[Federal Register Volume 69, Number 45 (Monday, March 8, 2004)]
[Notices]
[Pages 10712-10725]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E4-479]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 1997D-0530]
Food and Drug Adminstration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 009
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 of the List of Recognized Standards, Recognition List
Number: 009'' (Recognition List Number: 009), 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 ``Modification to the List of Recognized Standards,
Recognition List Number: 009'' 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 to recommend additional standards
for recognition to the contact person (see FOR FURTHER INFORMATION
CONTACT). Submit electronic comments by e-mail: [email protected].
This document may also be accessed on FDA's Internet site at http://www.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: 009 modifications and other standards related information.
FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices
and Radiological Health (CDRH) (HFZ-84), Food and Drug Administration,
2094 Gaither Rd., Rockville, MD 20850, 301-594-4766, ext.156.
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 guidance entitled
``Recognition and Use of Consensus Standards.'' This notice described
how FDA will implement its standard recognition program and provided
the initial list of recognized 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), and April 28, 2003 (68 FR 22391), FDA modified its
initial list of recognized 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 the List of Recognized Standards, Recognition List
Number: 009
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
[[Page 10713]]
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: 009'' to identify these current
modifications.
In the following table, FDA describes modifications that involve:
(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.
A. Biocompatibility
------------------------------------------------------------------------
Old Item Replacement
No. Standard Change Item No.
------------------------------------------------------------------------
36 ASTM F1408-02e1, Withdrawn and 71
Standard Practice for replaced with
Subcutaneous Screening newer version.
Test for Implant
Materials
------------------------------------------------------------------------
16 ASTM F1439-02, Standard Withdrawn and 72
Guide for Performance replaced with
of Lifetime Bioassay newer version.
for the Tumorigenic
Potential of Implant
Materials
------------------------------------------------------------------------
65 ASTM F2065-00e1, Withdrawn and 73
Standard Practice for replaced with
Testing for Alternative newer version.
Pathway Complement
Activation in Serum by
Solid Materials
------------------------------------------------------------------------
58 USP 26-NF 21 <87, Biological replaced with
Reactivity Test, In newer version.
Vitro--Direct Contact
Test
------------------------------------------------------------------------
59 USP 26-NF 21 <87, Biological replaced with
Reactivity Test, In newer version.
Vitro--Elution Test
------------------------------------------------------------------------
60 USP 26-NF 21<88, Biological replaced with
Reactivity Tests, In newer version.
Vivo--Procedure--Prepar
ation of Sample
------------------------------------------------------------------------
61 USP 26-NF 21<88, Biological replaced with
Reactivity Test, In newer version.
Vivo--Intracutaneous
Test
------------------------------------------------------------------------
62 USP 26-NF 21<88, Biological replaced with
Reactivity Tests, In newer version
Vivo--Systemic
Injection Test
------------------------------------------------------------------------
B. Dental/ENT
------------------------------------------------------------------------
Old Item Replacement
No. Standard Change Item No.
------------------------------------------------------------------------
46 ANSI/ADA Specification Withdrawn and 94
No. 14:1998, Dental replaced with
Base Metal Casting newer version;
Alloys Contact person
------------------------------------------------------------------------
49 ANSI/ADA Specification Withdrawn and 95
No. 17:1999, Denture replaced with
Base Temporary Relining newer version.
Resin
------------------------------------------------------------------------
53 ANSI/ADA Specification Withdrawn and 96
No. 30:2002, Dental replaced with
Zinc Oxide-Eugenol and newer version.
Zinc Oxide Non-Eugenol
Cements
------------------------------------------------------------------------
56 ANSI/ADA Specification Withdrawn and 97
No. 57:2000, Endodontic replaced with
Sealing Materials newer version.
------------------------------------------------------------------------
60 ANSI/ADA Specification Withdrawn and 98
No. 96:2000, Dental replaced with
Water-Based Cements newer version.
------------------------------------------------------------------------
66 ISO 4049:2000, Withdrawn and 99
Dentistry--Polymer- replaced with
Based Filling, newer version.
Restorative and Luting
Materials
------------------------------------------------------------------------
71 ISO 6876:2001, Dental Withdrawn and 100
Root Canal Sealing replaced with
Materials newer version.
------------------------------------------------------------------------
77 ISO 8891:1998, Dental Withdrawn and 101
Casting Alloys with replaced with
Noble Metal Content of newer version;
At Least 25% but less Contact person
than 75%
------------------------------------------------------------------------
79 ISO 9693, Metal-Ceramic Withdrawn and 102
Dental Restorative replaced with
Systems newer version;
Contact person
------------------------------------------------------------------------
C. General Hospital/General Plastic Surgery
[[Page 10714]]
------------------------------------------------------------------------
Old Item Replacement
No. Standard Change Item No.
------------------------------------------------------------------------
82 USP 26, Nonabsorbable Withdrawn and 97
Surgical Sutures replaced with
newer version
------------------------------------------------------------------------
88 USP 26 <11, Withdrawn and 98
Sterile Sodium Chloride replaced with
for Irrigation newer version
------------------------------------------------------------------------
89 USP 26, Absorbable Withdrawn and 99
Surgical Sutures replaced with
newer version
------------------------------------------------------------------------
90 USP 26 <881, Withdrawn and 100
Tensile Strength replaced with
newer version
------------------------------------------------------------------------
91 USP 26 <861, Withdrawn and 101
Sutures--Diameter replaced with
newer version
------------------------------------------------------------------------
92 USP 26<871, Withdrawn and 102
Sutures Needle replaced with
Attachment newer version
------------------------------------------------------------------------
93 USP 26, Sterile Water Withdrawn and 103
for Irrigation replaced with
newer version
------------------------------------------------------------------------
94 USP 26, Heparin Lock Withdrawn and 104
Flush Solution replaced with
newer version
------------------------------------------------------------------------
95 USP 26, Sodium Chloride Withdrawn and 105
Injection replaced with
newer version
------------------------------------------------------------------------
33 ASTM D3772-01, Standard Withdrawn and 106
Specification for replaced with
Rubber Finger Cots newer version
------------------------------------------------------------------------
5 ASTM F882-84 (2002), Withdrawn and 107
Standard Performance replaced with
and Safety newer version
Specification for
Cryosurgical Medical
Instrumentation
------------------------------------------------------------------------
D. In Vitro Diagnostic
------------------------------------------------------------------------
Old Item Replacement
No. Standard Change Item No.
------------------------------------------------------------------------
14 NCCLS C24-A2 Statistical Withdrawn and 85
Quality Control for replaced with
Quantitative newer version
Measurements:
Principles and
Definitions: Approved
Guideline--Second
Edition
------------------------------------------------------------------------
17 NCCLS C29-A2 Withdrawn and 86
Standardization of replaced with
Sodium and Potassium newer version
Ion Selective Electrode
Systems to the Flame
Photometric Reference
Method; Approved
Standard--Second
Edition
------------------------------------------------------------------------
19 NCCLS C31-A2 Ionized Withdrawn and 87
Calcium Determinations: replaced with
Precollection newer version
Variables, Specimen
Choice, Collection and
Handling: Approved
Guideline--Second
Edition
------------------------------------------------------------------------
2 NCCLS EP09-A2 Method Withdrawn and 92
Comparison and Bias replaced with
Estimation Using newer version
Patient Samples;
Approved Guideline--
Second Edition
------------------------------------------------------------------------
66 NCCLS EP10-A2 Withdrawn and 93
Preliminary Evaluation replaced with
of Quantitative newer version
Clinical Laboratory
Methods; Approved
Guideline--Second
Edition
------------------------------------------------------------------------
E. Materials
------------------------------------------------------------------------
Old Item Replacement
No. Standard Change Item No.
------------------------------------------------------------------------
1 ASTM F67-00, Standard Update 1
Specification for ``Process(es)
Unalloyed Titanium for Impacted'' to
Surgical Implant include Design
Applications (UNS Controls.
R50250, UNS R50550, UNS
R50700)
------------------------------------------------------------------------
[[Page 10715]]
2 ASTM F75-01, Standard Update 2
Specification for ``Process(es)
Cobalt-28 Chromium-6 Impacted'' to
Molybdenum Alloy include Design
Castings and Casting Controls.
Alloy for Surgical
Implants (UNS R30075)
------------------------------------------------------------------------
3 ASTM F90-01, Standard Update 3
Specification for ``Process(es)
Wrought Cobalt-20 Impacted'' to
Chromium-15 Tungsten-10 include Design
Nickel Alloy for Controls.
Surgical Implant
Applications (UNS
R30605)
------------------------------------------------------------------------
5 ASTM F138-00, Standard Update 5
Specification for ``Process(es)
Wrought 18 Chromium-14 Impacted'' to
Nickel-2.5 Molybdenum include Design
Stainless Steel Bar and Controls.
Wire for Surgical
Implants (UNS S31673)
------------------------------------------------------------------------
6 ASTM F139-00, Standard Update 6
Specification for ``Process(es)
Wrought 18 Chromium-14 Impacted'' to
Nickel-2.5 Molybdenum include Design
Stainless Steel Sheet Controls.
and Strip for Surgical
Implants (UNS S31673)
------------------------------------------------------------------------
7 ASTM F560-98, Standard Update 7
Specification for ``Process(es)
Unalloyed Tantalum for Impacted'' to
Surgical Implant include Design
Applications (UNS Controls.
R05200, UNS R05400)
------------------------------------------------------------------------
9 ASTM F563-00, Standard Update 9
Specification for ``Process(es)
Wrought Cobalt-20 Impacted'' to
Nickel-20 Chromium-3.5 include Design
Molybdenum-3.5 Tungsten- Controls.
5 Iron Alloy for
Surgical Implant
Applications (UNS
R30563)
------------------------------------------------------------------------
10 ASTM 603-00, Standard Update 10
Specification for High- ``Process(es)
Purity Dense Aluminum Impacted'' to
Oxide for Surgical include Design
Implant Application Controls.
------------------------------------------------------------------------
11 ASTM 620-00, Standard Update 11
Specification for ``Process(es )
Titanium-6 Aluminum-4 Impacted'' to
Vanadium ELI Alloy include Design
Forgings for Surgical Controls.
Implants (UNS R56401)
------------------------------------------------------------------------
13 ASTM F648-00, Standard Update 13
Specification for Ultra- ``Process(es)
High-Molecular-Weight Impacted'' to
Polyethylene Powder and include Design
Fabricated Form for Controls.
Surgical Implants
------------------------------------------------------------------------
14 ASTM 688-00, Standard Update 14
Specification for ``Process(es)
Wrought Cobalt-35 Impacted'' to
Nickel-20 Chromium-10 include Design
Molybdenum Alloy Plate, Controls.
Sheet, and Foil for
Surgical Implants
------------------------------------------------------------------------
15 ASTM F745-00, Standard Update 15
Specification for 18 ``Process(es)
Chromium-12.5 Impacted'' to
Molybdenum Stainless include Design
Steel for Cast and Controls.
Solution-Annealed
Surgical Implant
Applications
------------------------------------------------------------------------
16 ASTM F746-87 (1999), Update 16
Standard Test Method ``Process(es)
for Pitting or Crevice Impacted'' to
Corrosion of Metallic include Design
Surgical Implant Controls.
Materials
------------------------------------------------------------------------
19 ASTM F961-96, Standard Update 19
Specification for ``Process(es)
Cobalt-35 Nickel-20 Impacted'' to
Chromium-10 Molybdenum include Design
Alloy Forgings for Controls.
Surgical Implants (UNS
R30035)
------------------------------------------------------------------------
21 ASTM F1088-87(1992)e1, Update 21
Standard Specification ``Process(es)
for Beta-Tricalcium Impacted'' to
Phosphate for Surgical include Design
Implantation Controls.
------------------------------------------------------------------------
25 ASTM F1295-01, Standard Update 25
Specification for ``Process(es)
Wrought Titanium-6 Impacted'' to
Aluminum-7 Niobium include Design
Alloy for Surgical Controls.
Implant Applications
------------------------------------------------------------------------
26 ASTM F1314-01, Standard Update 26
Specification for ``Process(es)
Wrought Nitrogen Impacted'' to
Strengthened-22 include Design
Chromium-12.5 Nickel-5 Controls.
Manganese-2.5
Molybdenum Stainless
Steel Bar and Wire for
Surgical Implants
------------------------------------------------------------------------
27 ASTM F1341-99, Standard Update 27
Specification for ``Process(es)
Unalloyed Titanium Wire Impacted'' to
for Surgical Implant include Design
Applications Controls.
------------------------------------------------------------------------
30 ASTM F1537-00, Standard Update 30
Specification for ``Process(es)
Wrought Cobalt-28- Impacted'' to
Chromium-6-Molybdenum include Design
Alloy for Surgical Controls.
Implants
------------------------------------------------------------------------
[[Page 10716]]
32 ASTM F1586-02, Standard Update 32
Specification for ``Process(es)
Wrought Nitrogen Impacted'' to
Strengthened-21 include Design
Chromium-10 Nickel-3 Controls.
Manganese-2.5
Molybdenum Stainless
Steel Bar for Surgical
Implants
------------------------------------------------------------------------
33 ASTM F1609-95, Standard Update 33
Specification for ``Process(es)
Calcium Phosphate Impacted'' to
Coatings for include Design
Implantable Materials Controls.
------------------------------------------------------------------------
34 ASTM F1659-95, Standard Update 34
Test Method for Bending ``Process(es)
and Shear Testing of Impacted'' to
Calcium Phosphate include Design
Coatings on Solid Controls.
Metallic Substrates
------------------------------------------------------------------------
35 ASTM F1713-96, Standard Clarification of 35
Specification for Extent of
Wrought Titanium-13 Recognition;
Niobium-13 Zirconium Update
Alloy for Surgical ``Process(es)
Implant Applications Impacted'' to
include Design
Controls.
------------------------------------------------------------------------
36 ASTM F1801-97, Standard Update 36
Practice for Corrosion ``Process(es)
Fatigue Testing of Impacted'' to
Metallic Implant include Design
Materials Controls.
------------------------------------------------------------------------
37 ASTM F1813-01, Standard Clarification of 37
Specification for Extent of
Wrought Titanium--12 Recognition;
Molybdenum-6 Zirconium- Update
2 Iron Alloy for ``Process(es)
Surgical Implant (UNS Impacted'' to
R58120) include Design
Controls.
------------------------------------------------------------------------
38 ASTM F2005-00, Standard Update 38
Terminology for Nickel- ``Process(es)
Titanium Shape Memory Impacted'' to
Alloys include Design
Controls.
------------------------------------------------------------------------
39 ASTM F2052-00, Standard Update 39
Test Method for ``Process(es)
Measurement of Impacted'' to
Magnetically Induced include Design
Displacement Force on Controls.
Passive Implants in the
Magnetic Resonance
Environment
------------------------------------------------------------------------
40 ASTM F2063-00, Standard Cardiovascular 40
Specification for contact person.
Wrought Nickel-Titanium Clarification to
Shape Memory Alloys for Extent of
Medical Devices and Recognition with
Surgical Implants regard to
biocompatibility
requirements.
------------------------------------------------------------------------
41 ASTM F2066-01, Standard Cardiovascular 41
Specification for contact person;
Wrought Titanium-15 Clarification to
Molybdenum Alloy for Extent of
Surgical Implant Recognition
Applications (UNS
R58150)
------------------------------------------------------------------------
43 ASTM F2146-01, Standard Cardiovascular 43
Specification for contact person;
Wrought Titanium- Clarification to
3Aluminum-2.5Vanadium Extent of
Alloy Seamless Tubing Recognition
for Surgical Implant
Applications (UNS
R56320)
------------------------------------------------------------------------
44 ASTM F136-02, Standard Update 44
Specification for ``Process(es)
Wrought Titanium-6 Impacted'' to
Aluminum-4 Vanadium ELI include Design
(Extra Low Controls.
Interstitial) Alloy for
Surgical Implant
Applications (UNS
R56401)
------------------------------------------------------------------------
45 ASTM F562-02, Standard Update 45
Specification for ``Process(es)
Wrought 35Cobalt- Impacted'' to
35Nickel-20Chromium-10M include Design
olybdenum Alloy for Controls.
Surgical Implant
Applications (UNS
R30035)
------------------------------------------------------------------------
46 ASTM F621-02, Standard Update 46
Specification for ``Process(es)
Stainless Steel Impacted'' to
Forgings for Surgical include Design
Implants Controls
------------------------------------------------------------------------
47 ASTM F799-02, Standard Update 47
Specification for ``Process(es)
Cobalt-28 Chromium-6 Impacted'' to
Molybdenum Alloy include Design
Forgings for Surgical Controls.
Implants (UNS R31537,
R31538, R31539)
------------------------------------------------------------------------
48 ASTM F899-02, Standard Update 48
Specification for ``Process(es)
Stainless Steel for Impacted'' to
Surgical Instruments include Design
Controls.
------------------------------------------------------------------------
49 ASTM F1058-02, Standard Update 49
Specification for ``Process(es)
Wrought 40Cobalt- Impacted'' to
20Chromium-16Iron-15Nic include Design
kel-7Molybdenum Alloy Controls.
Wire and Strip for
Surgical Implant
Applications (UNS
R30003 and UNS R30008)
------------------------------------------------------------------------
50 ASTM F1091-02, Standard Update 50
Specification for ``Process(es)
Wrought Cobalt-20 Impacted'' to
Chromium-15 Tungsten-10 include Design
Nickel Alloy Surgical Controls.
Fixation Wire (UNS
R30605)
------------------------------------------------------------------------
[[Page 10717]]
51 ASTM 1108-02, Standard Update 51
Specification for ``Process(es)
Titanium -6Aluminum - Impacted'' to
4Vanadium Alloy include Design
Castings for Surgical Controls.
Implants (UNS R56406)
------------------------------------------------------------------------
52 ASTM F1350-02, Standard Update 52
Specification for ``Process(es)
Wrought 18 Chromium-14 Impacted'' to
Nickel-2.5 Molybdenum include Design
Stainless Steel Controls.
Surgical Fixation Wire
(UNS S31673)
------------------------------------------------------------------------
53 ASTM F1472-02, Standard Update 53
Specification for ``Process(es)
Wrought Titanium - Impacted'' to
6Aluminum -4Vanadium include Design
Alloy for Surgical Controls.
Implant Applications
(UNS R56400)
------------------------------------------------------------------------
54 ASTM F1580-01, Standard Update 54
Specification for ``Process(es)
Titanium and Titanium-6 Impacted'' to
Aluminum-4 Vanadium include Design
Alloy Powders for Controls.
Coatings of Surgical
Implants
------------------------------------------------------------------------
55 ASTM F2182-02, Standard Update 55
Test Method for ``Process(es)
Measurement of Radio Impacted'' to
Frequency Induced include Design
Heating Near Passive Controls.
Implants During
Magnetic Resonance
Imaging
------------------------------------------------------------------------
Dental 30 ISO 5832-1:1997, Transferred from 56
Ortho 62 Implants for Surgery-- dental/ENT and
Metallic Materials-- orthopaedics.
Part 1: Wrought
stainless steel
------------------------------------------------------------------------
Dental 31 ISO 5832-2:1999, Transferred from 57
Ortho 117 Implants for Surgery-- dental/ENT and
Metallic Materials-- orthopaedics.
Part 2: Unalloyed
Titanium
------------------------------------------------------------------------
Dental 32 ISO 5832-3:1996, Transferred from 58
Ortho 64 Implants for Surgery-- dental/ENT and
Metallic Materials-- orthopaedics.
Part 3: Wrought
titanium 6-aluminium 4-
vanadium alloy
------------------------------------------------------------------------
Dental 33 ISO 5382-4:1996, Transferred from 59
Ortho 65 Implants for Surgery-- dental/ENT and
Metallic Materials-- orthopaedics.
Part 4: Cobalt-chromium-
molybdenum casting
alloy
------------------------------------------------------------------------
Dental 34 ISO 5832-5:1993, Transferred from 60
Ortho 66 Implants for Surgery-- dental/ENT and
Metallic Materials-- orthopaedics.
Part 5: Wrought cobalt-
chromium-tungsten-
nickel alloy
------------------------------------------------------------------------
Dental 35 ISO 5832-6:1997, Transferred from 61
Ortho 67 Implants for Surgery-- dental/ENT and
Metallic Materials-- orthopaedics.
Part 6: Wrought cobalt-
nickel-chromium-
molybdenum alloy
------------------------------------------------------------------------
Dental 36 ISO 5832-9: 1992, Transferred from 62
Ortho 118 Implants for Surgery-- dental/ENT and
Metallic Materials-- orthopaedics.
Part 9: Wrought high
nitrogen stainless
steel
------------------------------------------------------------------------
Dental 38 ISO 5832-11: 1994, Transferred from 63
Ortho 70 Implants for Surgery-- dental/ENT and
Metallic Materials-- orthopaedics.
Part 11: Wrought
titanium 6-aluminium 7-
niobium alloy
------------------------------------------------------------------------
Dental 39 ISO 5832-12: 1996, Transferred from 64
Ortho 71 Implants for Surgery-- dental/ENT and
Metallic Materials-- orthopaedics.
Part 12: Wrought cobalt-
chromium-molybdenum
alloy
------------------------------------------------------------------------
Ortho 119 ISO 5834-2: 1998, Transferred from 65
Implants for Surgery-- orthopaedics.
Ultra-High-Molecular-
Weight Polyethylene--
Part 2: Moulded Forms
------------------------------------------------------------------------
Ortho 76 ISO 6474:1994, Implants Transferred from 66
for Surgery--Ceramic orthopaedics.
materials based on high
purity alumina
------------------------------------------------------------------------
Ortho 143 ISO 7153-1:1991/Amd Transferred from 67
1:1999, Surgical orthopaedics.
Instruments--Metallic
Materials--Part 1:
Stainless steel
------------------------------------------------------------------------
Ortho 84 ISO 13782: 1996, Transferred from 68
Implants for Surgery-- orthopaedics.
Metallic Materials--
Unalloyed tantalum for
surgical implant
applications
------------------------------------------------------------------------
Dental 37 ISO 5832-10:1996, Transferred from 69
Implants for Surgery-- dental/ENT.
Metallic Materials--
Part 10: Wrought
titanium 5-aluminium
2,5-iron
------------------------------------------------------------------------
F. Ophthalmic
[[Page 10718]]
------------------------------------------------------------------------
Old Item Replacement
No. Standard Change Item No.
------------------------------------------------------------------------
30 ANSI Z80.7-2002: Correction in 30
Ophthalmics--Intraocula publication date
r Lenses
------------------------------------------------------------------------
G. Orthopaedics
------------------------------------------------------------------------
Old Item Replacement
No. Standard Change Item No.
------------------------------------------------------------------------
58 ASTM F1781-97, Standard Added ``Design 58
Specification for Controls'' to
Elastomeric Flexible Process(es)
Hinge Finger Total Impacted
Joint Implants
------------------------------------------------------------------------
62 ISO 5832-1:1997, Withdrawn and 62
Implants for Surgery-- transferred to
Metallic materials-- Materials
Part 1: Wrought
stainless steel
------------------------------------------------------------------------
64 ISO 5832-3:1996, Withdrawn and 64
Implants for Surgery-- transferred to
Metallic materials-- Materials
Part 3: Wrought
titanium 6-aluminum 4-
vanadium alloy
------------------------------------------------------------------------
65 ISO 5832-4:1996, Withdrawn and 65
Implants for Surgery-- transferred to
Metallic materials-- Materials
Part 4: Cobalt-chromium-
molybdenum casting
alloy
------------------------------------------------------------------------
66 ISO 5832-5:1993, Withdrawn and 66
Implants for Surgery-- transferred to
Metallic materials-- Materials
Part 5: Wrought cobalt-
chromium-tungsten-
nickel alloy
------------------------------------------------------------------------
67 ISO 5832-6:1997, Withdrawn and 67
Implants for Surgery-- transferred to
Metallic materials-- Materials
Part 6: Wrought cobalt-
nickel-chromium-
molybdenum alloy
------------------------------------------------------------------------
70 ISO 5832-11:1994, Withdrawn and 70
Implants for Surgery-- transferred to
Metallic materials-- Materials
Part 11: Wrought
titanium 6-aluminum 7-
niobium alloy
------------------------------------------------------------------------
71 ISO 5832-12:1996, Withdrawn and 71
Implants for Surgery-- transferred to
Metallic materials-- Materials
Part 12: Wrought cobalt-
chromium-molybdenum
alloy
------------------------------------------------------------------------
73 ISO 5838-1:1995, Added ``Design 73
Implants for Surgery-- Controls'' to
Skeletal Pins and Process(es)
Wires--Part 1: Material Impacted
and Mechanical
Requirements
------------------------------------------------------------------------
74 ISO 5838-2:1991, Added ``Design 74
Implants for Surgery-- Controls'' to
Skeletal Pins and Process(es)
Wires--Part 2: Impacted
Steinmann Skeletal
Pins--Dimensions
------------------------------------------------------------------------
75 ISO 5838-3:1993, Added ``Design 75
Implants for Surgery-- Controls'' to
Skeletal Pins and Process(es)
Wires--Part 3: Impacted
Kirschner Skeletal
Wires
------------------------------------------------------------------------
76 ISO 6474-94, Implants Withdrawn and ..............
for surgery--Ceramic transferred to
materials based on high Materials
purity alumina
------------------------------------------------------------------------
78 ISO 7206-4:2002, Withdrawn and 165
Implants for Surgery-- replaced with
Partial and Total Hip newer version;
Joint Prostheses--Part Title change;
4: Determination of Added ``Design
Endurance Properties of Controls'' to
Stemmed Femoral Process(es)
Components Impacted
------------------------------------------------------------------------
79 ISO 7206-8:1995, Added ``Design 79
Implants for Surgery-- Controls'' to
Partial and Total Hip Process(es)
Joint Prostheses--Part Impacted
8: Endurance
Performance of Stemmed
Femoral Components with
Application of Torsion
------------------------------------------------------------------------
83 ISO 13402-95, Surgical Added ``Design 83
and Dental Hand Controls'' to
Instruments--Determinat Process(es)
ion of Resistance Impacted
Against Autoclaving,
Corrosion and Thermal
Exposure
------------------------------------------------------------------------
84 ISO 13782:1996, Implants Withdrawn and ..............
for Surgery--Metallic transferred to
materials--Unalloyed Materials
tantalum for surgical
implant applications
------------------------------------------------------------------------
85 ISO 14630:1997, Non- Added ``Design 85
Active Surgical Controls'' to
Implants--General Process(es)
Requirements Impacted
------------------------------------------------------------------------
[[Page 10719]]
101 ASTM F897-02, Standard Withdrawn and 166
Test Method for replaced with
Measuring Fretting newer version;
Corrosion of Added ``Design
Osteosynthesis Plates Controls'' to
and Screws Process(es)
Impacted
------------------------------------------------------------------------
104 ASTM F1089-02, Standard Withdrawn and 167
Test Method for replaced with
Corrosion of Surgical newer version;
Instruments Added ``Design
Controls'' to
Process(es)
Impacted
------------------------------------------------------------------------
107 ASTM F1147-99, Standard Added ``Design 107
Test Method for Tension Controls'' to
Testing of Calcium Process(es)
Phosphate and Metallic Impacted
Coatings
------------------------------------------------------------------------
111 ASTM F1814-97a, Standard Added ``Design 111
Guide for Evaluating Controls'' to
Modular Hip and Knee Process(es)
Joint Components Impacted
------------------------------------------------------------------------
113 ASTM F1377-98a, Standard Added ``Design 113
Specification for Controls'' to
Cobalt-28 Chromium-6 Process(es)
Molybdenum Powder for Impacted
Coating of Orthopedic
Implants (UNS R30075)
------------------------------------------------------------------------
114 ASTM F1798-97, Standard Added ``Design 114
Guide for Evaluating Controls'' to
the Static and Fatigue Process(es)
Properties of Impacted
Interconnection
Mechanisms and
Subassemblies Used in
Spinal Arthrodesis
Implants
------------------------------------------------------------------------
115 ASTM F1800-97, Standard Added ``Design 115
Test Method for Cyclic Controls'' to
Fatigue Testing of Process(es)
Metal Tibial Tray Impacted
Components of Total
Knee Joint Replacements
------------------------------------------------------------------------
117 ISO 5832-2:1999, Withdrawn and ..............
Implants for Surgery-- transferred to
Metallic Materials-- Materials
Part 2: Unalloyed
Titanium
------------------------------------------------------------------------
118 ISO 5832-9:1992, Withdrawn and ..............
Implants for Surgery-- transferred to
Metallic Materials-- Materials
Part 9: Wrought High
Nitrogen Stainless
Steel
------------------------------------------------------------------------
119 ISO 5834-2:1998, Withdrawn and ..............
Implants for Surgery-- transferred to
Ultra-High-Molecular Materials
Weight Polyethylene--
Part 2: Moulded Forms
------------------------------------------------------------------------
120 ASTM F382-99, Standard Added ``Design 120
Specification and Test Controls'' to
Method for Metallic Process(es)
Bone Plates Impacted
------------------------------------------------------------------------
121 ISO 7207-1:1994, Added ``Design 121
Implants for Surgery-- Controls'' to
Components for partial Process(es)
and total knee joint Impacted
prostheses--Part 1:
Classification,
definitions and
designation of
dimensions
------------------------------------------------------------------------
126 ASTM F366-82(2000), Added ``Design 126
Standard Specification Controls'' to
for Fixation Pins and Process(es)
Wires Impacted
------------------------------------------------------------------------
131 ASTM F1044-99, Standard Added ``Design 131
Test Method for Shear Controls'' to
Testing of Calcium Process(es)
Phosphate Coatings and Impacted
Metallic Coatings
------------------------------------------------------------------------
140 ASTM F1582-98, Standard Added ``Design 140
Terminology Relating to Controls'' to
Spinal Implants Process(es)
Impacted
------------------------------------------------------------------------
141 ASTM F1612-95(2000), Added ``Design 141
Standard Practice for Controls'' to
Cyclic Fatigue Testing Process(es)
of Metallic Stemmed Hip Impacted
Arthroplasty Femoral
Components With Torsion
------------------------------------------------------------------------
142 ASTM F1672-95(2000), Added ``Design 142
Standard Specification Controls'' to
for Resurfacing Process(es)
Patellar Prosthesis Impacted
------------------------------------------------------------------------
143 ISO 7153-1:1991/Amd. Withdrawn and 143
1:1999, Surgical transferred to
Instruments--Metallic Materials
Materials--Part 1:
Stainless steel
------------------------------------------------------------------------
152 ASTM F1160-00e1, Added ``Design 152
Standard Test Method Controls'' to
for Shear and Bending Process(es)
Fatigue Testing of Impacted
Calcium Phosphate and
Metallic Medical and
Composite Calcium
Phosphate/Metallic
Coatings
------------------------------------------------------------------------
155 ISO 7207-2:1998, Added ``Design 155
Implants for Surgery-- Controls'' to
Components for partial Process(es)
and total knee joint Impacted
prostheses--Part 2:
Articulating surfaces
made of metal, ceramic
and plastics materials
------------------------------------------------------------------------
[[Page 10720]]
159 ASTM F1717-01, Standard Added ``Design 159
Test Methods for Spinal Controls'' to
Implant Constructs in a Process(es)
Vertebrectomy Model Impacted
------------------------------------------------------------------------
161 ASTM F1264-01, Standard Added ``Design 161
Specification and Test Controls'' to
Methods for Process(es)
Intramedullary Fixation Impacted
Devices
------------------------------------------------------------------------
162 ASTM F564-02, Standard Added ``Design 162
Specification and Test Controls'' to
Methods for Metallic Process(es)
Bone Staples Impacted
------------------------------------------------------------------------
163 ASTM F543-02 Standard Added ``Design 163
Specification and Test Controls'' to
Methods for Metallic Process(es)
Medical Bone Screws Impacted
------------------------------------------------------------------------
164 ASTM F1541-02, Standard Added ``Design 164
Specification and Test Controls'' to
Methods for External Process(es)
Skeletal Fixation Impacted
Devices
------------------------------------------------------------------------
H. Radiology
------------------------------------------------------------------------
Old Item Replacement
No. Standard Change Item No.
------------------------------------------------------------------------
38 IEC 60601-2-15, Medical Withdrawn ..............
Electrical Equipment--
Part 2: Particular
Requirements for the
Safety of Capacitor
Discharge X-ray
Generators (1988)
------------------------------------------------------------------------
43 IEC 60601-2-33: Medical Withdrawn and 86
Electrical Equipment-- replaced with
Part 2, Particular newer version
Requirements for the
Safety of Magnetic
Resonance Equipment for
Medical Diagnosis (2002-
2005)
------------------------------------------------------------------------
60 IEC 61217 (2002-03), Withdrawn and 87
Radiotherapy Equipment-- replaced with
Coordinates, movements, newer version
and scales
------------------------------------------------------------------------
64 IEC 60601-2-45, Ed. 2.0, Correction date 64
(2001-05): Medical inserted
Electrical Equipment--
Part 2-45: Particular
Requirements for the
Safety of Mammographic
X-ray Equipment and
Mammographic
Stereotactic Devices
------------------------------------------------------------------------
78 NEMA PS 3.1 through PS Correction Parts 78
3.16 2000, Digital inserted in title
Imaging and
Communications in
Medicine (DICOM)
------------------------------------------------------------------------
I. Sterility
------------------------------------------------------------------------
Old Item Replacement
No. Standard Change Item No.
------------------------------------------------------------------------
1 AOAC 6.2.01:2000, Withdrawn and 94
Official Method 955.14, replaced with
Testing Disinfectants newer version
Against Salmonella
choleraesuis, Use-
Dilution Method
------------------------------------------------------------------------
2 AOAC 6.2.02:2000, Withdrawn and 95
Official Method 991.47, replaced with
Testing Disinfectants newer version
Against Salmonella
choleraesuis, Hard
Surface Carrier Test
Method
------------------------------------------------------------------------
3 AOAC 6.2.03:2000, Withdrawn and 96
Official Method 99l.48, replaced with
Testing Disinfectants newer version.
Against Staphylococcus
aureus, Hard Surface
Carrier Test Method
------------------------------------------------------------------------
4 AOAC 6.2.04:2000, Withdrawn and 97
Official Method 955.15, replaced with
Testing Disinfectants newer version
Against Staphylococcus
aureus, Use-Dilution
Method
------------------------------------------------------------------------
5 AOAC 6.2.05:2000, Withdrawn and 98
Official Method 99l.49, replaced with
Testing Disinfectants newer version
Against Pseudomonas
aeruginosa, Hard
Surface Carrier Test
Method
------------------------------------------------------------------------
6 AOAC 6.2.06:2000, Withdrawn and 99
Official Method 964.02, replaced with
Testing Disinfectants newer version
Against Pseudomonas
aeruginosa, Use-
Dilution Method
------------------------------------------------------------------------
[[Page 10721]]
7 AOAC 6.3.02, Official Withdrawn and 100
Method 955.17, replaced with
Fungicidal Activity of newer version
Disinfectants Using
Trichophyton
mentagrophytes
------------------------------------------------------------------------
8 AOAC 6.3.05:2000, Withdrawn and 101
Official Method 966.04, replaced with
Sporicidal Activity of newer version
Disinfectants
------------------------------------------------------------------------
9 AOAC 6.3.06:2000, Withdrawn and 102
Official Method 965.12, replaced with
Tuberculocidal Activity newer version
of Disinfectants
------------------------------------------------------------------------
24 ANSI/AAMI/ISO Contact person 24
11134:1993,
Sterilization of Health
Care Products--
Requirements for
Validation and Routine
Control-Industrial
Moist Heat
Sterilization
------------------------------------------------------------------------
25 ANSI/AAMI/ISO 11135- Contact person 25
1994, Medical Devices--
Validation and Routine
Control of Ethylene
Oxide Sterilization
------------------------------------------------------------------------
27 AAMI/ANSI/ISO Withdrawn and 103
11607:2000, Packaging replaced with
for Terminally newer version;
Sterilized Medical Add to Extent of
Devices Recognition
------------------------------------------------------------------------
51 ANSI/AAMI ST58:1996, Withdrawn and 104
Safe Use and Handling replaced with
of Glutaraldehyde-Based newer version
Products in Health Care
Facilities and ANSI/
AAMI ST58:1996/
Amendment 1 2002
------------------------------------------------------------------------
52 ANSI/AAMI ST59:1999, Updated Relevant 52
Sterilization of Health Guidance
Care Products--
Biological Indicators
Part 1: General
Requirements
------------------------------------------------------------------------
73 ANSI/AAMI ST46:2002, Withdrawn and 105
Steam Sterilization and replaced with
Sterility Assurance in newer version
Health Care Facilities
------------------------------------------------------------------------
75 ANSI/AAMI/ISO Title Correction; 75
11137:1994, Additional
Sterilization of Health Relevant
Care Products- Guidance; Contact
Requirements for person
Validation and Routine
Control-Radiation
Sterilization and
ISO11137:1995
(Amendment 1:2002)
------------------------------------------------------------------------
76 AAMI/ANSI/ISO 10993- Delete (e.g. 76
7:1995 (R) 2001, hemodialyzers)
Biological Evaluation from the Extent
of Medical Devices-- of Recognition
Part 7: Ethylene Oxide
Sterilization Residuals
------------------------------------------------------------------------
78 USP 26:2003, Biological Withdrawn and 106
Indicator for Dry Heat replaced with
Sterilization, Paper newer version
Carrier
------------------------------------------------------------------------
79 USP 26:2003, Biological Withdrawn and 107
Indicator for Ethylene replaced with
Oxide Sterilization, newer version
Paper Carrier
------------------------------------------------------------------------
80 USP 26:2003, Biological Withdrawn and 108
Indicator for Steam replaced with
Sterilization, Paper newer version
Carrier
------------------------------------------------------------------------
81 USP 26:2003, <61 Microbial Limits replaced with
Test newer version
------------------------------------------------------------------------
82 USP 26:2003, <71, Microbiological replaced with
Tests, Sterility Tests newer version
------------------------------------------------------------------------
83 USP 26:2003, <85 Biological Tests replaced with
and Assays, Bacterial newer version
Endotoxin Test (LA)
------------------------------------------------------------------------
84 USP 26:2003, <151 Pyrogen Test (USP replaced with
Rabbit Test) newer version
------------------------------------------------------------------------
85 USP 26:2003 <1211 Sterilization and replaced with
Sterility Assurance of newer version
Compendial Articles
------------------------------------------------------------------------
87 USP 26:2003, Transfusion Withdrawn and 114
and Infusion Assemblies replaced with
and Similar Medical newer version
Devices <161
------------------------------------------------------------------------
93 USP 26:2003, Biological Withdrawn and 115
Indicator for Steam replaced with
Sterilization newer version
------------------------------------------------------------------------
III. Listing of New Entries
[[Page 10722]]
The listing of new entries and consensus standards added as
``Modifications to the List of Recognized Standards'', under
Recognition List Number: 009,'' is as follows:
A. Anesthesia
------------------------------------------------------------------------
Reference No. and
Item No. Title of Standard Date
------------------------------------------------------------------------
45 Standard Specification for F1101-90 (1996)
Ventilators Intended for
use During Anesthesia
------------------------------------------------------------------------
46 Breathing Tubes Intended ISO 5367:2000
for use with Anesthetic
Apparatus and Ventilators
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
Reference No. and
Item No. Title of Standard Date
------------------------------------------------------------------------
79 Standard Practice for ASTM F619-02
Extraction of Medical
Plastics
------------------------------------------------------------------------
80 Standard Practice for ASTM F1877-98
Characterization of
Particles
------------------------------------------------------------------------
81 Standard Practice for ASTM F1905-98
Selecting Tests for
Determining the Propensity
of Materials to Cause
Immunotoxicity
------------------------------------------------------------------------
82 Standard Practice for ASTM F2147-01
Evaluation of Immune
Responses In
Biocompatibility Testing
Using ELISA Tests,
Lymphocyte, Proliferation,
and Cell Migration
------------------------------------------------------------------------
C. Cardiovascular/Neurology
------------------------------------------------------------------------
Reference No. and
Item No. Title of Standard Date
------------------------------------------------------------------------
50 Cardiac Defibrillator ANSI/AAMI DF2-1996
Devices (Revision of ANSI/
AAMI DF2-1989)
------------------------------------------------------------------------
51 Automatic External ANSI/AAMI DF39-1993
Defibrillators and Remote-
Control Defibrillators
------------------------------------------------------------------------
D. Dental/ENT
------------------------------------------------------------------------
Reference No. and
Item No. Title of Standard Date
------------------------------------------------------------------------
103 Denture Base Polymers ANSI/ADA
Specification No.
12:1999
------------------------------------------------------------------------
104 Pit and Fissure Sealants ANSI/ADA
Specification No.
39: 1999
------------------------------------------------------------------------
105 Resilient Lining Materials ANSI/ADA
for Removable Dentures, Specification No.
Part 2: Short-Term 75: 1997
Materials
------------------------------------------------------------------------
106 Dental Reversible/ ANSI/ADA
Irreversible Hydrocolloid Specification No.
Impression Material System 82: 1998
------------------------------------------------------------------------
107 Dental, Water-Based Cements ISO 9917-2:1998
------------------------------------------------------------------------
108 Dentistry, Resilient Lining ISO 10139-1:1991
Materials for Removable
Dentures--Part 1: Short-
Term Materials
------------------------------------------------------------------------
109 Dentistry, Reversible- ISO 13716: 1999
Irreversible Hydrocolloid
Impression Material
Systems
------------------------------------------------------------------------
E. In Vitro Diagnostic
[[Page 10723]]
------------------------------------------------------------------------
Reference No. and
Item No. Title of Standard Date
------------------------------------------------------------------------
88 Preparation and Validation NCCLS C37-A:1999
of Commutable Frozen Human
Serum Pools as Secondary
Reference Materials for
Cholesterol Measurement
Procedures: Approved
Guideline
------------------------------------------------------------------------
89 A Designated Comparison NCCLS C39-A:2000
Method for the Measurement
of Ionized Calcium in
Serum; Approved Standard
------------------------------------------------------------------------
------------------------------------------------------------------------
------------------------------------------------------------------------
94 User Protocol for NCCLS EP12-A:2002
Evaluation of Qualitative
Test Performance; Approved
Guideline
------------------------------------------------------------------------
95 User Demonstration of NCCLS EP15-A:2001
Performance for Precision
and Accuracy; Approved
Guideline
------------------------------------------------------------------------
96 Quality Management for Unit- NCCLS EP18-A:2002
Use Testing; Approved
Guideline
------------------------------------------------------------------------
97 Urinalysis and Collection, NCCLS GP16-A2:2001
Transportation, and
Preservation of Urine
Specimens--Second Edition;
Approved Guideline
------------------------------------------------------------------------
F. OB-GYN/Gastroenterology
------------------------------------------------------------------------
Reference No. and
Item No. Title of Standard Date
------------------------------------------------------------------------
28 Hemodialyzers ANSI/AAMI RD 16:1996/
A1:2002 Amendment 1
to ANSI/AAMI RD
16:1996
------------------------------------------------------------------------
29 Hemodialyzer Blood Tubing ANSI/AAMI RD 17:1994/
A1:2002 Amendment 1
to ANSI/AAMI RD
17:1994
------------------------------------------------------------------------
G. Ophthalmic
------------------------------------------------------------------------
Reference No. and
Item No. Title of Standard Date
------------------------------------------------------------------------
31 Optics and Optical ISO 11810:2002
Instruments--Lasers and
Laser-related Equipment--
Test Method for the Laser-
resistance of Surgical
Drapes and/or Patient-
protective Covers
------------------------------------------------------------------------
32 Optics and Optical ISO 11990:2003
Instruments--Lasers and
Laser-related Equipment--
Determination of Laser
Resistance of Tracheal
Tube Shafts
------------------------------------------------------------------------
H. Radiology
------------------------------------------------------------------------
Reference No. and
Item No. Title of Standard Date
------------------------------------------------------------------------
88 Medical Electrical IEC 60601-2-17
Equipment--Part 2: (1989)
Particular Requirements
for the Safety of Remote-
Controlled Automatically-
Driven Gamma-Ray
Afterloading Equipment
(1989)
------------------------------------------------------------------------
89 Optics and optical ISO 11810:2002
instruments--Lasers and
Laser-Related Equipment--
Test Method for the Laser-
Resistance of Surgical
Drapes and/or Patient-
Protective Covers
------------------------------------------------------------------------
90 Medical Electrical IEC 60601-2-1
Equipment--Part 2: Amendment 1--Ed.
Particular Requirements 2.0 (2002-05)
for Medical Electron
Accelerators
------------------------------------------------------------------------
[[Page 10724]]
91 Medical Electrical IEC 60601-2-8
Equipment--Part 2: Amendment 1 (1997-
Particular Requirements 98)
for the Safety of
Therapeutic X-ray
Equipment Operating in the
Range 10 kV to 1 MV
------------------------------------------------------------------------
92 Medical Electrical IEC 61674 (1997-10)
Equipment--Dosimeters with
Ionization Chambers and/or
Semi-Conductor Detectors
as used in X-ray
Diagnostic Imaging
------------------------------------------------------------------------
93 Medical Electrical IEC 61674 Amendment
Equipment--Dosimeters with 1 (2002-06)
Ionization Chambers and/or
Semi-Conductor Detectors
as used in X-ray
Diagnostic Imaging
------------------------------------------------------------------------
94 Medical Electrical IEC 60731 Amendment
Equipment--Dosimeters with 1 (2002-06)
Ionization Chambers as
used in Radiotherapy
------------------------------------------------------------------------
I. Sterility
------------------------------------------------------------------------
Reference No. and
Item No. Title of Standard Date
------------------------------------------------------------------------
116 Bacterial Endotoxins--Test ANSI/AAMI ST72:2002
Methodologies, Routine
Monitoring, and
Alternatives to Batch
Testing
------------------------------------------------------------------------
J. Tissue Engineering
------------------------------------------------------------------------
Reference No. and
Item No. Title of Standard Date
------------------------------------------------------------------------
3 Standard Guide for ASTM F2212-2002
Characterization of Type 1
Collagen as a Starting
Material for Surgical
Implants and Substrates
for Tissue Engineered
Medical Products
------------------------------------------------------------------------
IV. List of Recognized Standards
FDA maintains the agency's current list of ``FDA Recognized
Consensus Standards'' in a searchable database that may be accessed
directly at FDA's Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA will incorporate the
modifications and minor revisions described in this notice into the
database and, upon publication in the Federal Register, this
recognition of consensus standards will be effective. FDA will announce
additional modifications and minor revisions to the list of recognized
consensus standards, as needed, in the Federal Register once a year, or
more often, if necessary.
V. Recommendation of Standards for Recognition by FDA
Any person may recommend consensus standards as candidates for
recognition under the new provision of section 514 of the act by
submitting such recommendations, with reasons for the recommendation,
to the contact person (See FOR FURTHER INFORMATION CONTACT). To be
properly considered such recommendations should contain, at a minimum,
the following information: (1) Title of the standard, (2) any reference
number and date, (3) name and address of the national or international
standards development organization, (4) a proposed list of devices for
which a declaration of conformity to this standard should routinely
apply, and (5) a brief identification of the testing or performance or
other characteristics of 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 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 obtain a copy of ``Guidance on the Recognition and Use of
Consensus Standards'' by using the Internet. CDRH maintains a site on
the Internet for easy access to information including text, graphics,
and files that you may download to a personal computer with access to
the Internet. Updated on a regular basis, the CDRH home page includes
the guidance as well as the current list of recognized standards and
other standards related documents. After publication in the Federal
Register, this notice announcing ``Modification to the List of
Recognized Standards, Recognition List Number: 009'' 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 hyperlink at http://www.fda.gov/cdrh/stdsprog.html. This Federal Register notice of
modifications in FDA's recognition of consensus standards will be
available, upon publication, 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:
[[Page 10725]]
009.'' These modifications to the list or recognized standards are
effective upon publication of this notice in the Federal Register.
Dated: February 13, 2004.
Beverly Chernaik Rothstein,
Acting Deputy Director for Policy and Regulations, Center for Devices
and Radiological Health.
[FR Doc. E4-479 Filed 3-5-04; 8:45 am]
BILLING CODE 4160-01-S