[Federal Register Volume 70, Number 215 (Tuesday, November 8, 2005)]
[Notices]
[Pages 67713-67724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-22267]
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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: 013
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: 013'' (Recognition List Number: 013), 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: 013'' to the Division of Small Manufacturers,
International and Consumer Assistance, Center for Devices and
Radiological Health (HFZ-220), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive
labels to assist that office in processing your requests, or FAX your
request to 301-443-8818. Submit written comments concerning this
document, or recommendations for additional standards for recognition,
to the contact person (see FOR FURTHER INFORMATION CONTACT). Submit
electronic comments by e-mail: [email protected]. This document
may also be accessed on FDA's Internet site at http://www.fda.gov/cdrh/fedregin.html. See section VI of this document for electronic access to
the searchable
[[Page 67714]]
database for the current list of FDA recognized consensus standards,
including Recognition List Number: 013 modifications and other
standards related information.
FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices
and Radiological Health (HFZ-84), Food and Drug Administration, 12720
Twinbrook Pkwy., MD 20857, 301-827-0021.
I. Background
Section 204 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended
section 514 allows FDA to recognize consensus standards developed by
international and national organizations for use in satisfying portions
of device premarket review submissions or other requirements.
In a notice published in the Federal Register of February 25, 1998
(63 FR 9561), FDA announced the availability of a guidance entitled
``Recognition and Use of Consensus Standards.'' The notice described
how FDA would implement its standard recognition program and provided
the initial list of recognized standards.
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), June 18, 2004 (69 FR 34176), and October 4, 2004 (69 FR 59240),
FDA modified its initial list of FDA recognized consensus standards.
These notices describe the addition, withdrawal, and revision of
certain standards recognized by FDA. The agency maintains ``hypertext
markup language'' (HTML) and ``portable document format'' (PDF)
versions of the list of ``FDA Recognized Consensus Standards.'' Both
versions are publicly accessible at the agency's 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: 013
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: 013'' 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.
------------------------------------------------------------------------
Replacement Item
Old Item No. Standard Change No.
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
52 ASTM F1463-93 (1999), Withdrawn .................
Standard Specification
for Alarm Signals in
Medical Equipment Used
in Anesthesia and
Respiratory Care
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
1 ASTM E1262-88 (2003), Withdrawn and 83
Standard Guide for replaced
Performance of the with newer
Chinese Hamster Ovary version
Cell/Hypoxanthine
Guanine Phosphoribosyl
Transferase Gene
Mutation Assay
------------------------------------------------------------------------
2 ASTM E1263-97 (2003), Withdrawn and 84
Standard Guide for replaced
Conduct of with newer
Micronucleus Assays in version
Mammalian Bone Marrow
Erythrocytes
------------------------------------------------------------------------
3 ASTM E1280-97 (2003), Withdrawn and 85
Standard Guide for replaced
Performing the Mouse with newer
Lymphoma Assay for version
Mammalian Cell
Mutagenicity
------------------------------------------------------------------------
19 AAMI/ANSI/ISO10993-10: Withdrawn and 86
2002(E), Biological replaced
Evaluation of Medical with newer
Devices--Part 10: version
Tests for Irritation
and Sensitization
------------------------------------------------------------------------
20 AAMI/ANSI/ISO10993-10: Withdrawn 87
2002(E), Biological and replaced
Evaluation of Medical with newer
Devices--Part 10: version
Tests for Irritation
and Sensitization--
Maximization
Sensitization Test
------------------------------------------------------------------------
21 AAMI/ANSI/ISO10993- Extent of .................
11:1993, Biological Recognition
Evaluation of Medical and Relevant
Devices--Part 11: Guidance
Tests for Systemic
Toxicity
------------------------------------------------------------------------
28 AAMI/ANSI/ISO10993- Withdrawn 88
12:2002(E), Biological and replaced
Evaluation of Medical with newer
Devices--Part 12: version
Sample Preparation and
Reference Materials
------------------------------------------------------------------------
34 ASTM F749-98 (2002)e2, Withdrawn and 89
Standard Practice for replaced
Evaluating Material with newer
Extracts by version
Intracutaneous
Injection in the
Rabbit
------------------------------------------------------------------------
[[Page 67715]]
37 ASTM E1397-91 (2003), Withdrawn and 90
Standard Practice for replaced
the In Vitro Rat with newer
Hepatocyte DNA Repair version
Assay
------------------------------------------------------------------------
38 ASTM E1398-91 (2003), Withdrawn and 91
Standard Practice for replaced
the In Vivo Rat with newer
Hepatocyte DNA Repair version
Assay
------------------------------------------------------------------------
39 ASTM F748-04, Standard Withdrawn and 92
Practice for Selecting replaced
Generic Biological with newer
Test Methods for version
Materials and Devices
------------------------------------------------------------------------
40 ASTM F763-04, Standard Withdrawn and 93
Practice for Short- replaced
Term Screening of with newer
Implant Materials version
------------------------------------------------------------------------
41 ASTM F981-04, Standard Withdrawn and 94
Practice for replaced
Assessment of with newer
Compatibility of version
Biomaterials for
Surgical Implants with
Respect to Effect of
Materials on Muscle
and Bone
------------------------------------------------------------------------
42 ASTM F1984-99 (2003), Withdrawn and 95
Standard Practice for replaced
Testing for Whole with newer
Complement Activation version
in Serum by Solid
Materials
------------------------------------------------------------------------
43 ASTM F1903-98 (2003), Withdrawn and 96
Standard Practice for replaced
Testing for Biological with newer
Responses to Particles version
In Vitro
------------------------------------------------------------------------
45 ASTM F1983-99 (2003), Withdrawn and 97
Standard Practice for replaced
Assessment of with newer
Compatibility of version
Absorbable/Resorbable
Biomaterials for
Implant Applications
------------------------------------------------------------------------
51 AAMI/ANSI/ISO10993-1: Withdrawn and 98
2003(E), Biological replaced
Evaluation of Medical with newer
Devices--Part 1: version
Evaluation and Testing
------------------------------------------------------------------------
52 ASTM F1904-98e1 (2003), Withdrawn and 99
Standard Practice for replaced
Testing for Biological with newer
Responses to Particles version
In Vivo
------------------------------------------------------------------------
53 ASTM E1372-95 (2003), Withdrawn and 100
Standard Test Method replaced
for Conducting a 90- with newer
Day Oral Toxicity version
Study in Rats
------------------------------------------------------------------------
70 ASTM F750-87 (2002)e1, Relevant .................
Standard Practice for guidance
Evaluating Material
Extracts by Systemic
Injection in the Mouse
------------------------------------------------------------------------
74 USP 28-NF21Biological Withdrawn 101
Tests <87>, Biological and replaced
Reactivity Test, In with newer
Vitro--Direct Contact version
Test
------------------------------------------------------------------------
75 USP 28-NF21Biological Withdrawn and 102
Tests <87>, Biological replaced
Reactivity Test, In with newer
Vitro--Elution Test version
------------------------------------------------------------------------
76 USP 28-NF21Biological Withdrawn and 103
Tests <88>, Biological replaced
Reactivity Test, In with newer
Vivo Procedure-- version
Preparation of Sample
------------------------------------------------------------------------
77 USP 28-NF21Biological Withdrawn 104
Tests <88>, Biological and replaced
Reactivity Test, In with newer
Vitro, Classification version
of Plastics--
Intracutaneous Test
------------------------------------------------------------------------
78 USP 28-NF21Biological Withdrawn and 105
Tests <88>, Biological replaced
Reactivity Test, In with newer
Vitro, Classification version
of Plastics--Systemic
Injection Test
------------------------------------------------------------------------
79 ASTM F619-03, Standard Withdrawn and 106
Practice for replaced
Extraction of Medical with newer
Plastics version
------------------------------------------------------------------------
80 ASTM F1877 (2003)e1, Withdrawn 107
Standard Practice for and replaced
Characterization of with newer
Particles version
------------------------------------------------------------------------
81 ASTM F1905 (2003)e1, Withdrawn and 108
Standard Practice for replaced
Selecting Tests for with newer
Determining the version
Propensity of
Materials to Cause
Immunotoxicity
------------------------------------------------------------------------
B. Cardiovascular/Neurology
------------------------------------------------------------------------
4 ANSI/AAMI SP10:2002-- Withdrawn and 53
Manual, Electronic, or replaced
Automated with newer
Sphygmomanometers version
------------------------------------------------------------------------
5 ANSI/AAMI/ISO 7198:1998/ Withdrawn and 54
2001(R) 2004, replaced
Cardiovascular with newer
Implants--Tubular version
vascular prostheses
------------------------------------------------------------------------
[[Page 67716]]
14 ASTM F1830:05, Withdrawn and 55
Recommended Practice replaced
for Selection of Blood with newer
for In Vitro Hemolytic version
Evaluation of Blood
Pumps
------------------------------------------------------------------------
15 ASTM F1841:05, Withdrawn and 56
Recommended Practice replaced
for Assessment of with newer
Hemolysis in version
Continuous Flow Blood
Pumps
------------------------------------------------------------------------
48 ASTM F2129:04, Test Withdrawn and 57
Method for Conducting replaced
Cyclic Potentiodynamic with newer
Polarization version
Measurements to
Determine the
Corrosion
Susceptibility of
Small Implant Devices
------------------------------------------------------------------------
C. Dental/Ear, Nose, and Throat
------------------------------------------------------------------------
29 IEC 60601-2-18:2000 Withdrawn and 122
Amendment 1, Medical replaced
Electrical Equipment-- with newer
Part 2: Particular version
Requirements for the
Safety of Endoscopic
Equipment
------------------------------------------------------------------------
40 ANSI/ASA S3.6-2004, Withdrawn and 123
Specification for replaced
Audiometers with newer
version
------------------------------------------------------------------------
41 ANSI/ASA S3.22:2003, Withdrawn and 124
Specification of replaced
Hearing Aid with newer
Characteristics version
------------------------------------------------------------------------
61 ISO 1562:2004, Withdrawn and 125
Dentistry--Casting replaced
gold alloys with newer
version
------------------------------------------------------------------------
82 ISO 10477:2004, Withdrawn and 126
Dentistry--Polymer- replaced
based crown and bridge with newer
materials version
------------------------------------------------------------------------
D. General
------------------------------------------------------------------------
16 ASTM D903:1993, Test Contact .................
Methods for Peel or person
Stripping Strength of
Adhesive Bonds
------------------------------------------------------------------------
28 IEC 60601-1-2, (Second Extent of .................
Edition), Medical recognition
Electrical Equipment--
Part 1-2: General
Requirements for
Safety--Collateral
Standard:
Electromagnetic
Compatibility--Require
ments and Tests
------------------------------------------------------------------------
30 AAMI/IEC 60601-1-2, Title and .................
Medical Electrical extent of
Equipment--Part 1-2: recognition
General Requirements
for Safety--Collateral
standard:
Electromagnetic
Compatibility--Require
ments and Tests
(Edition 2:2001)
------------------------------------------------------------------------
2 IEC 60601-1, Medical Withdrawn .................
Electrical Equipment--
Part 1: General
Requirements for
Safety
------------------------------------------------------------------------
4 IEC 60601-1, Medical Contact .................
Electrical Equipment-- person,
Part 1: General devices
Requirements for affected and
Safety, 1988; extent of
Amendment 1, l991-11, recognition
Amendment 2, 1995-03
------------------------------------------------------------------------
E. General Hospital/General Plastic Surgery
------------------------------------------------------------------------
18 ISO 8537:1991 Sterile Contact .................
Single-Use Syringes, person
With or Without
Needle, for Insulin
------------------------------------------------------------------------
38 ASTM F1671-03: Standard Withdrawn and 130
Test Method for replaced
Resistance of with newer
Materials Used in version
Protective Clothing to
Penetration by Blood-
Borne Pathogens Using
Phi-X174 Bacteriophage
Penetration as a Test
System.
------------------------------------------------------------------------
48 ASTM D6499-03 Standard Withdrawn and 131
Test Method for the replaced
Immunological with newer
Measurement of version
Antigenic Protein in
Natural Rubber and its
Products
------------------------------------------------------------------------
31 Ophthalmic ISO 11810-1:2005: Transferred 132
89 Radiology Lasers and Laser- from
Related Equipment-- Ophthalmic
Test Method and and
Classification for the Radiology
Laser-Resistance of
Surgical Drapes and/or
Patient-Protective
Covers--Part 1:
Primary Ignition and
Penetration
------------------------------------------------------------------------
97 USP 28: 2005 Withdrawn and 133
Nonabsorbable Surgical replaced
Suture with newer
version
------------------------------------------------------------------------
[[Page 67717]]
98 USP 28<11>: 2005 Withdrawn and 134
Sterile Sodium replaced
Chloride for with newer
Irrigation version
------------------------------------------------------------------------
99 USP 28: 2005 Absorbable Withdrawn and 135
Surgical Suture replaced
with newer
version
------------------------------------------------------------------------
100 USP 28<881>: 2005 Withdrawn and 136
Tensile Strength replaced
with newer
version
------------------------------------------------------------------------
101 USP 28<861>: 2005 Withdrawn and 137
Sutures--Diameter replaced
with newer
version
------------------------------------------------------------------------
102 USP 28<871>: 2005 Withdrawn and 138
Sutures Needle replaced
Attachment with newer
version
------------------------------------------------------------------------
103 USP 28<11>: 2005 Withdrawn and 139
Sterile Water for replaced
Irrigation with newer
version
------------------------------------------------------------------------
104 USP 28<11>: 2005 Withdrawn and 140
Heparin Lock Flush replaced
Solution with newer
version
------------------------------------------------------------------------
105 USP 28<11>: 2005 Sodium Withdrawn and 141
Chloride Injection replaced
with newer
version
------------------------------------------------------------------------
11 ISO 594-1:1986 Conical Title and .................
Fittings With a 6% contact
(Luer) Taper for person
Syringes, Needles, and
Certain Other Medical
Equipment--Part 1:
General Requirements
------------------------------------------------------------------------
13 ISO 595-1:1986 Reusable Title and .................
All-Glass or Metal-and- contact
Glass Syringes for person
Medical Use--Part 1:
Dimensions
------------------------------------------------------------------------
14 ISO 595-2:1987 Reusable Title and .................
All-Glass or Metal-and- contact
Glass Syringes for person
Medical Use--Part 2:
Design, Performance
Requirements and Tests
------------------------------------------------------------------------
15 ISO 7864:1993 Sterile Contact .................
Hypodermic Needles for person
Single Use
------------------------------------------------------------------------
16 ISO 7886-1:1993 Sterile Title and .................
Hypodermic Syringes contact
for Single Use--Part person
1: Syringes for Manual
Use
------------------------------------------------------------------------
62 ISO 8536-6:1995 Title and .................
Infusion Equipment for contact
Medical Use--Part 6: person
Freeze Drying Closures
for Infusion Bottles
------------------------------------------------------------------------
63 ISO 8536-7-1999: Contact .................
Infusion Equipment for Person
Medical Use--Part 7:
Caps Made of Aluminum-
Plastics Combinations
for Infusion Bottles
------------------------------------------------------------------------
64 ISO 8536-3-1999: Title and .................
Infusion Equipment for contact
Medical Use--Part 3: person
Aluminum Caps for
Infusion Bottles
------------------------------------------------------------------------
66 ISO 8536-1-2000: Title and .................
Infusion equipment for Contact
medical use--Part 1: Person
Infusion glass bottles
------------------------------------------------------------------------
68 ISO 7886-2-1996: Title and ;
Sterile Hypodermic contact
Syringes for Single person
Use--Part 2: Syringes
for Use With Power-
Driven Syringe Pumps
------------------------------------------------------------------------
69 ISO 9626-1991: Title and .................
Stainless Steel Needle contact
Tubing for the person
Manufacture of Medical
Devices
------------------------------------------------------------------------
70 ASTM E825-98 (2003) Contact .................
Standard Specification person
for Phase Change-Type
Disposable Fever
Thermometer for
Intermittent
Determination of Human
Temperature
------------------------------------------------------------------------
111 IEC 60601-2-38 Medical Contact .................
Electrical Equipment-- person
Part 2: Particular
Requirements for the
Safety of Electrically
Operated Hospital Beds
------------------------------------------------------------------------
119 AAMI BF7: (R2002) Blood Contact .................
Transfusion Micro- person
Filters
------------------------------------------------------------------------
120 ASTM F1054-01: Standard Contact .................
Specification for person
Conical Fittings
------------------------------------------------------------------------
[[Page 67718]]
121 ISO 8536-2-2001: Contact .................
Infusion Equipment for person
Medical Use--Part 2:
Closures for Infusion
Bottles
------------------------------------------------------------------------
122 ISO 8536-5-2004: Title and .................
Infusion Equipment for contact
Medical Use--Part 5: person
Burette Infusion Sets
for Single Use,
Gravity Feed
------------------------------------------------------------------------
126 ISO 8536-4-2004: Contact .................
Infusion Equipment for person
Medical Use--Part 4:
Infusion Sets for
Single Use, Gravity
Feed
------------------------------------------------------------------------
127 ISO 1135-4-2004: Contact .................
Transfusion Equipment person
for Medical Use--Part
4: Transfusion Sets
for Single Use
------------------------------------------------------------------------
129 ISO 594-2:1998 Conical Contact .................
Fittings With a 6% person
(Luer) Taper for
Syringes, Needles, and
Certain Other Medical
Equipment--Part 2:
Lock Fittings
------------------------------------------------------------------------
F. In Vitro Diagnostic
------------------------------------------------------------------------
65 CLSI EP5-A2, Evaluation Withdrawn and 110
of Precision replaced
Performance of with new
Quantitative version
Measurement Methods;
Approved Guideline--
Second Edition
------------------------------------------------------------------------
54 CLSI D12-A2, Product codes .................
Immunoprecipitin
Analyses: Procedures
for Evaluating the
Performance of
Materials--Second
Edition; Approved
Guideline
------------------------------------------------------------------------
G. Materials
------------------------------------------------------------------------
9 ASTM F563-00: Standard Withdrawn .................
Specification for
Wrought Cobalt-20
Nickel-20 Chromium-3.5
Molybdenum-3.5
Tungsten-5 Iron Alloy
for Surgical Implant
Applications (UNS
R30563)
------------------------------------------------------------------------
13 ASTM F648-04: Standard Withdrawn and 106
Specification for replaced
Ultra-High-Molecular- with newer
Weight Polyethylene version
Powder and Fabricated
Form for Surgical
Implants
------------------------------------------------------------------------
16 ASTM F746-04: Standard Withdrawn and 107
Test Method for replaced
Pitting or Crevice with newer
Corrosion of Metallic version
Surgical Implant
Materials
------------------------------------------------------------------------
25 ASTM F1295-05: Standard Withdrawn and 108
Specification for replaced
Wrought Titanium-6 with newer
Aluminum-7 Niobium version
Alloy for Surgical
Implant Applications
(UNS R56700)
------------------------------------------------------------------------
34 ASTM F1659-95: Standard Withdrawn .................
Test Method for
Bending and Shear
Fatigue Testing of
Calcium Phosphate
Coatings on Solid
Metallic Substrates
------------------------------------------------------------------------
72 ASTM F2213-04: Standard Title .................
Test Method for
Measurement of
Magnetically Induced
Torque on Passive
Implants in the
Magnetic Resonance
Environment
------------------------------------------------------------------------
73 ASTM F561-05, Practice Withdrawn and 109
for Retrieval and replaced
Analysis of Implanted with newer
Medical Devices, and version
Associated Tissues
------------------------------------------------------------------------
74 ASTM F1377-04: Standard Withdrawn and 110
Specification for replaced
Cobalt-28 Chromium-6 with newer
Molybdenum Powder for version
Coating of Orthopedic
Implants (UNS R30075)
------------------------------------------------------------------------
75 ASTM F1160-05: Standard Withdrawn and 111
Test Method for Shear replaced
and Bending Fatigue with newer
Testing of Calcium version
Phosphate and Metallic
Medical and Composite
Calcium Phosphate/
Metallic Coatings
------------------------------------------------------------------------
80 ASTM F1088-04a: Title .................
Standard Specification
for Beta-Tricalcium
Phosphate for Surgical
Implantation
------------------------------------------------------------------------
83 ASTM F1044-05: Standard Withdrawn and 112
Test Method for Shear replaced
Testing of Calcium with newer
Phosphate Coatings and version
Metallic Coatings
------------------------------------------------------------------------
84 ASTM F1147-05: Standard Withdrawn and 113
Test Method for replaced
Tension Testing of with newer
Calcium Phosphate and version
Metal Coatings
------------------------------------------------------------------------
[[Page 67719]]
90 ASTM F2255-05: Standard Withdrawn and 114
Test Method for replaced
Strength Properties of with newer
Tissue Adhesives in version
Lap Shear by Tension
Loading
------------------------------------------------------------------------
91 ASTM F2256-05: Standard Withdrawn and 115
Test Method for replaced
Strength Properties of with newer
Tissue Adhesives in T- version
Peel by Tension
Loading
------------------------------------------------------------------------
92 ASTM F2258-05: Standard Withdrawn and 116
Test Method for replaced
Strength Properties of with newer
Tissue Adhesives in version
Tension
------------------------------------------------------------------------
93 ASTM F86-04: Standard Withdrawn and 117
Practice for Surface replaced
Preparation and with newer
Marking of Metallic version
Surgical Implants
------------------------------------------------------------------------
H. OB-GYN/Gastroenterology
------------------------------------------------------------------------
1 AAMI RD5:1992: Withdrawn .................
Hemodialysis systems
------------------------------------------------------------------------
17 ASTM D3492-03: Standard Withdrawn and 32
Specification for replaced
Rubber Contraceptives with newer
(Male Condoms) version
------------------------------------------------------------------------
24 ASTM F623-99e1: Withdrawn and 33
Standard Performance replaced
Specification for with newer
Foley Catheter version
------------------------------------------------------------------------
26 ISO 4074:2002/ Withdrawn and 34
Cor.1:2003(E): Natural replaced
Latex Rubber Condoms-- with newer
Requirements and Test version
Methods, Technical
Corrigendum 1
------------------------------------------------------------------------
27 ASTM D6324-99a Withdrawn and 35
(Reapproved 2004): replaced
Standard Test Methods with newer
for Male Condoms Made version
From Synthetic
Materials
------------------------------------------------------------------------
I. Ophthalmic
------------------------------------------------------------------------
31 ISO 11810:2002, Optics Withdrawn .................
and Optical newer
Instruments--Lasers version
and Laser-Related recognized
Equipment--Test Method under
for the Laser- General
Resistance of Surgical Hospital/
Drapes and/or Patient- General
Protective Covers Plastic
Surgery
------------------------------------------------------------------------
J. Orthopedic
------------------------------------------------------------------------
126 ASTM F366-04: Standard Withdrawn and 180
Specification for replaced
Fixation Pins and with newer
Wires version
------------------------------------------------------------------------
159 ASTM F1717-04: Standard Withdrawn and 181
Test Methods for replaced
Spinal Implant with newer
Constructs in a version
Vertebrectomy Model
------------------------------------------------------------------------
173 ASTM F1800-04: Standard Withdrawn and 182
Test Method for Cyclic replaced
Fatigue Testing of with newer
Metal Tibial Tray version
Components of Total
Knee Joint
Replacements
------------------------------------------------------------------------
K. Radiology
------------------------------------------------------------------------
1 ANSI PH 2.43-1982: Contact .................
Method for person
Sensitometry/Medical X-
Ray Screen-Film
------------------------------------------------------------------------
2 ANSI IT 1.48-1997 Title and .................
Photography (Films)-- contact
Medical Hard Copy person
Imaging Film-
Dimensions and
Specifications
------------------------------------------------------------------------
5 ANSI PH 2.50-1983: Contact .................
Method/Sensitometry person
Direct Exposure
Medical/Dental
------------------------------------------------------------------------
6 IEC 60806 (R1984) Title and .................
Determination of the contact
Maximum Symmetrical person
Radiation Field From a
Rotating Anode X-ray
Tube for Medical
Diagnosis
------------------------------------------------------------------------
8 IEC 60336 (R1993) Title .................
Medical Electrical
Equipment--X-ray Tube
Assemblies for Medical
Diagnosis--Characteris
tics of Focal Spots
------------------------------------------------------------------------
23 NEMA XR 10-1986 (R2003) Reaffirmation .................
Measurement of the
Maximum Symmetrical
Radiation Field from a
Rotating Anode X-Ray
Tube Used for Medical
Diagnosis
------------------------------------------------------------------------
[[Page 67720]]
34 IEC 60601-2-7-1998 Tile and .................
Medical Electrical contact
Equipment--Part 2-7: person
Particular
Requirements for the
Safety of High-Voltage
Generators of
Diagnostic X-ray
Generators
------------------------------------------------------------------------
37 IEC 60601-2-11-2004 133
Amendment 1--Medical
electrical equipment--
Part 2-11: Particular
requirements for the
Safety of Gamma Beam
Therapy Equipment
Withdrawn and Replaced
With Newer Version
------------------------------------------------------------------------
52 UL 544 (1998): Standard Contact .................
for Medical and Dental person
Equipment--Ed. 4.0
------------------------------------------------------------------------
56 IEC 61674-1997 Medical Withdrawn .................
Electrical Equipment--
Dosimeters With
Ionization Chambers
and/or Semi-Conductor
Detectors as Used in X-
ray Diagnostic Imaging
------------------------------------------------------------------------
57 IEC 60731-1997 Medical Title and .................
Electrical Equipment-- devices
Dosimeters With affected
Ionization Chambers as
Used in Radiotherapy
------------------------------------------------------------------------
61 UL 122 (1999): Standard Contact .................
for Photographic person
Equipment--Ed. 4.0
------------------------------------------------------------------------
62 UL 187 (1998): Standard Contact .................
for X-Ray Equipment-- person
Ed. 7.0
------------------------------------------------------------------------
79 NEMA XR 7-1995 (R2000) Title and .................
High-Voltage X-Ray contact
Cable Assemblies and person
Receptacles
------------------------------------------------------------------------
80 NEMA XR 9-1984 (R1994, Contact .................
R2000) Power Supply person
Guidelines for X-Ray
Machines
------------------------------------------------------------------------
81 NEMA XR 13-1990 (R1995, Contact .................
R2000) Mechanical person
Safety Standard for
Power Driven Motions
of Electromedical
Equipment
------------------------------------------------------------------------
82 NEMA XR 14-1990 (R1995, Contact .................
R2000) Recommended Person
Practices for Load
Bearing Mechanical
Assemblies Used in
Diagnostic Imaging
------------------------------------------------------------------------
89 ISO 11810:2002 Optics Withdrawn .................
and Optical Newer
Instruments--Lasers version
and Laser-Related recognized
Equipment--Test Method under
for the Laser- General
Resistance of Surgical Hospital/
Drapes and/or Patient- General
Protective Covers Plastic
Surgery
------------------------------------------------------------------------
107 ISO 11146-1:2005 Lasers Withdrawn and 134
and Laser-Related replaced
Equipment--Test with newer
Methods for Laser Beam version
Widths, Divergence
Angles and Beam
Propagation Ratios--
Part 1: Stigmatic and
Simple Astigmatic
Beams
------------------------------------------------------------------------
119 NEMA PS 3.1--3.18 Title .................
Digital Imaging and
Communications in
Medicine (DICOM) Set
------------------------------------------------------------------------
126 IEC 60601-2-28-1993 Title and .................
Medical Electrical contact
Equipment--Part 2: person
Particular
Requirements for the
Safety of X-ray Source
Assemblies and X-ray
Tube Assemblies for
Medical Diagnosis--Ed.
1.0
------------------------------------------------------------------------
127 IEC 60601-2-32-1994 Title and .................
Medical Electrical contact
Equipment--Part 2: person
Particular
Requirements for the
Safety of Associated
Equipment of X-ray
Equipment--Ed. 1.0
------------------------------------------------------------------------
129 NEMA NU 1-2001 (Errata Title .................
2004): Performance
Measurements of
Scintillation Cameras
------------------------------------------------------------------------
131 IEC 61217-2002 Title .................
Radiotherapy
Equipment--Coordinates
Movements and Scales
Consolidated Ed. 1.1
------------------------------------------------------------------------
132 IEC 60731-2002 Title and .................
Amendment 1--Medical devices
Electrical Equipment-- affected
Dosimeters With
Ionization Chambers as
Used in Radiotherapy
------------------------------------------------------------------------
L. Sterility
------------------------------------------------------------------------
48 ANSI/AAMI ST40:2004, Withdrawn and 152
Table-Top Dry Heat replaced
(Heated Air) with newer
Sterilization and version
Sterility Assurance in
Dental and Medical
Facilities, 2ed
------------------------------------------------------------------------
[[Page 67721]]
52 ANSI/AAMI ST59:1999, Title, .................
Sterilization of relevant
Health Care Products-- guidance,
Biological Indicators and contact
Part 1: General person
------------------------------------------------------------------------
70 ANSI/AAMI/ISO Contact .................
14161:2000, Person
Sterilization of
Health Care Products--
Biological Indicators--
Guidance for the
Selection, Use, and
Interpretation of
Results, 2ed.
------------------------------------------------------------------------
71 ANSI/AAMI ST8:2001, Contact .................
Hospital Steam Person
Sterilizers
------------------------------------------------------------------------
77 ANSI/AAMI ST24:1999, Title and .................
Automatic, General contact
Purpose Ethylene Oxide person
Sterilizers and
Ethylene Oxide
Sterilant Sources
Intended for Use in
Health Care
Facilities, 3ed.
------------------------------------------------------------------------
116 ANSI/AAMI ST72:2002, Relevant .................
Bacterial Endotoxins-- guidance
Test Methodologies,
Routine Monitoring,
and Alternatives to
Batch Testing
------------------------------------------------------------------------
117 ANSI/AAMI ST35:2003, Relevant .................
Safe Handling and guidance and
Biological contact
Decontamination of person
Medical Devices in
Health Care Facilities
and in Nonclinical
Settings
------------------------------------------------------------------------
119 ANSI/AAMI ST55:2003, Correct title .................
Table-Top Steam and contact
Sterilizers, 2ed. person
------------------------------------------------------------------------
124 USP 28:2005, Biological Withdrawn and 153
Indicator for Dry Heat replaced
Sterilization, Paper with newer
Carrier version
------------------------------------------------------------------------
125 USP 28:2005, Biological Withdrawn and 154
Indicator for Ethylene replaced
Oxide Sterilization, with newer
Paper Carrier version
------------------------------------------------------------------------
126 USP 28:2005, Biological Withdrawn and 155
Indicator for Steam replaced
Sterilization, Paper with newer
Carrier version
------------------------------------------------------------------------
127 USP28:2005, <61> Withdrawn and 156
Microbial Limits Test replaced
with newer
version
------------------------------------------------------------------------
128 USP 28:2005, <71>, Withdrawn and 157
Microbiological Tests, replaced
Sterility Tests with newer
version
------------------------------------------------------------------------
129 USP28:2005, <85>, Withdrawn and 158
Biological Tests and replaced
Assays, Bacterial with newer
Endotoxin Test (LAL) version
------------------------------------------------------------------------
130 USP28:2005 <151>, Withdrawn and 159
Pyrogen Test (USP replaced
Rabbit Test) with newer
version
------------------------------------------------------------------------
131 USP28:2005 <1211>, Withdrawn 160
Sterilization and and replaced
Sterility Assurance of with newer
Compendial Articles version
------------------------------------------------------------------------
132 USP28:2005 <161>, Withdrawn and 161
Transfusion and replaced
Infusion Assemblies with newer
and Similar Medical version
Devices
------------------------------------------------------------------------
133 USP 28:2005, Biological Withdrawn and 162
Indicator for Steam replaced
Sterilization--Self- with newer
Contained version
------------------------------------------------------------------------
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: 013, follows:
------------------------------------------------------------------------
Item No. Title of Standard Reference No. and Date
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
65 Medical Electrical Equipment-- ISO 21647:2005
Particular Requirements for
the Basic Safety and Essential
Performance of Respiratory Gas
Monitors
------------------------------------------------------------------------
66 Medical Electrical Equipment-- ISO 9919:2005
Particular Requirements for
the Basic Safety and Essential
Performance of Pulse Oximeter
Equipment for Medical Use
------------------------------------------------------------------------
[[Page 67722]]
B. Dental/Ear, Nose, Throat
------------------------------------------------------------------------
127 Root Canal Files, Type H ANSI/ADA Specification
(Hedstrom) No. 58:2004
------------------------------------------------------------------------
128 Dentistry--Elastomeric ISO/4823:2000 Technical
Impression Materials Corrigendum 1:2004
------------------------------------------------------------------------
129 Dentistry--Elastomeric ANSI/ADA Specification
Impression Materials No. 19:2000 Technical
Corrigendum 1:2004
------------------------------------------------------------------------
C. General
------------------------------------------------------------------------
34 Medical Electrical Equipment-- IEC 60601-1-2:2004
Part 1-2: General Requirements
for Safety--Collateral
Standard: Electromagnetic
Compatibility--Requirements
and tests (Edition 2:2001 with
Amendment 1:2004; Edition 2.1
(Edition 2:2001 Consolidated
With Amendment 1:2004))
------------------------------------------------------------------------
35 Medical Electrical Equipment-- AAMI/IEC 60601-1-2:2001
Part 1-2: General Requirements
for Safety--Collateral
standard: Electromagnetic
Compatibility--Requirements
and Tests (Edition 2:2001 with
Amendment 1:2004)
------------------------------------------------------------------------
D. General Hospital/General Plastic Surgery
------------------------------------------------------------------------
142 Medical Electrical Equipment-- ANSI/AAMI II36:2004
Part 2: Particular
Requirements for Safety of
Baby Incubators
------------------------------------------------------------------------
143 Medical Electrical Equipment-- ANSI/AAMI II51:2004
Part 2: Particular
Requirements for Safety of
Transport Incubators
------------------------------------------------------------------------
E. In Vitro Diagnostic
------------------------------------------------------------------------
109 Laboratory Automation: Data CLSI AUTO7-A:2004
Content for Specimen
Identification; Approved
Standard
------------------------------------------------------------------------
111 Collection, Transport, and CLSI H21-A4:2003
Processing of Blood Specimens
for Testing Plasma-Based
Coagulation Assays; Approved
Guideline--Fourth Edition
------------------------------------------------------------------------
112 Point-of-Care Monitoring of CLSI H49-A:2004
Anticoagulation Therapy;
Approved Guideline
------------------------------------------------------------------------
113 Assessing the Quality of CLSI I/LA23-A:2004
Immunoassay Systems:
Radioimmunoassays, and Enzyme,
Fluorescence, and Luminescence
Immunoassays; Approved
Guideline
------------------------------------------------------------------------
114 Standard Specification for Low- CLSI LIS01-A:2003
Level Protocol to Transfer
Messages Between Clinical
Laboratory Instruments and
Computer Systems
------------------------------------------------------------------------
115 Standard Specification for CLSI LIS02-A2:2004
Transferring Information
Between Clinical Instruments
and Computer Systems; Approved
Standard--Second Edition
------------------------------------------------------------------------
116 Standard Guide for Selection of CLSI LIS03-A:2003
a Clinical Laboratory
Information Management System
------------------------------------------------------------------------
117 Standard Guide for CLSI LIS04-A:2003
Documentation of Clinical
Laboratory Computer Systems
------------------------------------------------------------------------
118 Standard Specification for CLSI LIS05-A:2003
Transferring Clinical
Observations Between
Independent Computer Systems
------------------------------------------------------------------------
119 Standard Practice for Reporting CLSI LIS06-A:2003
Reliability of Clinical
Laboratory Information Systems
------------------------------------------------------------------------
120 Standard Specification for Use CLSI LIS07-A:2003
of Bar Codes on Specimen Tubes
in the Clinical Laboratory
------------------------------------------------------------------------
121 Standard Guide for Functional CLSI LIS08-A:2003
Requirements of Clinical
Laboratory Information
Management Systems
------------------------------------------------------------------------
122 Standard Guide for Coordination CLSI LIS09-A:2003
of Clinical Laboratory
Services Within the Electronic
Health Record Environment and
Networked Architectures
------------------------------------------------------------------------
[[Page 67723]]
123 Nucleic Acid Sequencing Methods CLSI MM9-A:2004
in Diagnostic Laboratory
Medicine
------------------------------------------------------------------------
F. Materials
------------------------------------------------------------------------
118 Standard Practice for Marking ASTM F2503-05
Medical Devices and Other
Items for Safety in the
Magnetic Resonance Environment
------------------------------------------------------------------------
G. OB-GYN/Gastroenterology
------------------------------------------------------------------------
36 Mechanical contraceptives-- ISO 8009:2004(E)
Reusable Natural and Silicone
Rubber Contraceptive
Diaphragms--Requirements and
Tests
------------------------------------------------------------------------
H. Radiology
------------------------------------------------------------------------
135 Medical electrical equipment-- IEC 60601-2-5:2000
Part 2-5: Particular
Requirements for the Safety of
Ultrasonic Physiotherapy
Equipment Ed. 2.0
------------------------------------------------------------------------
I. Sterility
------------------------------------------------------------------------
163 Sterilization of Medical ANSI/AAMI/ISO 11737-
Devices--Microbiological 3:2004
methods--Part 3: Guidance on
Evaluation and Interpretation
of Bioburden Data
------------------------------------------------------------------------
164 Sterilization of Medical ANSI/AAMI ST81:2004
Devices--Information To Be
Provided by the Manufacturer
for the Processing of
Resterilizable Medical Devices
------------------------------------------------------------------------
165 Cleanrooms and Associated ISO 14644-5:2004
Controlled Environments--Part
5: Operations
------------------------------------------------------------------------
166 Cleanrooms and Associated ISO 14644-7:2004
Controlled Environments--Part
7: Separative Devices (Clean
Air Hoods, Gloveboxes,
Isolators and Mini-
Environments)
------------------------------------------------------------------------
J. Tissue Engineering
------------------------------------------------------------------------
6 Standard Guide for Assessing ASTM F2450-04
Microstructure of Polymeric
Scaffolds for Use in Tissue
Engineered Medical Products
------------------------------------------------------------------------
7 Standard Guide for ASTM F2315-03
Immobilization or
Encapsulation of Living Cells
or Tissue in Alginate Gels
------------------------------------------------------------------------
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'' on 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 notice announcing ``Modifications to the
List of Recognized Standards, Recognition List Number: 013'' will be
available on the CDRH home page. You may access the CDRH home page at
http://www.fda.gov/cdrh.
You may access ``Guidance on the Recognition and Use of Consensus
Standards,'' and the searchable database for ``FDA Recognized Consensus
Standards'' through the hyperlink at http://www.fda.gov/cdrh/stdsprog.html.
[[Page 67724]]
This Federal Register document on modifications in FDA's
recognition of consensus standards is available at http://www.fda.gov/cdrh/fedregin.html.
VII. Submission of Comments and Effective Date
Interested persons may submit to the contact person (see FOR
FURTHER INFORMATION CONTACT) written or electronic comments regarding
this document. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified with the docket number found
in brackets in the heading of this document. FDA will consider any
comments received in determining whether to amend the current listing
of modifications to the list of recognized standards, Recognition List
Number: 013. These modifications to the list or recognized standards
are effective upon publication of this notice in the Federal Register.
Dated: October 10, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-22267 Filed 11-7-05; 8:45 am]
BILLING CODE 4160-01-S