[Federal Register Volume 76, Number 49 (Monday, March 14, 2011)]
[Notices]
[Pages 13631-13638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-5815]
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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: 026
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: 026'' (Recognition List Number: 026), 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: 026'' 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 e-mail:
[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: 026 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, 301-796-
6574.
I. Background
Section 204 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). Amended
section 514 allows FDA to recognize consensus standards developed by
international and national organizations for use in satisfying portions
of device premarket review submissions or other requirements.
In a notice published in the Federal Register of February 25, 1998
(63 FR 9561), FDA announced the availability of a guidance entitled
``Recognition and Use of Consensus Standards.'' The notice described
how FDA would implement its standard recognition program and provided
the initial list of recognized standards.
Modifications to the initial list of recognized standards, as
published in the Federal Register, are identified in Table 1 as
follows:
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).
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[[Page 13632]]
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: 026
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: 026'' 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 recognition Title of standard Change
No. No. \1\
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
1-56............. .............. CGA V-7.1 1997 Reaffirmation.
(R2003) (2008)
Standard Method of
Determining
Cylinder Valve
Outlet Connections
for Medical Gases--
First Edition.
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
2-96............. 2-162 ASTM F1903-10 Withdrawn and
Standard Practice replaced with
for Testing For newer version.
Biological
Responses to
Particles In Vitro.
2-117............ .............. ANSI/AAMI/ISO 10993- Extent of
3:2003/(R)2009 recognition.
Biological
evaluation of
medical devices--
Part 3: Tests for
genotoxicity,
carcinogenicity,
and reproductive
toxicity.
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
3-54............. .............. ANSI/AAMI/ISO Reaffirmation.
7198:1998/2001/
(R)2010
Cardiovascular
implants--Tubular
vascular prostheses.
3-58............. .............. ANSI/AAMI/ISO Reaffirmation.
5840:2005/(R)2010
Cardiovascular
implants--Cardiac
valve prostheses.
3-66............. .............. ASTM F 2081-06 Device
Standard Guide for affected,
Characterization Processes
and Presentation of impacted, Type
the Dimensional of standard,
Attributes of CFR citation
Vascular Stents. and product
codes, and
Contact
person.
------------------------------------------------------------------------
D. Dental/ENT
------------------------------------------------------------------------
4-89............. .............. ADA Specification Reaffirmation.
No. 53 Polymer-
Based Crowns and
Bridge Resins.
4-111............ .............. ADA Specification Withdrawn.
No. 13 Denture Cold-
Curing Repair
Resins: 1981
(Reaffirmed 2006).
4-112............ .............. ADA Specification Withdrawn.
No. 16 Dental
Impression Paste--
Zinc Oxide Eugenol
Type.
4-124............ 4-191 ANSI/ASA S3.22-2009 Withdrawn and
American National replaced with
Standard newer version.
Specification of
Hearing Aid
Characteristics.
4-127............ 4-192 ADA Specification 58 Withdrawn and
Root Canal Files, replaced with
Type H (Hedstrom) newer version.
2007.
4-138............ 4-193 ADA Specification Withdrawn and
No. 15 Artificial replaced with
Teeth for Dental newer version.
Prostheses.
4-148............ 4-194 ADA Specification Withdrawn and
No. 78 Dental replaced with
Obturating Cones. newer version.
4-158............ .............. ISO 10139-1:2005 Withdrawn
Dentistry--Soft duplicate. See
lining materials 4-189.
for removable
dentures--Part 1:
Materials for short-
term use Technical
Corrigendum 1:2006.
------------------------------------------------------------------------
E. General Hospital/General Plastic Surgery
------------------------------------------------------------------------
6-144............ 6-243 ASTM D5712-10 Withdrawn and
Standard Test replaced with
Method for Analysis a newer
of Aqueous version.
Extractable Protein
in Natural Rubber
and Its Products
Using the Modified
Lowry Method.
6-145............ .............. ASTM D3578-05 Reaffirmation.
Standard
Specification for
Rubber Examination
Gloves.
6-149............ .............. ASTM D7160-05 Reaffirmation.
(Reapproved 2010)
Standard Practice
for Determination
of Expiration
Dating for Medical
Gloves.
[[Page 13633]]
6-150............ .............. ASTM D7161-05 Reaffirmation.
(Reapproved 2010)
Standard Practice
for Determination
of Real Time
Expiration Dating
of Mature Medical
Gloves Stored Under
Typical Warehouse
Conditions.
6-165............ .............. ASTM D6977-04 Reaffirmation.
(Reapproved 2010)
Standard
Specification for
Polychloroprene
Examination Gloves
for Medical
Application.
6-167............ 6-244 ASTM D6319-10 Withdrawn and
Standard replaced with
Specification for newer version.
Nitrile Examination
Gloves for Medical
Application.
6-169............ .............. ASTM D3772-01 Reaffirmation.
(Reapproved 2010)
Standard
Specification for
Natural Rubber
Finger Cots.
6-201............ 6-245 ISO 8536-4 Fifth Withdrawn and
edition 2010-10-01 replaced with
Infusion equipment newer version.
for medical use--
Part 4: Infusion
sets for single
use, gravity feed.
6-218............ 6-246 USP 33-NF 28 2010 Withdrawn and
<11> Nonabsorbable replaced with
Surgical Suture. newer version.
6-220............ 6-247 USP 33-NF 28 2010 Withdrawn and
Absorbable Surgical replaced with
Suture. newer version.
6-221............ 6-248 USP 33-NF 28 2010 Withdrawn and
<881> Tensile replaced with
Strength. newer version.
6-222............ 6-249 USP 33-NF 28 2010 Withdrawn and
<861> Suture- replaced with
Diameter. newer version.
6-223............ 6-250 USP 33-NF 28 2010 Withdrawn and
<871> Sutures-- replaced with
Needle Attachment. newer version.
6-224............ 6-251 USP 33 NF-28 2010 Withdrawn and
<11> Sterile Water replaced with
for Irrigation. newer version.
6-225............ 6-252 USP 33 NF-28 2010 Withdrawn and
<11> Heparin Lock replaced with
Flush Solution. newer version.
------------------------------------------------------------------------
F. IVD
------------------------------------------------------------------------
7-183............ .............. CLSI M38-A2 Withdrawn
Reference Method duplicate. See
for Broth Dilution 7-171.
Antifungal
Susceptibility
Testing of
Filamentous Fungi.
7-188............ 7-218 CLSI M45-A2 Methods Withdrawn and
for Antimicrobial replaced with
Dilution and Disk newer version.
Susceptibility
Testing of
Infrequently
Isolated or
Fastidious
Bacteria; Approved
Guideline--Second
Edition.
------------------------------------------------------------------------
G. Materials
------------------------------------------------------------------------
8-10............. .............. ASTM F603-00 Withdrawn.
Standard
Specification for
High-Purity Dense
Aluminum Oxide for
Surgical Implant
Application.
8-88............. 8-195 ASTM F2024-10 Withdrawn and
Standard Practice replaced with
for X-Ray newer version.
Diffraction
Determination of
Phase Content of
Plasma-Sprayed
Hydroxyapatite
Coatings.
8-101............ .............. ASTM F 2118--03 Reaffirmation.
(Reapproved 2009)
Standard Test
Method for Constant
Amplitude of Force
Controlled Fatigue
Testing of Acrylic
Bone Cement
Materials.
8-103............ .............. ASTM F1801--97 Reaffirmation.
(Reapproved
2009)[epsi]\1\
Standard Practice
for Corrosion
Fatigue Testing of
Metallic Implant
Materials.
8-107............ .............. ASTM F746--04 Reaffirmation.
(Reapproved 2009)
[epsi]\1\ Standard
Test Method for
Pitting or Crevice
Corrosion of
Metallic Surgical
Implant Materials.
8-117............ .............. ASTM F86--04 Reaffirmation.
(Reapproved 2009)
Standard Practice
for Surface
Preparation and
Marking of Metallic
Surgical Implants.
------------------------------------------------------------------------
H. OB-GYN/Gastroenterology
------------------------------------------------------------------------
9-47............. .............. AAMI RD16 Withdrawn. See
Cardiovascular 9-65.
implants and
artificial organs--
Hemodialyzers,
hemodiafilters.
9-48............. .............. AAMI RD17 Withdrawn. See
Cardiovascular 9-66.
implants and
artificial organs--
Extracorporeal
blood circuit for
hemodialyzers,
hemodiafilters, and
hemofilters.
9-50............. .............. ANSI/AAMI RD52:2004/ Reaffirmation.
(R)2010 and ANSI/
AAMI RD52:2004/
A1:2007/(R)2010,
A2:2007/(R)2010,
A3:2009, & A4:2009
(Consolidated Text)
Dialysate for
haemodialysis.
9-51............. 9-65 ANSI/AAMI/ISO Withdrawn and
8637:2010 replaced with
Cardiovascular newer version.
implants and
extracorporeal
systems--Hemodialyz
ers,
hemodiafilters,
hemofilters and
hemoconcentrators.
9-52............. 9-66 ANSI/AAMI/ISO Withdrawn and
8638:2010 replaced with
Cardiovascular newer version.
implants and
extracorporeal
systems--Extracorpo
real blood circuit
for hemodialyzers,
hemodiafilters and
hemofilters.
9-55............. .............. ANSI/AAMI RD62:2006 Reaffirmation.
and ANSI/AAMI
RD62:2006/A1:2009
Water treatment
equipment for
haemodialysis
applications.
------------------------------------------------------------------------
[[Page 13634]]
I. Orthopedics
------------------------------------------------------------------------
11-168........... .............. ASTM F 1781-03 Reaffirmation.
(Reapproved 2009)
Standard
Specification for
Elastomeric
Flexible Hinge
Finger Total Joint
Implants.
11-183........... .............. ASTM F1875-98 Reaffirmation.
(Reapproved 2009)
Standard Practice
for Fretting
Corrosion Testing
of Modular Implant
Interfaces: Hip
Femoral Head-Bore
and Cone Taper
Interface.
------------------------------------------------------------------------
J. Physical Medicine
------------------------------------------------------------------------
16-30............ 16-167 ISO 7176-9: Third Withdrawn and
edition, 2009-11-15 replaced with
Wheelchairs--Part newer version.
9: Climatic tests
for electric
wheelchairs.
16-31............ 16-168 RESNA WC-1: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
1: Requirements and
Test Methods for
Wheelchairs
(including
Scooters) Section
1: Determination of
static stability.
16-32............ 16-169 RESNA WC-2: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
2: Additional
Requirements for
Wheelchairs
(including
Scooters) with
Electrical Systems
Section 2:
Determination of
dynamic stability
of electrically
powered wheelchairs.
16-33............ 16-170 RESNA WC-2: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
2: Additional
Requirements for
Wheelchairs
(including
Scooters) with
Electrical Systems
Section 3:
Determination of
effectiveness of
brakes.
16-34............ 16-171 RESNA WC-2: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
2: Additional
Requirements for
Wheelchairs
(including
Scooters) with
Electrical Systems
Section 4: Energy
consumption of
electrically
powered wheelchairs
and scooters for
determination of
theoretical
distance range.
16-35............ 16-172 RESNA WC-1: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
1: Requirements and
Test Methods for
Wheelchairs
(including
Scooters) Section
5: Determination of
dimensions, mass
and maneuvering
space.
16-36............ 16-173 RESNA WC-2: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
2: Additional
Requirements for
Wheelchairs
(including
Scooters) with
Electrical Systems
Section 6:
Determination of
maximum speed,
acceleration and
deceleration of
electrically
powered wheelchairs.
16-37............ 16-174 RESNA WC-1: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
1: Requirements and
Test Methods for
Wheelchairs
(including
Scooters) Section
7: Method of
Measurement of
Seating and Wheel
Dimensions.
16-38............ 16-175 RESNA WC-1: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
1: Requirements and
Test Methods for
Wheelchairs
(including
Scooters) Section
8: Requirements and
test methods for
static, impact and
fatigue strengths.
16-39............ 16-176 RESNA WC-2: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
2: Additional
Requirements for
Wheelchairs
(including
Scooters) with
Electrical Systems
Section 9: Climatic
tests for
electrically
powered wheelchairs.
16-40............ 16-177 RESNA WC-2: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
2: Additional
Requirements for
Wheelchairs
(including
Scooters) with
Electrical Systems
Section 10:
Determination of
obstacle-climbing
ability of
electrically
powered wheelchairs.
16-41............ 16-178 RESNA WC-1: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
1: Requirements and
Test Methods for
Wheelchairs
(including
Scooters) Section
11: Test dummies.
16-42............ 16-179 RESNA WC-1: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
1: Requirements and
Test Methods for
Wheelchairs
(including
Scooters) Section
13: Determination
of coefficient of
friction of test
surfaces.
16-43............ 16-180 RESNA WC-2: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
2: Additional
Requirements for
Wheelchairs
(including
Scooters) with
Electrical Systems
Section 14: Power
and control systems
for electrically
powered
wheelchairs--Requir
ements and test
methods.
16-44............ 16-181 RESNA WC-1: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
1: Requirements and
Test Methods for
Wheelchairs
(including
Scooters) Section
15: Requirements
for information
disclosure,
documentation and
labeling.
[[Page 13635]]
16-45............ 16-182 RESNA WC-1: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
1: Requirements and
Test Methods for
Wheelchairs
(including
Scooters) Section
16: Resistance to
ignition of
upholstered parts--
Requirements and
test methods.
16-46............ 16-183 RESNA WC-1: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
1: Requirements and
Test Methods for
Wheelchairs
(including
Scooters) Section
20: Determination
of the performance
of stand-up type
wheelchairs.
16-47............ 16-184 RESNA WC-1: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
1: Requirements and
Test Methods for
Wheelchairs
(including
Scooters) Section
22: Set-up
procedures.
16-48............ .............. ANSI/RESNA WC/Volume Withdrawn.
1-1998, Section 93:
Maximum Overall
Dimensions.
16-49............ .............. ANSI/RESNA WC/Volume Withdrawn.
1-1998, Section 0:
Nomenclature,
Terms, and
Definitions.
16-160........... 16-185 RESNA WC-2: 2009 Withdrawn and
American National replaced with
Standard for newer version.
Wheelchairs-Volume
2: Additional
Requirements for
Wheelchairs
(including
Scooters) with
Electrical Systems
Section 21:
Requirements and
test methods for
electromagnetic
compatibility of
electrically
powered wheelchairs
and motorized
scooters.
16-161........... 16-186 ASME A18.1-2008 Withdrawn and
(Revision of ASME replaced with
A18.1-2005) Safety newer version.
Standard for
Platform Lifts and
Stairway Chairlifts.
------------------------------------------------------------------------
K. Radiology
------------------------------------------------------------------------
12-122........... 12-217 IEC 62083 Edition Withdrawn and
2.0:2009-09 Medical replaced with
electrical newer version.
equipment--Requirem
ents for the safety
of radiotherapy
treatment planning
systems.
12-36............ .............. IEC 60601-2-9 (1996- Withdrawn.
10) Medical
electrical
equipment--Part 2:
Particular
requirements for
the safety of
patient contact
dosimeters used in
radiotherapy with
electrically
connected radiation
detectors--Ed. 2.0..
12-183........... 12-218 NEMA PS 3.1--3.18 Withdrawn and
(2009) Digital replaced with
Imaging and newer version.
Communications in
Medicine (DICOM)
Set.
------------------------------------------------------------------------
L. Software/Informatics
------------------------------------------------------------------------
13-4............. .............. UL 1998 Standard for Reaffirmation.
Safety Software in
Programmable
Components, Second
Edition.
------------------------------------------------------------------------
M. Sterility
------------------------------------------------------------------------
14-265........... 14-301 USP 33:2010 <61> Withdrawn and
Microbiological replaced with
Examination of newer version.
Nonsterile
Products: Microbial
Enumeration Tests.
14-266........... 14-302 USP 33: 2010 <71> Withdrawn and
Sterility Tests. replaced with
newer version.
14-267........... 14-303 USP 33:2010 <85> Withdrawn and
Bacterial replaced with
Endotoxins Test. newer version.
14-268........... 14-304 USP 33:2010 <151> Withdrawn and
Pyrogen Test. replaced with
newer version.
14-269........... 14-305 USP 33:2010 <161> Withdrawn and
Transfusion and replaced with
Infusion Assemblies newer version.
and Similar Medical
Devices.
14-270........... 14-306 USP 33:2010 Withdrawn and
Biological replaced with
Indicators for newer version.
Steam
Sterilization, Self-
Contained.
14-271........... 14-307 USP 33:2010 Withdrawn and
Biological replaced with
Indicator for Dry- newer version.
Heat Sterilization,
Paper Carrier.
14-272........... 14-308 USP 33:2010 Withdrawn and
Biological replaced with
Indicator for newer version.
Ethylene Oxide
Sterilization,
Paper Carrier.
14-273........... 14-309 USP 33:2010 Withdrawn and
Biological replaced with
Indicator for Steam newer version.
Sterilization,
Paper Carrier.
14-278........... 14-310 USP 33:2010 <62> Withdrawn and
Microbiological replaced with
Examination of newer version.
Nonsterile
Products: Tests for
Specified
Microorganisms.
------------------------------------------------------------------------
\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: 026.
[[Page 13636]]
Table 3--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
Reference No. and
Recognition No. Title of standard \1\ date
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
1-84.................. Anaesthetic and ISO 5366-3:2001
respiratory equipment-- TECHNICAL
Tracheostomy tubes--Part CORRIGENDUM 1.
3: Paediatric
tracheostomy tubes
TECHNICAL CORRIGENDUM 1.
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
2-163................. Biological evaluation of ANSI/AAMI/ISO 10993-
medical devices--Part 9: 9:2009.
Framework for
identification and
quantification of
potential degradation
products.
2-164................. Biological evaluation of ANSI/AAMI/ISO 10993-
medical devices--Part 13: 13:2010.
Identification and
quantification of
degradation products from
polymeric medical devices.
2-165................. Biological evaluation of ANSI/AAMI/ISO 10993-
medical devices--Part 14: 14:2001.
Identification and
quantification of
degradation products from
ceramics.
2-166................. Biological evaluation of ANSI/AAMI/ISO 10993-
medical devices--Part 16: 16:2010.
Toxicokinetic study
design for degradation
products and leachables.
2-167................. Biological evaluation of ISO/TS 10993-19
medical devices--Part 19: First edition 2006-
Physico-chemical, 06-01.
morphological and
topographical
characterization of
materials.
2-168................. Biological evaluation of ISO 10993-9 Second
medical devices-- Part 9: edition 2009-12-15.
Framework for
identification and
quantification of
potential degradation
products.
2-169................. Biological evaluation of ISO 10993-13 First
medical devices--Part 13: edition 1998-11-15.
Identification and
quantification of
degradation products from
polymeric medical devices.
2-170................. Biological evaluation of ISO 10993-14 First
medical devices--Part 14: edition 2001-11-15.
Identification and
quantification of
degradation products from
ceramics.
2-171................. Biological evaluation of ISO 10993-16 Second
medical devices--Part 16: edition 2010-02-15.
Toxicokinetic study
design for degradation
products and leachables.
2-172................. Biological evaluation of ANSI/AAMI/ISO
medical devices--Part 19: TIR10993-19:2006.
Physico-chemical,
morphological, and
topographical
characterization of
materials.
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
3-83.................. Implants for surgery-- ANSI/AAMI/ISO 14708-
Active implantable 5:2010.
medical devices--Part 5:
Circulatory support
devices.
3-84.................. Cardiovascular implants-- ANSI/AAMI/ISO 25539-
Endovascular devices-- 1:2003/A1:2005/
Part 1: Endovascular (R)2009.
prostheses Amendment 1:
Test methods.
3-85.................. Cardiovascular implants-- ANSI/AAMI/ISO 25539-
Endovascular devices-- 2:2008.
Part 2: Vascular stents.
3-86.................. Standard Guide for ASTM F 2394-07.
Measuring Securement of
Balloon Expandable
Vascular Stent Mounted on
Delivery System.
3-87.................. Standard Test Methods for ASTM F 2477-07.
in vitro Pulsatile
Durability Testing of
Vascular Stents.
3-88.................. Standard Guide for Finite ASTM F 2514-08.
Element Analysis (FEA) of
Metallic Vascular Stents
Subjected to Uniform
Radial Loading.
3-89.................. Active implantable medical ISO 27186 First
devices--Four-pole edition 2010-03-15.
connector system for
implantable cardiac
rhythm management
devices--Dimensional and
test requirements.
3-90.................. Cardiovascular implants-- ISO 7198 First
Tubular vascular edition 1998-08-01.
prostheses.
3-91.................. Cardiovascular implants-- ISO 5840 Fourth
Cardiac valve prostheses. edition 2005-03-01.
3-92.................. Implants for surgery-- ISO 14708-5 First
Active implantable edition 2010-02-01.
medical devices--Part 5:
Circulatory support
devices.
3-93.................. Cardiovascular implants-- ISO 25539-1 First
Endovascular device--Part edition 2001-11-13
1: Endovascular AMENDMENT 1 2005-07-
prostheses AMENDMENT 1: 15.
Test methods.
3-94.................. Cardiovascular implants-- ISO 25539-2 First
Endovascular devices-- edition 2008-09-01.
Part 2: Vascular stents.
------------------------------------------------------------------------
D. General
------------------------------------------------------------------------
5-63.................. Small-bore connectors for ISO 80369-1 First
liquids and gases in edition 2010-12-15.
healthcare applications--
Part 1: General
requirements.
5-64.................. Small bore connectors for AAMI/ISO/FDS-1 80369-
liquids and gases in 01 2010.
healthcare applications--
Part 1: General
requirements.
------------------------------------------------------------------------
E. Materials
------------------------------------------------------------------------
8-196................. Implants for surgery-- ISO 5832-1:2007
Metallic materials--Part TECHNICAL
1: Wrought stainless CORRIGENDUM 1 2008-
steel TECHNICAL 04-15.
CORRIGENDUM 1.
8-197................. Implants for surgery-- ISO 5832-12:2007
Metallic materials--Part TECHNICAL
12: Wrought cobalt- CORRIGENDUM 1 2008-
chromium-molybdenum alloy 09-15.
TECHNICAL CORRIGENDUM 1.
8-198................. Standard Guide for ASTM F 2102-
Evaluating the Extent of 06[epsi]1.
Oxidation in Ultra-High-
Molecular-Weight
Polyethylene Fabricated
Forms Intended for
Surgical Implants.
[[Page 13637]]
8-199................. Standard Specification for ASTM F 2633-07.
Wrought Seamless Nickel-
Titanium Shape Memory
Alloy Tube for Medical
Devices and Surgical
Implants.
8-200................. Standard Practice for ASTM F 2003-02
Accelerated Aging of (Reapproved 2008).
Ultra-High Molecular
Weight Polyethylene after
Gamma Irradiation in Air.
8-201................. Standard Test Method for ASTM F 2214-02
In Situ Determination of (Reapproved 2008).
Network Parameters of
Crosslinked Ultra High
Molecular Weight
Polyethylene (UHMWPE).
8-202................. Standard Test Method for ASTM F 2183-02
Small Punch Testing of (Reapproved 2008).
Ultra-High Molecular
Weight Polyethylene Used
in Surgical Implants.
------------------------------------------------------------------------
F. Nanotechnology
------------------------------------------------------------------------
18-1.................. Standard Guide for ASTM E 2490-09.
Measurement of Particle
Size Distribution of
Nanomaterials in
Suspension by Photon
Correlation Spectroscopy
(PCS).
------------------------------------------------------------------------
G. Ophthalmic
------------------------------------------------------------------------
10-62................. Ophthalmics--Ophthalmic ANSI Z80.10-2009.
Instruments--Tonometers.
10-63................. Ophthalmic implants-- ISO/TR 22979-2006.
Intraocular lenses--
Guidance on assessment of
the need for clinical
investigation of
intraocular lens design
modifications.
------------------------------------------------------------------------
H. Radiology
------------------------------------------------------------------------
12-219................ Medical electrical IEC 60336 (Fourth
equipment--X-ray tube edition--2005).
assemblies for medical
diagnosis--Characteristic
s of focal spots
CORRIGENDUM 1.
12-220................ Safety of laser products-- IEC 60825-1 (Second
Part 1: Equipment edition--2007).
classification and
requirements CORRIGENDUM
1.
12-221................ Evaluation and routine IEC 61223-3-4 First
testing in medical edition 2000-03.
imaging departments--Part
3-4: Acceptance tests--
Imaging performance of
dental X-ray equipment.
12-222................ Evaluation and routine IEC 61223-3-5 First
testing in medical edition 2004-08.
imaging departments--Part
3-5: Acceptance tests--
Imaging performance of
computed tomography X-ray
equipment.
12-223................ Evaluation and routine IEC 61223-3-5 (First
testing in medical edition 2004).
imaging departments--Part
3-5: Acceptance tests--
Imaging performance of
computed tomography X-ray
equipment CORRIGENDUM 1.
12-224................ Medical electrical IEC 60601-2-44
equipment--Part 2-44: (Third edition--
Particular requirements 2009).
for the basic safety and
essential performance of
X-ray equipment for
computed tomography
CORRIGENDUM 1.
12-225................ Computed Tomography Dose NEMA XR 25 2010.
Check.
12-226................ Evaluation and routine IEC 61223-2-6 Second
testing in medical edition 2006-11.
imaging departments--Part
2-6: Constancy tests--
Imaging performance of
computed tomography X-ray
equipment.
------------------------------------------------------------------------
I. Tissue Engineering
------------------------------------------------------------------------
15-25................. ASTM F2312--10 Standard ASTM F2312-10.
Terminology Relating to
Tissue Engineered Medical
Products.
15-26................. ASTM F2211--04 Standard ASTM F2211-04.
Classification for Tissue
Engineered Medical
Products (TEMPs).
------------------------------------------------------------------------
\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 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. CDRH maintains a site on
the
[[Page 13638]]
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: 026'' 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. It is no longer necessary to send two copies of mailed
comments. Comments are to be identified with the docket number found in
brackets in the heading of this document. FDA will consider any
comments received in determining whether to amend the current listing
of modifications to the list of recognized standards, Recognition List
Number: 026. These modifications to the list or recognized standards
are effective upon publication of this notice in the Federal Register.
Dated: March 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5815 Filed 3-11-11; 8:45 am]
BILLING CODE 4160-01-P