
[Federal Register Volume 78, Number 10 (Tuesday, January 15, 2013)]
[Notices]
[Pages 2998-3005]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-00605]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Food and Drug Administration Modernization Act of 1997: 
Modifications to the List of Recognized Standards, Recognition List 
Number: 030

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: 030'' (Recognition List Number: 030), 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: 030'' 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: 
standards@cdrh.fda.gov. This document may also be accessed on FDA's 
Internet site at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section VI of 
this document for electronic access to the searchable database for the 
current list of FDA recognized consensus standards, including 
Recognition List Number: 030 modifications and other standards related 
information.

FOR FURTHER INFORMATION CONTACT: Scott A. Colburn, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 3632, Silver Spring, MD 20993, 301-796-
6287.

I. Background

    Section 204 of the Food and Drug Administration Modernization Act 
of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). Amended 
section 514 allows FDA to recognize consensus standards developed by 
international and national organizations for use in satisfying portions 
of device premarket review submissions or other requirements.
    In a notice published in the Federal Register of February 25, 1998 
(63 FR 9561), FDA announced the availability of a guidance entitled 
``Recognition and Use of Consensus Standards.'' The notice described 
how FDA would implement its standard recognition program and provided 
the initial list of recognized standards.
    Modifications to the initial list of recognized standards, as 
published in the Federal Register, are identified in table 1 of this 
document.

      Table 1--Previous Publications 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).
August 20, 2012 (77 FR 50114).
------------------------------------------------------------------------

    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: 030

    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: 030'' 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

[[Page 2999]]

that involve the initial addition of standards not previously 
recognized by FDA.

                                               Table 2--Modifications to the List of Recognized Standards
--------------------------------------------------------------------------------------------------------------------------------------------------------
                              Replacement
    Old recognition No.     recognition No.                 Title of standard \1\                                         Change
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   A. Biocompatibility
--------------------------------------------------------------------------------------------------------------------------------------------------------
2-156.....................  ...............  AAMI/ANSI/ISO 10993-1:2009 Biological evaluation    Extent of recognition.
                                              of medical devices--Part 1: Evaluation and
                                              testing within a risk management process.
2-178.....................           2-191   ISO 10993-12 Fourth edition 2012-07-01 Biological   Withdrawn and replaced with newer version.
                                              evaluation of medical devices--Part 12: Sample
                                              preparation and reference materials.
2-184.....................           2-192   USP 35-NF30:2012<87> Biological Reactivity Test,    Withdrawn and replaced with newer version.
                                              In Vitro--Direct Contact Test.
2-185.....................           2-193   USP 35-NF30:2012 Biological Tests <87> Biological   Withdrawn and replaced with newer version.
                                              Reactivity Test, In Vitro--Elution Test.
2-186.....................           2-194   USP 35-NF30:2012 Biological Tests <88> Biological   Withdrawn and replaced with newer version.
                                              Reactivity Tests, In Vivo, Procedure Preparation
                                              of Sample.
2-187.....................           2-195   USP 35-NF30:2012 Biological Tests <88> Biological   Withdrawn and replaced with newer version.
                                              Reactivity Test, In Vitro, Classification of
                                              Plastics--Intracutaneous Test.
2-188.....................           2-196   USP 35-NF30:2012 Biological Tests <88> Biological   Withdrawn and replaced with newer version.
                                              Reactivity Tests, In Vivo, Classification of
                                              Plastics--Systemic Injection Test.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    B. Cardiovascular
--------------------------------------------------------------------------------------------------------------------------------------------------------
3-30......................           3-105   IEC 60601-2-25 Edition 2.0 2011-10 Medical          Withdrawn and replaced with newer version.
                                              electrical equipment--Part 2-25: Particular
                                              requirements for the basic safety and essential
                                              performance of electrocardiographs.
3-61......................  ...............  IEC 60601-2-27 Edition 3.0 2011-03 Medical          Withdrawn, see 3-95.
                                              electrical equipment--Part 2-27: Particular
                                              requirements for the basic safety and essential
                                              performance of electrocardiographic monitoring
                                              equipment.
3-101.....................  ...............  ANSI/AAMI/ISO 60601-2-27 Edition 3.0 2011-03        Withdrawn, see 3-100.
                                              Medical electrical equipment--Part 2-27:
                                              Particular requirements for the basic safety and
                                              essential performance of electrocardiographic
                                              monitoring equipment.
3-59......................  ...............  ISO 5841-3 Second edition 2000-10-15 Implants for   Title, processes impacted, related CFR citation(s) and
                                              surgery--Cardiac pacemakers--Part 3: Low-profile    procode(s), and relevant guidance.
                                              connectors [IS-1] for implantable pacemakers.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      C. Dental/ENT
--------------------------------------------------------------------------------------------------------------------------------------------------------
4-43......................  ...............  ADA/ANSI Specification No. 5, Dental Casting        Withdrawn, see 4-146.
                                              Alloys: 1997.
4-87......................           4-196   ANSI/ADA Specification No. 69, 2010 Dental Ceramic  Withdrawn and replaced with newer version.
4-94......................  ...............  Specification No.14, Dental Base Metal Casting      Withdrawn, see 4-146.
                                              Alloys: 1982 (Reaffirmed 1998).
4-96......................  ...............  ANSI/ADA Specification No. 30, Reaffirmed by ANSI   Reaffirmation.
                                              October 2010 Dental Zinc Oxide-Eugenol and Zinc
                                              Oxide Non-Eugenol Cements.
4-110.....................  ...............  ADA/ANSI ADA Specification No. 11, Agar Impression  Withdrawn.
                                              Materials: 1997.
4-113.....................  ...............  ADA/ANSI ADA Specification No. 20, Dental           Withdrawn.
                                              Duplicating Material; 1972 (Reaffirmed 1995).
4-131.....................           4-198   ISO 3107 Fourth edition 2011-03 Dentistry--Zinc     Withdrawn and replaced with newer version.
                                              oxide/Eugenol cements and zinc oxide/non-eugenol
                                              cements.
4-133.....................           4-199   ISO 6876 Third edition 2012-06-01 Dentistry--Root   Withdrawn and replaced with newer version.
                                              canal sealing materials.
4-147.....................  ...............  ADA/ANSI Specification No. 27, Resin-Based Filling  Withdrawn.
                                              Materials: 2005.
4-152.....................           4-201   ISO 9693 Second edition 1999-12-15 Metal-ceramic    Withdrawn and replaced with newer version.
                                              dental restorative systems.
4-158.....................  ...............  ISO 10139-1:2005, Dentistry--Soft lining materials  Withdrawn--Duplicate, see 4-189.
                                              for removable dentures--Part 1: Materials for
                                              short-term use Technical Corrigendum 1:2006.
4-192.....................           4-202   ANSI/ADA Specification No. 58, 2010 Root Canal      Withdrawn and replaced with newer version.
                                              Files, Type H (Hedstrom).
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                       D. General
--------------------------------------------------------------------------------------------------------------------------------------------------------
5-56......................  ...............  ISO 15223-2 First edition 2010-01-15 Medical        Withdrawn.
                                              devices--Symbols to be used with medical devices
                                              labels, labelling, and information to be
                                              supplied--Part 2: Symbol development, selection
                                              and validation.

[[Page 3000]]

 
5-68......................  ...............  AAMI/ANSI/ISO 15223-2, Medical devices--Symbols to  Withdrawn.
                                              be used with medical device labels, labellings,
                                              and information to be supplied--Part 2: Symbol
                                              development, selection and validation.
5-72......................            5-73   ISO 15223-1 Second Edition 2012-07-01 Medical       Withdrawn and replaced with new version.
                                              devices--Symbols to be used with medical device
                                              labels, labelling and information to be supplied--
                                              Part 1: General requirements.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                       E. General Hospital/General Plastic Surgery
--------------------------------------------------------------------------------------------------------------------------------------------------------
6-13......................  ...............  ISO 595-1 First edition 1986-12-15 Reusable all-    Contact person and title.
                                              glass or metal-and-glass syringes for medical
                                              use--Part 1: Dimensions.
6-14......................  ...............  ISO 595-2 First edition 1987-12-15 Reusable all-    Contact person.
                                              glass or metal-and-glass syringes for medical
                                              use--Part 2: Design, performance requirements and
                                              tests.
6-15......................  ...............  ISO 7864 Third edition 1993-05-15 Sterile           Contact person.
                                              hypodermic needles for single use.
6-107.....................  ...............  ASTM F 882-84 (Reapproved 2002) Standard            Withdrawn.
                                              Performance and Safety Specification for
                                              Cryosurgical Medical Instruments.
6-122.....................  ...............  ISO 8536-5 Second edition 2004-02-01 Infusion       Contact person.
                                              equipment for medical use--Part 5: Burette
                                              infusion sets for single use, gravity feed.
6-148.....................  ...............  ISO 7886-3 First edition 2005-03-01 Sterile         Contact person.
                                              hypodermic syringes for single use--Part 3: Auto-
                                              disable syringes for fixed-dose immunization.
6-170.....................  ...............  ISO 7886-1 First edition 1993-10-01 Sterile         Contact person and title.
                                              hypodermic syringes for single use--Part 1:
                                              Syringes for manual use.
6-203.....................           6-282   ASTM D6499-12 Standard Test Method for The          Withdrawn and replaced with newer version.
                                              Immunological Measurement of Antigenic Protein in
                                              Natural Rubber and its Products.
6-204.....................  ...............  ISO 8537 Second edition 2007-10-01 Sterile single-  Contact person.
                                              use syringes, with or without needle, for insulin.
6-255.....................           6-283   USP 35-NF30:2012 Sodium Chloride Irrigation.......  Withdrawn and replaced with newer version.
6-256.....................           6-284   USP 35-NF30:2012 Sodium Chloride Injection........  Withdrawn and replaced with newer version.
6-257.....................           6-285   USP 35-NF30:2012 Nonabsorbable Surgical Suture....  Withdrawn and replaced with newer version.
6-258.....................           6-286   USP 35-NF30:2012 <881> Tensile Strength...........  Withdrawn and replaced with newer version.
6-259.....................           6-287   USP 35-NF30:2012 <861> Sutures-Diameter...........  Withdrawn and replaced with newer version.
6-260.....................           6-288   USP 35-NF30:2012 <871> Sutures-Needle Attachment..  Withdrawn and replaced with newer version.
6-261.....................           6-289   USP 35-NF30:2012 Sterile Water for Irrigation.....  Withdrawn and replaced with newer version.
6-262.....................           6-290   USP 35-NF30:2012 Heparin Lock Flush Solution......  Withdrawn and replaced with newer version.
6-623.....................           6-291   USP 35-NF30:2012 Absorbable Surgical Suture.......  Withdrawn and replaced with newer version.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 F. In Vitro Diagnostics
--------------------------------------------------------------------------------------------------------------------------------------------------------
7-7.......................  ...............  CLSI/NCCLS LA1-A2 1994 Assessing the Quality of     Withdrawn.
                                              Radioimmunoassay Systems--Second Edition;
                                              Approved Guideline.
7-124.....................  ...............  CLSI/NCCLS I/LA24-A Fluorescence Calibration and    Withdrawn.
                                              Quantitative Measurement of Fluorescence
                                              Intensity; Approved Guideline.
7-99......................           7-232   CLSI MM05-A2 Nucleic Acid Amplification Assays for  Withdrawn and replaced with newer version.
                                              Molecular Hematopathology; Approved Guideline--
                                              Second Edition.
7-194.....................           7-233   CLSI EP17-A2 Evaluation of Detection Capability     Withdrawn and replaced with newer version.
                                              for Clinical Laboratory Measurement Procedures;
                                              Approved Guideline--Second Edition.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      G. Materials
--------------------------------------------------------------------------------------------------------------------------------------------------------
8-117.....................           8-228   ASTM F86-12 Standard Practice for Surface           Withdrawn and replaced with a newer version.
                                              Preparation and Marking of Metallic Surgical
                                              Implants.
8-124.....................  ...............  ASTM F2052-06e1 Standard Test Method for            Relevant guidance.
                                              Measurement of Magnetically Induced Displacement
                                              Force on Medical Devices in the Magnetic
                                              Resonance Environment.

[[Page 3001]]

 
8-128.....................  ...............  ASTM F2213-06 (Reapproved 2011) Standard Test       Relevant guidance.
                                              Method for Measurement of Magnetically Induced
                                              Torque on Medical Devices in the Magnetic
                                              Resonance Environment.
8-153.....................  ...............  ASTM F2119-07 Standard Test Method for Evaluation   Relevant guidance.
                                              of MR Image Artifacts from Passive Implants.
8-176.....................  ...............  ASTM F2503-08 Standard Practice for Marking         Relevant guidance.
                                              Medical Devices and Other Items for Safety in the
                                              Magnetic Resonance Environment.
8-227.....................  ...............  ASTM F2182-11a Standard Test Method for             Relevant guidance .
                                              Measurement of Radio Frequency Induced Heating On
                                              or Near Passive Implants During Magnetic
                                              Resonance Imaging.
8-137.....................           8-229   ASTM F75-12 Standard Specification for Cobalt-28    Withdrawn and replaced with a newer version.
                                              Chromium-6 Molybdenum Alloy Castings and Casting
                                              Alloy for Surgical Implants (UNS R30075).
8-142.....................           8-330   ASTM F1978-12 Standard Test Method for Measuring    Withdrawn and replaced with a newer version.
                                              Abrasion Resistance of Metallic Thermal Spray
                                              Coatings by Using the Taber Abraser.
8-155.....................           8-331   ASTM F1580-12 Standard Specification for Titanium   Withdrawn and replaced with a newer version.
                                              and Titanium-6 Aluminum-4 Vanadium Alloy Powders
                                              for Coatings of Surgical Implants.
8-209.....................           8-332   ASTM F899-12 Standard Specification for Wrought     Withdrawn and replaced with a newer version.
                                              Stainless Steels for Surgical Instruments.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               H. OB-GYN/Gastroenterology
--------------------------------------------------------------------------------------------------------------------------------------------------------
9-21......................  ...............  IS0 8600-4 First edition 1997-07-01 Optics and      Contact person.
                                              optical instruments--Medical endoscopes and
                                              certain accessories--Part 4: Determination of
                                              maximum width of insertion portion.
9-34......................  ...............  ISO 4074 First edition 2002-02-15 Corrected         Contact person.
                                              version 2002-12-01 Natural latex rubber condoms--
                                              Requirements and test methods.
9-36......................  ...............  ISO 8009 First edition 2004-10-01 Mechanical        Contact person.
                                              contraceptives--Reusable natural and silicone
                                              rubber contraceptive diaphragms--Requirements and
                                              tests.
9-37......................  ...............  ISO 8600-1 Second edition 2005-05-01 Optics and     Contact person.
                                              photonics--Medical endoscopes and endotherapy
                                              devices--Part 1: General requirements.
9-39......................  ...............  ISO 8600-5 First edition 2005-03-15 Optics and      Contact person.
                                              photonics--Medical endoscopes and endotherapy
                                              devices--Part 5: Determination of optical
                                              resolution of rigid endoscopes with optics.
9-40......................  ...............  ISO 8600-6 First edition 2005-03-15 Optics and      Contact person.
                                              photonics--Medical endoscopes and endotherapy
                                              devices--Part 6: Vocabulary.
9-43......................  ...............  ISO 16038 First edition 2005-11-01 Rubber condoms-- Contact person.
                                              Guidance on the use of ISO 4074 in the quality
                                              management of natural rubber latex condoms.
9-56......................  ...............  ASTM D 3492-08 Standard Specification for Rubber    Contact person.
                                              Contraceptives (Male Condoms).
9-61......................  ...............  IEC 60601-2-18 Edition 3.0 2009-08 Medical          Contact person.
                                              electrical equipment--Part 2-18: Particular
                                              requirements for the basic safety and essential
                                              performance of endoscopic equipment.
9-58......................  ...............  ASTM D6324-08 Standard Test Methods for Male        Withdrawn.
                                              Condoms Made from Polyurethane.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      I. Ophthalmic
--------------------------------------------------------------------------------------------------------------------------------------------------------
10-56.....................  ...............  ANSI Z80.12-2007 (R2012) American National          Reaffirmation.
                                              Standard for Ophthalmics--Multifocal Intraocular
                                              Lenses.
10-57.....................  ...............  ANSI Z80.13-2007 (R2012) American National          Reaffirmation.
                                              Standard for Ophthalmics--Phakic Intraocular
                                              Lenses.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     J. Orthopedics
--------------------------------------------------------------------------------------------------------------------------------------------------------
11-203....................  ...............  ASTM F1541-02 (Reapproved 2011) \[euroi]\1          Title.
                                              Standard Specification and Test Methods for
                                              External Skeletal Fixation Devices.
11-216....................  ...............  ASTM F1264-03 (Reapproved 2012) Standard            Reaffirmation.
                                              Specification and Test Methods for Intramedullary
                                              Fixation Devices.
11-229....................          11-244   ASTM F2083-11 Standard Specification for Total      Withdrawn and replaced with newer version.
                                              Knee Prosthesis.
11-233....................          11-245   ASTM F384-12 Standard Specifications and Test       Withdrawn and replaced with newer version.
                                              Methods for Metallic Angled Orthopedic Fracture
                                              Fixation Devices.

[[Page 3002]]

 
11-236....................          11-246   ASTM F1717-12 Standard Test Methods for Spinal      Withdrawn and replaced with newer version.
                                              Implant Constructs in a Vertebrectomy Model.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      K. Sterility
--------------------------------------------------------------------------------------------------------------------------------------------------------
14-64.....................  ...............  ASTM F1929-98 (Reapproved 2004) Standard Test       Relevant guidance.
                                              Method for Detecting Seal Leaks in Porous Medical
                                              Packaging by Dye Penetration.
14-169....................  ...............  ASTM F2391-05 (Reapproved 2011) Standard Test       Relevant guidance.
                                              Method for Measuring Package and Seal Integrity
                                              Using Helium as the Tracer Gas.
14-197....................  ...............  ASTM F1608-00 (Reapproved 2009) Standard Test       Relevant guidance.
                                              Method for Microbial Ranking of Porous Packaging
                                              Materials (Exposure Chamber Method).
14-211....................          14-362   AOAC 6.2.01:2012 Official Method 955.14 Testing     Withdrawn and replaced with newer version.
                                              Disinfectants against Salmonella enterica, Use-
                                              Dilution Method.
14-212....................  ...............  AOAC 6.2.02:2006 Official Method 991.47 Testing     Relevant guidance.
                                              Disinfectants against Salmonella choleraesuis,
                                              Hard Surface Carrier Test Method.
14-213....................  ...............  AOAC 6.2.03:2006 Official Method 991.48 Testing     Relevant guidance.
                                              Disinfectants against Staphylococcus aureus, Hard
                                              Surface Carrier Test Method.
14-215....................  ...............  AOAC 6.2.05:2006 Official Method 991.49 Testing     Relevant guidance.
                                              Disinfectants against Pseudomonas aeruginosa,
                                              Hard Surface Carrier Test Method.
14-216....................          14-363   AOAC 6.2.06:2012 Official Method 964.02 Testing     Withdrawn and replaced with newer version.
                                              Disinfectants against Pseudomonas aeruginosa, Use-
                                              Dilution Method.
14-217....................  ...............  AOAC 6.3.02:2006 Official Method 955.17 Fungicidal  Relevant guidance.
                                              Activity of Disinfectants Using Trichophyton
                                              mentagrophytes.
14-218....................  ...............  AOAC 6.3.05:2006 Official Method 966.04 Sporicidal  Relevant guidance.
                                              Activity of Disinfectants Method I.
14-225....................          14-364   ANSI/AAMI/ISO 11137-2:2012 Sterilization of health  Withdrawn and replaced with newer version.
                                              care products--Radiation--Part 2: Establishing
                                              the sterilization dose.
14-229....................  ...............  ASTM F1980-07 (Reapproved 2011) Standard Guide for  Relevant guidance.
                                              Accelerated Aging of Sterile Barrier Systems for
                                              Medical Devices.
14-235....................  ...............  ASTM F1140-07 Standard Test Methods for Internal    Relevant guidance.
                                              Pressurization Failure Resistance of Unrestrained
                                              Packages.
14-236....................  ...............  ASTM F2054-07 Standard Test Method for Burst        Relevant guidance.
                                              Testing of Flexible Package Seals Using Internal
                                              Air Pressurization Within Restraining Plates.
14-238....................  ...............  ANSI/AAMI/ISO 11140-5:2007/(R)2012 Sterilization    Reaffirmation.
                                              of health care products--Chemical indicators--
                                              Part 5: Class 2 indicators for Bowie and Dick air
                                              removal test sheets and packs.
14-256....................  ...............  ASTM F2095-07e1 Standard Test Methods for Pressure  Relevant guidance and editorial change.
                                              Decay Leak Test for Flexible Packages With and
                                              Without Restraining Plates.
14-257....................  ...............  ASTM D3078-02 (Reapproved 2008) [euro] 1 Standard   Relevant guidance and editorial change.
                                              Test Method for Determination of Leaks in
                                              Flexible Packaging by Bubble Emission.
14-278....................  ...............  ANSI/AAMI/ISO 10993-7:2008(R)2012 Biological        Reaffirmation.
                                              evaluation of medical devices--Part 7: Ethylene
                                              oxide sterilization residuals.
14-282....................  ...............  ASTM F2338-09 Standard Test Method for              Relevant guidance.
                                              Nondestructive Detection of Leaks in Packages by
                                              Vacuum Decay Method.
14-283....................  ...............  ASTM F88/F88M-09 Standard Test Method for Seal      Relevant guidance.
                                              Strength of Flexible Barrier Materials.
14-288....................  ...............  ASTM F1886/F1886M-09 Standard Test Method for       Relevant guidance.
                                              Determining Integrity of Seals for Flexible
                                              Packaging by Visual Inspection.
14-296....................  ...............  ANSI/AAMI/ISO 11138-1:2006/(R)2010 Sterilization    Relevant guidance, extent of recognition and title.
                                              of health care products--Biological indicators--
                                              Part 1: General requirements.
14-299....................  ...............  ASTM F2097-10 Standard Guide for Design and         Relevant guidance.
                                              Evaluation of Primary Flexible Packaging for
                                              Medical Products.
14-300....................  ...............  ASTM D4169-09 Standard Practice for Performance     Relevant guidance.
                                              Testing of Shipping Containers and Systems.
14-313....................  ...............  ASTM F2475-11 Standard Guide for Biocompatibility   Relevant guidance.
                                              Evaluation of Medical Device Packaging Materials.
14-315....................          14-366   USP 35-NF30:2012 <61> Microbiological Examination   Withdrawn and replaced with newer version.
                                              of Nonsterile Products: Microbial Enumeration
                                              Tests.
14-316....................          14-367   USP 35-NF30:2012 <71> Sterility Tests.............  Withdrawn and replaced with newer version.
14-317....................          14-368   USP 35-NF30:2012 <85> Bacterial Endotoxins Test...  Withdrawn and replaced with newer version.
14-318....................          14-369   USP 35-NF30:2012 <151> Pyrogen Test (USP Rabbit     Withdrawn and replaced with newer version.
                                              Test).

[[Page 3003]]

 
14-319....................          14-370   USP 35-NF30:2012 <161> Transfusion and Infusion     Withdrawn and replaced with newer version
                                              Assemblies and Similar Medical Devices.
14-320....................          14-371   USP 35-NF30:2012 Biological Indicator for Steam     Withdrawn and replaced with newer version.
                                              Sterilization, Self-Contained.
14-321....................          14-372   USP 35-NF30:2012 Biological Indicator for Dry-Heat  Withdrawn and replaced with newer version.
                                              Sterilization, Paper Carrier.
14-322....................          14-373   USP 35-NF30:2012 Biological Indicator for Ethylene  Withdrawn and replaced with newer version.
                                              Oxide Sterilization, Paper Carrier.
14-323....................          14-374   USP 35-NF30:2012 Biological Indicator for Steam     Withdrawn and replaced with newer version.
                                              Sterilization, Paper Carrier.
14-324....................          14-375   USP 35-NF30:2012 <62> Microbiological Examination   Withdrawn and replaced with newer version.
                                              of Nonsterile Products: Tests for Specified
                                              Microorganisms.
14-329....................          14-365   ISO 11137-2 Second edition 2012-03-15               Withdrawn and replaced with newer version.
                                              Sterilization of health care products--Radiation--
                                              Part 2: Establishing the sterilization dose.
14-335....................  ...............  ISO 10993-7 Second edition 2008-10-15 Biological    Extent of recognition and relevant guidance.
                                              evaluation of medical devices--Part 7: Ethylene
                                              oxide sterilization residuals.
14-338....................  ...............  ISO 11138-1 Second edition 2006-07-01               Relevant guidance and extent of recognition.
                                              Sterilization of health care products--Biological
                                              indicators--Part 1: General requirements.
14-345....................  ...............  ISO/ASTM 51261 First edition 2002-03-15 Guide for   Relevant guidance.
                                              selection and calibration of dosimetry systems
                                              for radiation processing.
14-359....................  ...............  ASTM F2096-11 Standard Test Method for Detecting    Relevant guidance.
                                              Gross Leaks in Packaging by Internal
                                              Pressurization (Bubble Test).
14-360....................  ...............  ANSI/AAMI ST72:2011 Bacterial endotoxins--Test      Relevant guidance.
                                              methods, routine monitoring, and alternatives to
                                              batch testing.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.

III. 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: 030.

                                                Table 3--New Entries to the List of Recognized Standards
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      Recognition  No.                           Title of standard \1\                                         Reference No. and date
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    A. Cardiovascular
--------------------------------------------------------------------------------------------------------------------------------------------------------
3-106......................  Medical electrical equipment--Part 2-25: Particular            ANSI/AAMI/IEC 60601-2-25:2011.
                              requirements for the basic safety and essential performance
                              of electrocardiographs.
3-107......................  Medical electrical equipment--Part 2-30: Particular            IEC 80601-2-30 Edition 1.0 2009-01.
                              requirements for the basic safety and essential performance
                              of automated non-invasive sphygmomanometers.
3-108......................  Medical electrical equipment--Part 2-30: Particular            IEC 80601-2-30 (First edition--2009).
                              requirements for the basic safety and essential performance
                              of automated non-invasive sphygmomanometers CORRIGENDUM 1.
3-109......................  Active implantable medical devices--Four-pole connector        ANSI/AAMI/ISO 27186:2010.
                              system for implantable cardiac rhythm management devices--
                              Dimensional and test requirements.
3-110......................  Active implantable medical devices--Guidance for designation   AAMI TIR41:2011.
                              of left ventricle and implantable cardioverter defibrillator
                              lead connectors and pulse generator connector cavities for
                              implantable pacemakers and implantable cardioverter
                              defibrillators.
3-111......................  Cardiovascular implants--Endovascular devices--Part 3: Vena    ANSI/AAMI/ISO 25539-3: 2011.
                              cava filters.
3-112......................  Cardiovascular implants and artificial organs--Blood-gas       ANSI/AAMI/ISO 7199: 2009.
                              exchangers (oxygenators).
3-113......................  Cardiovascular implants and artificial organs--Blood-gas       ISO 7199 Second edition 2009-04-15.
                              exchangers (oxygenators).
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      B. Dental/ENT
--------------------------------------------------------------------------------------------------------------------------------------------------------
4-200......................  Dentistry--Mercury and alloys for dental amalgam AMENDMENT 1:  ISO 24234 First edition 2004-10-15 AMENDMENT 1 2011-08-15.
                              Requirements for marking and manufacturer's instructions
                              concerning mercury.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                       C. General
--------------------------------------------------------------------------------------------------------------------------------------------------------
5-74.......................  Medical electrical equipment--Part 1: General requirements     ANSI/AAMI ES60601-1:2005/C1:2009/(R)2012.
                              for basic safety and essential performance, Amendment 1.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                       D. General Hospital/General Plastic Surgery
--------------------------------------------------------------------------------------------------------------------------------------------------------
6-292......................  Sterile hypodermic syringes for single use--Part 1: Syringes   ISO 7886-1:1993 TECHNICAL CORRIGENDUM 1 Published 1995-11-
                              for manual use.                                                01.

[[Page 3004]]

 
6-293......................  Sharps injury protection--Requirements and test methods--      ISO 23907 First edition 2012-09-01.
                              Sharps containers.
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                                                                 E. In Vitro Diagnostics
--------------------------------------------------------------------------------------------------------------------------------------------------------
7-234......................  Assessment of the Diagnostic Accuracy of Laboratory Tests      CLSI EP24-A2.
                              Using Receiver Operating Characteristic Curves; Approved
                              Guideline--Second Edition.
7-235......................  Evaluation of Stability of In Vitro Diagnostic Reagents;       CLSI EP25-A.
                              Approved Guideline.
7-236......................  Methods for Antimicrobial Susceptibility Testing for Human     CLSI M43-A.
                              Mycoplasmas; Approved Guideline.
7-237......................  Molecular Methods for Clinical Genetics and Oncology Testing;  CLSI MM01-A3.
                              Approved Guideline--Third Edition.
7-238......................  Quantitative Molecular Methods for Infectious Diseases;        CLSI MM06-A2.
                              Approved Guideline--Second Edition.
7-239......................  Metrological Traceability and Its Implementation; A Report...  CLSI X5-R.
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                                                                      F. Materials
--------------------------------------------------------------------------------------------------------------------------------------------------------
8-333......................  Standard Specification for High-Purity Dense Magnesia          ASTM F2393-12.
                              Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant
                              Applications.
8-334......................  Standard Test Method for Extracting Residue from Metallic      ASTM F2459-12.
                              Medical Components and Quantifying via Gravimetric Analysis.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               G. OB-GYN/Gastroenterology
--------------------------------------------------------------------------------------------------------------------------------------------------------
9-79.......................  Water treatment equipment for haemodialysis applications and   ISO 26722 First edition 2009-04-15.
                              related therapies.
9-80.......................  Medical electrical equipment--Part 2-16: Particular            IEC 60601-2-16 Edition 4.0 2012-03.
                              requirements for the basic safety and essential performance
                              of haemodialysis, haemodiafiltration and haemofiltration
                              equipment.
9-81.......................  Mechanical contraceptives--Reusable natural and silicone       ISO 8009 First edition 2004-10-01 ISO 8009: 2004/Amd. 1:
                              rubber contraceptive diaphragms--Requirements and tests.       2012 (E) AMENDMENT 1 2012-02-15
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      H. Ophthalmic
--------------------------------------------------------------------------------------------------------------------------------------------------------
10-75......................  Ophthalmic implants--Intraocular lenses--Part 7: Clinical      ISO 11979-7 Second edition 2006-05-01 AMENDMENT 1 2012-01-
                              investigations AMENDMENT 1.                                    15.
10-76......................  Ophthalmic implants--Intraocular lenses--Part 8: Fundamental   ISO 11979-8 Second edition 2006-07-01 AMENDMENT 1 2011-05-
                              requirements AMENDMENT 1.                                      15.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      I. Orthopedic
--------------------------------------------------------------------------------------------------------------------------------------------------------
11-247.....................  Standard Guide for Mechanical and Functional Characterization  ASTM F2789-10.
                              of Nucleus Devices.
11-250.....................  Implants for surgery--Wear of total hip joint prostheses--     ISO 14242-3 First edition 2009-03-15.
                              Part 3: Loading and displacement parameters for orbital
                              bearing type wear testing machines and corresponding
                              environmental conditions for test.
11-249.....................  Implants for surgery--Wear of total hip joint prostheses--     ISO 14242-2 First edition 2000-09-15.
                              Part 2: Methods of measurement.
11-248.....................  Implants for surgery--Wear of total hip joint prostheses--     ISO 14242-1 Second edition 2012-01-15.
                              Part 1: Loading and displacement parameters for wear-testing
                              machines and corresponding environmental conditions for test.
11-251.....................  Standard Practice for Measurement of Positional Accuracy of    ASTM F2554-10.
                              Computer Assisted Surgical Systems.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      J. Radiology
--------------------------------------------------------------------------------------------------------------------------------------------------------
12-250.....................  Medical electrical equipment--Part 2-44: Particular            IEC 60601-2-44 (Third edition-2009).
                              requirements for the basic safety and essential performance
                              of X-ray equipment for computed tomography CORRIGENDUM 1.
12-251.....................  Medical electrical equipment--Part 2-44: Particular            IEC 60601-2-44 Edition 3.0 2012-08 Amendment 1.
                              requirements for the basic safety and essential performance
                              of X-ray equipment for computed tomography.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 K. Software/Informatics
--------------------------------------------------------------------------------------------------------------------------------------------------------
13-33......................  Validation of software for regulated processes...............  AAMI TIR362007.
13-34......................  Medical device software--Part 1: Guidance on the application   IEC/TR 80002-1 Edition 1.0 2009-09.
                              of ISO 14971 to medical device software.
13-35......................  Application of quality management system concepts to medical   ANSI/AAMI SW87 2012.
                              device data systems.
13-36......................  Guidance on the use of AGILE practices in the development of   AAMI TIR45 2012.
                              medical device software.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 3005]]

 
                                                                      L. Sterility
--------------------------------------------------------------------------------------------------------------------------------------------------------
14-376.....................  Sterilization of health care products--Moist heat--Part 2:     ANSI/AAMI/ISO TIR 17665-2:2009.
                              Guidance on the application of ANSI/AAMI/ISO 17665-1.
14-377.....................  Standard Test Method for Using Aerosol Filtration for          ASTM F2638-12.
                              Measuring the Performance of Porous Packaging Materials as a
                              Surrogate Microbial Barrier.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 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 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: 030'' 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: 030. These modifications to the list or recognized standards 
are effective upon publication of this notice in the Federal Register.

    Dated: January 9, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-00605 Filed 1-14-13; 8:45 am]
BILLING CODE 4160-01-P


