[Federal Register Volume 71, Number 213 (Friday, November 3, 2006)]
[Notices]
[Pages 64718-64725]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-18604]
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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: 016
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: 016'' (Recognition List Number: 016), 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: 016'' to
the Division of Small Manufacturers, International and Consumer
Assistance, Center for Devices and Radiological
[[Page 64719]]
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 Web site at http://www.fda.gov/cdrh/fedregin.html.
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: 016 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, 12720
Twinbrook Pkwy., Rockville, MD 20857, 301-827-0021.
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.
FDA has modified its initial list of recognized standards in the
following Federal Register notices:
Table 1.
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Federal Register Cite
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October 16, 1998 (63 FR 55617)
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July 12, 1999 (64 FR 37546)
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November 15, 2000 (65 FR 69022)
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May 7, 2001 (66 FR 23032)
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January 14, 2002 (67 FR 1774)
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October 2, 2002 (67 FR 61893)
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April 28, 2003 (68 FR 22391)
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March 8, 2004 (69 FR 10712)
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June 18, 2004 (69 FR 34176)
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October 4, 2004 (69 FR 59240)
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May 27, 2005 (70 FR 30756)
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November 8, 2005 (70 FR 67713)
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March 31, 2006 (71 FR 16313)
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June 23, 2006 (71 FR 36121)
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These notices describe the addition, withdrawal, and revision of
certain standards recognized by FDA. The agency maintains ``hypertext
markup language'' (HTML) and ``portable document format'' (PDF)
versions of the list of ``FDA Recognized Consensus Standards.'' Both
versions are publicly accessible at the agency's Web 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: 016
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: 016'' to identify these current
modifications.
In table 1 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
------------------------------------------------------------------------
39 CGA V-5: 2005, Diameter-Index Withdrawn and 68
Safety System replaced with
(Noninterchangeable Low newer version
Pressure Connections for
Medical Gas Applications)
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53 ASTM F1464-93 (2005), Withdrawn and 69
Standard Specification for replaced with
Oxygen Concentrators for newer version
Domiciliary Use
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65 ISO 21647: 2005, Medical Devices ...............
Electrical Equipment-- affected,
Particular Requirements for Code of
the Basic Safety and Federal
Essential Performance of Regulations
Respiratory Gas Monitors citation, and
relevant
guidance
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B. Biocompatibility
------------------------------------------------------------------------
107 ASTM F1877-05, Standard Withdrawn and 114
Practice for replaced with
Characterization of newer version
Particles
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108 ASTM F1905-98 (2003), Title ...............
Standard Practice for
Selecting Tests for
Determining the Propensity
of Materials for Cause
Immunotoxicity
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[[Page 64720]]
C. Dental/Ear, Nose, and Throat (ENT)
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49 ANSI/ADA Specification No. Withdrawn and 130
17: 1983 (R1999), Denture replaced with
Base Temporary Relining newer version
Resins
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64 ISO 3107: 2004, Dental Zinc Withdrawn and 131
Oxide/Eugenol Cements and replaced with
Zinc Oxide Non-Eugenol newer version
Cements
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66 ISO 4049: 1988, Dentistry-- Withdrawn. ...............
Resin-Based Filling Refer to item
Materials no. 99
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70 ISO 6874: 2005, Dental Resin- Withdrawn and 132
Based Pit and Fissure replaced with
Sealants newer version
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71 ISO 6876: 2001, Dental Root Withdrawn and 133
Canal Sealing Materials replaced with
newer version
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74 ISO 7494-1: 2004, Dentistry-- Withdrawn and 134
Dental Units--Part 1: replaced with
General Requirements and newer version
Test Methods
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114 ANSI/ADA Specification No. Title ...............
48: 1989, Visible Curing
Units
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116 ISO 10139-1: 2005, Dentistry-- Withdrawn and 135
Soft Lining Materials for replaced with
Removable Dentures--Part 1: newer version
Materials for Short-Term Use
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D. General Hospital/General Plastic Surgery
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83 ASTM D6319-00a (2005), Withdrawn and 167
Standard Specification for replaced with
Nitrile Examination Gloves newer version
for Medical Application
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87 ASTM D3577-06, Standard Withdrawn and 168
Specification for Rubber replaced with
Surgical Gloves newer version
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106 ASTM D3772-01 (2005), Withdrawn and 169
Standard Specification for replaced with
Natural Rubber Finger Cots newer version
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E. In Vitro Diagnostics
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003 CLSI/NCCLS GP10-A 1995, Contact person ...............
Assessment of the Clinical
Accuracy of Laboratory Tests
Using Receiver Operating
Characteristic (ROC) Plots;
Approved Guideline
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004 CLSI/NCCLS GP14-A 1996, Contact person ...............
Labeling of Home-Use In
Vitro Testing Products;
Approved Guideline
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007 CLSI/NCCLS LA1-A2 1994, Contact person ...............
Assessing the Quality of
Radioimmunoassay Systems--2d
ed.; Approved Guideline
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012 CLSI/NCCLS C12-A, Definitions Contact person ...............
of Quantities and
Conventions Related to Blood
pH and Gas Analysis;
Approved Standard
------------------------------------------------------------------------
013 CLSI/NCCLS C21-A, Performance Contact person ...............
Characteristics for Devices
Measuring PO2 and PCO2 in
Blood Samples; Approved
Standard
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015 CLSI/NCCLS C25-A, Fractional Contact person ...............
Oxyhemoglobin, Oxygen
Content and Saturation, and
Related Quantities in Blood:
Terminology, Measurement,
and Reporting; Approved
Guideline
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016 CLSI/NCCLS C27-A, Blood Gas Contact person ...............
Preanalytical
Considerations: Specimen
Collection, Calibration, and
Controls; Approved Guideline
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018 CLSI/NCCLS C30-A, Ancillary Contact person ...............
(Bedside) Blood Glucose
Testing
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038 CLSI/NCCLS I/LA10-A, Contact person ...............
Choriogonadotropin Testing:
Nomenclature, Reference
Preparations, Assay
Performance, and Clinical
Application; Approved
Guideline
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039 CLSI/NCCLS I/LA17-A, Contact person ...............
Assessing the Quality of
Systems for Alpha-
Fetoprotein (AFP) Assays
Used in Prenatal Screening
and Diagnosis of Neural Tube
Defects; Approved Guideline
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[[Page 64721]]
043 CLSI/NCCLS LA4-A3, Blood Contact person ...............
Collection on Filter Paper
for Neonatal Screening
Programs; Approved Standard--
3d ed.
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048 CLSI/NCCLS T/DM6-A, Blood Contact person ...............
Alcohol Testing in the
Clinical Laboratory;
Approved Guideline
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051 CLSI/NCCLS GP 27-A, Using Contact person ...............
Proficiency Testing (PT) to
Improve the Clinical
Laboratory; Approved
Guideline
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052 CLSI/NCCLS NRSCL 8-A, Contact person ...............
Terminology and Definitions
for Use in National
Committee for Clinical
Laboratory Standards (NCCLS)
Documents; Approved Standard
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055 CLSI/NCCLS H18-A2, Procedures Contact person ...............
for the Handling and
Processing of Blood
Specimens; Approved
Guideline
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059 CLSI/NCCLS AUTO2-A, Contact person ...............
Laboratory Automation: Bar
Codes for Specimen Container
Identification; Approved
Standard
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F. Materials
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40 ASTM F2063-05, Standard Withdrawn and 122
Specification for Wrought replaced with
Nickel-Titanium Shape Memory newer version
Alloys for Medical Devices
and Surgical Implants
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48 ASTM F899-02, Standard Contact person ...............
Specification for Stainless
Steel for Surgical
Instruments
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60 ISO 5832-5: 2005, Implants Withdrawn and 123
for Surgery--Metallic replaced with
Materials--Part 5: Wrought newer version
Cobalt-Chromium-Tungsten-
Nickel Alloy
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65 ISO 5834-2: 2006, Implants Withdrawn and 127
for Surgery--Ultra-High- replaced with
Molecular-Weight newer version
Polyethylene--Part 2:
Moulded Forms
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67 ISO 7153-1: 1991/Amd. 1: Contact person ...............
1999, Surgical Instruments--
Metallic Materials--Part 1:
Stainless Steel
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70 ASTM F2052-06e1, Standard Withdrawn and 124
Test Method for Measurement replaced with
of Magnetically Induced newer version
Displacement Force on
Medical Devices in the
Magnetic Resonance
Environment
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72 ASTM F2213-06, Standard Test Withdrawn and 128
Method for Measurement of replaced with
Magnetically Induced Torque newer version
on Passive Implants in the
Magnetic Resonance
Environment
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85 ASTM F1854-01, Standard Test Contact person ...............
Method for Stereological
Evaluation of Porous
Coatings on Medical Implants
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86 ASTM F1926-03, Standard Test Contact person ...............
Method for Evaluation of the
Environmental Stability of
Calcium Phosphate Coatings
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88 ASTM F2024-00, Standard Contact person ...............
Practice for X-Ray
Diffraction Determination of
Phase Content of Plasma-
Sprayed Hydroxyapatite
Coatings
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89 ASTM F1873-98, Standard Contact person ...............
Specification for High-
Purity Dense Yttria
Tetragonal Zirconium Oxide
Polycrystal (Y-TZP) for
Surgical Implant
Applications
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94 ASTM F601-03, Standard Contact person ...............
Practice for Fluorescent
Penetrant Inspection of
Metallic Surgical Implants
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99 ASTM F2004-05, Standard Test Withdrawn and 125
Method for Transformation replaced with
Temperature of Nickel- newer version
Titanium Alloys by Thermal
Analysis
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103 ASTM F1801-97 (2004), Contact person ...............
Standard Practice for
Corrosion Fatigue Testing of
Metallic Implant Materials
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106 ASTM F648-04, Standard Contact person ...............
Specification for Ultra-High-
Molecular-Weight
Polyethylene Powder and
Fabricated Form for Surgical
Implants
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109 ASTM F561-05a, Standard Withdrawn and 126
Practice for Retrieval and replaced with
Analysis of Medical Devices, newer version
and Associated Tissues and
Fluids
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[[Page 64722]]
111 ASTM F1160-05, Standard Test Contact person ...............
Method for Shear and Bending
Fatigue Testing of Calcium
Phosphate and Metallic
Medical and Composite
Calcium Phosphate/Metallic
Coatings
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112 ASTM F1044-05, Standard Test Contact person ...............
Method for Shear Testing of
Calcium Phosphate Coatings
and Metallic Coatings
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113 ASTM F1147-05, Standard Test Contact person ...............
Method for Tension Testing
of Calcium Phosphate and
Metal Coatings
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117 ASTM F86-04, Standard Contact person ...............
Practice for Surface
Preparation and Marking of
Metallic Surgical Implants
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G. Obstetrics-Gynecology (OB-GYN)/Gastroenterology
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28 ANSI/AAMI RD16: 1996/A1: 2002/ Reaffirmation ...............
(R)2005, Hemodialyzers
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29 ANSI/AAMI RD17: 1994/A1: 2002/ Reaffirmation ...............
(R)2005, Hemodialyzer Blood
Tubing
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31 ANSI/AAMI ID54: 1996/(R)2005, Reaffirmation ...............
Enteral Feeding Set Adapters
and Connectors
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H. Ophthalmic
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20 ISO 11979-1: 1999, Ophthalmic Contact person ...............
Implants--Intraocular
Lenses--Part 1: Vocabulary
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22 ISO 11979-3: 1999, Ophthalmic Contact person ...............
Implants--Intraocular
Lenses--Part 3: Mechanical
Properties and Test Methods
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32 ISO 11990: 2003, Optics and Withdrawn and ...............
Optical Instruments--Lasers transferred
and Laser-Related Equipment-- to Radiology
Determination of Laser
Resistance of Tracheal Tube
Shafts
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I. Orthopedic/Physical Medicine
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85 ISO 14630: 2005, Non-Active Withdrawn and 194
Surgical Implants--General replaced with
Requirements newer version
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141 ASTM F1612-95 (2005), Withdrawn and 195
Standard Practice for Cyclic replaced with
Fatigue Testing of Metallic newer version
Stemmed Hip Arthroplasty
Femoral Components With
Torsion
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142 ASTM F1672-95 (2005), Withdrawn and 196
Standard Specification for replaced with
Resurfacing Patellar newer version
Prosthesis
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150 ASTM F983-86 (2005), Standard Withdrawn and 197
Practice for Permanent replaced with
Marking of Orthopaedic newer version
Implant Components
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162 ASTM F564-02 (2006), Standard Withdrawn and 201
Specification and Test replaced with
Methods for Metallic Bone newer version
Staples
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174 ASTM F382-99 (2003) e1, Withdrawn and 198
Standard Specification and replaced with
Test Method for Metallic newer version
Bone Plates
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176 ASTM F565-04, Standard Withdrawn and 199
Practice for Care and replaced with
Handling of Orthopedic newer version
Implants and Instruments
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193 ASTM F2083-06, Standard Withdrawn and 200
Specification for Total Knee replaced with
Prosthesis newer version
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J. Radiology
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32 ISO 11990: 2003, Optics and Transferred 144
(Opthal Optical Instruments--Lasers from
mic) and Laser-Related Equipment-- Ophthalmic,
Determination of Laser type of
Resistance of Tracheal Tube standard, and
Shafts contact
person
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92 IEC 61674 (1997-10), Medical Withdrawn and 145
Electrical Cquipment-- replaced
Dosimeters With Ionization
Chambers and/or Semi-
Conductor Detectors as Used
in X-Ray Diagnostic Imaging
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[[Page 64723]]
93 IEC 61674 (2002), Amendment Withdrawn and 145
1, Medical Electrical replaced
Equipment--Dosimeters With
Ionization Chambers and/or
Semi-Conductor Detectors as
Used in X-Ray Diagnostic
Imaging
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118 IEC 60601-2-17 (2005), Withdrawn and 146
Medical Electrical replaced with
Equipment--Part 2-17: newer version
Particular Requirements for
the Safety of Automatically-
Controlled Brachytherapy
Afterloading Equipment
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135 IEC 60601-2-5 (2005), Medical Withdrawn and 147
Electrical Equipment--Part 2- replaced with
5: Particular Requirements newer version
for the Safety of Ultrasonic
Physiotherapy Equipment ed.
2.0
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8 IEC 60336 (2005), Medical Withdrawn and 149
Electrical Equipment--X-Ray replaced with
Tube Assemblies for Medical newer version
Diagnosis--Characteristics
of Focal Spots
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K. Sterility
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74 ANSI/AAMI ST 60: 1996, Withdrawn ...............
Sterilization of Health Care
Products--Chemical
Indicators--Part 1: General
Requirements
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103 ISO 11607-2000, Packaging for Withdrawn ...............
Terminally Sterilized
Medical Devices
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III. Listing of New Entries
The listing of new entries and consensus standards, added as
modifications to the list of recognized standards under Recognition
List Number: 016, follows:
Table 3.
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Item No. Title of Standard Reference No. and Date
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A. Dental/ENT
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136 Standard Practice for Describing System Output ASTM F2504-05
of Implantable Middle Ear Hearing Devices
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B. General Hospital/General Plastic Surgery
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160 Sterile Single-Use Syringes, With or Without ISO 8537: 1991/Amendment 1: 2000
Needle, for Insulin
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161 Sterile, Single-Use Intravascular Catheters-- ISO 10555-1: 1996/Amendment 1: 1999,
Part 1: General Requirements Amendment 2: 2004
----------------------------------------------------------------------------------------------------------------
162 Infusion Equipment for Medical Use--Part 1: ISO 8536-1: 2000/Amendment 1: 2004
Infusion Glass Bottles
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163 Stainless Steel Needle Tubing for the ISO 9626: 1991/Amendment 1: 2001
Manufacture of Medical Devices
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164 Sterile, Single-Use Intravascular Catheters-- ISO 10555-5: 1996/Amendment 1: 1999,
Part 5: Over-Needle Peripheral Catheters Corrigendum 1: 2002
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165 Standard Specification for Polychloroprene ASTM D6977-04
Examination Gloves for Medical Application
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166 Standard Specification for Puncture Resistance ASTM F2132-01
of Materials Used in Containers for Discarded
Medical Needles and Other Sharps
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C. In Vitro Diagnostics
----------------------------------------------------------------------------------------------------------------
124 Fluorescence Calibration and Quantitative CLSI/NCCLS I/LA24-A
Measurement of Fluorescence Intensity; Approved
Guideline
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125 Procedures for the Recovery and Identification CLSI M28-A2, Vol. 25, No. 16
of Parasites from the Intestinal Tract;
Approved Guideline
----------------------------------------------------------------------------------------------------------------
126 Susceptibility Testing of Mycobacteria, CLSI M24-A, Vol. 23, No. 18
Nocardiae, and Other Aerobic Actinomycetes
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D. OB-GYN/Gastroenterology
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[[Page 64724]]
38 Optics and Optical Instruments--Medical ISO 8600-3: 1997/Amendment 1: 2003
Endoscopes and Endoscopic Accessories Part 3:
Determination of Field of View and Direction of
View of Endoscopes with Optics
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39 Optics and Photonics--Medical Endoscopes and ISO 8600-5: 2005
Endotherapy Devices--Part 5: Determination of
Optical Resolution of Rigid Endoscopes with
Optics
----------------------------------------------------------------------------------------------------------------
40 Optics and Photonics--Medical Endoscopes and ISO 8600-6: 2005
Endotherapy Devices--Part 6: Vocabulary
----------------------------------------------------------------------------------------------------------------
E. Radiology
----------------------------------------------------------------------------------------------------------------
145 Medical Electrical Equipment--Dosimeters with IEC 61674 (1997), (2002), Amendment 1
Ionization Chambers and/or Semi-Conductor
Detectors as Used in X-Ray Diagnostic Imaging
----------------------------------------------------------------------------------------------------------------
148 Medical Electrical Equipment--Part 2-37: IEC 60601-2-37 (2005), Amendment 2
Particular Requirements for the Safety of
Ultrasonic Medical Diagnostic and Monitoring
Equipment
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F. Software
----------------------------------------------------------------------------------------------------------------
8 Medical Device Software--Software Life Cycle IEC 62304 ed. 1.0 (2006)
Processes
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G. Sterility
----------------------------------------------------------------------------------------------------------------
193 Packaging for Terminally Sterilized Medical ANSI/AAMI/ISO 11607-1: 2006
Devices--Part 1: Requirements for Materials,
Sterile Barrier Systems, and Packaging Systems,
3d ed.
----------------------------------------------------------------------------------------------------------------
194 Packaging for Terminally Sterilized Medical ANSI/AAMI/ISO 11607-2: 2006
Devices--Part 2: Validation Requirements for
Forming, Sealing, and Assembly Processes, 1st
ed.
----------------------------------------------------------------------------------------------------------------
195 Sterilization of Health Care Products--Chemical ANSI/AAMI/ISO 11140-1: 2005
Indicators--Part 1: General Requirements, 2d
ed.
----------------------------------------------------------------------------------------------------------------
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 Web site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA will incorporate the
modifications and minor revisions described in this notice into the
database and, upon publication in the Federal Register, this
recognition of consensus standards will be effective. FDA will announce
additional modifications and minor revisions to the list of recognized
consensus standards, as needed, in the Federal Register once a year, or
more often, if necessary.
V. Recommendation of Standards for Recognition by FDA
Any person may recommend consensus standards as candidates for
recognition under section 514 of the act by submitting such
recommendations, with reasons for the recommendation, to the contact
person (see FOR FURTHER INFORMATION CONTACT). To be properly considered
such recommendations should contain, at a minimum, the following
information: (1) Title of the standard, (2) any reference number and
date, (3) name and address of the national or international standards
development organization, (4) a proposed list of devices for which a
declaration of conformity to this standard should routinely apply, and
(5) a brief identification of the testing or performance or other
characteristics of the device(s) that would be addressed by a
declaration of conformity.
VI. Electronic Access
You may obtain a copy of ``Guidance on the Recognition and Use of
Consensus Standards'' by using the Internet. CDRH maintains a site on
the Internet for easy access to information 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 ``Modifications to the List of
Recognized Standards, Recognition List Number: 016'' 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.fda.gov/cdrh/fedregin.html.
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. Submit a single copy of electronic comments or two paper
copies of any mailed comments, 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: 016. These modifications to the list of recognized standards
are effective upon publication of this notice in the Federal Register.
[[Page 64725]]
Dated: October 27, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-18604 Filed 11-2-06; 8:45 am]
BILLING CODE 4160-01-S