2-125.........  2-197...........  ASTM F749-13 Standard  Withdrawn and
                                   Practice for           replaced with
                                   Evaluating Material    newer version.
                                   Extracts by
                                   Intracutaneous
                                   Injection in the
                                   Rabbit.
2-135.........  2-198...........  ANSI/AAMI/ISO 10993-   Withdrawn and
                                   12:2012 Biological     replaced with
                                   evaluation of          newer version.
                                   medical devices--
                                   Part 12:Sample
                                   preparation and
                                   reference materials.
2-146.........                    ASTM F2148-07          Reaffirmation.
                                   (Reapproved 2012)
                                   Standard Practice
                                   for Evaluation of
                                   Delayed Contact
                                   Hypersensitivity
                                   Using the Murine
                                   Local Lymph Node
                                   Assay (LLNA).
2-152.........                    ISO 10993-10:2002/     Withdrawn, see
                                   Amd.1:2006(E)          2-174.
                                   Biological
                                   evaluation of
                                   medical devices--
                                   Part 10: Tests for
                                   irritation and
                                   delayed-type
                                   hypersensitivity
                                   AMENDMENT 1.
2-192.........  2-199...........  USP 36-NF31:2013 <87>  Withdrawn and
                                   Biological             replaced with
                                   Reactivity Test, In    newer version.
                                   Vitro--Direct
                                   Contact Test.
2-193.........  2-200...........  USP 36-                Withdrawn and
                                   NF31:2013Biological    replaced with
                                   Tests <87>             newer version.
                                   Biological
                                   Reactivity Tests, In
                                   Vitro--Elution Test.
2-194.........  2-201...........  USP 36-NF31:2013       Withdrawn and
                                   Biological Tests       replaced with
                                   <88> Biological        newer version.
                                   Reactivity Tests, In
                                   Vivo Procedure
                                   Preparation of
                                   Sample.
2-195.........  2-202...........  USP 36-NF31:2013       Withdrawn and
                                   Biological Tests       replaced with
                                   <88> Biological        newer version.
                                   Reactivity Tests, In
                                   Vitro Classification
                                   of Plastics--
                                   Intracutaneous Test.
2-196.........  2-203...........  USP 36-NF31:2013       Withdrawn and
                                   Biological Tests       replaced with
                                   <88> Biological        newer version.
                                   Reactivity Tests, In
                                   Vivo Classification
                                   of Plastics--
                                   Systemic Injection
                                   Test.
------------------------------------------------------------------------
                   C. Cardiovascular
------------------------------------------------------------------------
3-38..........  3-115...........  IEC 60601-2-34         Newer version
                                   Edition 3.0 2011-05    with
                                   Medical Electrical     transition
                                   Equipment--Part 2-     period.
                                   34: Particular
                                   Requirements for the
                                   Basic Safety and
                                   Essential
                                   Performance of
                                   Invasive Blood
                                   Pressure Monitoring
                                   Equipment.
3-55..........                    ASTM F1830-97          Reaffirmation.
                                   (Reapproved 2013)
                                   Standard Practice
                                   for Selection of
                                   Blood for In Vitro
                                   Evaluation of Blood
                                   Pumps.
3-56..........                    ASTM F1841-97          Reaffirmation.
                                   (Reapproved 2013)
                                   Standard Practice
                                   for Assessment of
                                   Hemolysis in
                                   Continuous Flow
                                   Blood Pumps.
3-66..........                    ASTM F2081-06          Reaffirmation.
                                   (Reapproved 2013)
                                   Standard Guide for
                                   Characterization and
                                   Presentation of the
                                   Dimensional
                                   Attributes of
                                   Vascular Stents.
3-79..........                    ASTM F2079-09          Reaffirmation.
                                   (Reapproved 2013)
                                   Standard Test Method
                                   for Measuring
                                   Intrinsic Elastic
                                   Recoil of Balloon-
                                   Expandable Stents.
3-86..........                    ASTM F2394-07          Reaffirmation.
                                   (Reapproved 2013)
                                   Standard Guide for
                                   Measuring Securement
                                   of Balloon
                                   Expandable Vascular
                                   Stent Mounted on
                                   Delivery System.
3-87..........                    ASTM F2477-07          Reaffirmation.
                                   (Reapproved 2013)
                                   Standard Test
                                   Methods for in vitro
                                   Pulsatile Durability.
3-81..........  3-117...........  ANSI/AAMI/ISO 81060-2  Withdrawn and
                                   Second edition 2013-   replaced with
                                   05-01, Non-Invasive    newer version.
                                   Sphygmomanometers--P
                                   art 2: Clinical
                                   Validation of
                                   Automated
                                   Measurement Type.
3-94..........  3-116...........  ISO 25539-2 Second     Withdrawn and
                                   edition 2012-12-01     replaced with
                                   Cardiovascular         newer version.
                                   Implants--Endovascul
                                   ar Devices--Part 2:
                                   Vascular Stents Part
                                   2: Vascular Stent.
------------------------------------------------------------------------

[[Page 47705]]

 
                     D. Dental/ENT
------------------------------------------------------------------------
4-75..........                    ISO 7785-1 Second      Withdrawn, see
                                   edition 1997-08-01     4-206.
                                   Dental Handpieces--
                                   Part 1: High-Speed
                                   Air Turbine
                                   Handpieces.
4-76..........                    ISO 7785-2 Second      Withdrawn, see
                                   edition 1995-08-0      4-206.
                                   Dental Handpieces--
                                   Part 2: Straight and
                                   Geared Angle
                                   Handpieces.
4-83..........                    ISO 11498 First        Withdrawn, see
                                   edition 1997-02-15     4-206.
                                   Dental Handpieces:
                                   Dental Low-Voltage
                                   Electrical Motors.
4-84..........                    ISO 13294 First        Withdrawn, see
                                   edition 1997-05-01     4-206.
                                   Dental Handpieces--
                                   Dental Air-Motors.
4-90..........                    ANSI S3.39:1987        Reaffirmation.
                                   (Reaffirmed by ANSI
                                   June 15, 2012)
                                   American National
                                   Standard
                                   Specifications for
                                   Instruments to
                                   Measure Aural
                                   Acoustic Impedance
                                   and Admittance
                                   (Aural Acoustic
                                   Immittance).
4-119.........                    ANSI/ADA               Reaffirmation.
                                   Specification No.
                                   82:1998/ISO
                                   13716:1999
                                   Reaffirmed by ANSI:
                                   January 2009 Dental
                                   Reversible/
                                   Irreversible
                                   Hydrocolloid
                                   Impression Material
                                   Systems.
4-123.........  4-203...........  ANSI/ASA S3.6-2010     Withdrawn and
                                   (Revision of ANSI      replaced with
                                   S3.6-2004)             newer version.
                                   Specification for
                                   Audiometers.
4-167.........                    ANSI/ASA S3.21-2004    Reaffirmation.
                                   (R2009) Methods for
                                   Manual Pure-Tone
                                   Threshold Audiometry.
4-172.........  4-204...........  ANSI/ASA S3.42-2012/   Withdrawn and
                                   Part 2/IEC 60118-      replaced with
                                   15:2012 American       newer version.
                                   National Standard
                                   Testing Hearing
                                   Aids--Part 2:
                                   Methods for
                                   characterizing
                                   signal processing in
                                   hearing aids with a
                                   speech-like signal
                                   (a nationally
                                   adopted
                                   international
                                   standard).
4-187.........                    IEC 60601-2-18         Transition
                                   Edition 3.0 2009-08    period
                                   Medical electrical     extended.
                                   equipment--Part 2-
                                   18: Particular
                                   requirements for the
                                   basic safety and
                                   essential
                                   performance of
                                   endoscopic equipment.
------------------------------------------------------------------------
                       E. General
------------------------------------------------------------------------
5-53..........                    IEC 60601-1-2 Edition  Transition
                                   3.0 2007-03 Medical    period
                                   electrical             extended.
                                   equipment--Part 1-2:
                                   General requirements
                                   for basic safety and
                                   essential
                                   performance--Collate
                                   ral standard:
                                   Electromagnetic
                                   compatibility--Requi
                                   rements and tests.
5-54..........                    ANSI/AAMI/IEC 60601-1- Reaffirmation
                                   2:2007/(R)2012         and transition
                                   Medical electrical     period
                                   equipment--Part 1-2:   extended.
                                   General requirements
                                   for basic safety and
                                   essential
                                   performance--Collate
                                   ral standard:
                                   Electromagnetic
                                   compatibility--Requi
                                   rements and tests.
5-55..........  5-76............  IEC 60601-1-8 Edition  Withdrawn and
                                   2.1 2012-11 Medical    replaced with
                                   electrical             newer version.
                                   equipment--Part 1-8:   Transition
                                   General requirements   period
                                   for basic safety and   extended.
                                   essential
                                   performance--Collate
                                   ral standard:
                                   General
                                   requirements, tests,
                                   and guidance for
                                   alarm systems in
                                   medical electrical
                                   equipment and
                                   medical electrical
                                   systems.
5-71..........  5-77............  ANSI/AAMI ES60601-     Withdrawn and
                                   1:2005/(R)2012 and     replaced with
                                   A1:2012, C1:2009/      new version.
                                   (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).
5-74..........  5-77............  ANSI/AAMI ES60601-     Withdrawn and
                                   1:2005/(R)2012 and     replaced with
                                   A1:2012, C1:2009/      new version.
                                   (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).
------------------------------------------------------------------------
      F. General Hospital/General Plastic Surgery
------------------------------------------------------------------------
6-9...........  6-300...........  IEC 60601-2-21         Newer version
                                   Edition 2.0 2009-02    with
                                   Medical electrical     transition
                                   equipment--Part 2-     period.
                                   21: Particular
                                   requirements for the
                                   basic safety and
                                   essential
                                   performance of
                                   infant radiant
                                   warmers.
6-29..........  6-298...........  IEC 60601-2-19         Newer version
                                   Edition 2.0 2009-02    with
                                   Medical electrical     transition
                                   equipment--Part 2-     period.
                                   19: Particulars for
                                   the basic safety and
                                   essential
                                   performance of
                                   infant incubators.
6-32..........  6-299...........  IEC 60601-2-20         Newer version
                                   Edition 2.0 2009-02    with
                                   Medical electrical     transition
                                   equipment--Part 2-     period.
                                   20: Particular
                                   requirements for the
                                   basic safety and
                                   essential
                                   performance of
                                   infant radiant
                                   warmers.
6-116.........  6-294...........  ISO 11608-3 Second     Withdrawn and
                                   edition 2012-10-01     replaced with
                                   Needle-based           newer version.
                                   injection systems
                                   for medical use--
                                   Requirements and
                                   test methods--Part
                                   3: Finished
                                   containers.
6-119.........  6-295...........  ANSI/AAMI BF7:2012     Withdrawn and
                                   Blood transfusion      replaced with
                                   microfilters.          newer version.
6-147.........                    ASTM D6978--05         Reaffirmation.
                                   (Reapproved 2013)
                                   Standard Practice
                                   for Assessment of
                                   Resistance of
                                   Medical Gloves to
                                   Permeation by
                                   Chemotherapy Drugs.

[[Page 47706]]

 
6-174.........                    ISO 11608-4 First      Contact person.
                                   edition 2006-03-15
                                   Pen-injectors for
                                   medical use--Part 4:
                                   Requirements and
                                   test methods for
                                   electronic and
                                   electromechanical
                                   pen-injectors.
6-179.........                    ISO 21649 First        Contact person.
                                   edition 2006-06-01,
                                   Needle-free
                                   injectors for
                                   medical use--
                                   Requirements and
                                   test methods.
6-112.........  6-296...........  ANSI/AAMI PB70:2012    Withdrawn and
                                   Liquid barrier         replaced with
                                   performance and        newer version.
                                   classification of
                                   protective apparel
                                   and drapes intended
                                   for use in health
                                   care facilities.
6-214.........                    ASTM D6355--07         Reaffirmation.
                                   (Reapproved 2012)
                                   Standard Test Method
                                   for Human Repeat
                                   Insult Patch Testing
                                   of Medical Gloves.
6-216.........                    ISO 8536-7 Third       Contact person.
                                   edition 2009-01-15
                                   Infusion equipment
                                   for medical use--
                                   Part 7: Caps made of
                                   aluminium-plastics
                                   combinations for
                                   infusion bottles.
6-227.........                    ANSI/AAMI/IEC 60601-2- Transition
                                   21:2009, Medical       period
                                   electrical             extended.
                                   equipment--Part 2-
                                   21: Particular
                                   requirements for the
                                   basic safety and
                                   essential
                                   performance of
                                   infant radiant
                                   warmers.
6-228.........                    IEC 60601-2-2 Edition  Transition
                                   5.0 2009-02, Medical   period
                                   Electrical             extended.
                                   Equipment--Part 2-2:
                                   Particular
                                   requirements for the
                                   basic safety and
                                   essential
                                   performance of high
                                   frequency surgical
                                   equipment and high
                                   frequency surgical
                                   accessories.
6-229.........                    ANSI/AAMI/IEC 60601-2- Transition
                                   2:2009, Medical        period
                                   electrical             extended.
                                   equipment--Part 2-2:
                                   Particular
                                   requirements for the
                                   basic safety and
                                   essential
                                   performance of high
                                   frequency surgery
                                   equipment and high
                                   frequency surgical
                                   accessories.
6-230.........                    ANSI/AAMI/IEC 60601-2- Transition
                                   19:2009, Medical       period
                                   Electrical             extended.
                                   Equipment--Part 2-
                                   19: Particular
                                   requirements for the
                                   basic safety and
                                   essential
                                   performance of
                                   infant incubators.
6-231.........                    ANSI/AAMI/IEC 60601-2- Transition
                                   20:2009, Medical       period
                                   Electrical             extended.
                                   Equipment--Part 2-
                                   20: Particular
                                   requirements for the
                                   basic safety and
                                   essential
                                   performance of
                                   infant transport
                                   incubators.
6-233.........                    IEC 60601-2-52         Transition
                                   Edition 1.0 2009-12    period
                                   Medical electrical     extended.
                                   equipment--Part 2-
                                   52: Particular
                                   requirements for
                                   basic safety and
                                   essential
                                   performance of
                                   medical beds.
6-234.........                    IEC 60601-2-50         Contact person.
                                   Edition 2.0 2009-03
                                   Medical electrical
                                   equipment--Part 2-
                                   50: Particular
                                   requirements for the
                                   basic safety and
                                   essential
                                   performance of
                                   infant phototherapy
                                   equipment.
6-235.........                    ANSI/AAMI/IEC 60601-2- Contact person.
                                   50:2009 Medical
                                   Electrical
                                   Equipment--Part 2-
                                   50: Particular
                                   requirements for the
                                   basic safety and
                                   essential
                                   performance of
                                   infant phototherapy
                                   equipment.
6-239.........                    ISO 8536-6 Second      Contact person.
                                   edition 2009-11-15
                                   Infusion equipment
                                   for medical use--
                                   Part 6: Freeze
                                   drying closures for
                                   infusion bottles.
6-240.........                    ISO 8536-3 Third       Contact person.
                                   edition 2009-06-01
                                   Infusion equipment
                                   for medical use--
                                   Part 3: Aluminum
                                   caps for infusion
                                   bottles.
6-241.........  6-297...........  ISO 1135-4 Fifth       Withdrawn and
                                   edition 2012-03-01     replaced with
                                   Transfusion            newer version.
                                   equipment for
                                   medical use--Part 4:
                                   Transfusion sets for
                                   single use.
6-274.........                    ISO 11608-1 Second     Contact person.
                                   edition 2012-04-01
                                   Needle-based
                                   injection systems
                                   for medical use--
                                   Requirements and
                                   test methods--Part
                                   1: Needle-based
                                   injection systems.
6-275.........                    ISO 11608-2 Second     Contact person.
                                   edition 2012-04-01
                                   Needle-based
                                   injection systems
                                   for medical use--
                                   Requirements and
                                   test methods--Part
                                   2: Needles.
6-276.........                    ISO 8536-1 Fourth      Contact person.
                                   edition 2011-09-01
                                   Infusion equipment
                                   for medical use--
                                   Part 1: Infusion
                                   glass bottles.
------------------------------------------------------------------------
                G. In Vitro Diagnostics
------------------------------------------------------------------------
7-3...........                    CLSI/NCCLS GP10-A      Withdrawn, see
                                   1995, Assessment of    7-234.
                                   the Clinical
                                   Accuracy of
                                   Laboratory Tests
                                   Using Receiver
                                   Operating
                                   Characteristic (ROC)
                                   Plots; Approved
                                   Guideline.
7-4...........                    CLSI/NCCLS GP14-A      Withdrawn.
                                   1996, Labeling of
                                   Home-Use In Vitro
                                   Testing Products;
                                   Approved Guideline.
7-37..........                    NCCLS I/LA6-A,         Withdrawn.
                                   Detection and
                                   Quantitation of
                                   Rubella IgG
                                   Antibody: Evaluation
                                   and Performance
                                   Criteria for
                                   Multiple Component
                                   Test Products,
                                   Specimen Handling,
                                   and Use of Test
                                   Products in the
                                   Clinical Laboratory;
                                   Approved Guideline.
7-41..........                    NCCLS I/LA19-A,        Withdrawn.
                                   Primary Reference
                                   Preparations Used to
                                   Standardize
                                   Calibration of
                                   Immunochemical
                                   Assays for Serum
                                   Prostate Specific
                                   Antigen (PSA);
                                   Approved Guideline
                                   (1997).
7-154.........                    CLSI MM02-A2,          Withdrawn.
                                   Immunoglobulin and T-
                                   Cell Receptor Gene
                                   Rearrangement Assays.

[[Page 47707]]

 
7-171.........                    CLSI M38-A2,           Extent of
                                   Reference Method for   recognition,
                                   Broth Dilution         process
                                   Antifungal             affected, and
                                   Susceptibility         contact
                                   Testing of             person.
                                   Filamentous Fungi;
                                   Approved Standard--
                                   Second Edition.
7-178.........                    CLSI M22-A3, Quality   Extent of
                                   Control for            recognition,
                                   Commercially           process
                                   Prepared               affected, and
                                   Microbiological        contact
                                   Culture Media;         person.
                                   Approved Standard--
                                   Third Edition.
7-179.........  7-240...........  CLSI M27-S4,           Withdrawn and
                                   Reference Method for   replaced with
                                   Broth Dilution         newer version.
                                   Antifungal
                                   Susceptibility
                                   Testing of Yeasts;
                                   Fourth Informational
                                   Supplement.
7-200.........                    CLSI M48-A,            Extent of
                                   Laboratory Detection   recognition,
                                   and Identification     type of
                                   of Mycobacteria;       standard, and
                                   Approved Guideline.    process
                                                          affected.
7-206.........                    CLSI I/LA 20-A2        Relevant
                                   Analytical             guidance.
                                   Performance
                                   Characteristics and
                                   Clinical Utility of
                                   Immunological Assays
                                   for Human
                                   Immunoglobulin E
                                   (IgE) Antibodies and
                                   Defined Allergen
                                   Specificities;
                                   Approved Guideline--
                                   Second Edition.
7-215.........                    CLSI M44-A2, Method    Extent of
                                   for Antifungal Disk    recognition,
                                   Diffusion              process
                                   Susceptibility         affected, and
                                   Testing of Yeast;      contact
                                   Approved Guideline--   person.
                                   Second Edition..
7-217.........                    CLSI M44-S3, Zone      Extent of
                                   Diameter               recognition,
                                   Interpretive           process
                                   Standards,             affected, and
                                   Corresponding          contact
                                   Minimal Inhibitory     person.
                                   Concentration (MIC)
                                   Interpretive
                                   Breakpoints, and
                                   Quality Control
                                   Limits for
                                   Antifungal Disk
                                   Diffusion
                                   Susceptibility
                                   Testing of Yeasts;
                                   Third Informational
                                   Supplement.
7-218.........                    CLSI M45-A2, Methods   Extent of
                                   for Antimicrobial      recognition
                                   Dilution and Disk      and process
                                   Susceptibility         affected.
                                   Testing of
                                   Infrequently
                                   Isolated or
                                   Fastidious Bacteria;
                                   Approved Guideline--
                                   Second Edition.
7-222.........                    CLSI M24-A2,           Extent of
                                   Susceptibility         recognition,
                                   Testing of             process
                                   Mycobacteria,          affected,
                                   Nocardiae and other    contact
                                   Aerobic                person, and
                                   Actinomycetes;         title and type
                                   Approved Standards--   of standard.
                                   Second Edition.
7-228.........                    CLSI M11-A8, Methods   Extent of
                                   for Antimicrobial      recognition,
                                   Susceptibility         process
                                   Testing of Anaerobic   affected, and
                                   Bacteria; Approved     contact
                                   Standard--Eighth       person.
                                   Edition.
7-229.........                    CLSI M02-A11,          Extent of
                                   Performance            recognition,
                                   Standards for          process
                                   Antimicrobial Disk     affected, and
                                   Susceptibility         contact
                                   Tests; Approved        person.
                                   Standard--Eleventh
                                   Edition.
7-230.........                    CLSI M07-A9, Methods   Extent of
                                   for Dilution           recognition,
                                   Antimicrobial          process
                                   Susceptibility Tests   affected, and
                                   for Bacteria That      contact
                                   Grow Aerobically;      person.
                                   Approved Standard--
                                   Ninth Edition.
7-231.........  7-241...........  CLSI M100-S23,         Withdrawn and
                                   Performance            replaced with
                                   Standards for          newer version.
                                   Antimicrobial
                                   Susceptibility
                                   Testing; Twenty-
                                   Third Informational
                                   Supplement.
7-234.........                    CLSI EP24-A2,          Extent of
                                   Assessment of the      recognition.
                                   Diagnostic Accuracy
                                   of Laboratory Tests
                                   Using Receiver
                                   Operating
                                   Characteristic
                                   Curves; Approved
                                   Guideline--Second
                                   Edition.
------------------------------------------------------------------------
                      H. Materials
------------------------------------------------------------------------
8-122.........  8-335...........  ASTM F2063-12          Withdrawn and
                                   Standard               replaced with
                                   Specification for      newer version.
                                   Wrought Nickel-
                                   Titanium Shape
                                   Memory Alloys for
                                   Medical Devices and
                                   Surgical Implants.
8-147.........  8-336...........  ASTM F562-13 Standard  Withdrawn and
                                   Specification for      replaced with
                                   Wrought 35Cobalt-      newer version.
                                   35Nickel-20Chromium-
                                   10Molybdenum Alloy
                                   for Surgical Implant
                                   Applications (UNS
                                   R30035).
8-153.........                    ASTM F2119-07          Reaffirmation.
                                   (Reapproved 2013)
                                   Standard Test Method
                                   for Evaluation of MR
                                   Image Artifacts from
                                   Passive Implants.
8-154.........  8-337...........  ASTM F621-12 Standard  Withdrawn and
                                   Specification for      replaced with
                                   Stainless Steel        newer version.
                                   Forgings for
                                   Surgical Implants.
8-156.........  8-338...........  ASTM F139-12 Standard  Withdrawn and
                                   Specification for      replaced with
                                   Wrought 18Chromium-    newer version.
                                   14Nickel-
                                   2.5Molybdenum
                                   Stainless Steel
                                   Sheet and Strip for
                                   Surgical Implants
                                   (UNS S31673).
8-158.........                    ASTM F1713-08          Reaffirmation.
                                   (Reapproved 2013)
                                   Standard
                                   Specification for
                                   Wrought Titanium-
                                   13Niobium-13
                                   Zirconium Alloy for
                                   Surgical Implant
                                   Applications (UNS
                                   R58130).
8-166.........  8-339...........  ASTM F1091-12          Withdrawn and
                                   Standard               replaced with
                                   Specification for      newer version.
                                   Wrought Cobalt-
                                   20Chromium-
                                   15Tungsten-10Nickel
                                   Alloy Surgical
                                   Fixation Wire (UNS
                                   R30605).
8-203.........  8-340...........  ASTM F2026-12          Withdrawn and
                                   Standard               replaced with
                                   Specification for      newer version.
                                   Polyetheretherketone
                                   (PEEK) Polymers for
                                   Surgical Implant
                                   Applications.
8-219.........  8-341...........  ASTM F136-12a          Withdrawn and
                                   Standard               replaced with
                                   Specification for      newer version.
                                   Wrought Titanium-
                                   6Aluminum-4Vanadium
                                   ELI (Extra Low
                                   Interstitial) Alloy
                                   for Surgical Implant
                                   Applications (UNS
                                   R56401).
8-222.........  8-342...........  ASTM F1537-11          Withdrawn and
                                   Standard               replaced with
                                   Specification for      newer version.
                                   Wrought Cobalt-
                                   28Chromium-
                                   6Molybdenum Alloys
                                   for Surgical
                                   Implants (UNS
                                   R31537, UNS R31538,
                                   and UNS R31539).
8-332.........  8-343...........  ASTM F899-12b          Withdrawn and
                                   Standard               replaced with
                                   Specification for      newer version.
                                   Wrought Stainless
                                   Steels for Surgical
                                   Instruments.
------------------------------------------------------------------------

[[Page 47708]]

 
               I. OB-GYN/Gastroenterology
------------------------------------------------------------------------
9-31..........                    ANSI/AAMI ID54:1996/   Reaffirmation.
                                   (R)2012 Enteral
                                   feeding set adapters
                                   and connectors.
9-60..........                    IEC 60601-2-16         Withdrawn, see
                                   Edition 3.0 2008-04    9-80.
                                   Medical electrical
                                   equipment--Part 2-
                                   16: Particular
                                   requirements for
                                   basic safety and
                                   essential
                                   performance of
                                   haemodialysis,
                                   haemodiafiltration
                                   and haemofiltration.
9-61..........                    IEC 60601-2-18         Transition
                                   Edition 3.0 2009-08    period
                                   Medical electrical     extended.
                                   equipment--Part 2-
                                   18: Particular
                                   requirements for the
                                   basic safety and
                                   essential
                                   performance of
                                   endoscopic equipment.
9-72..........  9-81............  ANSI/AAMI/IEC 60601-2- Newer version
                                   16:2012 Medical        with
                                   electrical             transition
                                   equipment--Part 2-     period.
                                   16: Particular
                                   requirements for
                                   basic safety and
                                   essential
                                   performance of
                                   hemodialysis,
                                   hemodiafiltration
                                   and hemofiltration
                                   equipment.
9-62..........                    IEC 60601-2-2 Edition  Transition
                                   5.0 2009-02 Medical    period
                                   electrical             extended.
                                   equipment--Part 2-2:
                                   Particular
                                   requirements for the
                                   basic safety and
                                   essential
                                   performance of
                                   frequency surgical
                                   equipment and high
                                   frequency surgical
                                   accessories.
9-63..........                    IEC 60601-2-16 (Third  Withdrawn, see
                                   edition--2008),        9-80.
                                   Medical electrical
                                   equipment--Part 2-
                                   16: Particular
                                   requirements for
                                   basic safety and
                                   essential
                                   performance of
                                   haemodialysis,
                                   haemodiafiltration
                                   and haemofiltration
                                   equipment
                                   CORRIGENDUM 1.
9-64..........                    ANSI/AAMI/IEC 60601-2- Transition
                                   2:2009 Medical         period
                                   electrical             extended.
                                   equipment--Part 2-2:
                                   Particular
                                   requirements for the
                                   basic safety and
                                   essential
                                   performance of high
                                   frequency surgery
                                   equipment and high
                                   frequency surgical
                                   accessories.
9-80..........                    IEC 60601-2-16         Transition
                                   Edition 4.0 2012-03    period
                                   Medical electrical     extended.
                                   equipment--Part 2-
                                   16: Particular
                                   requirements for the
                                   basic safety and
                                   essential
                                   performance of
                                   haemodialysis,
                                   haemodiafiltration
                                   and haemofiltration
                                   equipment.
------------------------------------------------------------------------
                     J. Ophthalmic
------------------------------------------------------------------------
10-15.........  10-77...........  ISO 9394 Third         Withdrawn and
                                   edition 2012-10-01     replaced with
                                   Ophthalmic optics--    newer version.
                                   Contact lenses and
                                   contact lens care
                                   products--Determinat
                                   ion of
                                   biocompatibility by
                                   ocular study with
                                   rabbit eyes.
10-36.........  10-78...........  ISO 11979-3 Third      Withdrawn and
                                   edition 2012-12-01     replaced with
                                   Ophthalmic implants--  newer version.
                                   Intraocular lenses--
                                   Part 3: Mechanical
                                   properties and test
                                   methods.
10-40.........  10-79...........  ISO 11979-1 Third      Withdrawn and
                                   edition 2012-09-15     replaced with
                                   Ophthalmic implants--  newer version.
                                   Intraocular lenses--
                                   Part 1: Vocabulary.
10-45.........  10-80...........  ISO 18369-2 Second     Withdrawn and
                                   edition 2012-12-01     replaced with
                                   Ophthalmic optics--    newer version.
                                   Contact lenses--Part
                                   2: Tolerances.
10-56.........                    ANSI Z80.12-2007       Reaffirmation.
                                   (R2012) American
                                   National Standard
                                   for Ophthalmics--
                                   Multifocal
                                   Intraocular Lenses.
10-57.........                    ANSI Z80.13-2007       Reaffirmation.
                                   (R2012) American
                                   National Standard
                                   for Ophthalmics--
                                   Phakic Intraocular
                                   Lenses.
10-76.........                    ISO 11979-8 Second     Withdrawn.
                                   edition 2006-07-01
                                   AMENDMENT 1 2011-05-
                                   15 Ophthalmic
                                   implants--Intraocula
                                   r lenses--Part 8:
                                   Fundamental
                                   requirements.
------------------------------------------------------------------------
                     K. Orthopedics
------------------------------------------------------------------------
11-73.........  11-252..........  ISO 5838-1 Third       Withdrawn and
                                   edition 2013-03-01     replaced with
                                   Implants for           a newer
                                   surgery--Metallic      version.
                                   skeletal pins and
                                   wires--Part 1:
                                   General requirements.
11-206........  11-253..........  ASTM F1800-12          Withdrawn and
                                   Standard Practice      replaced with
                                   for Cyclic Fatigue     a newer
                                   Testing of Metal       version.
                                   Tibial Tray
                                   Components of Total
                                   Knee Joint
                                   Replacements.
11-208........  11-254..........  ISO 14630 Fourth       Withdrawn and
                                   edition 2012-12-01     replaced with
                                   Non-active surgical    a newer
                                   implants--General      version.
                                   requirements.
11-213........                    ASTM F1223-08          Reaffirmation.
                                   (Reapproved 2012)
                                   Standard Test Method
                                   for Determination of
                                   Total Knee
                                   Replacement
                                   Constraint.
11-215........                    ASTM F897-02           Reaffirmation.
                                   (Reapproved 2013)
                                   Standard Test Method
                                   for Measuring
                                   Fretting Corrosion
                                   of Osteosynthesis
                                   Plates and Screws.
11-242........                    ASTM F1839-08          Reaffirmation.
                                   (Reapproved 2012)
                                   Standard
                                   Specification for
                                   Rigid Polyurethane
                                   Foam for Use as a
                                   Standard Material
                                   for Testing
                                   Orthopaedic Devices
                                   and Instruments.
11-246........  11-255..........  ASTM F1717-13          Withdrawn and
                                   Standard Test          replaced with
                                   Methods for Spinal     a newer
                                   Implant Constructs     version.
                                   in a Vertebrectomy
                                   Model.
------------------------------------------------------------------------
                  L. Physical Medicine
------------------------------------------------------------------------
16-24.........  16-190..........  ISO 7176-11 Second     Withdrawn and
                                   edition 2012-12-01     replaced with
                                   Wheelchairs--Part      a newer
                                   11: Test dummies.      version.

[[Page 47709]]

 
16-28.........  16-191..........  ISO 7176-16 Second     Withdrawn and
                                   edition 2012-12-01     replaced with
                                   Wheelchairs--Part      a newer
                                   16: Resistance to      version.
                                   ignition of postural
                                   support devices.
16-50.........  16-192..........  ISO 7176-3 Third       Withdrawn and
                                   edition 2012-12-15     replaced with
                                   Wheelchairs--Part 3:   a newer
                                   Determination of       version.
                                   effectiveness of
                                   brakes.
------------------------------------------------------------------------
                      M. Radiology
------------------------------------------------------------------------
12-34.........  12-201..........  IEC 60601-2-54         Newer version
                                   Edition 1.0 2009-06    with
                                   Medical electrical     transition
                                   equipment--Part 2-     period.
                                   54: Particular
                                   requirements for the
                                   basic safety and
                                   essential
                                   performance of X-ray
                                   equipment for
                                   radiography and
                                   radioscopy.
12-54.........  12-254..........  IEC 60601-2-8 Edition  Newer version
                                   2.0 2010-11 Medical    with extended
                                   electrical             transition
                                   equipment--Part 2-8:   period.
                                   Particular
                                   requirements for the
                                   basic safety and
                                   essential
                                   performance of
                                   therapeutic X-ray
                                   equipment operating
                                   in the range 10 kV
                                   to 1 MV.
12-127........  12-201..........  IEC 60601-2-54         Newer version
                                   Edition 1.0 2009-06    with
                                   Medical electrical     transition
                                   equipment--Part 2-     period.
                                   54: Particular
                                   requirements for the
                                   basic safety and
                                   essential
                                   performance of X-ray
                                   equipment for
                                   radiography and
                                   radioscopy.
12-133........  12-255..........  IEC 60601-2-11         Newer version
                                   Edition 3.0 2013-01    with
                                   Medical electrical     transition
                                   equipment--Part 2-     period.
                                   11: Particular
                                   requirements for the
                                   basic safety and
                                   essential
                                   performance of gamma
                                   beam therapy
                                   equipment.
12-202........                    IEC 60601-2-43         Transition
                                   Edition 2.0 2010-03    period
                                   Medical electrical     extended.
                                   equipment--Part 2-
                                   43: Particular
                                   requirements for the
                                   basic safety and
                                   essential
                                   performance of X-ray
                                   equipment for
                                   interventional
                                   procedures.
12-203........  12-256..........  IEC 60601-2-44         Newer version
                                   Edition 3.1 2012-09    with extended
                                   Medical electrical     transition
                                   equipment--Part 2-     period.
                                   44: Particular
                                   requirements for the
                                   basic safety and
                                   essential
                                   performance of X-ray
                                   equipment for
                                   computed tomography.
12-204........                    IEC 60601-2-28         Transition
                                   Edition 2.0 2010-03    period
                                   Medical electrical     extended.
                                   equipment--Part 2-
                                   28: Particular
                                   requirements for the
                                   basic safety and
                                   essential
                                   performance of X-ray
                                   tube assemblies for
                                   medical diagnosis.
12-205........                    IEC 60601-2-5 Edition  Transition
                                   3.0 2009-07 Medical    period
                                   electrical             extended.
                                   equipment--Part 2-5:
                                   Particular
                                   requirements for the
                                   basic safety and
                                   essential
                                   performance of
                                   ultrasonic
                                   physiotherapy
                                   equipment.
12-206........                    IEC 60601-2-1 Edition  Transition
                                   3.0 2009-10 Medical    period
                                   electrical             extended.
                                   equipment--Part 2-1:
                                   Particular
                                   requirements for the
                                   basic safety and
                                   essential
                                   performance of
                                   electron
                                   accelerators in the
                                   range 1 MeV to 50
                                   MeV.
12-207........                    IEC 60601-2-33         Transition
                                   Edition 3.0 2010-03    period
                                   Medical electrical     extended.
                                   equipment--Part 2-
                                   33: Particular
                                   requirements for the
                                   basic safety and
                                   essential
                                   performance of
                                   magnetic resonance
                                   equipment for
                                   medical diagnostic.
12-208........                    IEC 60601-2-22 Third   Transition
                                   Edition 2007-05        period
                                   Medical electrical     extended.
                                   equipment--Part 2-
                                   22: Particular
                                   requirements for
                                   basic safety and
                                   essential
                                   performance of
                                   surgical, cosmetic,
                                   therapeutic and
                                   diagnostic laser
                                   equipment.
12-209........                    IEC 60601-2-37         Transition
                                   Edition 2.0 2007-08    period
                                   Medical electrical     extended.
                                   equipment--Part 2-
                                   37: Particular
                                   requirements for the
                                   basic safety and
                                   essential
                                   performance of
                                   ultrasonic medical
                                   diagnostic and
                                   monitoring equipment.
12-210........                    IEC 60601-1-3 Edition  Transition
                                   2.0 2008-01 Medical    period
                                   electrical             extended.
                                   equipment--Part 1-3:
                                   General requirements
                                   for basic safety and
                                   essential
                                   performance--Collate
                                   ral Standard:
                                   Radiation protection
                                   in diagnostic X-ray
                                   equipment.
12-211........                    IEC 60601-2-29         Transition
                                   Edition 3.0 2008-06    period
                                   Medical electrical     extended.
                                   equipment Part 2-29:
                                   Particular
                                   requirements for the
                                   basic safety and
                                   essential
                                   performance of
                                   radiotherapy
                                   simulators.
12-224........                    IEC 60601-2-44 (Third  Withdrawn, see
                                   edition -2009)         12-256.
                                   Medical electrical
                                   equipment--Part 2-
                                   44: Particular
                                   requirements for the
                                   basic safety and
                                   essential
                                   performance of X-ray
                                   equipment for
                                   computed tomography
                                   CORRIGENDUM 1.
12-236........                    IEC 60601-2-45         Transition
                                   Edition 3.0 2011-02    period
                                   Medical electrical     extended.
                                   equipment--Part 2-
                                   45: Particular
                                   requirements for the
                                   safety and essential
                                   performance of
                                   mammographic X-ray
                                   equipment and
                                   mammographic
                                   stereotactic devices.
12-250........                    IEC 60601-2-44         Withdrawn, see
                                   Edition 3.0 2012-08    12-256.
                                   Amendment 1 Medical
                                   electrical
                                   equipment--Part 2-
                                   44: Particular
                                   requirements for the
                                   basic safety and
                                   essential
                                   performance of X-ray
                                   equipment for
                                   computed tomography.
------------------------------------------------------------------------
                      N. Sterility
------------------------------------------------------------------------
14-64.........  14-378..........  ASTM F1929-12          Withdrawn and
                                   Standard Test Method   replaced with
                                   for Detecting Seal     newer version.
                                   Leaks in Porous
                                   Medical Packaging by
                                   Dye Penetration.

[[Page 47710]]

 
14-230........                    ASTM F2203-02          Reaffirmation.
                                   (Reapproved 2012)
                                   Standard Test Method
                                   for Linear
                                   Measurement Using
                                   Precision Steel Rule.
14-231........                    ASTM F2217-02          Reaffirmation.
                                   (Reapproved 2012)
                                   Standard Practice
                                   for Coating/Adhesive
                                   Weight Determination.
14-235........                    ASTM F1140 -07         Reaffirmation.
                                   (Reapproved 2012)
                                   Standard Test
                                   Methods for Internal
                                   Pressurization
                                   Failure Resistance
                                   of Unrestrained
                                   Packages.
14-236........                    ASTM F2054-07          Reaffirmation.
                                   (Reapproved 2012)
                                   Standard Test Method
                                   for Burst Testing of
                                   Flexible Package
                                   Seals Using Internal
                                   Air Pressurization
                                   Within Restraining
                                   Plates.
14-244........  14-379..........  ISO 14644-8 Second     Withdrawn and
                                   edition 2013-02-15     replaced with
                                   Cleanrooms and         newer version.
                                   associated
                                   controlled
                                   environments--Part
                                   8: Classification of
                                   air cleanliness by
                                   chemical
                                   concentration (ACC).
14-264........                    ANSI/AAMI ST8:2008     Contact person.
                                   Hospital steam
                                   sterilizers.
14-275........                    ANSI/AAMI ST41:2008/   Reaffirmation.
                                   (R)2012 Ethylene
                                   oxide sterilization
                                   in health care
                                   facilities: Safety
                                   and effectiveness.
14-281........  14-380..........  ASTM F17-12 Standard   Withdrawn and
                                   Terminology Relating   replaced with
                                   to Flexible Barrier    newer version.
                                   Packaging.
14-295........                    ANSI/AAMI ST81:2004/   Relevant
                                   (R)2010                guidance.
                                   Sterilization of
                                   medical devices--
                                   Information to be
                                   provided by the
                                   manufacturer for the
                                   processing of
                                   resterilizable
                                   medical devices.
14-311........                    ANSI/AAMI ST55:2010    Contact person
                                   Table-top steam
                                   sterilizers.
14-312........  14-394..........  ANSI/AAMI ST79:2010 &  Withdrawn and
                                   A1:2010 & A2:2011 &    replaced with
                                   A3:2012                newer version.
                                   (Consolidated Text)
                                   Comprehensive guide
                                   to steam
                                   sterilization and
                                   sterility assurance
                                   in health care
                                   facilities.
14-341........                    ASTM E2303-11 [euro]1  Editorial
                                   Standard Guide for     change.
                                   Absorbed-Dose
                                   Mapping in Radiation
                                   Processing
                                   Facilities.
14-345........  14-381..........  ISO/ASTM 51261 Second  Withdrawn and
                                   edition 2013-04-15     replaced with
                                   Practice for           newer version.
                                   calibration of
                                   routine dosimetry
                                   systems for
                                   radiation processing.
14-346........  14-382..........  ISO/ASTM 51276 Third   Withdrawn and
                                   edition 2012-07-15     replaced with
                                   Practice for use of    newer version.
                                   a
                                   polymethylmethacryla
                                   te dosimetry system.
14-347........  14-383..........  ISO/ASTM 51702 Third   Withdrawn and
                                   edition 2013-04-15     replaced with
                                   Practice for           newer version.
                                   dosimetry in a gamma
                                   facility for
                                   radiation processing.
14-349........                    ANSI/AAMI/ISO 13408-   Reaffirmation.
                                   3:2006/(R)2012
                                   Aseptic processing
                                   of health care
                                   products--Part 3:
                                   Lyophilization.
14-350........                    ANSI/AAMI/ISO 13408-   Reaffirmation.
                                   4:2005/(R)2012
                                   Aseptic processing
                                   of health care
                                   products--Part 4:
                                   Clean-in-place
                                   technologies.
14-351........                    ANSI/AAMI/ISO 13408-   Reaffirmation.
                                   5:2006/(R)2012
                                   Aseptic processing
                                   of health care
                                   products--Part 5:
                                   Sterilization in
                                   place.
------------------------------------------------------------------------
                 O. Tissue Engineering
------------------------------------------------------------------------
15-5..........  15-37...........  ASTM F2347--11         Withdrawn and
                                   Standard Guide for     replaced with
                                   Characterization and   newer version.
                                   Testing of
                                   Hyaluronan as
                                   Starting Materials
                                   Intended for Use in
                                   Biomedical and
                                   Tissue Engineered
                                   Medical Product
                                   Applications.
15-14.........                    ASTM F2603 -06         Reaffirmation.
                                   (Reapproved 2012)
                                   Standard Guide for
                                   Interpreting Images
                                   of Polymeric Tissue
                                   Scaffolds.
15-29.........                    ASTM F2259 -10         Reaffirmation.
                                   (Reapproved 2012)
                                   [euro]1 Standard
                                   Test Method for
                                   Determining the
                                   Chemical Composition
                                   and Sequence in
                                   Alginate by Proton
                                   Nuclear Magnetic
                                   Resonance (\1\H NMR)
                                   Spectroscopy.
15-32.........                    ASTM F2260 -03         Reaffirmation.
                                   (Reapproved 2012)
                                   [euro]1 Standard
                                   Test Method for
                                   Determining Degree
                                   of Deacetylation in
                                   Chitosan Salts by
                                   Proton Nuclear
                                   Magnetic Resonance
                                   (\1\H NMR)
                                   Spectroscopy.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
  of the respective organizations.

III. Listing of New Entries

    In table 2, FDA provides the listing of new entries and consensus 
standards added as modifications to the list of recognized standards 
under Recognition List Number: 031.

        Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
                                                     Reference No. and
   Recognition No.       Title of standard \1\              Date
------------------------------------------------------------------------
                              A. Anesthesia
------------------------------------------------------------------------
1-90................  Oxygen concentrators for     ISO 8359 Second
                       medical use--Safety          edition 1996-12-15
                       requirements.                Amendment 1 2012-07-
                                                    01

[[Page 47711]]

 
1-92................  Sleep apnoea breathing       ISO 17510-2 Second
                       therapy--Part 2: Masks and   edition 2007-10-01
                       application accessories.
------------------------------------------------------------------------
                              B. Dental/ENT
------------------------------------------------------------------------
4-205...............  Dentistry--Handpieces and    ISO 14457 First
                       motors.                      edition 2012-09-15
------------------------------------------------------------------------
                               C. General
------------------------------------------------------------------------
5-75................  Medical devices--Symbols to  ANSI/AAMI/ISO 15223-1
                       be used with medical         2012
                       device labels, labeling,
                       and information to be
                       supplied--Part 1: General
                       requirements.
------------------------------------------------------------------------
                         D. In Vitro Diagnostics
------------------------------------------------------------------------
7-242...............  Hemolysis, Icterus, and      CLSI C56-A
                       Lipemia/Turbidity Indices
                       as Indicators of
                       Interference in Clinical
                       Laboratory Analysis;
                       Approved Guideline.
7-243...............  Method for Antifungal Disk   CLSI M51-A
                       Diffusion Susceptibility
                       Testing of Nondermatophyte
                       Filamentous Fungi;
                       Approved Guideline.
------------------------------------------------------------------------
                              E. Neurology
------------------------------------------------------------------------
17-11...............  Medical electrical           IEC 60601-2-10
                       equipment--Part 2-10:        Edition 2.0 2012-06
                       Particular requirements
                       for the basic safety and
                       essential performance of
                       nerve and muscle
                       stimulators.
------------------------------------------------------------------------
                              F. Radiology
------------------------------------------------------------------------
12-251..............  Medical electrical           IEC 60601-2-63
                       equipment--Part 2-63:        Edition 1.0 2012-09
                       Particular requirements
                       for the basic safety and
                       essential performance of
                       dental extra-oral X-ray
                       equipment.
12-252..............  Medical electrical           IEC 60601-2-65
                       equipment--Part 2-65:        Edition 1.0 2012-09
                       Particular requirements
                       for the basic safety and
                       essential performance of
                       dental intra-oral X-ray
                       equipment.
12-253..............  Medical electrical           IEC 60976 Edition 2.0
                       equipment--Medical           2007-10
                       electron accelerators--
                       Functional performance
                       characteristics.
------------------------------------------------------------------------
                         G. Software/Informatics
------------------------------------------------------------------------
13-37...............  Laboratory Automation: Data  NCCLS AUTO7-A
                       Content for Specimen
                       Identification; Approved
                       Standard.
------------------------------------------------------------------------
                              H. Sterility
------------------------------------------------------------------------
14-384..............  Biological evaluation of     ISO 10993-7:2008
                       medical devices--Part 7:     TECHNICAL
                       Ethylene oxide               CORRIGENDUM 1
                       sterilization residuals.     Published 2009-11-15
14-385..............  Aseptic processing of        ANSI/AAMI/ISO 13408-
                       health care products--Part   1:2008/(R2011)
                       1: General requirements.
14-386..............  Aseptic processing of        ISO 13408-1 Second
                       health care products--Part   edition 2008-06-15
                       1: General requirements.
14-387..............  Aseptic processing of        ANSI/AAMI/ISO 13408-
                       health care products--Part   7:2012
                       7: Alternate processes for
                       medical devices and
                       combination products.
14-388..............  Aseptic processing of        ISO 13408-7 First
                       health care products--Part   edition 2012-08-01
                       7: Alternate processes for
                       medical devices and
                       combination products.
14-389..............  Cleanrooms and associated    ISO 14644-9 First
                       controlled environments--    edition 2012-08-15
                       Part 9: Classification of
                       surface cleanliness by
                       particle concentration.
14-390..............  Cleanrooms and associated    ISO 14644-10 First
                       controlled environments--    edition 2013-03-01
                       Part 10: Classification of
                       surface cleanliness by
                       chemical concentration.
14-391..............  Practice for dosimetry in    ISO/ASTM 51608 Second
                       an X-ray (bremsstrahlung)    edition 2005-05-15
                       facility for radiation
                       processing.
14-392..............  Practice for dosimetry in    ISO/ASTM 51649 Second
                       an electron beam facility    edition 2005-05-15
                       for radiation processing
                       at energies between 300
                       keV and 25 MeV.
14-393..............  Practice for dosimetry in    ISO/ASTM 51818 Second
                       an electron beam facility    edition 2009-06-15
                       for radiation processing
                       at energies between 80 and
                       300 keV.
------------------------------------------------------------------------
                          I. Tissue Engineering
------------------------------------------------------------------------
15-38...............  Standard Guide for           ATSM F2883--11
                       Characterization of
                       Ceramic and Mineral Based
                       Scaffolds used for Tissue-
                       Engineered Medical
                       Products (TEMPs) and as
                       Device for Surgical
                       Implant Applications.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
  of the respective organizations.

IV. List of Recognized Standards

    FDA maintains the Agency's current list of FDA recognized consensus 
standards in a searchable database that may be accessed directly at 
FDA's Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA will incorporate the modifications 
and revisions described in this notice into the database and, upon 
publication in the Federal Register, this recognition of consensus 
standards will be effective. FDA will announce additional modifications 
and revisions to the list of

[[Page 47712]]

recognized consensus standards, as needed, in the Federal Register once 
a year, or more often, if necessary. Beginning with Recognition List 
Number: 033, FDA will no longer be announcing minor revisions to the 
list of recognized consensus standards such as technical contact 
person, relevant guidance, processes affected, CFR citations, and 
product codes.

V. Recommendation of Standards for Recognition by FDA

    Any person may recommend consensus standards as candidates for 
recognition under section 514 of the FD&C Act by submitting such 
recommendations, with reasons for the recommendation, to the contact 
person (see FOR FURTHER INFORMATION CONTACT). To be properly 
considered, such recommendations should contain, at a minimum, the 
following information: (1) 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: 031'' will be available on the CDRH home page. 
You may access the CDRH home page at http://www.fda.gov/MedicalDevices.
    You may access ``Guidance on the Recognition and Use of Consensus 
Standards,'' and the searchable database for ``FDA Recognized Consensus 
Standards'' at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards.
    This Federal Register document on modifications in FDA's 
recognition of consensus standards is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.

VII. Submission of Comments and Effective Date

    Interested persons may submit to the contact person (see FOR 
FURTHER INFORMATION CONTACT) either electronic or written comments 
regarding this document. It is only necessary to send one set of 
comments. Comments are to be identified with the docket number found in 
brackets in the heading of this document. FDA will consider any 
comments received in determining whether to amend the current listing 
of modifications to the list of recognized standards, Recognition List 
Number: 031. These modifications to the list of recognized standards 
are effective upon publication of this notice in the Federal Register.

    Dated: July 31, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-19019 Filed 8-5-13; 8:45 am]
BILLING CODE 4160-01-P