[Federal Register Volume 69, Number 191 (Monday, October 4, 2004)]
[Notices]
[Pages 59240-59250]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 04-22183]
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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: 011
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: 011'' (Recognition List Number: 011), 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 on a 3.5''
diskette of ``Modifications to the List of Recognized Standards,
Recognition List Number: 011'' to the Division of Small Manufacturers
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:
standards@cdrh.fda.gov. This document may also be accessed on FDA's
Internet 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: 011 modifications and other standards related
information.
FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices
and Radiological Health (HFZ-84), Food and
[[Page 59241]]
Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 301-594-
4766, ext.156.
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 will implement its standard recognition program and provided
the initial list of FDA recognized consensus standards.
In Federal Register notices published on 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), and June 18, 2004 (69 FR 34176), FDA modified its initial list
of FDA recognized consensus standards. These notices described 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 Recognition List Number: 011
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: 011'' 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 1.
------------------------------------------------------------------------
Old Item Replacement
No. Standard Change Item No.
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
1 ASTM F920-93 (1999), Standard Withdrawn 50
Specification for Minimum and
Performance and Safety replaced
Requirements for Resuscitators with newer
Intended for Use With Humans version
------------------------------------------------------------------------
2 ASTM F1100-90 (1997), Standard Withdrawn 51
Specification for Ventilators and
Intended for Use in Critical replaced
Care with newer
version
------------------------------------------------------------------------
5 ASTM F1463-93 (1999), Standard Withdrawn 52
Specification for Alarm Signals and
in Medical Equipment Used in replaced
Anesthesia and Respiratory Care with newer
version
------------------------------------------------------------------------
6 ASTM F1464-93 (1999), Standard Withdrawn 53
Specification for Oxygen and
Concentrators for Domiciliary replaced
Use with newer
version
------------------------------------------------------------------------
8 PVHO-1-2002, Safety Standard for Withdrawn 54
Pressure Vessels for Human and
Occupancy replaced
with newer
version
------------------------------------------------------------------------
23 ASTM F1054-01, Standard Withdrawn 55
Specification for Conical and
Fittings replaced
with newer
version
------------------------------------------------------------------------
24 ASTM F1456-01, Standard Withdrawn 59
Specification for Minimum and
Performance and Safety replaced
Requirements for Capnometers with newer
version
------------------------------------------------------------------------
25 ASTM F1462-93, Specification for Withdrawn ..............
Oxygen Analyzers
------------------------------------------------------------------------
34 ASTM PS127: 2000, Standard Test Withdrawn ..............
Method for Evaluating the
Ignition Sensitivity and Fault
Tolerance of Oxygen Regulators
Used for Medical and Emergency
Applications
------------------------------------------------------------------------
40 CGA V-7.1: 1997 (reaffirmed Withdrawn 56
2003), Standard Method for and
Determining Cylinder Valve replaced
Outlet Connections for Medical with newer
Gases version
------------------------------------------------------------------------
45 ASTM 1101-90 (2003) e1, Standard Withdrawn 57
Specification for Ventilators and
Intended for Use During replaced
Anesthesia with newer
version
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B. Cardiovascular/Neurology
------------------------------------------------------------------------
[[Page 59242]]
1 ANSI/AAMI EC12: 2000, Disposable Withdrawn 52
Electrocardiogram (ECG) and
Electrodes replaced
with newer
version
------------------------------------------------------------------------
4 AAMI SP10: 1992, Electronic or Change in ..............
Automated Sphygmomanometers processes
affected
and
contact
person
------------------------------------------------------------------------
44 ANSI/AAMI BP22: 1994 (R2001), Change in ..............
Blood Pressure Transducers processes
affected
and
contact
person
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C. Dental/Ear, Nose, and Throat
------------------------------------------------------------------------
22 ASTM/F1377-92, Standard Transfer to ..............
Specification for Cobalt- materials
Chromium-Molybdenum Powder for
Coating of Orthopaedic Implants
------------------------------------------------------------------------
42 ANSI/ADA Specification No. 3: Withdrawn ..............
1994, Dental Impression Compound
------------------------------------------------------------------------
43 ANSI/ADA Specification No. 5: Change date ..............
1997, Dental Casting Alloys of
standard
------------------------------------------------------------------------
44 ANSI/ADA Specification No. 11: Withdrawn 110
1997, Agar Impression Material and
replaced
with newer
version
------------------------------------------------------------------------
45 ANSI/ADA Specification No. 13: Withdrawn 111
1999, Dental Cold-Curing Repair and
Resin replaced
with newer
version
------------------------------------------------------------------------
48 ANSI/ADA Specification No. 16: Withdrawn 112
1999, Dental Impression Paste and
Zinc Oxide-Eugenol Materials replaced
with newer
version
------------------------------------------------------------------------
51 ANSI/ADA Specification No. 20: Withdrawn 113
1995, Dental Duplicating and
Material replaced
with newer
version
------------------------------------------------------------------------
55 ANSI/ADA Specification No. 48: Withdrawn 114
1989, Ultraviolet Activator and and
Disclosing Lights replaced
with newer
version
------------------------------------------------------------------------
67 ISO 6871-1: 1994, Dental Base Title ..............
Metal Casting Alloys--Part 1: correction
Cobalt-Based Alloys--Technical
Corrigendum 1: 1998
------------------------------------------------------------------------
80 ISO 9917-1: 2003, Dental Water Withdrawn 115
Based Cements--Part 1: Powder/ and
Liquid Acid-Base Cements--first replaced
edition with newer
version
------------------------------------------------------------------------
81 ISO 10139-1: 1999, Dentistry-- Withdrawn 116
Resilient Lining Materials for and
Removable Dentures--Part 1: replaced
Short-Term Materials with newer
version
------------------------------------------------------------------------
90 ANSI/ASA S3.39: 1987 (R2002), Change date ..............
Specification for Instruments to of
Measure Aural Acoustic Impedance standard
and Admittance (Aural Acoustic
Immittance)
------------------------------------------------------------------------
103 ANSI/ADA Specification No. 12: Withdrawn 117
2002, Denture Base Polymers and
replaced
with newer
version
------------------------------------------------------------------------
105 ANSI/ADA Specification No. 75: Title ..............
1997 (R2003), Resilient Lining correction
Materials for Removable
Dentures--Part 1: Short-Term
Materials
------------------------------------------------------------------------
106 ANSI/ADA Specification No. 82: Withdrawn 119
2003, Dental Reversible/ and
Irreversible Hydrocolloid replaced
Impression Material System with newer
version
------------------------------------------------------------------------
108 ISO 10139-2: 1999, Dentistry-- Withdrawn 120
Soft Lining Materials for and
Removable Dentures--Part 2: replaced
Materials for Long-Term Use with newer
version
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D. General
------------------------------------------------------------------------
10 AAMI/ISO 14971-1, Medical Withdrawn ..............
Devices--Risk Management--Part
1: Application of Risk Analysis
------------------------------------------------------------------------
21 CEN EN 1441: 1997, Medical Withdrawn ..............
Devices--Risk Management
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E. In Vitro Diagnostic
------------------------------------------------------------------------
23 NCCLS H1-A5, Tubes and Additives Withdrawn 102
for Venous Blood Specimen and
Collection; Approved Standard replaced
with newer
version
------------------------------------------------------------------------
[[Page 59243]]
69 NCCLS H3-A5, Procedures for the Withdrawn 103
Collection of Diagnostic Blood and
Specimens by Venipuncture; replaced
Approved Standard with newer
version
------------------------------------------------------------------------
24 NCCLS H7-A3, Procedure for Withdrawn 104
Determining Packed Cell Volume and
by the Microhematocrit Method; replaced
Approved Standard--third edition with newer
version
------------------------------------------------------------------------
33 NCCLS H30-A2, Procedure for the Withdrawn 105
Determination of Fibrinogen in and
Plasma; Approved Guideline-- replaced
second edition with newer
version
------------------------------------------------------------------------
57 NCCLS M2-A8, Performance Withdrawn 106
Standards for Antimicrobial Disk and
Susceptibility Tests; Approved replaced
Standard--eighth edition with newer
version
------------------------------------------------------------------------
75 NCCLS M11-A6, Methods for Withdrawn 107
Dilution Antimicrobial and
Susceptibility Tests for replaced
Bacteria That Grow Aerobically, with newer
Approved Standard--sixth edition version
------------------------------------------------------------------------
56 NCCLS M7-A6, Methods for Withdrawn 108
Antimicrobial Susceptibility and
Testing of Anaerobic Bacteria; replaced
Approved Standard--sixth edition with newer
version
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F. Materials
------------------------------------------------------------------------
5 ASTM F138-03, Standard Withdrawn 76
Specification for Wrought 18 and
Chromium-14 Nickel-2.5 replaced
Molybdenum Stainless Steel Bar with newer
and Wire for Surgical Implants version
(UNS S31673)
------------------------------------------------------------------------
6 ASTM F139-03, Standard Withdrawn 77
Specification for Wrought 18 and
Chromium-14 Nickel-2.5 replaced
Molybdenum Stainless Steel Sheet with newer
and Strip for Surgical Implants version
(UNS S31673)
------------------------------------------------------------------------
7 ASTM F560-04, Standard Withdrawn 78
Specification for Unalloyed and
Tantalum for Surgical Implant replaced
Applications (UNS R05200, UNS with newer
R05400) version
------------------------------------------------------------------------
13 ASTM F648-00e1, Standard Change date ..............
Specification for Ultra-High- of
Molecular-Weight Polyethylene standard
Powder and Fabricated Form for
Surgical Implants
------------------------------------------------------------------------
16 ASTM F746-87 (1999), Standard Change in ..............
Test Method for Pitting or processes
Crevice Corrosion of Metallic affected
Surgical Implant Materials
------------------------------------------------------------------------
19 ASTM F961-03, Standard Withdrawn 79
Specification for Cobalt-35 and
Nickel-20 Chromium-10 Molybdenum replaced
Alloy Forgings for Surgical with newer
Implants (UNS R30035) version
------------------------------------------------------------------------
21 ASTM F1088-04, Standard Withdrawn 80
Specification for Beta- and
Tricalcium Phosphate for replaced
Surgical Implantation with newer
version
------------------------------------------------------------------------
33 ASTM F1609-03, Standard Withdrawn 81
Specification for Calcium and
Phosphate for Coatings for replaced
Implantable Materials with newer
version
------------------------------------------------------------------------
34 ASTM F1659-95, Standard Test Change in ..............
Method for Bending and Shear processes
Fatigue Testing of Calcium affected
Phosphate Coatings on Solid
Metallic Substrates
------------------------------------------------------------------------
35 ASTM F1713-03, Standard Withdrawn 82
Specification for Wrought and
Titanium-13 Niobium-13 Zirconium replaced
Alloy for Surgical Implant with newer
Applications version
------------------------------------------------------------------------
40 ASTM F2063-00, Standard Change in ..............
Specification for Wrought Nickel- extent of
Titanium Shape Memory Alloys for recognitio
Medical Devices and Surgical n, contact
Implants person,
and
processes
affected
------------------------------------------------------------------------
42 ASTM F2119-01, Standard Test Change in ..............
Method for Evaluation of MR processes
Image Artifacts From Passive affected
Implants
------------------------------------------------------------------------
48 ASTM F899-02, Standard Change in ..............
Specification for Stainless processes
Steel for Surgical Instruments affected
------------------------------------------------------------------------
70 ASTM F2052-02, Standard Test Withdrawn ..............
Method for Measurement of
Magnetically Induced
Displacement Force on Medical
Devices in the Magnetic
Resonance Environment
------------------------------------------------------------------------
72 ASTM F2213-04, Standard Test Change in ..............
Method for Measurement of processes
Magnetically Induced Torque on affected
Medical Devices in the Magnetic
Resonance Environment
------------------------------------------------------------------------
Ortho ASTM F561-97 (2003), Practice for Transferred 73
Microbial Withdrawn 127
Limits Test and
replaced
with newer
version
------------------------------------------------------------------------
110 USP 27: 2004, <71> Withdrawn 128
Microbiological Tests, Sterility and
Tests replaced
with newer
version
------------------------------------------------------------------------
111 USP 27: 2004, <85> Biological Withdrawn 129
Tests and Assays, Bacterial and
Endotoxin Test (LAL) replaced
with newer
version
------------------------------------------------------------------------
112 USP 27: 2004, <151> Pyrogen Test Withdrawn 130
(USP Rabbit Test) and
replaced
with newer
version
------------------------------------------------------------------------
113 USP 27: 2004, <1211> Withdrawn 131
Sterilization and Sterility and
Assurance of Compendial Articles replaced
with newer
version
------------------------------------------------------------------------
114 USP 27: 2004, <161> Transfusion Withdrawn 132
and Infusion Assemblies and and
Similar Medical Devices replaced
with newer
version
------------------------------------------------------------------------
115 USP 27: 2004, Biological Withdrawn 133
Indicator for Steam and
Sterilization--Self-Contained replaced
with newer
version
------------------------------------------------------------------------
116 ANSI/AAMI ST72: 2002, Bacterial Change in ..............
Endotoxins--Test Methodologies, relevant
Routine Monitoring, and guidance
Alternatives to Batch Testing
------------------------------------------------------------------------
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: 011, follows:
Table 2.
------------------------------------------------------------------------
Reference No.
Item No. Title of Standard and Date
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
58 Standard Test Method for Evaluating the ASTM G175-03
Ignition Sensitivity and Fault Tolerance
of Oxygen Regulators Used for Medical
and Emergency Applications
������������������������������������������������������������������������
B. Dental/ENT
------------------------------------------------------------------------
121 Dentistry--Dental Units--Part 2: Water ISO 7494-2:
and Air Supply 2003
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C. General Hospital/General Plastic Surgery
------------------------------------------------------------------------
112 Liquid Barrier Performance and ANSI/AAMI PB70:
Classification of Protective Apparel and 2003
Drapes Intended for Use in Health Care
Facilitates
------------------------------------------------------------------------
113 Standard Specification for Performance of ASTM F2100-04
Materials Used in Medical Face Masks
������������������������������������������������������������������������
D. Materials
------------------------------------------------------------------------
[[Page 59248]]
85 Standard Test Method for Stereological ASTM F1854-01
Evaluation of Porous Coatings on Medical
Implants
------------------------------------------------------------------------
86 Standard Test Method for Evaluation of ASTM F1926-03
the Environmental Stability of Calcium
Phosphate Coatings
------------------------------------------------------------------------
87 Standard Test Method for Measuring ASTM F1978-00e1
Abrasion Resistance of Metallic Thermal
Spray Coatings by Using the TaberT
Abraser
------------------------------------------------------------------------
88 Standard Practice for X-Ray Diffraction ASTM F2024-00
Determination of Phase Content of Plasma-
Sprayed Hydroxyapatite Coatings
------------------------------------------------------------------------
89 Standard Specification for High-Purity ASTM F1873-98
Dense Yttria Tetragonal Zirconium Oxide
Polycrystal (Y-TZP) for Surgical Implant
Applications
------------------------------------------------------------------------
90 Standard Test Method for Strength ASTM F2255-03
Properties of Tissue Adhesives in Lap
Shear by Tension Loading
------------------------------------------------------------------------
91 Standard Test Method for Strength ASTM F2256-03
Properties of Tissue Adhesives in T-Peel
by Tension Loading
------------------------------------------------------------------------
92 Standard Test Method for Strength ASTM F2258-03
Properties of Tissue Adhesives in
Tension
------------------------------------------------------------------------
96 Standard Test Method for In Vitro ASTM 1635-95
Degradation Testing of Poly (L-lactic (2000)
Acid) Resin and Fabricated Form for
Surgical Implants
------------------------------------------------------------------------
97 Standard Test Method for Conducting ASTM F2129-04
Cyclic Potentiodynamic Polarization
Measurements to Determine the Corrosion
Susceptibility of Small Implant Devices
------------------------------------------------------------------------
98 Standard Specification for Acrylic Bone ASTM F451-99ae1
Cement
------------------------------------------------------------------------
99 Standard Test Method for Transformation ASTM F2004-03
Temperature of Nickel-Titanium Alloys by
Thermal Analysis
------------------------------------------------------------------------
100 Standard Terminology for Nickel-Titanium ASTM F2005-00
Shape Memory Alloys
------------------------------------------------------------------------
101 Test Method for Constant Amplitude of ASTM F2118-03
Force Controlled Fatigue Testing of
Acrylic Bone Cement Materials
------------------------------------------------------------------------
102 Standard Test Method for Determination of ASTM F2082-03
Transformation Temperature of Nickel-
Titanium Shape Memory Alloys by Bend and
Free Recovery
������������������������������������������������������������������������
E. OB-GYN/Gastroenterology
------------------------------------------------------------------------
30 Water Treatment Equipment for ANSI/AAMI RD62:
Hemodialysis Applications 2001
������������������������������������������������������������������������
F. Ophthalmic
------------------------------------------------------------------------
33 Contact Lens Care Products--Vocabulary, ANSI Z80.18
Performance Specifications, and Test
Methodology
������������������������������������������������������������������������
G. Orthopaedic
------------------------------------------------------------------------
178 Standard Practice for Cyclic Fatigue ASTM F1440-92
Testing of Metallic Stemmed Hip (2002)
Arthroplasty Femoral Components Without
Torsion
------------------------------------------------------------------------
179 Standard Specification for Femoral ASTM F2068-03
Prostheses--Metallic Implants
������������������������������������������������������������������������
H. Physical Medicine
------------------------------------------------------------------------
46 Determination of Performance of Stand-Up ANSI/RESNA WC/
Type Wheelchairs volume 1--
1998, section
20
------------------------------------------------------------------------
47 Set Up Procedures ANSI/RESNA WC/
volume 1--
1998, section
22
------------------------------------------------------------------------
48 Maximum Overall Dimensions ANSI/RESNA WC/
volume 1--
1998, section
93
------------------------------------------------------------------------
49 Nomenclature, Terms, and Definitions ANSI/RESNA WC/
volume 1--
1998, section
0
������������������������������������������������������������������������
I. Radiology
------------------------------------------------------------------------
[[Page 59249]]
101 Recommended Practice for Photobiological ANSI/ESNA RP-
Safety for Lamps and Lamp Systems-- 27.1.96
General Requirements
------------------------------------------------------------------------
102 Recommended Practice for Photobiological ANSI/ESNA RP-
Safety for Lamps and Lamp Systems-- 27.2.00
Measurement Techniques
------------------------------------------------------------------------
103 Recommended Practice for Photobiological ANSI/ESNA RP-
Safety for Lamps and Lamp Systems--Risk 27.3.96
Group Classification and Labeling
------------------------------------------------------------------------
106 Optics and Optical Instruments--Lasers ISO 17526: 2003
and Laser-Related Equipment--Lifetime of
Lasers
------------------------------------------------------------------------
107 Lasers and Laser-Related Equipment--Test ISO 11146: 1999
Methods for Laser Beam Parameters--Beam
Widths, Divergence Angle, and Beam
Propagation Factor
------------------------------------------------------------------------
108 Lasers and Laser-Related Equipment-- ISO 11254-1:
Determination of Laser-Induced Damage 2000
Threshold of Optical Surfaces--Part 1: 1-
on-1 Test
------------------------------------------------------------------------
109 Lasers and Laser-Related Equipment-- ISO 11254-2:
Determination of Laser-Induced Damage 2001
Threshold of Optical Surfaces--Part 2: S-
on-1 Test
------------------------------------------------------------------------
110 Optics and Optical Instruments--Lasers ISO 11551: 2003
and Laser-Related Equipment--Test Method
for Absorptance of Optical Laser
Components (revision of ISO 11551: 1997)
------------------------------------------------------------------------
111 Optics and Optical Instruments--Lasers ISO 11554: 2003
and Laser-Related Equipment--Test
Methods for Laser Beam Power, Energy,
and Temporal Characteristics (revision
of ISO 11554: 1998)
------------------------------------------------------------------------
112 Lasers and Laser-Related Equipment--Test ISO 11670: 2003
Methods for Laser Beam Parameters--Beam
Positional Stability (revision of ISO
11670: 1999)
------------------------------------------------------------------------
113 Lasers and Laser-Related Equipment--Test ISO 12005: 2003
Methods for Laser Beam Parameters--
Polarization (revision of ISO 12005:
1999)
------------------------------------------------------------------------
114 Optics and Optical Instruments--Lasers ISO 13694: 2000
and Laser-Related Equipment--Test
Methods for Laser Beam Power (Energy)
Density Distribution
------------------------------------------------------------------------
115 Optics and Photonics--Lasers and Laser- ISO 13695: 2004
Related Equipment--Test Methods for the
Spectral Characteristics of Lasers
------------------------------------------------------------------------
116 Optics and Optical Instruments--Test ISO 13696: 2002
Methods for Radiation Scattered by
Optical Components
------------------------------------------------------------------------
117 Lasers and Laser-Related Equipment--Test ISO 15367-1:
Methods for Determination of the Shape 2003
of a Laser Beam Wavefront--Part 1:
Terminology and Fundamental Aspects
------------------------------------------------------------------------
120 Particular Requirements for the Safety of IEC 60601-2-44
X-Ray Equipment for Computed Tomography (ed. 2.1)
������������������������������������������������������������������������
J. Sterility
------------------------------------------------------------------------
134 Resistometers Used for Characterizing the ANSI/AAMI ST44:
Performance of Biological and Chemical 2002
Indicators
------------------------------------------------------------------------
135 Sterilization of Health Care Products-- ANSI/AAMI ST63:
Requirements for the Development, 2002
Validation, and Routine Control of an
Industrial Sterilization Process for
Medical Devices--Dry Heat
------------------------------------------------------------------------
136 Sterilization of Health Care Products-- ANSI/AAMI ST67:
Requirements for Products Labeled 2003
``Sterile''
------------------------------------------------------------------------
137 Sterilization of Health Care Products-- ANSI/AAMI/ISO
Vocabulary TIR 11139:
2002
------------------------------------------------------------------------
138 Aseptic Processing of Health Care ISO 13408-2:
Products--Part 2: Filtration 2003
------------------------------------------------------------------------
139 Cleanrooms and Associated Controlled ISO 14644-1:
Environments--Part 1: Classification of 1999
Air Cleanliness
------------------------------------------------------------------------
140 Cleanrooms and Associated Controlled ISO 14644-2:
Environments--Part 2: Specifications for 2000
Testing and Monitoring to Prove
Continued Compliance With ISO 14644-1
------------------------------------------------------------------------
141 Cleanrooms and Associated Controlled ISO 14644-4:
Environments--Part 4: Design, 2001
Construction, and Start-Up
------------------------------------------------------------------------
142 Cleanrooms and Associated Controlled ISO 14698-1:
Environments--Biocontamination Control-- 2003
Part 1: General Principles and Methods
------------------------------------------------------------------------
143 Cleanrooms and Associated Controlled ISO 14698-2:
Environments--Biocontamination Control-- 2003
Part 2: Evaluation and Interpretation of
Biocontamination Data
������������������������������������������������������������������������
[[Page 59250]]
K. Tissue Engineering
------------------------------------------------------------------------
5 Standard Guide for Characterization and ASTM F2347-2003
Testing of Hyaluronan as Starting
Material Intended for Use in Biomedical
and Tissue Engineered Medical Product
Applications
------------------------------------------------------------------------
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 document into the database and, upon publication in
the Federal Register, this recognition of consensus standards will be
effective. FDA will announce additional modifications and minor
revisions to the list of recognized consensus standards, as needed, in
the Federal Register once a year, or more often, if necessary.
V. Recommendation of Standards for Recognition by FDA
Any person may recommend consensus standards as candidates for
recognition under the new provision of section 514 of the act by
submitting such recommendations, with reasons for the recommendation,
to the contact person (see FOR FURTHER INFORMATION CONTACT). To be
properly considered, such recommendations should contain, at a minimum,
the following information: (1) Title of the standard, (2) any reference
number and date, (3) name and address of the national or international
standards development organization, (4) a proposed list of devices for
which a declaration of conformity to this standard should routinely
apply, and (5) a brief identification of the testing or performance or
other characteristics of the device(s) that would be addressed by a
declaration of conformity.
VI. Electronic Access
In order to receive ``Guidance on the Recognition and Use of
Consensus Standards'' via your fax machine, call the Center for Devices
and Radiological Health (CDRH) Facts-On-Demand system at 800-899-0381
or 301-827-0111 from a touch-tone telephone. Press 1 to enter the
system. At the second voice prompt press 1 to order a document. Enter
the document number 321 followed by the pound sign. Follow the
remaining voice prompts to complete your request.
You may also 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 document announcing ``Modifications to the
List of Recognized Standards, Recognition List Number: 011,'' 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. 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: 011. These modifications
to the list or recognized standards are effective upon publication of
this document in the Federal Register.
Dated: September 21, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-22183 Filed 10-1-04; 8:45 am]
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