Food and Drug Administration Modernization Act of 1997:
Federal Register: March 14, 2011 (Volume 76, Number 49)
Notices
Page 13631-13638
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:fr14mr11-85
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: 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: 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).
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\
-
Anesthesia
1-56............. .............. CGA V-7.1 1997
Reaffirmation.
(R2003) (2008)
Standard Method of
Determining
Cylinder Valve
Outlet Connections for Medical Gases--
First Edition.
-
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.
-
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.
-
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.
-
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
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
Tensile
replaced with
Strength.
newer version. 6-222............
6-249 USP 33-NF 28 2010
Withdrawn and
Suture-
replaced with
Diameter.
newer version. 6-223............
6-250 USP 33-NF 28 2010
Withdrawn and
Sutures--
replaced with
Needle Attachment. newer version. 6-224............
6-251 USP 33 NF-28 2010
Withdrawn and
Sterile Water replaced with for Irrigation.
newer version. 6-225............
6-252 USP 33 NF-28 2010
Withdrawn and
Heparin Lock
replaced with
Flush Solution.
newer version.
-
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.
-
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.
-
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.
-
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.
-
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.
-
Sterility
14-265...........
14-301 USP 33:2010 Withdrawn and
Microbiological
replaced with
Examination of
newer version.
Nonsterile
Products: Microbial
Enumeration Tests. 14-266...........
14-302 USP 33: 2010 Withdrawn and
Sterility Tests.
replaced with newer version. 14-267...........
14-303 USP 33:2010 Withdrawn and
Bacterial
replaced with
Endotoxins Test.
newer version. 14-268...........
14-304 USP 33:2010 Withdrawn and
Pyrogen Test.
replaced with newer version. 14-269...........
14-305 USP 33:2010 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 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
-
Anesthesia
1-84.................. Anaesthetic and
ISO 5366-3:2001 respiratory equipment--
TECHNICAL
Tracheostomy tubes--Part
CORRIGENDUM 1. 3: Paediatric tracheostomy tubes
TECHNICAL CORRIGENDUM 1.
-
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.
-
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.
-
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.
-
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.
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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.
-
Nanotechnology
18-1.................. Standard Guide for
ASTM E 2490-09.
Measurement of Particle
Size Distribution of
Nanomaterials in
Suspension by Photon
Correlation Spectroscopy
(PCS).
-
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.
-
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
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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
