[Federal Register Volume 72, Number 243 (Wednesday, December 19, 2007)]
[Notices]
[Pages 71924-71930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-24580]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0226]
Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 019
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: 019'' (Recognition List Number: 019), 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: 019'' to
the Division of Small Manufacturers, International and Consumer
Assistance, Center for Devices and Radiological Health (HFZ-220), Food
and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send
two self-addressed adhesive labels to assist that office in processing
your requests, or fax your request to 301-443-8818. 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.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/cdrhnew.cfm. 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: 019
modifications and other standards related information.
FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices
and Radiological Health (HFZ-84), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 240-276-0533.
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 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
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Federal Register Cite
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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)
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These notices describe the addition, withdrawal, and revision of
certain standards recognized by FDA. The agency maintains ``hypertext
markup
[[Page 71925]]
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: 019
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: 019 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.
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Old Item Replacement
No. Standard Change Item No.
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A. Anesthesia
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11 IEC 60601-3-1:1996-08 Medical Title Change ..............
Electrical Equipment - Part Contact person
3-1: Essential Performance
Requirement for
Transcutaneous Oxygen and
Carbon Dioxide Partial
Pressure Monitoring
Equipment
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18 ISO 8359:1996 Oxygen Contact person ..............
Concentrators for Medical
Use - Safety Requirements
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51 ASTM F1100-90(1997) Standard Contact person ..............
Specification for Relevant
Ventilators Intended for Use guidance
in Critical Care
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57 ASTM F1101-90(2003)e1 Contact person ..............
Standard Specification for
Ventilators Intended for Use
During Anesthesia
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59 ASTM F1456-01 Standard Relevant ..............
Specification for Minimum guidance
Performance and Safety
Requirements for Capnometers
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60 IEC 60601-2-12:(2001-10) Contact person ..............
Medical Electrical Equipment Relevant
- Part 2-12: Particular guidance
Requirements for the Safety
of Lung Ventilators -
Critical Care Ventilators
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61 IEC 60601-2-13(2003-05):, Relevant ..............
Medical electrical equipment guidance
- Part 2-13: Particular
requirements for the safety
and essential performance of
anaesthetic systems
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65 ISO 21647: 2004 Medical Title Change ..............
Electrical Equipment - Relevant
Particular Requirements for guidance
the Basic Safety and
Essential Performance of
Respiratory Gas Monitors
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69 ASTM F1464-93(2005) Standard Contact person ..............
Specification for Oxygen
Concentrators for
Domiciliary Use
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70 ASTM F 1246-91 (2005) Contact person ..............
Standard Specification for Relevant
Electrically Powered Home guidance
Care Ventilators, Part 1 -
Positive-Pressure
Ventilators and Ventilator
Circuits
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71 ISO 10651-5:2006 Lung Contact person ..............
Ventilators for Medical Use -
Particular Requirements for
Basic Safety and Essential
Performance - Part 5: Gas-
powered Emergency
Resuscitators
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B. General
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20 ASTM F1140:1988: Standard Withdrawn ..............
Test Method for Failure
Resistance of Unrestrained
and Nonrigid Packages for
Medical Applications
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C. General Hospital/General Plastic Surgery
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21 ISO 10555-3: 1996 Sterile, Withdrawn 171
Single-use Intravascular duplicate
Catheters - Part 3: Central
Venous Catheters
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81 ASTM E1061-01(2007) Standard Withdrawn and 200
Specification for Direct- replaced with
Reading Liquid Crystal newer version
Forehead Thermometers
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[[Page 71926]]
111 IEC 60601-2-38: 1996 Medical Withdrawn 182
Electrical Equipment - Part duplicate
2: Particular Requirements
for the Safety of
Electrically Operated
Hospital Beds
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117 ASTM F2172-02:, Standard Contact person ..............
Specification for Blood/
Intravenous Fluid/Irrigation
Fluid Warmers
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121 ISO 8536-2-2001 Infusion Withdrawn 173
Equipment for Medical Use - duplicate
Part 2: Closures for
Infusion Bottles
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126 ISO 8536-4:2007 Infusion Withdrawn and 201
Equipment for Medical Use -- replaced with
Part 4: Infusion Sets for newer version
Single-use, Gravity Feed
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162 ISO 8536-1:2000/Amendment Withdrawn 172
1:2004 Infusion Equipment duplicate
for Medical Use - Part 1:
Infusion Glass Bottles
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D. In Vitro Diagnostics
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31 CLSI H20-A2 Reference Withdrawn and 130
Leukocyte (WBC) Differential replaced with
Count (Proportional) and newer version
Evaluation of Instrumental
Methods; Approved Standard--
Second Edition
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E. Materials
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3 ASTM F90-07 Standard Withdrawn and 145
Specification for Wrought replaced with
Cobalt-20 Chromium-15 newer version
Tungsten-10 Nickel Alloy for
Surgical Implant
Applications (UNS R30605)
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30 ASTM F1537-07 Standard Withdrawn and 152
Specification for Wrought replaced with
Cobalt-28Chromium-6Molybdenu newer version
m Alloys for Surgical
Implants (UNS R31537, UNS
R31538, and UNS R31539)
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41 ASTM F2066-07 Standard Withdrawn and 146
Specification for Wrought replaced with
Titanium-15 Molybdenum Alloy newer version
for Surgical Implant
Applications (UNS R58150)
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42 ASTM F2119-07 Standard Test Withdrawn and 153
Method for Evaluation of MR replaced with
Image Artifacts from Passive newer version
Implants
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45 ASTM F562-07 Standard Withdrawn and 147
Specification for Wrought replaced with
35Cobalt-35Nickel-20Chromium newer version
-10Molybdenum Alloy for
Surgical Implant
Applications (UNS R30035)
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48 ASTM F899-07 Standard Withdrawn and 148
Specification for Stainless replaced with
Steel for Surgical newer version
Instruments
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56 ISO 5832-1:2007 Implants for Withdrawn and 149
Surgery -- Metallic replaced with
Materials -- Part 1: Wrought newer version
Stainless Steel
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62 ISO 5832-9:2007 Implants for Withdrawn and 150
Surgery - Metallic Materials replaced with
- Part 9: Wrought High newer version
Nitrogen Stainless Steel
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64 ISO 5832-12:2007 Implants for Withdrawn and 151
surgery -- Metallic replaced with
materials -- Part 12: newer version
Wrought cobalt-chromium-
molybdenum alloy
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F. OB-GYN/Gastroenterology
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5 IEC 60601-2-18 (1996) Medical Withdrawn 42
Electrical Equipment - Part duplicate
2: Particular Requirements
for the Safety of Endoscopic
Equipment
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G. Ophthalmic
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35 ISO 10939:2007 Ophthalmic Contact person ..............
Instruments -- Slit-lamp
Microscopes
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37 ISO 10942:2006 Ophthalmic Contact person ..............
Instruments -- Direct
ophthalmoscopes
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38 ISO 10943:2006 Ophthalmic Contact person ..............
Instruments -- Indirect
ophthalmoscopes
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39 ISO 12865:2006 Ophthalmic Contact person ..............
Instruments -- Retinoscopes
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51 ISO 15004-2:2007 Ophthalmic Contact person ..............
Instruments--Fundamental
Requirements and Test
Methods Part 2: Light Hazard
Protection
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H. Radiology
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[[Page 71927]]
7 IEC / ISO 10918-1:1994 Withdrawn 150
Information Technology-- duplicate
Digital Compression and
Coding of Continuous-tone
Still Images - Part 1:
Requirements and Guidelines
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76 NU 2-2007 Performance Withdrawn and 167
Measurements of Positron replaced with
Emission Tomographs newer version
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84 IEC 60825-1 Ed. 2.0 (2007) Withdrawn and 168
Safety of Laser Products - replaced with
Part 1: Equipment newer version
Classification and
Requirements
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85 IEC 60601-2-22 Ed. 3.0 (2007) Withdrawn and 169
Medical Electrical Equipment replaced with
- Part 2-22: Particular newer version
Requirements for Basic
Safety and Essential
Performance of Surgical,
Cosmetic, Therapeutic and
Diagnostic Laser Equipment
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90 IEC 60601-2-1 (1998-06) Withdrawn 152
Medical Electrical Equipment duplicate
- Part 2-1: Particular
Requirements for the Safety
of Electron Accelerators in
the Range 1 MeV to 50 MeV
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102 ANSI / IESNA RP-27.2-2000 Contact person ..............
Recommended Practice for
Photobiological Safety for
Lamps and Lamp Systems -
Measurement Techniques
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103 ANSI / IESNA RP-27.3-1996 Contact person ..............
Recommended Practice for
Photobiological Safety for
Lamps - Risk Group
Classification and Labeling
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112 ISO 11670:2003 Lasers and Withdrawn 156
Laser-related Equipment - duplicate
Test Methods for Laser Beam
Parameters - Beam Positional
Stability
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114 ISO 13694:2000 Optics and Withdrawn 157
Optical Instruments - Lasers duplicate
and Laser-related Equipment -
Test Methods for Laser Beam
Power (energy) Density
Distribution
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119 NEMA PS 3.1 - 3.18 (2007) Withdrawn and 170
Digital Imaging and replaced with
Communications in Medicine newer version
(DICOM) Set
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153 ANSI / IESNA RP-27.1-2005 Contact person ..............
Recommended Practice for
Photobiological Safety for
Lamps and Lamp Systems -
General Requirements
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I. Software/Informatics
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4 ANSI/UL 1998 Software in Relevant ..............
Programmable Components guidance
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5 IEC 60601-3-1:1996-08 Medical Relevant ..............
electrical equipment - Part guidance
3-1: Essential performance
requirement for
transcutaneous oxygen and
carbon dioxide partial
pressure monitoring
equipment
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8 IEC 62304 Ed. 1.0 Medical Relevant ..............
device software - Software guidance
life cycle processes
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J. Sterility
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25 ANSI/AAMI/ISO 11135-1:2007 Withdrawn and 228
Sterilization of Health Care replaced with
Products - Ethylene oxide - newer version
Part 1: Requirements for the
Development, Validation and
Routine Control of a
Sterilization Process for
Medical Devices
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63 ASTM F1886: 1998 (2004) Relevant ..............
Standard Test Method for guidance
Determining Integrity of
Seals for Medical Packaging
by Visual Inspection
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64 ASTM F1929:1998 (2004) Relevant ..............
Standard Test Method for guidance
Detecting Seal Leaks in
Porous Medical Packaging by
Dye Penetration
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86 ASTM F1980-07 Standard Guide Withdrawn and 229
for Accelerated Aging of replaced with
Sterile Barrier Systems for newer version
Medical Devices
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120 ASTM D3078:2002 Standard Test Relevant ..............
Method for Determination of guidance
Leaks in Flexible Packaging
by Bubble Emission
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136 AAMI/ANSI ST67:2003 Relevant ..............
Sterilization of Health Care guidance
Products - Requirements for
Products Labeled 'Sterile'
1st edition
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144 ASTM F2203-02(2007) Standard Withdrawn and 230
Test Method for Linear replaced with
Measurement Using Precision newer version
Steel Rule
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[[Page 71928]]
145 ASTM F2217-02(2007) Standard Withdrawn and 231
Practice for Coating/ replaced with
Adhesive Weight newer version
Determination
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146 ASTM F2227-02(2007) Standard Withdrawn and 232
Test Method for Non- replaced with
Destructive Detection of newer version
Leaks in Non-sealed and
Empty Medical Packaging
Trays by CO2 Tracer Gas
Method
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147 ASTM F2228-02(2007) Standard Withdrawn and 233
Test Method for Non- replaced with
Destructive Detection of newer version
Leaks in Medical Packaging
Which Incorporates Porous
Barrier Material by CO2
Tracer Gas Method
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167 ASTM F2097-07 Standard Guide Withdrawn and 234
for Design and Evaluation of replaced with
Primary Flexible Packaging newer version
for Medical Products
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168 ASTM F2338-05 Standard Test Relevant ..............
Method for Nondestructive guidance
Detection of Leaks in
Packages by Vacuum Decay
Method
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169 ASTM F2391-05 Standard Test Relevant ..............
Method for Measuring Package guidance
and Seal Integrity Using
Helium as Tracer Gas
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170 ASTM F2475-05 Standard Guide Relevant ..............
for Biocompatibility guidance
Evaluation of Medical Device
Packaging Materials
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193 AAMI/ANSI/ISO 11607-1:2006 Relevant ..............
Packaging for Terminally guidance
Sterilized Medical Devices -
Part 1: Requirements for
Materials, Sterile Barrier
Systems and Packaging
Systems, 3ed.
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194 AAMI/ANSI/ISO 11607-2:2006 Relevant ..............
Packaging for Terminally guidance
Sterilized Medical Devices -
Part 2: Validation
Requirements for Forming,
Sealing and Assembly
Processes, 1ed.
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196 ASTM F1140-07 Standard Test Withdrawn and 235
Methods for Internal replaced with
Pressurization Failure newer version
Resistance of Unrestrained
Packages
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197 ASTM F1608:00(2004) Standard Relevant ..............
Test Method for Microbial guidance
Ranking of Porous Packaging
Materials (Exposure Chamber
Method)
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198 ASTM F2054-07 Standard Test Withdrawn and 236
Method for Burst Testing of replaced with
Flexible Package Seals Using newer version
Internal Air Pressurization
Within Restraining Plates
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199 ASTM D4169-05 Standard Relevant ..............
Practice for Performance guidance
Testing of Shipping
Containers and Systems
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200 ASTM F88-07 Standard Test Withdrawn and 237
Method for Seal Strength of replaced with
Flexible Barrier Materials newer version
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K. Tissue Engineering
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2 ASTM F2103-01(2007)e1 Withdrawn and 12
Standard Guide for replaced with
Characterization and Testing newer version
of Chitosan Salts as
Starting Materials Intended
for Use in Biomedical and
Tissue-Engineered Medical
Product Applications
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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: 019.
Table 3.
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Item No. Title of Standard Reference No. & Date
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A. Anesthesia
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76 Anaesthetic and Respiratory ISO 26825:2007
Equipment--User-applied Labels
for Syringes Containing Drugs
Used During Anaesthesia--
Colours, Design and Performance
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B. Dental/ ENT
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[[Page 71929]]
145 Dentistry--Membrane Materials for ISO 22803:2004
Guided Tissue Regeneration in
Oral and Maxillofacial Surgery--
Contents of a Technical File
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146 Dentistry--Metallic Materials for ISO 22674: 2006
Fixed and Removable Restorations
and Appliances
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C. General Hospital/ General Plastic Surgery
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202 Lasers and Laser-related ISO 11810-2:2007
Equipment -- Test Method and
Classification for the Laser-
resistance of Surgical Drapes
and/or Patient-protective Covers
-- Part 2: Secondary Ignition
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D. Ophthalmic
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53 Ophthalmic optics--Contact Lenses ISO 18369-1:2006
-- Part 1: Vocabulary,
Classification System and
Recommendations for Labeling
Specifications
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54 Ophthalmic Optics- Contact Lenses- ISO 18369-4:2006
Part 4: Physicochemical
Properties of Contact Lens
Materials
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55 Ophthalmic implants -- ISO 11979-6:2007
Intraocular Lenses -- Part 6:
Shelf-life and Transport
Stability
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E. Radiology
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171 Optics and Photonics -- Microlens ISO 14880-2:2006
Arrays -- Part 2: Test Methods
for Wavefront Aberrations
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172 Optics and Photonics -- Microlens ISO 14880-3:2006
Arrays -- Part 3: Test Methods
for Optical Properties Other
than Wavefront Aberrations
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173 Optics and Photonics -- Microlens ISO 14880-4:2006
Arrays -- Part 4: Test Methods
for Geometrical Properties
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174 Optics and Photonics -- Lasers ISO 13697:2006
and Laser-related Equipment --
Test Methods for Specular
Reflectance and Regular
Transmittance of Optical Laser
Components
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175 Optics and Photonics -- Lasers ISO 24013:2006
and Laser-related Equipment --
Measurement of Phase Retardation
of Optical Components for
Polarized Laser Radiation
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176 Evaluation and Routine Testing in IEC 61223-3-2 Ed. 2.0
Medical Imaging Departments - (2007)
Part 3-2: Acceptance Tests -
Imaging Performance of
Mammographic X-ray Equipment
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F. Sterility
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238 Sterilization of Health Care ANSI/AAMI/ISO11140-
Products - Chemical Indicators - 5:2007
Part 5: Class 2 Indicators for
Bowie and Dick-type Air Removal
Tests
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239 Aseptic Processing of Health Care ISO 13408-3:2006
Products--Part 3: Lyophilization
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240 Aseptic Processing of Health Care ISO 13408-5:2006
Products--Part 5: Sterilization-
in-place
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241 Aseptic Processing of Health Care ISO 13408-6:2005
Products--Part 6: Isolator
Systems
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242 Cleanrooms and Associated ISO 14644-3:2005
Controlled Environments--Part 3:
Test Methods
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243 Cleanrooms and Associated ISO 14644-6:2007
Controlled Environments--Part 6:
Vocabulary
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244 Cleanrooms and Associated ISO 14644-8:2006
Controlled Environments - Part
8: Classification of Airborne
Molecular Contamination
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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
[[Page 71930]]
the device(s) that would be addressed by a declaration of conformity.
VI. Electronic Access
You may obtain a copy of ``Guidance on the Recognition and Use of
Consensus Standards'' by using the Internet. CDRH maintains a site on
the Internet for easy access to information including text, graphics,
and files that you may download to a personal computer with access to
the Internet. Updated on a regular basis, the CDRH home page includes
the guidance as well as the current list of recognized standards and
other standards related documents. After publication in the Federal
Register, this notice announcing ``Modification to the List of
Recognized Standards, Recognition List Number: 019'' will be available
on the CDRH home page. You may access the CDRH home page at http://www.fda.gov/cdrh.
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/cdrh/stdsprog.html.
This Federal Register document on modifications in FDA's
recognition of consensus standards is available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/cdrhnew.cfm.
VII. Submission of Comments and Effective Date
Interested persons may submit to the contact person (see FOR
FURTHER INFORMATION CONTACT) written or electronic comments regarding
this document. Two copies of any mailed comments are to be submitted,
except that individuals may submit one paper copy. 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: 019. These modifications
to the list or recognized standards are effective upon publication of
this notice in the Federal Register.
Dated: December 13, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-24580 Filed 12-18-07; 8:45 am]
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