[Federal Register: October 4, 2004 (Volume 69, Number 191)]
[Notices]
[Page 59240-59250]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04oc04-76]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
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
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
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
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
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
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
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
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
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
< gree Retrieval and Analysis of to
k1 Implanted Medical Devices and materials
Associated Tissues
------------------------------------------------------------------------
[[Page 59244]]
Ortho ASTM 601-03, Standard Practice Transferred 94
< gree for Fluorescent Penetrant to
k3 Inspection of Metallic Surgical materials
Implants
------------------------------------------------------------------------
Ortho ASTM F1147-99, Standard Test Transferred 84
< gree Method for Tension Testing of to
k07 Calcium Phosphate and Metal materials
Coating
------------------------------------------------------------------------
Ortho/ ASTM F1377-98a, Standard Transferred 74
PM Specification for Cobalt-28 to
< gree Chromium-6 Molybdenum Powder for materials
k13 Coating of Orthopedic Implants
Dental (UNS R30075)
< gree
k 22
------------------------------------------------------------------------
Ortho ASTM F86-01, Standard Practice Transferred 93
< gree for Surface Preparation and to
k24 Marking of Metallic Surgical materials
Implants
------------------------------------------------------------------------
Ortho ASTM F1044-99, Standard Test Transferred 83
< gree Method for Shear Testing of to
k31 Calcium Phosphate Coatings and materials
Metallic Coatings
------------------------------------------------------------------------
Ortho ASTM F1160-00e1, Standard Test Transferred 75
< gree Method for Shear and Bending to
k52 Fatigue Testing of Calcium materials
Phosphate and Metallic Medical
and Composite Calcium Phosphate/
Metallic Coatings
------------------------------------------------------------------------
Ortho ASTM F629-02, Standard Practice Transferred 95
< gree for Radiography of Cast Metallic to
k60 Surgical Implants materials
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
G. OB-GYN/Gastroenterology
------------------------------------------------------------------------
16 AAMI/ANSI ID54: 1996 (R)2001, Withdrawn 31
Enteral Feeding Set Adapters and and
Connectors replaced
with newer
version
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
H. Orthopaedic
------------------------------------------------------------------------
58 ASTM F1781-03, Standard Withdrawn 168
Specification for Elastomeric and
Flexible Hinge Finger Total replaced
Joint Implants with newer
version
------------------------------------------------------------------------
91 ASTM F561-97, Practice for Transferred 73
Retrieval and Analysis of to
Implanted Medical Devices and materials
Associated Tissues
------------------------------------------------------------------------
93 ASTM F601-98, Standard Practice Transferred 94
for Fluorescent Penetrant to
Inspection of Metallic Surgical materials
Implants
------------------------------------------------------------------------
107 ASTM F1147-99, Standard Test Transferred 84
Method for Tension Testing of to
Calcium Phosphate and Metal materials
Coatings
------------------------------------------------------------------------
111 ASTM F1814-97a (2003), Standard Withdrawn 171
Guide for Evaluating Modular Hip and
and Knee Joint Components replaced
with newer
version
------------------------------------------------------------------------
113 ASTM F1377-98a, Standard Transferred 74
Specification for Cobalt-28 to
Chromium-6 Molybdenum Powder for materials
Coating of Orthopedic Implants
(UNS R30075)
------------------------------------------------------------------------
114 ASTM F1798-97 (2003), Standard Withdrawn 172
Guide for Evaluating the Static and
and Fatigue Properties of replaced
Interconnection Mechanisms and with newer
Subassemblies Used in Spinal version
Arthrodesis Implants
------------------------------------------------------------------------
115 ASTM F1800-97 (2003), Standard Withdrawn 173
Test Method for Cyclic Fatigue and
Testing of Metal Tibial Tray replaced
Components of Total Knee Joint with newer
Replacements version
------------------------------------------------------------------------
120 ASTM F382-99 (2003), Standard Withdrawn 174
Specification and Test Method and
for Metallic Bone Plates replaced
with newer
version
------------------------------------------------------------------------
124 ASTM F86-01, Standard Practice Transferred 93
for Surface Preparation and to
Marking of Metallic Surgical materials
Implants
------------------------------------------------------------------------
131 ASTM F1044-99, Standard Test Transferred 83
Method for Shear Testing of to
Calcium Phosphate Coatings and materials
Metallic Coatings
------------------------------------------------------------------------
140 ASTM F1582-98 (2003), Standard Withdrawn 175
Terminology Relating to Spinal and
Implants replaced
with newer
version
------------------------------------------------------------------------
145 ASTM F565-00 (2003), Standard Withdrawn 176
Practice for Care and Handling and
of Orthopedic Implants and replaced
Instruments with newer
version
------------------------------------------------------------------------
[[Page 59245]]
152 ASTM F1160-00e1, Standard Test Transferred 75
Method for Shear and Bending to
Fatigue Testing of Calcium materials
Phosphate and Metallic Medical
and Composite Calcium Phosphate/
Metallic Coatings
------------------------------------------------------------------------
160 ASTM F629-02, Standard Practice Transferred 95
for Radiography of Cast Metallic to
Surgical Implants materials
------------------------------------------------------------------------
161 ASTM F1264-03, Standard Withdrawn 177
Specification and Test Methods and
for Intramedullary Fixation replaced
Devices with newer
version
------------------------------------------------------------------------
165 ISO 7206-4: 2002, Implants for Withdrawn ..............
Surgery--Partial and Total Hip
Joint Prostheses--Part 4:
Determination of Endurance
Properties of Stemmed Femoral
Components
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
I. Physical Medicine
------------------------------------------------------------------------
1 ANSI/RESNA WC/volume--1998, Withdrawn 31
Section 1: Determination of and
Static Stability replaced
with newer
version
------------------------------------------------------------------------
2 ANSI/RESNA WC/volume 2--1998, Withdrawn 32
Section 2: Determination of and
Dynamic Stability of Electric replaced
Wheelchairs with newer
version
------------------------------------------------------------------------
3 ANSI/RESNA WC/volume 2--1998, Withdrawn 33
Section 3: Test Methods and and
Requirements for the replaced
Effectiveness of Brakes with newer
version
------------------------------------------------------------------------
4 ANSI/RESNA WC/volume 2--1998, Withdrawn 34
Section 4: Determination of and
Energy Consumption of Electric replaced
Wheelchairs and Scooters-- with newer
Theoretical Range version
------------------------------------------------------------------------
5 ANSI/RESNA WC/volume 1--1998, Withdrawn 35
Section 5: Determination of and
Overall Dimensions, Mass, and replaced
Turning Space with newer
version
------------------------------------------------------------------------
6 ANSI/RESNA WC/volume 2--1998, Withdrawn 36
Section 6: Determination of and
Maximum Speed, Acceleration, and replaced
Retardation of Electric with newer
Wheelchairs version
------------------------------------------------------------------------
7 ANSI/RESNA WC/volume 1--1998, Withdrawn 37
Section 7: Method of Measurement and
of Seating and Wheel Dimensions replaced
with newer
version
------------------------------------------------------------------------
8 ANSI/RESNA WC/volume 1--1998, Withdrawn 38
Section 8: Requirements and Test and
Methods for Static, Impact, and replaced
Fatigue Strengths with newer
version
------------------------------------------------------------------------
9 ANSI/RESNA WC/volume 2--1998, Withdrawn 39
Section 9: Climatic Tests for and
Electric Wheelchairs replaced
with newer
version
------------------------------------------------------------------------
10 ANSI/RESNA WC/volume 2--1998, Withdrawn 40
Section 10: Determination of and
Obstacle-Climbing Ability of replaced
Electric Wheelchairs with newer
version
------------------------------------------------------------------------
11 ANSI/RESNA WC/volume 1--1998, Withdrawn 41
Section 11: Test Dummies and
replaced
with newer
version
------------------------------------------------------------------------
12 ANSI/RESNA WC/volume 1--1998, Withdrawn 42
Section 13: Determination of and
Coefficient of Friction of Test replaced
Surfaces with newer
version
------------------------------------------------------------------------
13 ANSI/RESNA WC/volume 2--1998, Withdrawn 43
Section 14: Power and Control and
Systems for Electric replaced
Wheelchairs--Requirements and with newer
Test Methods version
------------------------------------------------------------------------
14 ANSI/RESNA WC/volume 1--1998, Withdrawn 44
Section 15: Requirements for and
Information Disclosure, replaced
Documentation, and Labeling with newer
version
------------------------------------------------------------------------
15 ANSI/RESNA WC/volume 1--1998, Withdrawn 45
Section 16: Resistance to and
Ignition of Upholstered Parts-- replaced
Requirements and Test Methods with newer
version
------------------------------------------------------------------------
18 ISO 7176-3: 2003, Wheelchairs-- Withdrawn 50
Part 3: Determination of and
Effectiveness of Brakes replaced
with newer
version
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
J. Radiology
------------------------------------------------------------------------
39 IEC 60601-2-17, Medical Withdrawn ..............
Electrical Equipment--Part 2:
Particular Requirements for the
Safety of Remote-Controlled
Automatically-Drive Gamma-Ray
Afterloading Equipment (1989)
Amendment No. 1 to IEC 601-2-17
(1996)
------------------------------------------------------------------------
71 NEMA UD 2-2004, Revision 3: Withdrawn 105
Acoustic Output Measurement and
Standard for Diagnostic replaced
Ultrasound Equipment with newer
version
------------------------------------------------------------------------
[[Page 59246]]
72 NEMA UD 3-2004, Revision 2: Withdrawn 100
Standard for Real Time Display and
of Thermal and Mechanical replaced
Acoustic Output Indices on with newer
Diagnostic Ultrasound Equipment version
------------------------------------------------------------------------
78 NEMA PS 3, Set: Digital Imaging Withdrawn 119
and Communications in Medicine and
(DICOM) Set replaced
with newer
version
------------------------------------------------------------------------
86 IEC 60601-2-33 (2002-05), Medical Withdrawn 104
Electrical Equipment--Part 2-33: and
Particular Requirements for the replaced
Safety of Magnetic Resonance with newer
Equipment for Medical Diagnosis version
------------------------------------------------------------------------
88 IEC 60601-2-17 (2004-01), Medical Withdrawn 118
Electrical Equipment--Part 2-17: and
Particular Requirements for the replaced
Safety of Automatically- with newer
Controlled Brachytherapy version
Afterloading Equipment
------------------------------------------------------------------------
94 IEC 60731 Amendment 1 (2002-06), Withdrawn 98
Medical Electrical Equipment-- and
Dosimeters With Ionization replaced
Chambers as Used in Radiotherapy with newer
version
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
K. Sterility
------------------------------------------------------------------------
16 ANSI/AAMI ST35: 2003, Safe Withdrawn 117
Handling and Biological and
Decontamination of Reusable replaced
Medical Devices in Health Care with newer
Facilities and in Nonclinical version
Settings
------------------------------------------------------------------------
17 ANSI/AAMI ST44: 1992, BIER/EO Gas Withdrawn ..............
Vessels
------------------------------------------------------------------------
18 ANSI/AAMI ST45: 1992, BIER/Steam Withdrawn ..............
Vessels
------------------------------------------------------------------------
20 ANSI/AAMI ST50: 2004, Dry Heat Withdrawn 118
(Heated Air) Sterilizers and
replaced
with newer
version
------------------------------------------------------------------------
21 ANSI/AAMI ST55: 2003, Table-Top Withdrawn 119
Steam Sterilizers and
replaced
with newer
version
------------------------------------------------------------------------
48 ANSI/AAMI ST40: 1992/(R)1998, Change in ..............
Table-Top Dry Heat (Heated Air) relevant
Sterilizers and Sterility guidance
Assurance in Dental and Medical and
Facilities contact
person
------------------------------------------------------------------------
50 ANSI/AAMI ST42: 1998, Steam Contact ..............
Sterilization and Sterility person
Assurance Using Table-Top
Sterilizers in Office-Based,
Ambulatory-Care Medical,
Surgical, and Dental Facilities
------------------------------------------------------------------------
52 ANSI/AAMI ST59: 1999, Change in ..............
Sterilization of Health Care relevant
Products--Biological Indicators-- guidance
Part 1: General Requirements
------------------------------------------------------------------------
53 ANSI/AAMI ST66: 1999, Contact ..............
Sterilization of Health Care person
Products--Chemical Indicators--
Part 2: Class 2 Indicators for
Air Removal Test Sheets and
Packs
------------------------------------------------------------------------
56 ASTM D3078: 2002, Standard Test Withdrawn 120
Method for Determination of and
Leaks in Flexible Packaging by replaced
Bubble Emission with newer
version
------------------------------------------------------------------------
57 ASTM D4169: 2004, Standard Withdrawn 121
Practice for Performance Testing and
of Shipping Containers and replaced
Systems with newer
version
------------------------------------------------------------------------
58 ASTM F88: 2000, Standard Test Withdrawn 122
Method for Seal Strength of and
Flexible Barrier Materials replaced
with newer
version
------------------------------------------------------------------------
63 ASTM F1886: 1998 (2004), Standard Reaffirmati ..............
Test Method for Determining on
Integrity of Seals for Medical
Packaging by Visual Inspection
------------------------------------------------------------------------
64 ASTM F1929: 1998 (2004), Standard Reaffirmati ..............
Test Method for Detecting Seal on
Leaks in Porous Medical
Packaging by Dye Penetration
------------------------------------------------------------------------
72 ANSI/AAMI ST33: 1996, Guidelines Contact ..............
for the Selection and Use of person
Reusable Rigid Sterilization
Container Systems for Ethylene
Oxide Sterilization and Steam
Sterilization in Health Care
Facilities
------------------------------------------------------------------------
74 ANSI/AAMI ST60: 1996, Contact ..............
Sterilization of Health Care person
Products--Chemical Indicators--
Part 1: General Requirements
------------------------------------------------------------------------
75 ANSI/AAMI/ISO 11137: 1994, Change in ..............
Sterilization of Health Care title,
Products--Requirements for relevant
Validation and Routine Control-- guidance,
Radiation Sterilization and ANSI/ and
AAMI/ISO 11137: 1994/Amendment contact
1: 2002 person
------------------------------------------------------------------------
[[Page 59247]]
91 ASTM F2096: 2004, Standard Test Withdrawn 123
Method for Detecting Gross Leaks and
in Porous Medical Packaging by replaced
Internal Pressurization (Bubble with newer
Test) version
------------------------------------------------------------------------
103 AAMI/ANSI/ISO 11607: 2000, Change in ..............
Packaging for Terminally relevant
Sterilized Medical Devices guidance
------------------------------------------------------------------------
105 ANSI/AAMI ST46: 2002, Steam Contact ..............
Sterilization and Sterility person
Assurance in Health Care
Facilities
------------------------------------------------------------------------
106 USP 27: 2004, Biological Withdrawn 124
Indicator for Dry Heat and
Sterilization, Paper Carrier replaced
with newer
version
------------------------------------------------------------------------
107 USP 27: 2004, Biological Withdrawn 125
Indicator for Ethylene Oxide and
Sterilization, Paper Carrier replaced
with newer
version
------------------------------------------------------------------------
108 USP 27: 2004, Biological Withdrawn 126
Indicator for Steam and
Sterilization, Paper Carrier replaced
with newer
version
------------------------------------------------------------------------
109 USP 27: 2004, <61> 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
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/stdsprog.html
.
This Federal Register document on modifications in FDA's
recognition of consensus standards is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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]
BILLING CODE 4160-01-S