[Federal Register Volume 77, Number 161 (Monday, August 20, 2012)]
[Notices]
[Pages 50114-50121]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-20323]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Food and Drug Administration Modernization Act of 1997: 
Modifications to the List of Recognized Standards, Recognition List 
Number: 029

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: 029'' (Recognition List Number: 029), 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 of this document 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: 029'' 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

[[Page 50115]]

VI of this document for electronic access to the searchable database 
for the current list of FDA recognized consensus standards, including 
Recognition List Number: 029 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. 3628, Silver Spring, MD 20993, 301-796-
6574.

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, are identified in table 1 of this 
document.

       Table 1--Previous Publication of Standard Recognition Lists
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
February 25, 1998 (63 FR 9561).
October 16, 1998 (63 FR 55617).
July 12, 1999 (64 FR 37546).
November 15, 2000 (65 FR 69022).
May 7, 2001 (66 FR 23032).
January 14, 2002 (67 FR 1774).
October 2, 2002 (67 FR 61893).
April 28, 2003 (68 FR 22391).
March 8, 2004 (69 FR 10712).
June 18, 2004 (69 FR 34176).
October 4, 2004 (69 FR 59240).
May 27, 2005 (70 FR 30756).
November 8, 2005 (70 FR 67713).
March 31, 2006 (71 FR 16313).
June 23, 2006 (71 FR 36121).
November 3, 2006 (71 FR 64718).
May 21, 2007 (72 FR 28500).
September 12, 2007 (72 FR 52142).
December 19, 2007 (72 FR 71924).
September 9, 2008 (73 FR 52358).
March, 18, 2009 (74 FR 11586).
September 8, 2009 (74 FR 46203).
May 5, 2010 (75 FR 24711).
June 10, 2010 (75 FR 32943).
October 4, 2010 (75 FR 61148).
March 14, 2011 (76 FR 13631).
August 2, 2011 (76 FR 46300).
March 16, 2012 (77 FR 15765).
------------------------------------------------------------------------

    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 of this document 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: 029

    FDA is announcing the addition, withdrawal, correction, and 
revision of certain consensus standards the Agency will recognize for 
use in satisfying premarket reviews 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: 029'' to identify these current 
modifications.
    In table 2 of this document, FDA describes the following 
modifications: (1) The withdrawal of standards and their replacement by 
others, (2) the correction of errors made by FDA in listing previously 
recognized standards, and (3) the changes to the supplementary 
information sheets of recognized standards that describe revisions to 
the applicability of the standards.
    In section III of this document, FDA lists modifications the Agency 
is making that involve the initial addition of standards not previously 
recognized by FDA.

                           Table 2--Modifications to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
                              Replacement recognition
   Old  recognition No.                 No.                  Title of standard \1\               Change
----------------------------------------------------------------------------------------------------------------
                                               A. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-115.....................  2-189.....................  ASTM F895-11 Standard Test      Withdrawn and replaced
                                                         Method for Agar Diffusion       with newer version.
                                                         Cell Culture Screening for
                                                         Cytotoxicity.
2-164.....................  2-190.....................  ANSI/AAMI/ISO 10993-13:2010     Withdrawn and replaced
                                                         Biological evaluation of        with newer version.
                                                         medical devices--Part 13:
                                                         Identification and
                                                         quantification of degradation
                                                         products from polymeric
                                                         medical devices.
2-165.....................  ..........................  ANSI/AAMI/ISO 10993-14:2001/    Reaffirmation.
                                                         (R)2011 Biological evaluation
                                                         of medical devices--Part 14:
                                                         Identification and
                                                         quantification of degradation
                                                         products from ceramics.
----------------------------------------------------------------------------------------------------------------
                                                B. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-37......................  1-87......................  IEC 60601-2-23(1999-12)         Transferred to
                                                         Medical electrical equipment--  Anesthesia.
                                                         Part 2-23: Particular
                                                         requirements for the safety,
                                                         including essential
                                                         performance, of
                                                         transcutaneous partial
                                                         pressure monitoring equipment.
3-44......................  ..........................  ANSI/AAMI BP22:1994/(R)2011     Reaffirmation.
                                                         Blood pressure transducers.
3-55......................  ..........................  ASTM F1830-97 (Reapproved       Extent of recognition.
                                                         2005) Standard Practice for
                                                         Selection of Blood for in
                                                         vitro Evaluation of Blood
                                                         Pumps.
3-56......................  ..........................  ASTM F1841-97 (Reapproved       Extent of recognition.
                                                         2005) Standard Practice for
                                                         Assessment of Hemolysis in
                                                         Continuous Flow Blood Pumps.

[[Page 50116]]

 
3-62......................  3-102.....................  IEC 60601-2-31 Edition 2.1      Withdrawn and replaced
                                                         2011-09 Medical electrical      with newer version.
                                                         equipment--Part 2-31:
                                                         Particular requirements for
                                                         the basic safety and
                                                         essential performance of
                                                         external cardiac pacemakers
                                                         with internal power source.
----------------------------------------------------------------------------------------------------------------
                                                   C. General
----------------------------------------------------------------------------------------------------------------
5-28......................  ..........................  IEC 60601-1-2, (Second          Withdrawn.
                                                         Edition, 2001), Medical
                                                         Electrical Equipment--Part 1-
                                                         2: General Requirements for
                                                         Safety--Collateral Standard:
                                                         Electromagnetic
                                                         Compatibility--Requirements
                                                         and Tests.
5-30......................  ..........................  ANSI/AAMI/IEC 60601-1-2:2001,   Withdrawn.
                                                         Medical Electrical Equipment--
                                                         Part 1-2: General
                                                         Requirements for Safety--
                                                         Collateral Standard:
                                                         Electromagnetic
                                                         Compatibility--Requirements
                                                         and Tests.
5-40......................  ..........................  ISO 14971 Second edition 2007-  Extent of recognition.
                                                         03-01, Medical devices--
                                                         Application of risk
                                                         management to medical devices.
5-52......................  5-71......................  ANSI/AAMI ES60601-1:2005/       Withdrawn and replaced
                                                         (R)2012 and C1:2009/(R)2012     with new version.
                                                         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).
5-56......................  ..........................  ISO 15223-2 First edition 2010- Contact person.
                                                         01-15, Medical devices--
                                                         Symbols to be used with
                                                         medical devices labels,
                                                         labeling, and information to
                                                         be supplied--Part 2: Symbol
                                                         development, selection and
                                                         validation.
5-59......................  5-72......................  ISO/FDIS 15223-1 2012 Medical   Withdrawn and replaced
                                                         devices--Symbols to be used     with new version.
                                                         with medical device labels,
                                                         labeling and information to
                                                         be supplied--Part 1: General
                                                         requirements.
5-61......................  ..........................  ANSI/AAMI/ISO 15223-1:2007,     Withdrawn.
                                                         Medical devices--Symbols to
                                                         be used with medical device
                                                         labels, labeling, and
                                                         information to be supplied--
                                                         Part 1: General requirements.
----------------------------------------------------------------------------------------------------------------
                                   D. General Hospital/General Plastic Surgery
----------------------------------------------------------------------------------------------------------------
6-110.....................  ..........................  ASTM F 882-84 (Reapproved       Withdrawn.
                                                         2002), Standard Performance
                                                         and Safety Specification for
                                                         Cryosurgical Medical
                                                         Instruments.
6-114.....................  6-274.....................  ISO 11608-1 Second edition      Withdrawn and replaced
                                                         2012-04-01 Needle-based         with newer version.
                                                         injection systems for medical
                                                         use--Requirements and test
                                                         methods--Part 1: Needle-based
                                                         injection systems.
6-115.....................  6-275.....................  ISO 11608-2 Second edition      Withdrawn and replaced
                                                         2012-04-01 Needle-based         with newer version.
                                                         injection systems for medical
                                                         use--Requirements and test
                                                         methods--Part 2: Needles.
6-117.....................  ..........................  ASTM F2172-02 (Reapproved       Contact person.
                                                         2011), Standard Specification
                                                         for Blood/Intravenous Fluid/
                                                         Irrigation Fluid Warmers.
6-118.....................  ..........................  ASTM F2196-02, Standard         Withdrawn. See 6-238.
                                                         Specification for Circulating
                                                         Liquid and Forced Air Patient
                                                         Temperature Management
                                                         Devices.
6-119.....................  ..........................  ANSI/AAMI BF7:1989/(R)2011      Reaffirmation.
                                                         Blood transfusion
                                                         microfilters.
6-132.....................  ..........................  ISO 11810-1 First edition 2005- Contact person.
                                                         02-15, Lasers and laser-
                                                         related equipment--Test
                                                         method and classification for
                                                         the laser-resistance of
                                                         surgical drapes and/or
                                                         patient-protective covers--
                                                         Part 1: Primary ignition and
                                                         penetration.
6-172.....................  6-276.....................  ISO 8536-1 Fourth edition 2011- Withdrawn and replaced
                                                         09-01 Infusion equipment for    with newer version.
                                                         medical use--Part 1: Infusion
                                                         glass bottles.
6-175.....................  ..........................  ASTM D5151-06 (Reapproved       Reaffirmation.
                                                         2011) Standard Test Method
                                                         for Detection of Holes in
                                                         Medical Gloves.
6-178.....................  ..........................  ASTM D6124-06 (Reapproved       Reaffirmation and
                                                         2011) Standard Test Method      Contact person.
                                                         for Residual Powder on
                                                         Medical Gloves.
6-183.....................  ..........................  ASTM D5250-06 (Reapproved       Reaffirmation and
                                                         2011) Standard Specification    contact person.
                                                         for Poly(vinyl chloride)
                                                         Gloves for Medical
                                                         Application.
6-202.....................  ..........................  ISO 11810-2:2007, Lasers and    Title and contact
                                                         laser-related equipment--Test   person.
                                                         method and classification for
                                                         the laser-resistance of
                                                         surgical drapes and/or
                                                         patient-protective covers--
                                                         Part 2: Secondary ignition.
6-236.....................  ..........................  IEC 80601-2-59 Edition 1.0      Title and contact
                                                         2008-10 Medical electrical      person.
                                                         equipment--Part 2-59:
                                                         Particular requirements for
                                                         the basic safety and
                                                         essential performance of
                                                         screening thermographs for
                                                         human febrile temperature
                                                         screening.
6-237.....................  ..........................  IEC 80601-2-59 (First edition-- Title and contact
                                                         2008) Medical electrical        person.
                                                         equipment--Part 2-59:
                                                         Particular requirements for
                                                         the basic safety and
                                                         essential performance of
                                                         screening thermographs for
                                                         human febrile temperature
                                                         screening CORRIGENDUM1.
6-238.....................  ..........................  IEC 80601-2-35 Edition 2.0      Contact person.
                                                         2009-10, Medical electrical
                                                         equipment--Part 2-35:
                                                         Particular requirements for
                                                         the basic safety and
                                                         essential performance of
                                                         heating devices using
                                                         blankets, pads or mattresses
                                                         and intended for heating in
                                                         medical use.

[[Page 50117]]

 
6-241.....................  ..........................  ISO 1135-4 Fourth edition 2010- Contact person.
                                                         04-15, Transfusion equipment
                                                         for medical use--Part 4:
                                                         Transfusion sets for single
                                                         use.
6-242.....................  ..........................  ISO 8536-2 Third edition 2010-  Contact person.
                                                         03-15, Infusion equipment for
                                                         medical use--Part 2: Closures
                                                         for infusion bottles.
6-245.....................  ..........................  ISO 8536-4 Fifth edition 2010-  Contact person.
                                                         10-01, Infusion equipment for
                                                         medical use--Part 4: Infusion
                                                         sets for single use, gravity
                                                         feed.
6-273.....................  ..........................  ISO 23908 First edition 2011-   Contact person.
                                                         06-11, Sharps injury
                                                         protection--Requirements and
                                                         test methods--Sharps
                                                         protection features for
                                                         single-use hypodermic
                                                         needles, introducers for
                                                         catheters and needles used
                                                         for blood sampling.
----------------------------------------------------------------------------------------------------------------
                                             E. In Vitro Diagnostics
----------------------------------------------------------------------------------------------------------------
7-54......................  ..........................  CLSI D12-A2, Immunoprecipitin   Withdrawn.
                                                         Analyses: Procedures for
                                                         Evaluating the Performance of
                                                         Materials--Second Edition;
                                                         Approved Guideline.
7-76......................  ..........................  NCCLS M15-A, Laboratory         Contact person and type
                                                         Diagnosis of Blood-borne        of standard.
                                                         Parasitic Diseases; Approved
                                                         Guideline.
7-146.....................  ..........................  CLSI M6-A2, Protocols for       Contact person and
                                                         Evaluating Dehydrated Mueller-  title.
                                                         Hinton Agar; Approved
                                                         Standard--Second Edition.
7-148.....................  ..........................  CLSI M28-A2, Procedures for     Contact person and
                                                         the Recovery and                title.
                                                         Identification of Parasites
                                                         From the Intestinal Tract;
                                                         Approved Guideline--Second
                                                         Edition.
7-157.....................  7-228.....................  CLSI M11-A8, Methods for        Withdrawn and replaced
                                                         Antimicrobial Susceptibility    with newer version.
                                                         Testing of Anaerobic
                                                         Bacteria; Approved Standard-
                                                         Eighth Edition.
7-171.....................  ..........................  CLSI M38-A2, Reference Method   Contact person and
                                                         for Broth Dilution Antifungal   title.
                                                         Susceptibility Testing of
                                                         Filamentous Fungi; Approved
                                                         Standard--Second Edition.
7-179.....................  ..........................  CLSI M27-S3, Reference Method   Contact person and
                                                         for Broth Dilution Antifungal   title.
                                                         Susceptibility Testing of
                                                         Yeasts; Third Informational
                                                         Supplement.
7-184.....................  ..........................  CLSI M40-A, Quality Control of  Contact person and
                                                         Microbiological Transport       title.
                                                         Systems; Approved Standard.
7-195.....................  7-229.....................  CLSI M02-A11, Performance       Withdrawn and replaced
                                                         Standards for Antimicrobial     with newer version.
                                                         Disk Susceptibility Tests;
                                                         Approved Standard--Eleventh
                                                         Edition.
7-196.....................  7-230.....................  CLSI M07-A9, Methods for        Withdrawn and replaced
                                                         Dilution Antimicrobial          with newer version.
                                                         Susceptibility Tests for
                                                         Bacteria That Grow
                                                         Aerobically; Approved
                                                         Standard--Ninth Edition.
7-197.....................  ..........................  CLSI M35-A2, Abbreviated        Contact person and
                                                         Identification of Bacteria      title.
                                                         and Yeast; Approved
                                                         Guideline--Second Edition.
7-198.....................  ..........................  CLSI M23-A3, Development of In  Contact person and
                                                         Vitro Susceptibility Testing    title.
                                                         Criteria and Quality Control
                                                         Parameters; Approved
                                                         Guideline--Third Edition.
7-200.....................  ..........................  CLSI M48-A, Laboratory          Contact person and
                                                         Detection and Identification    title.
                                                         of Mycobacteria; Approved
                                                         Guideline.
7-215.....................  ..........................  CLSI M44-A2, Method for         Contact person.
                                                         Antifungal Disk Diffusion
                                                         Susceptibility Testing of
                                                         Yeast; Approved Guideline-
                                                         Second Edition.
7-216.....................  7-231.....................  CLSI M100-S22, Performance      Withdrawn and replaced
                                                         Standards for Antimicrobial     with newer version.
                                                         Susceptibility Testing;
                                                         Twenty-Second Informational
                                                         Supplement.
7-217.....................  ..........................  CLSI M44-S3, Zone Diameter      Contact person.
                                                         Interpretive Standards,
                                                         Corresponding Minimal
                                                         Inhibitory 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 for        Contact person.
                                                         Antimicrobial Dilution and
                                                         Disk Susceptibility Testing
                                                         of Infrequently Isolated or
                                                         Fastidious Bacteria; Approved
                                                         Guideline--Second Edition.
----------------------------------------------------------------------------------------------------------------
                                                  F. Materials
----------------------------------------------------------------------------------------------------------------
8-108.....................  8-216.....................  ASTM F1295-11 Standard          Withdrawn and replaced
                                                         Specification for Wrought       with newer version.
                                                         Titanium-6Aluminum-7Niobium
                                                         Alloy for Surgical Implant
                                                         Applications (UNS R56700).
8-111.....................  ..........................  ASTM F1160-05 (Reapproved       Reaffirmation.
                                                         2011) Standard Test Method
                                                         for Shear and Bending Fatigue
                                                         Testing of Calcium Phosphate
                                                         and Metallic Medical and
                                                         Composite Calcium Phosphate/
                                                         Metallic Coatings.
8-112.....................  ..........................  ASTM F1044-05 (Reapproved       Reaffirmation.
                                                         2011) Standard Test Method
                                                         for Shear Testing of Calcium
                                                         Phosphate Coatings and
                                                         Metallic Coatings.
8-113.....................  ..........................  ASTM F1147-05 (Reapproved       Reaffirmation.
                                                         2011) Standard Test Method
                                                         for Tension Testing of
                                                         Calcium Phosphate and
                                                         Metallic Coatings.
8-127.....................  ..........................  ISO 5834-2:2006, Implants for   Withdrawn. See 8-208.
                                                         surgery--Ultra-high-molecular-
                                                         weight polyethylene--Part 2:
                                                         Moulded forms.
8-128.....................  ..........................  ASTM F2213-06 (Reapproved       Reaffirmation and
                                                         2011) Standard Test Method      relevant guidance.
                                                         for Measurement of
                                                         Magnetically Induced Torque
                                                         on Medical Devices in the
                                                         Magnetic Resonance
                                                         Environment.

[[Page 50118]]

 
8-130.....................  8-217.....................  ASTM F620-11 Standard           Withdrawn and replaced
                                                         Specification for Titanium      with newer version.
                                                         Alloy Forgings for Surgical
                                                         Implants in the Alpha Plus
                                                         Beta Condition.
8-131.....................  8-218.....................  ASTM F799-11 Standard           Withdrawn and replaced
                                                         Specification for Cobalt-       with newer version.
                                                         28Chromium-6Molybdenum Alloy
                                                         Forgings for Surgical
                                                         Implants (UNS R31537, R31538,
                                                         R31539).
8-164.....................  8-219.....................  ASTM F136-11 Standard           Withdrawn and replaced
                                                         Specification for Wrought       with newer version.
                                                         Titanium-6Aluminum-4Vanadium
                                                         ELI (Extra Low Interstitial)
                                                         Alloy for Surgical Implant
                                                         Applications (UNS R56401).
8-174.....................  8-220.....................  ASTM F629-11 Standard Practice  Withdrawn and replaced
                                                         for Radiography of Cast         with newer version.
                                                         Metallic Surgical Implants.
8-180.....................  8-221.....................  ASTM F2066-11 Standard          Withdrawn and replaced
                                                         Specification for Wrought       with newer version.
                                                         Titanium-15 Molybdenum Alloy
                                                         for Surgical Implant
                                                         Applications (UNS R58150).
8-182.....................  8-222.....................  ASTM F1537-11 Standard          Withdrawn and replaced
                                                         Specification for Wrought       with newer version.
                                                         Cobalt-28Chromium-6Molybdenum
                                                         Alloys for Surgical Implants
                                                         (UNS R31537, UNS R31538, and
                                                         UNS R31539).
8-186.....................  8-223.....................  ASTM F2759-11 Standard Guide    Withdrawn and replaced
                                                         for Assessment of the Ultra     with newer version.
                                                         High Molecular Weight
                                                         Polyethylene (UHMWPE) Used in
                                                         Orthopedic and Spinal Devices.
8-210.....................  8-227.....................  ASTM F2182-11a Standard Test    Withdrawn and replaced
                                                         Method for Measurement of       with newer version.
                                                         Radio Frequency Induced
                                                         Heating On or Near Passive
                                                         Implants During Magnetic
                                                         Resonance Imaging.
----------------------------------------------------------------------------------------------------------------
                                                 G. Orthopedics
----------------------------------------------------------------------------------------------------------------
11-175....................  ..........................  ASTM F1582-98 (Reapproved       Reaffirmation.
                                                         2011) Standard Terminology
                                                         Relating to Spinal Implants.
11-185....................  ..........................  ASTM F2267-04 (Reapproved       Reaffirmation.
                                                         2011) Standard Test Method
                                                         for Measuring Load Induced
                                                         Subsidence of Intervertebral
                                                         Body Fusion Device Under
                                                         Static Axial Compression.
11-186....................  11-235....................  ASTM F2077-11 Test Methods For  Withdrawn and replaced
                                                         Intervertebral Body Fusion      with newer version.
                                                         Devices.
11-195....................  ..........................  ASTM F1612-95 (2005), Standard  Withdrawn. See 11-225.
                                                         Practice for Cyclic Fatigue
                                                         Testing of Metallic Stemmed
                                                         Hip Arthroplasty Femoral
                                                         Components with Torsion.
11-203....................  ..........................  ASTM F1541-02 (Reapproved       Reaffirmation and
                                                         2011) Standard Specification    contact person.
                                                         and Test Methods for External
                                                         Skeletal Fixation Devices.
11-220....................  ..........................  ASTM F2068-09, Standard         Extent of recognition
                                                         Specification for Femoral       and CFR citations.
                                                         Prostheses--Metallic Implants.
11-230....................  11-236....................  ASTM F1717-11a Standard Test    Withdrawn and replaced
                                                         Methods for Spinal Implant      with newer version.
                                                         Constructs in a Vertebrectomy
                                                         Model.
----------------------------------------------------------------------------------------------------------------
                                              H. Physical Medicine
----------------------------------------------------------------------------------------------------------------
16-172....................  ..........................  ANSI/RESNA WC/Volume 1--1998,   Duplicate. See 16-188.
                                                         Section 5: Determination of
                                                         Overall Dimensions, Mass, and
                                                         Turning Space--Wheelchair.
16-186....................  16-189....................  ASME A18.1-2011 (Revision of    Withdrawn and replaced
                                                         ASME A18.1-2008) Safety         with newer version.
                                                         Standard for Platform Lifts
                                                         and Stairway Chairlifts.
----------------------------------------------------------------------------------------------------------------
                                                  I. Radiology
----------------------------------------------------------------------------------------------------------------
12-102....................  ..........................  ANSI/IESNA RP-27.2-00           CFR citation and product
                                                         Recommended Practice for        codes, devices
                                                         Photobiological Safety for      affected, processes
                                                         Lamps & Lamp Systems--          impacted, and contact
                                                         Measurement Techniques.         person.
12-153....................  ..........................  ANSI/IESNA RP-27.1-05           CFR citation and product
                                                         Recommended Practice for        codes, devices
                                                         Photobiological Safety for      affected, processes
                                                         Lamps and Lamp Systems--        impacted, and contact
                                                         General Requirements.           person.
12-179....................  ..........................  ANSI/IESNA RP-27.3-07           Extent of recognition,
                                                         Recommended Practice for        CFR citation and
                                                         Photobiological Safety for      product codes, devices
                                                         Lamps--Risk Group               affected, processes
                                                         Classification and Labeling.    impacted, type of
                                                                                         standard, contact
                                                                                         person, and relevant
                                                                                         guidance.
----------------------------------------------------------------------------------------------------------------
                                             J. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-8......................  ..........................  IEC 62304 First edition 2006-   Extent of recognition.
                                                         05 Medical device software--
                                                         Software life cycle processes.
----------------------------------------------------------------------------------------------------------------

[[Page 50119]]

 
                                                  K. Sterility
----------------------------------------------------------------------------------------------------------------
14-55.....................  14-358....................  ANSI/AAMI/ISO 14160:2011        Withdrawn and replaced
                                                         Sterilization of health care    with newer version.
                                                         products--Liquid chemical
                                                         sterilizing agents for single-
                                                         use medical devices utilizing
                                                         animal tissues and their
                                                         derivatives--Requirements for
                                                         characterization,
                                                         development, validation and
                                                         routine control of a
                                                         sterilization process for
                                                         medical devices.
14-123....................  14-359....................  ASTM F2096-11 Standard Test     Withdrawn and replaced
                                                         Method for Detecting Gross      with newer version.
                                                         Leaks in Packaging by
                                                         Internal Pressurization
                                                         (Bubble Test).
14-227....................  ..........................  ANSI/AAMI/ISO 11737-1:2006 (R)  Reaffirmation and
                                                         2011, Sterilization of health   contact person.
                                                         care products--
                                                         Microbiological methods--Part
                                                         1: Determination of the
                                                         population of microorganisms
                                                         on product.
14-229....................  ..........................  ASTM F1980-07 (Reapproved       Reaffirmation.
                                                         2011) Standard Guide for
                                                         Accelerated Aging of Sterile
                                                         Barrier Systems for Medical
                                                         Devices.
14-264....................  ..........................  AAMI/ANSI ST8:2008, Hospital    Contact person.
                                                         steam sterilizers.
14-277....................  ..........................  ISO TS 17665-2:2009,            Extent of recognition
                                                         Sterilization of health care    and contact person.
                                                         products--Moist heat--Part 2:
                                                         Guidance on the application
                                                         of ISO 17665-1.
14-292....................  14-360....................  ANSI/AAMI ST72:2011 Bacterial   Withdrawn and replaced
                                                         endotoxins--Test methods,       with newer version.
                                                         routine monitoring, and
                                                         alternatives to batch testing.
14-311....................  ..........................  AAMI/ANSI ST55:2010, Table-top  Contact person.
                                                         steam sterilizers.
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.

Listing of New Entries

    In table 3 of this document, FDA provides the listing of new 
entries and consensus standards added as modifications to the list of 
recognized standards under Recognition List Number: 029.

        Table 3--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
                                                      Reference No. and
    Recognition No.        Title of standard \1\            date
------------------------------------------------------------------------
                              A. Anesthesia
------------------------------------------------------------------------
1-86..................  Respiratory tract           ISO 8185 Third
                         humidifiers for medical     edition 2007-07-01.
                         use--Particular
                         requirements for
                         respiratory
                         humidification systems.
1-87..................  Medical electrical          60601-2-23 Edition
                         equipment--Part 2-23:       3.0 2011-02.
                         Particular requirements
                         for the basic safety and
                         essential performance of
                         transcutaneous partial
                         pressure monitoring
                         equipment.
1-88..................  Medical electrical          ISO 80601-2-12 First
                         equipment--Part 2-12:       edition 2011-04-15.
                         Particular requirements
                         for basic safety and
                         essential performance of
                         critical care ventilators.
1-89..................  Medical electrical          ISO 80601-2-12:2011
                         equipment--Part 2-12:       TECHNICAL
                         Particular requirements     CORRIGENDUM 1.
                         for basic safety and
                         essential performance of
                         critical care ventilators.
------------------------------------------------------------------------
                            B. Cardiovascular
------------------------------------------------------------------------
3-101.................  Medical electrical          ANSI/AAMI/IEC 60601-
                         equipment--Part 2-27:       2-27:2011.
                         Particular requirements
                         for the basic safety and
                         essential performance of
                         electrocardiographic
                         monitoring equipment.
3-103.................  Cardiovascular implants--   ISO 25539-3 First
                         Endovascular devices--      edition 2011-12-01.
                         Part 3: Vena cava filters.
3-104.................  Standard Guide for          ASTM F2914-12.
                         Identification of Shelf-
                         life Test Attributes for
                         Endovascular Devices.
------------------------------------------------------------------------
               C. General Hospital/General Plastic Surgery
------------------------------------------------------------------------
6-277.................  Prefilled syringes--Part    ISO 11040-4 Second
                         4: Glass barrels for        edition 2007-02-01.
                         injectables.
6-278.................  Prefilled syringes--Part    ISO 11040-5 Third
                         5: Plunger stoppers for     edition 2012-01-15.
                         injectables.
6-279.................  Medical electrical          IEC 60601-2-19
                         equipment--Part 2-19:       (Second edition--
                         Particular requirements     2009).
                         for the basic safety and
                         essential performance of
                         infant incubators
                         CORRIGENDUM 1.
6-280.................  Medical electrical          IEC 60601-2-20
                         equipment--Part 2-20:       (Second edition--
                         Particular requirements     2009).
                         for the basic safety and
                         essential performance of
                         infant transport
                         incubators CORRIGENDUM 1.
6-281.................  Medical electrical          IEC 80601-2-35
                         equipment--Part 2-35:       (Second edition--
                         Particular requirements     2009).
                         for the basic safety and
                         essential performance of
                         heating devices using
                         blankets, pads or
                         mattresses and intended
                         for heating in medical
                         use CORRIGENDUM 1.
------------------------------------------------------------------------
                              D. Materials
------------------------------------------------------------------------
8-224.................  Standard Guide for          ASTM F2102--06
                         Evaluating the Extent of    [euro]\1\.
                         Oxidation in Ultra-High-
                         Molecular-Weight
                         Polyethylene Fabricated
                         Forms Intended for
                         Surgical Implants.

[[Page 50120]]

 
8-225.................  Standard Practice for       ASTM F2003--02
                         Accelerated Aging of        (Reapproved 2008).
                         Ultra-High Molecular
                         Weight Polyethylene after
                         Gamma Irradiation in Air.
8-226.................  Standard Specification for  ASTM F603--12.
                         High-Purity Dense
                         Aluminum Oxide for
                         Medical Application.
------------------------------------------------------------------------
                       E. OB-GYN/Gastroenterology
------------------------------------------------------------------------
9-75..................  Optics and Optical          ISO 8600-3 First
                         instruments--Medical        edition 1997-07-01.
                         endoscopes and endoscopic
                         accessories--Part 3:
                         Determination of field of
                         view and direction of
                         view of endoscopes with
                         optics.
9-76..................  Water for haemodialysis     ISO 13959 Second
                         and related therapies.      edition 2009-04-15.
9-77..................  Guidance for the            ISO 23500 First
                         preparation and quality     edition 2011-05-15.
                         management of fluids for
                         haemodialysis and related
                         therapies.
9-78..................  Quality of dialysis fluid   ISO 11663 First
                         for haemodialysis and       edition 2009-04-15.
                         related therapies.
------------------------------------------------------------------------
                              F. Ophthalmic
------------------------------------------------------------------------
10-73.................  American National Standard  ANSI Z80.21-2010.
                         for Ophthalmics--
                         Instruments--General-
                         Purpose Clinical Visual
                         Acuity Charts.
10-74.................  Ophthalmic instruments--    ISO 10940 Second
                         Fundus cameras.             edition 2009-08-01.
------------------------------------------------------------------------
                              G. Orthopedic
------------------------------------------------------------------------
11-237................  Implants for surgery--      ISO 7206-6 First
                         Partial and total hip       edition 1992-03-l5.
                         joint prostheses--Part 6:
                         Determination of
                         endurance properties of
                         head and neck region of
                         stemmed femoral
                         components.
11-238................  Standard Specification for  ASTM F 2033-12.
                         Total Hip Joint
                         Prosthesis and Hip
                         Endoprosthesis Bearing
                         Surfaces Made of
                         Metallic, Ceramic, and
                         Polymeric Materials.
11-239................  Standard Test Methods for   ASTM F2345-03
                         Determination of Static     (Reapproved 2008).
                         and Cyclic Fatigue
                         Strength of Ceramic
                         Modular Femoral Heads.
11-240................  Standard Specification and  ASTM F382-99
                         Test Method for Metallic    (Reapproved 2008).
                         Bone Plates.
11-241................  Standard Specification and  ASTM F543-07
                         Test Methods for Metallic   [euro]\1\.
                         Medical Bone Screws.
11-242................  Standard Specification for  ASTM F1839-08
                         Rigid Polyurethane Foam     [euro]\2\.
                         for Use as a Standard
                         Material for Testing
                         Orthopaedic Devices and
                         Instruments.
11-243................  Standard Test Methods for   ASTM F2346-05
                         Static and Dynamic          (Reapproved 2011).
                         Characterization of
                         Spinal Artificial Discs.
------------------------------------------------------------------------
                              H. Radiology
------------------------------------------------------------------------
12-249................  Photobiological safety of   IEC 62471 First
                         lamps and lamp systems.     edition 2006-07.
------------------------------------------------------------------------
                         I. Software/Informatics
------------------------------------------------------------------------
13-31.................  Specimen Labels: Content    CLSI AUTO12-A.
                         and Location, Fonts, and
                         Label Orientation;
                         Approved Standard.
13-32.................  Medical device software--   ANSI/AAMI/IEC
                         Software life cycle         62304:2006.
                         processes.
------------------------------------------------------------------------
                              J. Sterility
------------------------------------------------------------------------
14-361................  Sterilization of health     ISO 14160 Second
                         care products--Liquid       edition 2011-07-01.
                         chemical sterilizing
                         agents for single-use
                         medical devices utilizing
                         animal tissues and their
                         derivatives--Requirements
                         for characterization,
                         development, validation
                         and routine control of a
                         sterilization process for
                         medical devices.
------------------------------------------------------------------------
 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 minor 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 minor revisions to the list of recognized consensus standards, as 
needed, in the Federal Register once a year, or more often, if 
necessary.

V. Recommendation of Standards for Recognition by FDA

    Any person may recommend consensus standards as candidates for 
recognition under the new provision of 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

[[Page 50121]]

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. 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: 029'' 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 no longer necessary to send two copies 
of mailed 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: 029. These modifications to the list of 
recognized standards are effective upon publication of this notice in 
the Federal Register.

    Dated: August 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-20323 Filed 8-17-12; 8:45 am]
BILLING CODE 4160-01-P