[Federal Register Volume 75, Number 191 (Monday, October 4, 2010)]
[Notices]
[Pages 61148-61157]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-24788]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2004-N-0451] (formerly Docket No. 2004N-0226)
Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 025
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a
publication containing modifications the Agency is making to the list
of standards FDA recognizes for use in premarket reviews (FDA
recognized consensus standards). This publication, entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 025'' (Recognition List Number: 025), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.
DATES: Submit either electronic or written comments concerning this
document at any time. See section VII 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: 025'' 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 20993-0002. Send two self-addressed adhesive labels
to assist that office in processing your requests, or fax your request
to 301-847-8149. Submit written comments concerning this document, or
recommendations for additional standards for recognition, to the
contact person (see FOR FURTHER INFORMATION CONTACT). Submit electronic
comments by email: [email protected]. This document may also be
accessed on FDA's Internet site at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section VI of
this document for electronic access to the searchable database for the
current list of FDA recognized consensus standards, including
Recognition List Number: 025 modifications and other standards related
information.
FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 3632, Silver Spring, MD 20993-0002, 301-
796-6574.
SUPPLEMENTARY INFORMATION:
I. Background
Section 204 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal
Food, Drug, and Cosmetic Act (the 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
[[Page 61149]]
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) November 8, 2005 (70 FR 67713)
------------------------------------------------------------------------
October 16, 1998 (63 FR 55617) March 31, 2006 (71 FR 16313)
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July 12, 1999 (64 FR 37546) June 23, 2006 (71 FR 36121)
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November 15, 2000 (65 FR 69022) November 3, 2006 (71 FR 64718)
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May 7, 2001 (66 FR 23032) May 21, 2007 (72 FR 28500)
------------------------------------------------------------------------
January 14, 2002 (67 FR 1774) September 12, 2007 (72 FR 52142)
------------------------------------------------------------------------
October 2, 2002 (67 FR 61893) December 19, 2007 (72 FR 71924)
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April 28, 2003 (68 FR 22391) September 9, 2008 (73 FR 52358)
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March 8, 2004 (69 FR 10712) March, 18, 2009 (74 FR 11586)
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June 18, 2004 (69 FR 34176) September 8, 2009 (74 FR 46203)
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October 4, 2004 (69 FR 59240) May 5, 2010 (75 FR 24711)
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May 27, 2005 (70 FR 30756) June 10, 2010 (75 FR 32943)
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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: 025
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: 025'' 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
Old Recognition No. Recognition No. Title of Standard\1\ Change
----------------------------------------------------------------------------------------------------------------
A. Anesthesia
----------------------------------------------------------------------------------------------------------------
1-61 1-82 IEC 60601-2-13 Edition 3.1 2009-08 Medical Withdrawn and replaced
electrical equipment--Part 2-13: with newer version
Particular requirements for the safety
and essential performance of anaesthetic
systems
----------------------------------------------------------------------------------------------------------------
B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-96 ..................... ASTM F 1903-98 (Reapproved 2003) Standard Type of standard and
Practice for Testing For Biological Contact person
Responses to Particles in vitro
----------------------------------------------------------------------------------------------------------------
2-98 2-156 ANSI/AAMI/ISO 10993-1:2009 Biological Withdrawn and replaced
evaluation of medical devices--Part 1: with newer version
Evaluation and testing within a risk
management process
----------------------------------------------------------------------------------------------------------------
2-100 ..................... ASTM E1372-95 (2003) Standard Test Method Withdrawn
for Conducting a 90-Day Oral Toxicity
Study in Rats
----------------------------------------------------------------------------------------------------------------
2-115 ..................... ASTM F 895--84 (Reapproved 2006) Standard Title, Type of
Test Method for Agar Diffusion Cell standard , Relevant
Culture Screening for Cytotoxicity guidance and Contact
person
----------------------------------------------------------------------------------------------------------------
2-117 ..................... ANSI/AAMI/ISO 10993-3:2003/(R)2009 Reaffirmation, CDRH
Biological evaluation of medical devices - Office(s) and
Part 3: Tests for genotoxicity, Division(s)
carcinogenicity, and reproductive associated with
toxicity recognized standard
and Contact person
----------------------------------------------------------------------------------------------------------------
2-118 ..................... ANSI/AAMI/ISO 10993-11:2006 Biological Contact person
evaluation of medical devices--Part 11:
Tests for systemic toxicity
----------------------------------------------------------------------------------------------------------------
2-119 ..................... ASTM F 813-07 Standard Practice for Direct Title, Type of
Contact Cell Culture Evaluation of standard and Contact
Materials for Medical Devices person
----------------------------------------------------------------------------------------------------------------
2-135 ..................... ANSI/AAMI/ISO 10993-12:2007 Biological Title and Contact
evaluation of medical devices--Part 12: person
Sample preparation and reference
materials
----------------------------------------------------------------------------------------------------------------
[[Page 61150]]
2-147 2-157 USP 33--NF 28 2010 Biological Tests <87> Withdrawn and replaced
Biological Reactivity Test, In Vitro-- with newer version
Direct Contact Test
----------------------------------------------------------------------------------------------------------------
2-148 2-158 USP 33-NF28 2010 Biological Tests <87> Withdrawn and replaced
Biological Reactivity Test, In Vitro-- with newer version
Elution Test
----------------------------------------------------------------------------------------------------------------
2-149 2-159 USP 33-NF28 2010 Biological Tests <88> Withdrawn and replaced
Biological Reactivity Tests, In Vivo, with newer version
Procedure--Preparation of Sample
----------------------------------------------------------------------------------------------------------------
2-150 2-160 USP 33-NF28 2010 Biological Tests <88> Withdrawn and replaced
Biological Reactivity Tests, In Vivo, with newer version
Classification of Plastics--
Intracutaneous Test
----------------------------------------------------------------------------------------------------------------
2-151 2-161 USP 33-NF28 2010 Biological Tests <88> Withdrawn and replaced
Biological Reactivity Tests, In Vivo, with newer version
Classification of Plastics--Systemic
Injection Test
----------------------------------------------------------------------------------------------------------------
C. Cardiology
----------------------------------------------------------------------------------------------------------------
3-74 3-79 ASTM F 2079--09 Standard Test Method for Withdrawn and replaced
Measuring Intrinsic Elastic Recoil of with newer version
Balloon-Expandable Stents
----------------------------------------------------------------------------------------------------------------
3-75 ..................... ANSI/AAMI SP10:2002/(R)2008 & ANSI/AAMI Title and Extent of
SP10:2002/A1:2003/(R)2008 & ANSI/AAMI recognition
SP10:2002/A2:2006/(R)2008 Manual,
electronic or automated sphygmomanometers
----------------------------------------------------------------------------------------------------------------
D. Dental/ENT
----------------------------------------------------------------------------------------------------------------
4-86 ..................... ANSI/ADA Specification No. 38 2000 Reaffirmation
(Reaffirmed 2010) Metal-Ceramic Dental
Restorative Systems
----------------------------------------------------------------------------------------------------------------
4-91 ..................... ANSI/ADA Specification No. 80 2001 Reaffirmation
(Reaffirmed 2007) Dental Materials--
Determination of Color Stability Test
Procedure
----------------------------------------------------------------------------------------------------------------
4-107 4-188 ISO 9917-2 Second edition 2010-04-15 Withdrawn and replaced
Dentistry--Water-based cements--Part 2: with newer version
Resin-modified cements
----------------------------------------------------------------------------------------------------------------
4-117 ..................... ANSI/ADA Specification No. 12 2002 Reaffirmation
(Reaffirmed 2007) Denture Base Polymers
----------------------------------------------------------------------------------------------------------------
4-119 ..................... ANSI/ADA Specification No. 82 1998 Reaffirmation
(Reaffirmed 2009)--Dental Reversible/
Irreversible Hydrocolloid Impression
Material Systems
----------------------------------------------------------------------------------------------------------------
4-139 ..................... ANSI/ADA Specification No. 48-Visible Reaffirmation
Light Curing Units: 2004, Reaffirmed 2009
----------------------------------------------------------------------------------------------------------------
4-160 ..................... ANSI/ASA S3.1-1999 (Reaffirmed 2003) Reaffirmation
(Reaffirmed 2008) Maximum Permissible
Ambient Noise Levels for Audiometric Test
Rooms
----------------------------------------------------------------------------------------------------------------
4-164 ..................... ANSI/ASA S3.7-1997 (Reaffirmed 2003) Reaffirmation
(Reaffirmed 2008) Methods for Coupler
Calibration of Earphones
----------------------------------------------------------------------------------------------------------------
4-166 ..................... ANSI/ASA S3.20-1995 (Reaffirmed 2003) Reaffirmation
(Reaffirmed 2008) Bioacoustical
Terminology
----------------------------------------------------------------------------------------------------------------
4-167 ..................... ANSI/ASA S3.21-2004 (Reaffirmed 2009) Reaffirmation
Methods for Manual Pure-Tone Threshold
Audiometry
----------------------------------------------------------------------------------------------------------------
4-169 4-190 ANSI/ASA S3.35-2010 (Revision of ANSI Withdrawn and replaced
S3.35-2004) Method of Measurement of with newer version
Performance Characteristics of Hearing
Aids Under Simulated Real-Ear Working
Conditions
----------------------------------------------------------------------------------------------------------------
E. General
----------------------------------------------------------------------------------------------------------------
5-31 ..................... ISO 15223:2000 Medical device symbols to Withdrawn
be used with medical device labels,
labeling and information to be supplied--
First Edition: Amendment 1: 08/01/2002;
Amendment 2: 02/15/2004
----------------------------------------------------------------------------------------------------------------
5-32 ..................... CEN EN 980:1996+A1:1999+A2:2001 Graphical Withdrawn
Symbols for Use in the Labelling of
Medical Devices
----------------------------------------------------------------------------------------------------------------
[[Page 61151]]
5-38 5-62 ANSI/ASQ Z1.4-2008 Sampling Procedures and Withdrawn and replaced
Tables for Inspection by Attributes with newer version
----------------------------------------------------------------------------------------------------------------
F. General Hospital/General Plastic Surgery
----------------------------------------------------------------------------------------------------------------
6-62 6-239 ISO 8536-6 Second edition 2009-11-15 Withdrawn and replaced
Infusion equipment for medical use--Part with newer version
6: Freeze drying closures for infusion
bottles
----------------------------------------------------------------------------------------------------------------
6-64 6-240 ISO 8536-3 Third edition 2009-06-01 Withdrawn and replaced
Infusion equipment for medical use-- Part with newer version
3: Aluminum caps for infusion bottles
----------------------------------------------------------------------------------------------------------------
6-70 ..................... ASTM E825-98 (Reapproved 2009) Standard Reaffirmation
Specification for Phase Change-Type
Disposable Fever Thermometer for
Intermittent Determination of Human
Temperature
----------------------------------------------------------------------------------------------------------------
6-110 ..................... ASTM F 1441-03 (Reapproved 2009) Standard Reaffirmation
Specification for Soft-Tissue Expander
Devices
----------------------------------------------------------------------------------------------------------------
6-112 ..................... ANSI/AAMI PB70:2003/(R)2009 Liquid barrier Reaffirmation
performance and classification of
protective apparel and drapes intended
for use in health care facilities
----------------------------------------------------------------------------------------------------------------
6-123 ..................... ASTM E667-98 (Reapproved 2009) Standard Reaffirmation
Specification for Mercury-in-Glass,
Maximum Self-Registering Clinical
Thermometers
----------------------------------------------------------------------------------------------------------------
6-124 ..................... ASTM E1104-98 (Reapproved 2009) Standard Reaffirmation
Specification for Clinical Thermometer
Probe Covers and Sheaths
----------------------------------------------------------------------------------------------------------------
6-125 ..................... ASTM E1965-98 (Reapproved 2009) Standard Reaffirmation
Specification for Infrared Thermometers
for Intermittent Determination of Patient
Temperature
----------------------------------------------------------------------------------------------------------------
6-127 6-241 ISO 1135-4 Forth edition 2010-04-15 Withdrawn and replaced
Transfusion equipment for medical use-- with newer version
Part 4: Transfusion sets for single use
----------------------------------------------------------------------------------------------------------------
6-173 6-242 ISO 8536-2 Third edition 2010-03-15 Withdrawn and replaced
Infusion equipment for medical use--Part with newer version
2: Closures for infusion bottles
----------------------------------------------------------------------------------------------------------------
G. IVD
----------------------------------------------------------------------------------------------------------------
7-49 7-210 CLSI H26-A2 Validation, Verification, and Withdrawn and replaced
Quality Assurance of Automated Hematology with newer version
Analyzers; Approved Standard-Second
Edition
----------------------------------------------------------------------------------------------------------------
7-82 7-211 CLSI C34-A3 Sweat Testing: Sample Withdrawn and replaced
Collection and Quantitative Chloride with newer version
Analysis; Approved Guideline-Third
Edition
----------------------------------------------------------------------------------------------------------------
7-96 7-212 CLSI EP18-A2 Risk Management Techniques to Withdrawn and replaced
Identify and Control Laboratory Error with newer version
Sources; Approved Guideline-Second
Edition
----------------------------------------------------------------------------------------------------------------
7-100 ..................... ISO 15197 First edition 2003-05-01 In Title
vitro diagnostic test systems--
Requirements for blood-glucose monitoring
systems for self testing in managing
diabetes mellitus
----------------------------------------------------------------------------------------------------------------
7-141 7-213 CLSI H18-A4 Procedures for the Handling Withdrawn and replaced
and Processing of Blood Specimens for with newer version
Common Laboratory Tests; Approved
Guideline-Fourth Edition
----------------------------------------------------------------------------------------------------------------
7-181 7-214 CLSI M35-A2 Abbreviated Identification of Withdrawn, see 7-197
Bacteria and Yeast; Approved Guideline-
Second Edition
----------------------------------------------------------------------------------------------------------------
7-186 7-215 CLSI M44-A2 Method for Antifungal Disk Withdrawn and Replaced
Diffusion Susceptibility Testing of with newer version
Yeasts; Approved Guideline-Second Edition
----------------------------------------------------------------------------------------------------------------
7-199 7-216 CLSI M100-S20 Performance Standards for Withdrawn and Replaced
Antimicrobial Susceptibility Testing; with newer version
Twentieth Informational Supplement
----------------------------------------------------------------------------------------------------------------
7-208 7-217 CLSI M44-S3, Zone Diameter Interpretive Withdrawn and replaced
Standards, Corresponding Minimal with newer version
Inhibitory Concentration (MIC)
Interpretive Breakpoints, and Quality
Control Limits for Antifungal Disk
Diffusion Susceptibility Testing of
Yeasts; Third Informational Supplement
----------------------------------------------------------------------------------------------------------------
H. Materials
----------------------------------------------------------------------------------------------------------------
[[Page 61152]]
8-66 8-191 ISO 6474-1 First edition Implants for Withdrawn and replaced
surgery--Ceramic materials--Part 1: with newer version
Ceramic materials based on high purity
alumina
----------------------------------------------------------------------------------------------------------------
8-71 8-192 ASTM F2182--09 Standard Test Method for Withdraw and replaced
Measurement of Radio Frequency Induced with newer version
Heating On or Near Passive Implants
During Magnetic Resonance Imaging
----------------------------------------------------------------------------------------------------------------
8-85 8-193 ASTM F 1854--09 Standard Test Method for Withdraw and replaced
Stereological Evaluation of Porous with newer version
Coatings on Medical Implants
----------------------------------------------------------------------------------------------------------------
8-88 ..................... ASTM F2024-00 Standard Practice for X-ray Type of standard and
Diffraction Determination of Phase Contact person
Content of Plasma-Sprayed Hydroxyapatite
Coatings
----------------------------------------------------------------------------------------------------------------
8-130 ..................... ASTM F 620--06 Standard Specification for Type of standard
Alpha Plus Beta Titanium Alloy Forgings
for Surgical Implants
----------------------------------------------------------------------------------------------------------------
8-131 ..................... ASTM F 799--06 Standard Specification for Type of standard
Cobalt-28Chromium-6Molybdenum Alloy
Forgings for Surgical Implants (UNS
R31537, R31538, R31539)
----------------------------------------------------------------------------------------------------------------
8-137 ..................... ASTM F 75--07, Standard Specification for Type of standard
Cobalt-28 Chromium-6 Molybdenum Alloy
Castings and Casting Alloy for Surgical
Implants (UNS R30075)
----------------------------------------------------------------------------------------------------------------
8-138 ..................... ASTM F 745--07 Standard Specification for Type of standard
18Chromium-12.5Nickel-2.5Molybdenum
Stainless Steel for Cast and Solution-
Annealed Surgical Implant Applications
----------------------------------------------------------------------------------------------------------------
8-156 ..................... ASTM F 139--08 Standard Specification for Type of standard
Wrought 18Chromium-14Nickel-2.5Molybdenum
Stainless Steel Sheet and Strip for
Surgical Implants (UNS S31673)
----------------------------------------------------------------------------------------------------------------
8-183 ..................... ASTM F 560--08 Standard Specification for Type of standard
Unalloyed Tantalum for Surgical Implant
Applications (UNS R05200, UNS R05400)
----------------------------------------------------------------------------------------------------------------
I. Neurology
----------------------------------------------------------------------------------------------------------------
17-2 ..................... ASTM F1542-94 (2000) Standard Withdrawn
Specification for the Requirements and
Disclosure of Self-Closing Aneurysm Clips
----------------------------------------------------------------------------------------------------------------
17-6 17-9 ASTM F 2129-08 Standard Test Method for Withdrawn and replaced
Conducting Cyclic Potentiodynamic with newer version
Polarization Measurements to Determine
the Corrosion Susceptibility of Small
Implant Devices
----------------------------------------------------------------------------------------------------------------
J. OB-GYN/Gastroenterology
----------------------------------------------------------------------------------------------------------------
9-23 ..................... ASTM F1518-00 Standard Practice for Withdrawn
Cleaning and Disinfection of Flexible
Fiberoptic and Video Endoscopes Used in
the Examination of the Hollow Viscera
----------------------------------------------------------------------------------------------------------------
K. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-12 10-59 ISO 11980 Second edition 2009-10-15 Withdrawn and replaced
Ophthalmic optics--Contact lenses and with newer version
contact lens care products--Guidance for
clinical investigations
----------------------------------------------------------------------------------------------------------------
10-30 ..................... ANSI Z80.7 (2002) Ophthalmics--Intraocular Withdrawn
Lenses
----------------------------------------------------------------------------------------------------------------
10-34 ..................... ANSI Z80.20 (2004) Ophthalmics--Contact Withdrawn
lenses- Standard Terminology, Tolerances,
Measurements and Physicochemical
Properties
----------------------------------------------------------------------------------------------------------------
10-44 10-60 ISO 11981 Second edition 2009-07-01 Withdrawn and replaced
Ophthalmic optics--Contact lenses and with newer version
contact lens care products- Determination
of physical compatibility of contact lens
care products with contact lenses
----------------------------------------------------------------------------------------------------------------
L. Orthopedics
----------------------------------------------------------------------------------------------------------------
11-171 ..................... ASTM F 1814--97a (Reapproved 2009) Reaffirmation
Standard Guide for Evaluating Modular Hip
and Knee Joint Components
----------------------------------------------------------------------------------------------------------------
[[Page 61153]]
11-179 11-220 ASTM F 2068--09 Standard Specification for Withdrawn and replaced
Femoral Prostheses--Metallic Implants with newer version
----------------------------------------------------------------------------------------------------------------
11-180 ..................... ASTM F 366--04 (Reapproved 2009) Standard Reaffirmation
Specification for Fixation Pins and Wires
----------------------------------------------------------------------------------------------------------------
11-181 11-221 ASTM F 1717--09 Standard Test Methods for Withdrawn and replaced
Spinal Implant Constructs in a with newer version
Vertebrectomy Model
----------------------------------------------------------------------------------------------------------------
11-188 11-222 ISO 14243-1 Second edition 2009-11-15 Withdrawn and replaced
Implants for surgery--Wear of total knee- with newer version
joint prostheses--Part 1: Loading and
displacement parameters for wear-testing
machines with load control and
corresponding environmental conditions
for test
----------------------------------------------------------------------------------------------------------------
11-189 11-223 ISO 14243-2 Second edition 2009-11-15 Withdrawn and replaced
Implants for surgery--Wear of total knee- with newer version
joint prostheses--Part 2: Methods of
measurement
----------------------------------------------------------------------------------------------------------------
11-197 ..................... ASTM F 983--86 (Reapproved 2009) Standard Reaffirmation
Practice for Permanent Marking of
Orthopaedic Implant Components
----------------------------------------------------------------------------------------------------------------
11-199 ..................... ASTM F 565--04 (Reapproved 2009) e Reaffirmation
Standard Practice for Care and Handling
of Orthopedic Implants and Instruments
----------------------------------------------------------------------------------------------------------------
11-203 ..................... ASTM F 1541--02 (Reapproved 2007) e Title, Type of
Standard Specification and Test Methods standard and Relevant
for External Skeletal Fixation Devices guidance
----------------------------------------------------------------------------------------------------------------
11-210 ..................... ASTM F 543--07e Standard Specification and Title, Type of
Test Methods for Metallic Medical Bone standard and Relevant
Screws guidance
----------------------------------------------------------------------------------------------------------------
11-214 ..................... ASTM F 382--99 (Reapproved 2008) e Title and Type of
Standard Specification and Test Method standard
for Metallic Bone Plates
----------------------------------------------------------------------------------------------------------------
M. Sterility
----------------------------------------------------------------------------------------------------------------
14-54 14-287 ANSI/AAMI/ISO 11737-2:2009 Sterilization Withdrawn and replaced
of medical devices--Microbiological with newer version
methods--Part 2: Tests of sterility
performed in the definition, validation
and maintenance of a sterilization
process
----------------------------------------------------------------------------------------------------------------
14-55 ..................... AAMI/ANSI/ISO 14160:1998/(R)2008 Contact person
Sterilization of single-use medical
devices incorporating materials of animal
origin--Validation and routine control of
sterilization by liquid chemical
----------------------------------------------------------------------------------------------------------------
14-63 14-288 ASTM F1886/F1886M-09 Standard Test Method Withdrawn and replaced
for Determining Integrity of Seals for with newer version
Flexible Packaging by Visual Inspection
----------------------------------------------------------------------------------------------------------------
14-77 14-290 ANSI/AAMI ST:24:1999/(R)2009 Automatic, Withdrawn and replaced
general purpose ethylene oxide with newer version
sterilizers and ethylene oxide sterilant
sources intended for use in health care
facilities
----------------------------------------------------------------------------------------------------------------
14-88 14-291 ANSI/AAMI/ISO 14937:2009 Sterilization of Withdrawn and replaced
health care products--General with newer version
requirements for characterization of a
sterilizing agent and the development,
validation and routine control of a
sterilization process for medical devices
----------------------------------------------------------------------------------------------------------------
14-116 14-292 ANSI/AAMI ST72:2002/(R)2010 Bacterial Withdrawn and replaced
Endotoxins--Test methodologies, routine with newer version
monitoring, and alternatives to batch
testing
----------------------------------------------------------------------------------------------------------------
14-118 14-293 ANSI/AAMI ST50:2004/(R)2010 Dry heat Withdrawn and replaced
(heated air) sterilizers with newer version
----------------------------------------------------------------------------------------------------------------
14-152 14-294 ANSI/AAMI ST40:2004/(R)2010 Table-top dry Withdrawn and replaced
heat (heated air) sterilization and with newer version
sterility assurance in health care
facilities
----------------------------------------------------------------------------------------------------------------
14-164 14-295 ANSI/AAMI ST81:2004/(R)2010 Sterilization Withdrawn and replaced
of medical devices--Information to be with newer version
provided by the manufacturer for the
processing of resterilizable medical
devices
----------------------------------------------------------------------------------------------------------------
14-181 ..................... AAMI/ANSI ST58: 2005 Chemical Contact person
sterilization and high-level disinfection
in health care facilities
----------------------------------------------------------------------------------------------------------------
[[Page 61154]]
14-197 ..................... ASTM F1608-00 (Reapproved 2009) Standard Reaffirmation
Test Method for Microbial Ranking of
Porous Packaging Materials (Exposure
Chamber Method)
----------------------------------------------------------------------------------------------------------------
14-211 ..................... AOAC 6.2.01:2006 Official Method 955.14 Contact person
Testing Disinfectants against Salmonella
choleraesuis, Use-Dilution Method
----------------------------------------------------------------------------------------------------------------
14-212 ..................... AOAC 6.2.02:2006 Official Method 991.47 Contact person
Testing Disinfectants against Salmonella
choleraesuis, Hard Surface Carrier Test
Method
----------------------------------------------------------------------------------------------------------------
14-213 ..................... AOAC 6.2.03:2006 Official Method 991.48 Contact person
Testing Disinfectant against
Staphylococcus aureus, Hard Surface
Carrier Test Method
----------------------------------------------------------------------------------------------------------------
14-214 ..................... AOAC 6.2.04:2006 Official Method 955.15 Contact person
Testing Disinfectants Against
Staphylococcus aureus, Use-Dilution
Method
----------------------------------------------------------------------------------------------------------------
14-215 ..................... AOAC 6.2.05:2006 Official Method 991.49 Contact person
Testing Disinfectants against Pseudomonas
aeruginosa, Hard Surface Carrier Test
Method
----------------------------------------------------------------------------------------------------------------
14-216 ..................... AOAC 6.2.06:2006 Official Method 964.02 Contact person
Testing Disinfectants against Pseudomonas
aeruginosa, Use-Dilution Method
----------------------------------------------------------------------------------------------------------------
14-217 ..................... AOAC 6.3.02:2006 Official Method 955.17 Contact person
Fungicidal Activity of Disinfectants
Using Trichophyton mentagrophytes
----------------------------------------------------------------------------------------------------------------
14-218 ..................... AOAC 6.3.05:2006 Official Method 966.04 Contact person
Sporicidal Activity of Disinfectants
Method I
----------------------------------------------------------------------------------------------------------------
14-219 ..................... AOAC 6.3.06:2006 Official Method 965.12 Contact person
Tuberculocidal Activity of Disinfectants
----------------------------------------------------------------------------------------------------------------
14-223 14-296 ANSI/AAMI/ISO 11138-1:2006/(R)2010 Withdrawn and replaced
Sterilization of health care products-- with newer version
Biological indicators--Part 1: General
requirements
----------------------------------------------------------------------------------------------------------------
14-224 14-297 ANSI/AAMI/ISO 11137-1:2006/(R)2010 Withdrawn and replaced
Sterilization of health care products-- with newer version
Radiation--Part 1: Requirements for
development, validation, and routine
control of a sterilization process for
medical devices
----------------------------------------------------------------------------------------------------------------
14-226 14-298 ANSI/AAMI/ISO 11137-3:2006/(R)2010 Withdrawn and replaced
Sterilization of health care products-- with newer version
Radiation--Part 3: Guidance on dosimetric
aspects
----------------------------------------------------------------------------------------------------------------
14-234 14-299 ASTM F2097-10 Standard Guide for Design Withdrawn and replaced
and Evaluation of Primary Flexible with newer version
Packaging for Medical Products
----------------------------------------------------------------------------------------------------------------
14-265 ..................... USP 32:2009 <61> Microbiological Contact person
Examination of Nonsterile Products:
Microbial Enumeration Tests
----------------------------------------------------------------------------------------------------------------
14-266 ..................... USP 32:2009 <71> Sterility Tests Contact person
----------------------------------------------------------------------------------------------------------------
14-267 ..................... USP 32:2009 <85> Bacterial Endotoxins Test Contact person
----------------------------------------------------------------------------------------------------------------
14-268 ..................... USP 32:2009 <151> Pyrogen Test Contact person
----------------------------------------------------------------------------------------------------------------
14-269 ..................... USP 32:2009 <161> Transfusion and Infusion Contact person
Assemblies and Similar Medical Devices
----------------------------------------------------------------------------------------------------------------
14-270 ..................... USP 32:2009 Biological Indicator for Steam Contact person
Sterilization--Self Contained
----------------------------------------------------------------------------------------------------------------
14-271 ..................... USP 32: 2009 Biological Indicator for Dry- Contact person
Heat Sterilization, Paper Carrier
----------------------------------------------------------------------------------------------------------------
14-272 ..................... USP 32:2009 Biological Indicator for Contact person
Ethylene Oxide Sterilization, Paper
Carrier
----------------------------------------------------------------------------------------------------------------
14-273 ..................... USP 32:2009 Biological Indicator for Steam Contact person
Sterilization, Paper Carrier
----------------------------------------------------------------------------------------------------------------
14-278 ..................... USP 32:2009 <62> Microbiological Contact person
Examination of Nonsterile Products: Tests
for Specified Microorganisms
----------------------------------------------------------------------------------------------------------------
14-280 ..................... AAMI/ANSI ST79:2006 and A1:2008, A2:2009 Contact person
(Consolidated Text) Comprehensive guide
to steam sterilization and sterility
assurance in health care facilities
----------------------------------------------------------------------------------------------------------------
[[Page 61155]]
14-284 14-300 ASTM D4169-09 Standard Practice for Withdrawn and replaced
Performance Testing of Shipping with newer version
Containers and Systems
----------------------------------------------------------------------------------------------------------------
14-285 ..................... AAMI/ANSI/ISO 14161:2009 Sterilization of Contact person
health care products--Biological
indicators--Guidance for the selection,
use and interpretation of results
----------------------------------------------------------------------------------------------------------------
N. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-16 15-19 ASTM F2450-10 Standard Guide for Assessing Withdrawn and replaced
Microstructure of Polymeric Scaffolds for with newer version
Use in Tissue-Engineered Medical Products
----------------------------------------------------------------------------------------------------------------
\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: 025.
Table 3.--New Entries to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
Recognition No. Title of Standard\1\ Reference No. & Date
----------------------------------------------------------------------------------------------------------------
A. Anesthesia
----------------------------------------------------------------------------------------------------------------
1-83 Medical electrical equipment--Particular requirements for ISO 21647:2004 TECHNICAL
the basic safety and essential performance of respiratory CORRIGENDUM 1
gas monitors
----------------------------------------------------------------------------------------------------------------
B. Cardiology
----------------------------------------------------------------------------------------------------------------
3-80 Non-invasive sphygmomanometers--Part 1: Requirements and ANSI/AAMI/ISO 81060-1:2007
test methods for non-automated measurement type
----------------------------------------------------------------------------------------------------------------
3-81 Non-invasive sphygmomanometers - Part 2: Clinical validation ANSI/AAMI/ISO 81060-2:2009
of automated measurement type
----------------------------------------------------------------------------------------------------------------
3-82 Implants for surgery - Cardiac pacemakers - Part 3: Low- IS0 5841 -3:2000 TECHNICAL
profile connectors [IS-I] for implantable pacemakers CORRIGENDUM 1
TECHNICAL CORRIGENDUM 1
----------------------------------------------------------------------------------------------------------------
C. Dental/ENT
----------------------------------------------------------------------------------------------------------------
4-189 Dentistry--Soft lining materials for removable dentures-- ISO 10139-1:2005 TECHNICAL
Part 1: Materials for short-term use CORRIGENDUM 1 2006-03-01
----------------------------------------------------------------------------------------------------------------
D. General
----------------------------------------------------------------------------------------------------------------
5-56 Medical devices--Symbols to be used with medical device ISO 15223-2 First edition
labels, labelling, and information to be supplied--Part 2: 2010-01-15
Symbol development, selection and validation
----------------------------------------------------------------------------------------------------------------
5-57 Human factors engineering--Design of medical devices ANSI/AAMI HE75:2009
----------------------------------------------------------------------------------------------------------------
5-58 Medical electrical equipment--Part 1-11: General IEC 60601-1-11 Edition 1.0
requirements for basic safety and essential performance-- 2010-04
Collateral Standard: Requirements for medical electrical
equipment and medical electrical systems used in the home
healthcare environment
----------------------------------------------------------------------------------------------------------------
5-59 Medical devices - Symbols to be used with medical device ISO 15223-1 First Edition
labels, labelling and information to be supplied--Part 1: 2007
General requirements
----------------------------------------------------------------------------------------------------------------
5-60 Medical electrical equipment - Part 1-2: General IEC 60601-1-2 (2007) Third
requirements for basic safety and essential performance - edition/I-SH 01
Collateral standard: Electromagnetic compatibility -
Requirements and tests, Interpretation Sheet
----------------------------------------------------------------------------------------------------------------
5-61 Medical devices - Symbols to be used with medical device ANSI/AAMI/ISO 15223-1:2007
labels, labeling, and information to be supplied--Part 1:
General requirements
----------------------------------------------------------------------------------------------------------------
E. Materials
----------------------------------------------------------------------------------------------------------------
8-194 Standard Test Method for Measurement of Camber, Cast, Helix ASTM F 2754/F 2754M--09
and Direction of Helix of Coiled Wire
----------------------------------------------------------------------------------------------------------------
[[Page 61156]]
8-195 Standard Specification for Wrought Seamless Nickel-Titanium ASTM F 2633-07
Shape Memory Alloy Tube for Medical Devices and Surgical
Implants
----------------------------------------------------------------------------------------------------------------
F. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-61 Ophthalmic optics--Contact lenses--Part 1: Vocabulary, ISO 18369-1 First edition
classification system and recommendations for labelling 2006-08-05 AMENDMENT 1
specifications AMENDMENT 1 2009-02-15
----------------------------------------------------------------------------------------------------------------
G. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-224 Standard Test Methods for Occipital-Cervical and Occipital- ASTM F 2706--08
Cervical-Thoracic Spinal Implant Constructs in a
Vertebrectomy Model
----------------------------------------------------------------------------------------------------------------
H. Radiology
----------------------------------------------------------------------------------------------------------------
12-212 Medical electrical equipment--Characteristics of digital X- IEC 62220-1 First Edition
ray imaging devices--Part 1: Determination of the detective 2003-10
quantum efficiency
----------------------------------------------------------------------------------------------------------------
12-213 Medical electrical equipment--Characteristics of digital X- IEC 62220-1-2 First
ray imaging devices--Part 1-2: Determination of the Edition 2007-06
detective quantum efficiency--Detectors used in mammography
----------------------------------------------------------------------------------------------------------------
12-214 Medical electrical equipment--Characteristics of digital X- IEC 62220-1-3 Edition 1.0
ray imaging devices--Part 1-3: Determination of the 2008-06
detective quantum efficiency--Detectors used in dynamic
imaging
----------------------------------------------------------------------------------------------------------------
12-215 Medical electrical equipment--Exposure index of digital X- IEC 62494-1 Edition 1.0
ray imaging systems--Part 1: Definitions and requirements 2008-08
for general radiography
----------------------------------------------------------------------------------------------------------------
12-216 Medical electrical equipment - Medical image display systems IEC 62563-1 Edition 1.0
- Part 1: Evaluation methods 2009-12
----------------------------------------------------------------------------------------------------------------
I. Sterility
----------------------------------------------------------------------------------------------------------------
14-289 Cleanrooms and associated controlled environments-- ISO 14698-2:2003 TECHNICAL
Biocontamination control--Part 2: Evaluation and CORRIGENDUM 1
interpretation of biocontamination data
----------------------------------------------------------------------------------------------------------------
J. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-20 Standard Guide for Characterization and Testing of Raw or ASTM F 2027-08
Starting Biomaterials for Tissue-Engineered Medical
Products
----------------------------------------------------------------------------------------------------------------
15-21 Standard Guide for Characterization and Testing of ASTM F 2150-07
Biomaterial Scaffolds Used in Tissue-Engineered Medical
Products
----------------------------------------------------------------------------------------------------------------
15-22 Standard Guide for Assessment of Surface Texture of Non- ASTM F 2791-00
Porous Biomaterials in Two Dimensions
----------------------------------------------------------------------------------------------------------------
15-23 Standard Guide for Quantitating Cell Viability within ASTM F 2739-08
Biomaterial Scaffolds
----------------------------------------------------------------------------------------------------------------
15-24 Standard Guide for Pre-clinical in vivo Evaluation in ASTM F 2721-09
Critical Size Segmental Bone Defects
----------------------------------------------------------------------------------------------------------------
\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 the new provision of section 514 of the 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. CDRH maintains a site on
the Internet for easy access to information
[[Page 61157]]
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: 025'' 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'' through the hyperlink 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. It is no longer necessary to sent 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: 025. These modifications to the list or recognized standards
are effective upon publication of this notice in the Federal Register.
Dated: September 28, 2010.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2010-24788 Filed 10-1-10; 8:45 am]
BILLING CODE 4160-01-S