Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 013, 67713-67724 [05-22267]
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Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices
records are both relevant and necessary
to the litigation.
B. Additional Provisions Affecting
Routine Use Disclosures. This system
contains Protected Health Information
(PHI) as defined by HHS regulation
‘‘Standards for Privacy of Individually
Identifiable Health Information’’ (45
CFR Parts 160 and 164, Subparts A and
E , 65 Fed. Reg. 82462 (12–28–00)).
Disclosures of PHI authorized by these
routine uses may only be made if, and
as, permitted or required by the
‘‘Standards for Privacy of Individually
Identifiable Health Information.’’
In addition, our policy will be to
prohibit release even of not directly
identifiable information, except
pursuant to one of the routine uses or
if required by law, if we determine there
is a possibility that an individual can be
identified through implicit deduction
based on small cell sizes (instances
where the patient population is so small
that individuals who are familiar with
the enrollees could, because of the small
size, use this information to deduce the
identity of the beneficiary).
POLICIES AND PRACTICES FOR STORING,
RETRIEVING, ACCESSING, RETAINING, AND
DISPOSING OF RECORDS IN THE SYSTEM:
RETENTION AND DISPOSAL:
Records are maintained in a secure
storage area with identifiers. Disposal
occurs 6 years and 3 months from the
time the individual accesses the
MPDPF.
SYSTEM MANAGER AND ADDRESS:
Director, Beneficiary Information
Services Group, Center for Beneficiary
Choices, CMS, Mail Stop S1–01–26,
7500 Security Boulevard, Baltimore,
Maryland, 21244–1850.
NOTIFICATION PROCEDURE:
STORAGE:
For purpose of access, the subject
individual should write to the system
manager who will require the system
name, HICN, and for verification
purposes, the subject individual’s name
(woman’s maiden name, if applicable).
Computer diskette and on magnetic
storage media.
RETRIEVABILITY:
Information can be retrieved by the
individual identifiable information of
the beneficiary.
RECORD ACCESS PROCEDURE:
SAFEGUARDS:
CMS has safeguards in place for
authorized users and monitors such
users to ensure against excessive or
unauthorized use. Personnel having
access to the system have been trained
in the Privacy Act and information
security requirements. Employees who
maintain records in this system are
instructed not to release data until the
intended recipient agrees to implement
appropriate management, operational
and technical safeguards sufficient to
protect the confidentiality, integrity and
availability of the information and
information systems and to prevent
unauthorized access.
This system will conform to all
applicable Federal laws and regulations
and Federal, HHS, and CMS policies
and standards as they relate to
information security and data privacy.
These laws and regulations include but
are not limited to: the Privacy Act of
1974; the Federal Information Security
Management Act of 2002; the Computer
Fraud and Abuse Act of 1986; the
Health Insurance Portability and
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Accountability Act of 1996; the EGovernment Act of 2002, the ClingerCohen Act of 1996; the Medicare
Modernization Act of 2003, and the
corresponding implementing
regulations. OMB Circular A–130,
Management of Federal Resources,
Appendix III, Security of Federal
Automated Information Resources also
applies. Federal, HHS, and CMS
policies and standards include but are
not limited to: all pertinent National
Institute of Standards and Technology
publications; HHS Information Systems
Program Handbook and the CMS
Information Security Handbook.
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For purpose of access, use the same
procedures outlined in Notification
Procedures above. Requestors should
also reasonably specify the record
contents being sought. (These
procedures are in accordance with
Department regulation 45 CFR 5b.5
(a)(2).)
CONTESTING RECORD PROCEDURES:
The subject individual should contact
the system manager named above, and
reasonably identify the record and
specify the information to be contested.
State the corrective action sought and
the reasons for the correction with
supporting justification. (These
procedures are in accordance with
Department regulation 45 CFR 5b.7.)
RECORD SOURCE CATEGORIES:
Sources of information contained in
this records system include data
collected from the initial voluntary
inquiry made by or on behalf of the
individual and validated through the
Medicare Beneficiary Database.
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67713
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
OF THE ACT:
None.
[FR Doc. 05–22192 Filed 11–7–05; 8:45 am]
BILLING CODE 4120–03–P
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: standards@cdrh.fda.gov. This
document may also be accessed on
FDA’s Internet site at https://
www.fda.gov/cdrh/fedregin.html. See
section VI of this document for
electronic access to the searchable
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Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices
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.
Old Item No.
Standard
Change
Replacement Item
No.
A. Anesthesia
52
ASTM F1463–93 (1999), Standard Specification for Alarm Signals
in Medical Equipment Used in Anesthesia and Respiratory Care
Withdrawn
1
ASTM E1262–88 (2003), Standard Guide for Performance of the
Chinese Hamster Ovary Cell/Hypoxanthine Guanine
Phosphoribosyl Transferase Gene Mutation Assay
Withdrawn and replaced with
newer version
83
2
ASTM E1263–97 (2003), Standard Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow Erythrocytes
Withdrawn and replaced with
newer version
84
3
ASTM E1280–97 (2003), Standard Guide for Performing the
Mouse Lymphoma Assay for Mammalian Cell Mutagenicity
Withdrawn and replaced with
newer version
85
19
AAMI/ANSI/ISO10993–10: 2002(E), Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Sensitization
Withdrawn and replaced with
newer version
86
20
AAMI/ANSI/ISO10993–10: 2002(E), Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Sensitization—
Maximization Sensitization Test
Withdrawn and replaced with
newer version
87
21
AAMI/ANSI/ISO10993–11:1993, Biological Evaluation of Medical
Devices—Part 11: Tests for Systemic Toxicity
Extent of Recognition and
Relevant Guidance
28
AAMI/ANSI/ISO10993–12:2002(E), Biological Evaluation of Medical
Devices—Part 12: Sample Preparation and Reference Materials
Withdrawn and replaced with
newer version
88
34
ASTM F749–98 (2002)e2, Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
Withdrawn and replaced with
newer version
89
B. Biocompatibility
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TABLE 1.—Continued
Old Item No.
Standard
Change
Replacement Item
No.
37
ASTM E1397–91 (2003), Standard Practice for the In Vitro Rat
Hepatocyte DNA Repair Assay
Withdrawn and replaced with
newer version
90
38
ASTM E1398–91 (2003), Standard Practice for the In Vivo Rat
Hepatocyte DNA Repair Assay
Withdrawn and replaced with
newer version
91
39
ASTM F748–04, Standard Practice for Selecting Generic Biological
Test Methods for Materials and Devices
Withdrawn and replaced with
newer version
92
40
ASTM F763–04, Standard Practice for Short-Term Screening of
Implant Materials
Withdrawn and replaced with
newer version
93
41
ASTM F981–04, Standard Practice for Assessment of Compatibility
of Biomaterials for Surgical Implants with Respect to Effect of
Materials on Muscle and Bone
Withdrawn and replaced with
newer version
94
42
ASTM F1984–99 (2003), Standard Practice for Testing for Whole
Complement Activation in Serum by Solid Materials
Withdrawn and replaced with
newer version
95
43
ASTM F1903–98 (2003), Standard Practice for Testing for Biological Responses to Particles In Vitro
Withdrawn and replaced with
newer version
96
45
ASTM F1983–99 (2003), Standard Practice for Assessment of
Compatibility of Absorbable/Resorbable Biomaterials for Implant
Applications
Withdrawn and replaced with
newer version
97
51
AAMI/ANSI/ISO10993–1: 2003(E), Biological Evaluation of Medical
Devices—Part 1: Evaluation and Testing
Withdrawn and replaced with
newer version
98
52
ASTM F1904–98e1 (2003), Standard Practice for Testing for Biological Responses to Particles In Vivo
Withdrawn and replaced with
newer version
99
53
ASTM E1372–95 (2003), Standard Test Method for Conducting a
90-Day Oral Toxicity Study in Rats
Withdrawn and replaced with
newer version
100
70
ASTM F750–87 (2002)e1, Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse
Relevant guidance
74
USP 28–NF21Biological Tests <87>, Biological Reactivity Test, In
Vitro—Direct Contact Test
Withdrawn and replaced with
newer version
101
75
USP 28–NF21Biological Tests <87>, Biological Reactivity Test, In
Vitro—Elution Test
Withdrawn and replaced with
newer version
102
76
USP 28–NF21Biological Tests <88>, Biological Reactivity Test, In
Vivo Procedure—Preparation of Sample
Withdrawn and replaced with
newer version
103
77
USP 28–NF21Biological Tests <88>, Biological Reactivity Test, In
Vitro, Classification of Plastics—Intracutaneous Test
Withdrawn and replaced with
newer version
104
78
USP 28–NF21Biological Tests <88>, Biological Reactivity Test, In
Vitro, Classification of Plastics—Systemic Injection Test
Withdrawn and replaced with
newer version
105
79
ASTM F619–03, Standard Practice for Extraction of Medical Plastics
Withdrawn and replaced with
newer version
106
80
ASTM F1877 (2003)e1, Standard Practice for Characterization of
Particles
Withdrawn and replaced with
newer version
107
81
ASTM F1905 (2003)e1, Standard Practice for Selecting Tests for
Determining the Propensity of Materials to Cause Immunotoxicity
Withdrawn and replaced with
newer version
108
B. Cardiovascular/Neurology
4
ANSI/AAMI SP10:2002—Manual, Electronic, or Automated Sphygmomanometers
Withdrawn and replaced with
newer version
53
5
ANSI/AAMI/ISO 7198:1998/2001(R) 2004, Cardiovascular Implants—Tubular vascular prostheses
Withdrawn and replaced with
newer version
54
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TABLE 1.—Continued
Old Item No.
Replacement Item
No.
Standard
Change
14
ASTM F1830:05, Recommended Practice for Selection of Blood for
In Vitro Hemolytic Evaluation of Blood Pumps
Withdrawn and replaced with
newer version
55
15
ASTM F1841:05, Recommended Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
Withdrawn and replaced with
newer version
56
48
ASTM F2129:04, Test Method for Conducting Cyclic
Potentiodynamic Polarization Measurements to Determine the
Corrosion Susceptibility of Small Implant Devices
Withdrawn and replaced with
newer version
57
C. Dental/Ear, Nose, and Throat
29
IEC 60601–2–18:2000 Amendment 1, Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of
Endoscopic Equipment
Withdrawn and replaced with
newer version
122
40
ANSI/ASA S3.6–2004, Specification for Audiometers
Withdrawn and replaced with
newer version
123
41
ANSI/ASA S3.22:2003, Specification of Hearing Aid Characteristics
Withdrawn and replaced with
newer version
124
61
ISO 1562:2004, Dentistry—Casting gold alloys
Withdrawn and replaced with
newer version
125
82
ISO 10477:2004, Dentistry—Polymer-based crown and bridge materials
Withdrawn and replaced with
newer version
126
16
ASTM D903:1993, Test Methods for Peel or Stripping Strength of
Adhesive Bonds
Contact person
28
IEC 60601–1–2, (Second Edition), Medical Electrical Equipment—
Part 1–2: General Requirements for Safety—Collateral Standard:
Electromagnetic Compatibility—Requirements and Tests
Extent of recognition
30
AAMI/IEC 60601–1–2, Medical Electrical Equipment—Part 1–2:
General Requirements for Safety—Collateral standard: Electromagnetic Compatibility—Requirements and Tests (Edition
2:2001)
Title and extent of recognition
2
IEC 60601–1, Medical Electrical Equipment—Part 1: General Requirements for Safety
Withdrawn
4
IEC 60601–1, Medical Electrical Equipment—Part 1: General Requirements for Safety, 1988; Amendment 1, l991–11, Amendment 2, 1995–03
Contact person, devices affected and extent of recognition
D. General
E. General Hospital/General Plastic Surgery
18
ISO 8537:1991 Sterile Single-Use Syringes, With or Without Needle, for Insulin
Contact person
38
ASTM F1671–03: Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne
Pathogens Using Phi-X174 Bacteriophage Penetration as a Test
System.
Withdrawn and replaced with
newer version
130
48
ASTM D6499–03 Standard Test Method for the Immunological
Measurement of Antigenic Protein in Natural Rubber and its
Products
Withdrawn and replaced with
newer version
131
31 Ophthalmic
89 Radiology
ISO 11810–1:2005: Lasers and Laser-Related Equipment—Test
Method and Classification for the Laser-Resistance of Surgical
Drapes and/or Patient-Protective Covers—Part 1: Primary Ignition and Penetration
Transferred from Ophthalmic
and Radiology
132
97
USP 28: 2005 Nonabsorbable Surgical Suture
Withdrawn and replaced with
newer version
133
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67717
TABLE 1.—Continued
Old Item No.
Standard
Change
Replacement Item
No.
98
USP 28<11>: 2005 Sterile Sodium Chloride for Irrigation
Withdrawn and replaced with
newer version
134
99
USP 28: 2005 Absorbable Surgical Suture
Withdrawn and replaced with
newer version
135
100
USP 28<881>: 2005 Tensile Strength
Withdrawn and replaced with
newer version
136
101
USP 28<861>: 2005 Sutures—Diameter
Withdrawn and replaced with
newer version
137
102
USP 28<871>: 2005 Sutures Needle Attachment
Withdrawn and replaced with
newer version
138
103
USP 28<11>: 2005 Sterile Water for Irrigation
Withdrawn and replaced with
newer version
139
104
USP 28<11>: 2005 Heparin Lock Flush Solution
Withdrawn and replaced with
newer version
140
105
USP 28<11>: 2005 Sodium Chloride Injection
Withdrawn and replaced with
newer version
141
11
ISO 594–1:1986 Conical Fittings With a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment—Part 1:
General Requirements
Title and contact person
13
ISO 595–1:1986 Reusable All-Glass or Metal-and-Glass Syringes
for Medical Use—Part 1: Dimensions
Title and contact person
14
ISO 595–2:1987 Reusable All-Glass or Metal-and-Glass Syringes
for Medical Use—Part 2: Design, Performance Requirements
and Tests
Title and contact person
15
ISO 7864:1993 Sterile Hypodermic Needles for Single Use
Contact person
16
ISO 7886–1:1993 Sterile Hypodermic Syringes for Single Use—
Part 1: Syringes for Manual Use
Title and contact person
62
ISO 8536–6:1995 Infusion Equipment for Medical Use—Part 6:
Freeze Drying Closures for Infusion Bottles
Title and contact person
63
ISO 8536–7–1999: Infusion Equipment for Medical Use—Part 7:
Caps Made of Aluminum-Plastics Combinations for Infusion Bottles
Contact Person
64
ISO 8536–3–1999: Infusion Equipment for Medical Use—Part 3:
Aluminum Caps for Infusion Bottles
Title and contact person
66
ISO 8536–1–2000: Infusion equipment for medical use—Part 1: Infusion glass bottles
Title and Contact Person
68
ISO 7886–2–1996: Sterile Hypodermic Syringes for Single Use—
Part 2: Syringes for Use With Power-Driven Syringe Pumps
Title and contact person
69
ISO 9626–1991: Stainless Steel Needle Tubing for the Manufacture of Medical Devices
Title and contact person
70
ASTM E825–98 (2003) Standard Specification for Phase ChangeType Disposable Fever Thermometer for Intermittent Determination of Human Temperature
Contact person
111
IEC 60601–2–38 Medical Electrical Equipment—Part 2: Particular
Requirements for the Safety of Electrically Operated Hospital
Beds
Contact person
119
AAMI BF7: (R2002) Blood Transfusion Micro-Filters
Contact person
120
ASTM F1054–01: Standard Specification for Conical Fittings
Contact person
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TABLE 1.—Continued
Old Item No.
Standard
Change
Replacement Item
No.
121
ISO 8536–2–2001: Infusion Equipment for Medical Use—Part 2:
Closures for Infusion Bottles
Contact person
122
ISO 8536–5–2004: Infusion Equipment for Medical Use—Part 5:
Burette Infusion Sets for Single Use, Gravity Feed
Title and contact person
126
ISO 8536–4–2004: Infusion Equipment for Medical Use—Part 4:
Infusion Sets for Single Use, Gravity Feed
Contact person
127
ISO 1135–4–2004: Transfusion Equipment for Medical Use—Part
4: Transfusion Sets for Single Use
Contact person
129
ISO 594–2:1998 Conical Fittings With a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment—Part 2:
Lock Fittings
Contact person
65
CLSI EP5–A2, Evaluation of Precision Performance of Quantitative
Measurement Methods; Approved Guideline—Second Edition
Withdrawn and replaced with
new version
54
CLSI D12–A2, Immunoprecipitin Analyses: Procedures for Evaluating the Performance of Materials—Second Edition; Approved
Guideline
Product codes
9
ASTM F563–00: Standard Specification for Wrought Cobalt-20
Nickel-20 Chromium-3.5 Molybdenum-3.5 Tungsten-5 Iron Alloy
for Surgical Implant Applications (UNS R30563)
Withdrawn
13
ASTM F648–04: Standard Specification for Ultra-High-MolecularWeight Polyethylene Powder and Fabricated Form for Surgical
Implants
Withdrawn and replaced with
newer version
106
16
ASTM F746–04: Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
Withdrawn and replaced with
newer version
107
25
ASTM F1295–05: Standard Specification for Wrought Titanium–6
Aluminum–7 Niobium Alloy for Surgical Implant Applications
(UNS R56700)
Withdrawn and replaced with
newer version
108
34
ASTM F1659–95: Standard Test Method for Bending and Shear
Fatigue Testing of Calcium Phosphate Coatings on Solid Metallic
Substrates
Withdrawn
72
ASTM F2213–04: Standard Test Method for Measurement of Magnetically Induced Torque on Passive Implants in the Magnetic
Resonance Environment
Title
73
ASTM F561–05, Practice for Retrieval and Analysis of Implanted
Medical Devices, and Associated Tissues
Withdrawn and replaced with
newer version
109
74
ASTM F1377–04: Standard Specification for Cobalt–28 Chromium–
6 Molybdenum Powder for Coating of Orthopedic Implants (UNS
R30075)
Withdrawn and replaced with
newer version
110
75
ASTM F1160–05: Standard Test Method for Shear and Bending
Fatigue Testing of Calcium Phosphate and Metallic Medical and
Composite Calcium Phosphate/Metallic Coatings
Withdrawn and replaced with
newer version
111
80
ASTM F1088–04a: Standard Specification for Beta-Tricalcium
Phosphate for Surgical Implantation
Title
83
ASTM F1044–05: Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
Withdrawn and replaced with
newer version
112
84
ASTM F1147–05: Standard Test Method for Tension Testing of
Calcium Phosphate and Metal Coatings
Withdrawn and replaced with
newer version
113
F. In Vitro Diagnostic
110
G. Materials
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TABLE 1.—Continued
Old Item No.
Replacement Item
No.
Standard
Change
90
ASTM F2255–05: Standard Test Method for Strength Properties of
Tissue Adhesives in Lap Shear by Tension Loading
Withdrawn and replaced with
newer version
114
91
ASTM F2256–05: Standard Test Method for Strength Properties of
Tissue Adhesives in T-Peel by Tension Loading
Withdrawn and replaced with
newer version
115
92
ASTM F2258–05: Standard Test Method for Strength Properties of
Tissue Adhesives in Tension
Withdrawn and replaced with
newer version
116
93
ASTM F86–04: Standard Practice for Surface Preparation and
Marking of Metallic Surgical Implants
Withdrawn and replaced with
newer version
117
H. OB-GYN/Gastroenterology
1
AAMI RD5:1992: Hemodialysis systems
Withdrawn
17
ASTM D3492–03: Standard Specification for Rubber Contraceptives (Male Condoms)
Withdrawn and replaced with
newer version
32
24
ASTM F623–99e1: Standard Performance Specification for Foley
Catheter
Withdrawn and replaced with
newer version
33
26
ISO 4074:2002/Cor.1:2003(E): Natural Latex Rubber Condoms—
Requirements and Test Methods, Technical Corrigendum 1
Withdrawn and replaced with
newer version
34
27
ASTM D6324–99a (Reapproved 2004): Standard Test Methods for
Male Condoms Made From Synthetic Materials
Withdrawn and replaced with
newer version
35
ISO 11810:2002, Optics and Optical Instruments—Lasers and
Laser-Related Equipment—Test Method for the Laser-Resistance of Surgical Drapes and/or Patient-Protective Covers
Withdrawn newer version
recognized under General
Hospital/ General Plastic
Surgery
126
ASTM F366–04: Standard Specification for Fixation Pins and
Wires
Withdrawn and replaced with
newer version
180
159
ASTM F1717–04: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
Withdrawn and replaced with
newer version
181
173
ASTM F1800–04: Standard Test Method for Cyclic Fatigue Testing
of Metal Tibial Tray Components of Total Knee Joint Replacements
Withdrawn and replaced with
newer version
182
1
ANSI PH 2.43–1982: Method for Sensitometry/Medical X-Ray
Screen-Film
Contact person
2
ANSI IT 1.48–1997 Photography (Films)—Medical Hard Copy Imaging Film-Dimensions and Specifications
Title and contact person
5
ANSI PH 2.50–1983: Method/Sensitometry Direct Exposure Medical/Dental
Contact person
6
IEC 60806 (R1984) Determination of the Maximum Symmetrical
Radiation Field From a Rotating Anode X-ray Tube for Medical
Diagnosis
Title and contact person
8
IEC 60336 (R1993) Medical Electrical Equipment—X-ray Tube Assemblies for Medical Diagnosis—Characteristics of Focal Spots
Title
23
NEMA XR 10–1986 (R2003) Measurement of the Maximum Symmetrical Radiation Field from a Rotating Anode X-Ray Tube
Used for Medical Diagnosis
Reaffirmation
I. Ophthalmic
31
J. Orthopedic
K. Radiology
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Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices
TABLE 1.—Continued
Old Item No.
Standard
Change
34
IEC 60601–2–7–1998 Medical Electrical Equipment—Part 2–7:
Particular Requirements for the Safety of High-Voltage Generators of Diagnostic X-ray Generators
Tile and contact person
37
IEC 60601–2–11–2004 Amendment 1—Medical electrical equipment—Part 2–11: Particular requirements for the Safety of
Gamma Beam Therapy Equipment Withdrawn and Replaced
With Newer Version
133
52
UL 544 (1998): Standard for Medical and Dental Equipment—Ed.
4.0
Contact person
56
IEC 61674–1997 Medical Electrical Equipment—Dosimeters With
Ionization Chambers and/or Semi-Conductor Detectors as Used
in X-ray Diagnostic Imaging
Withdrawn
57
IEC 60731–1997 Medical Electrical Equipment—Dosimeters With
Ionization Chambers as Used in Radiotherapy
Title and devices affected
61
UL 122 (1999): Standard for Photographic Equipment—Ed. 4.0
Contact person
62
UL 187 (1998): Standard for X-Ray Equipment—Ed. 7.0
Contact person
79
NEMA XR 7–1995 (R2000) High-Voltage X-Ray Cable Assemblies
and Receptacles
Title and contact person
80
NEMA XR 9–1984 (R1994, R2000) Power Supply Guidelines for
X-Ray Machines
Contact person
81
NEMA XR 13–1990 (R1995, R2000) Mechanical Safety Standard
for Power Driven Motions of Electromedical Equipment
Contact person
82
NEMA XR 14–1990 (R1995, R2000) Recommended Practices for
Load Bearing Mechanical Assemblies Used in Diagnostic Imaging
Contact Person
89
ISO 11810:2002 Optics and Optical Instruments—Lasers and
Laser-Related Equipment—Test Method for the Laser-Resistance of Surgical Drapes and/or Patient-Protective Covers
Withdrawn Newer version
recognized under General
Hospital/General Plastic
Surgery
107
ISO 11146–1:2005 Lasers and Laser-Related Equipment—Test
Methods for Laser Beam Widths, Divergence Angles and Beam
Propagation Ratios—Part 1: Stigmatic and Simple Astigmatic
Beams
Withdrawn and replaced with
newer version
119
NEMA PS 3.1—3.18 Digital Imaging and Communications in Medicine (DICOM) Set
Title
126
IEC 60601–2–28–1993 Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of X-ray Source Assemblies
and X-ray Tube Assemblies for Medical Diagnosis—Ed. 1.0
Title and contact person
127
IEC 60601–2–32–1994 Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of Associated Equipment of
X-ray Equipment—Ed. 1.0
Title and contact person
129
NEMA NU 1–2001 (Errata 2004): Performance Measurements of
Scintillation Cameras
Title
131
IEC 61217–2002 Radiotherapy Equipment—Coordinates Movements and Scales Consolidated Ed. 1.1
Title
132
IEC 60731–2002 Amendment 1—Medical Electrical Equipment—
Dosimeters With Ionization Chambers as Used in Radiotherapy
Title and devices affected
ANSI/AAMI ST40:2004, Table-Top Dry Heat (Heated Air) Sterilization and Sterility Assurance in Dental and Medical Facilities, 2ed
Withdrawn and replaced with
newer version
Replacement Item
No.
134
L. Sterility
48
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152
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Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices
TABLE 1.—Continued
Old Item No.
Replacement Item
No.
Standard
Change
52
ANSI/AAMI ST59:1999, Sterilization of Health Care Products—Biological Indicators Part 1: General
Title, relevant guidance, and
contact person
70
ANSI/AAMI/ISO 14161:2000, Sterilization of Health Care Products—Biological Indicators—Guidance for the Selection, Use,
and Interpretation of Results, 2ed.
Contact Person
71
ANSI/AAMI ST8:2001, Hospital Steam Sterilizers
Contact Person
77
ANSI/AAMI ST24:1999, Automatic, General Purpose Ethylene
Oxide Sterilizers and Ethylene Oxide Sterilant Sources Intended
for Use in Health Care Facilities, 3ed.
Title and contact person
116
ANSI/AAMI ST72:2002, Bacterial Endotoxins—Test Methodologies,
Routine Monitoring, and Alternatives to Batch Testing
Relevant guidance
117
ANSI/AAMI ST35:2003, Safe Handling and Biological Decontamination of Medical Devices in Health Care Facilities and in
Nonclinical Settings
Relevant guidance and contact person
119
ANSI/AAMI ST55:2003, Table-Top Steam Sterilizers, 2ed.
Correct title and contact person
124
USP 28:2005, Biological Indicator for Dry Heat Sterilization, Paper
Carrier
Withdrawn and replaced with
newer version
153
125
USP 28:2005, Biological Indicator for Ethylene Oxide Sterilization,
Paper Carrier
Withdrawn and replaced with
newer version
154
126
USP 28:2005, Biological Indicator for Steam Sterilization, Paper
Carrier
Withdrawn and replaced with
newer version
155
127
USP28:2005, <61> Microbial Limits Test
Withdrawn and replaced with
newer version
156
128
USP 28:2005, <71>, Microbiological Tests, Sterility Tests
Withdrawn and replaced with
newer version
157
129
USP28:2005, <85>, Biological Tests and Assays, Bacterial
Endotoxin Test (LAL)
Withdrawn and replaced with
newer version
158
130
USP28:2005 <151>, Pyrogen Test (USP Rabbit Test)
Withdrawn and replaced with
newer version
159
131
USP28:2005 <1211>, Sterilization and Sterility Assurance of
Compendial Articles
Withdrawn and replaced with
newer version
160
132
USP28:2005 <161>, Transfusion and Infusion Assemblies and
Similar Medical Devices
Withdrawn and replaced with
newer version
161
133
USP 28:2005, Biological Indicator for Steam Sterilization—SelfContained
Withdrawn and replaced with
newer version
162
III. Listing of New Entries
The listing of new entries and
consensus standards added as
Item No.
modifications to the list of recognized
standards under Recognition List
Number: 013, follows:
Title of Standard
Reference No. and Date
A. Anesthesia
65
Medical Electrical Equipment—Particular Requirements for the Basic
Safety and Essential Performance of Respiratory Gas Monitors
ISO 21647:2005
66
Medical Electrical Equipment—Particular Requirements for the Basic
Safety and Essential Performance of Pulse Oximeter Equipment
for Medical Use
ISO 9919:2005
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Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices
Item No.
Title of Standard
Reference No. and Date
B. Dental/Ear, Nose, Throat
127
Root Canal Files, Type H (Hedstrom)
ANSI/ADA Specification No. 58:2004
128
Dentistry—Elastomeric Impression Materials
ISO/4823:2000 Technical Corrigendum 1:2004
129
Dentistry—Elastomeric Impression Materials
ANSI/ADA Specification No. 19:2000 Technical
Corrigendum 1:2004
34
Medical Electrical Equipment—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))
IEC 60601–1–2:2004
35
Medical Electrical Equipment—Part 1–2: General Requirements for
Safety—Collateral standard: Electromagnetic Compatibility—Requirements and Tests (Edition 2:2001 with Amendment 1:2004)
AAMI/IEC 60601–1–2:2001
C. General
D. General Hospital/General Plastic Surgery
142
Medical Electrical Equipment—Part 2: Particular Requirements for
Safety of Baby Incubators
ANSI/AAMI II36:2004
143
Medical Electrical Equipment—Part 2: Particular Requirements for
Safety of Transport Incubators
ANSI/AAMI II51:2004
109
Laboratory Automation: Data Content for Specimen Identification;
Approved Standard
CLSI AUTO7–A:2004
111
Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays; Approved Guideline—
Fourth Edition
CLSI H21–A4:2003
112
Point-of-Care Monitoring of Anticoagulation Therapy; Approved
Guideline
CLSI H49–A:2004
113
Assessing the Quality of Immunoassay Systems:
Radioimmunoassays, and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guideline
CLSI I/LA23–A:2004
114
Standard Specification for Low-Level Protocol to Transfer Messages
Between Clinical Laboratory Instruments and Computer Systems
CLSI LIS01–A:2003
115
Standard Specification for Transferring Information Between Clinical
Instruments and Computer Systems; Approved Standard—Second
Edition
CLSI LIS02–A2:2004
116
Standard Guide for Selection of a Clinical Laboratory Information
Management System
CLSI LIS03–A:2003
117
Standard Guide for Documentation of Clinical Laboratory Computer
Systems
CLSI LIS04–A:2003
118
Standard Specification for Transferring Clinical Observations Between Independent Computer Systems
CLSI LIS05–A:2003
119
Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems
CLSI LIS06–A:2003
120
Standard Specification for Use of Bar Codes on Specimen Tubes in
the Clinical Laboratory
CLSI LIS07–A:2003
121
Standard Guide for Functional Requirements of Clinical Laboratory
Information Management Systems
CLSI LIS08–A:2003
122
Standard Guide for Coordination of Clinical Laboratory Services
Within the Electronic Health Record Environment and Networked
Architectures
CLSI LIS09–A:2003
E. In Vitro Diagnostic
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Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices
Item No.
123
Title of Standard
67723
Reference No. and Date
Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine
CLSI MM9–A:2004
Standard Practice for Marking Medical Devices and Other Items for
Safety in the Magnetic Resonance Environment
ASTM F2503–05
F. Materials
118
G. OB-GYN/Gastroenterology
36
Mechanical contraceptives—Reusable Natural and Silicone Rubber
Contraceptive Diaphragms—Requirements and Tests
ISO 8009:2004(E)
Medical electrical equipment—Part 2–5: Particular Requirements for
the Safety of Ultrasonic Physiotherapy Equipment Ed. 2.0
IEC 60601–2–5:2000
163
Sterilization of Medical Devices—Microbiological methods—Part 3:
Guidance on Evaluation and Interpretation of Bioburden Data
ANSI/AAMI/ISO 11737–3:2004
164
Sterilization of Medical Devices—Information To Be Provided by the
Manufacturer for the Processing of Resterilizable Medical Devices
ANSI/AAMI ST81:2004
165
Cleanrooms and Associated Controlled Environments—Part 5: Operations
ISO 14644–5:2004
166
Cleanrooms and Associated Controlled Environments—Part 7: Separative Devices (Clean Air Hoods, Gloveboxes, Isolators and MiniEnvironments)
ISO 14644–7:2004
H. Radiology
135
I. Sterility
J. Tissue Engineering
6
Standard Guide for Assessing Microstructure of Polymeric Scaffolds
for Use in Tissue Engineered Medical Products
ASTM F2450–04
7
Standard Guide for Immobilization or Encapsulation of Living Cells
or Tissue in Alginate Gels
ASTM F2315–03
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 https://
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
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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
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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 https://
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
https://www.fda.gov/cdrh/stdsprog.html.
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67724
Federal Register / Vol. 70, No. 215 / Tuesday, November 8, 2005 / Notices
This Federal Register document on
modifications in FDA’s recognition of
consensus standards is available at
https://www.fda.gov/cdrh/fedregin.html.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Submit written or electronic
comments on this draft guidance by
February 6, 2006.
ADDRESSES: Submit written requests for
single copies on a 3.5″ diskette of the
draft guidance document entitled ‘‘Class
II Special Controls Guidance Document:
Tinnitus Masker Devices’’ to the
Division of Small Manufacturers,
International, and Consumer Assistance
(HFZ–220), Center for Devices and
Radiological Health, Food and Drug
Administration, 1350 Piccard Dr.,
Rockville, MD 20850. Send one selfaddressed adhesive label to assist that
office in processing your request, or fax
your request to 301–443–8818. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
draft guidance.
Submit written comments concerning
this draft guidance to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://
www.fda.gov/dockets/ecomments.
Identify comments with the docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Teresa Cygnarowicz, Center for Devices
and Radiological Health (HFZ–460),
Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
301–594–2980.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
I. Background
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
[Docket No. 2005D–0344]
Draft Guidance for Industry and Food
and Drug Administration Staff; Class II
Special Controls Guidance Document:
Tinnitus Masker Devices; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Class II Special Controls
Guidance Document: Tinnitus Masker
Devices.’’ The draft guidance describes
a means by which tinnitus masker
devices may comply with the
requirement of special controls for class
II devices. Elsewhere in this issue of the
Federal Register, FDA is publishing a
proposed rule to amend the
classification regulations for the tinnitus
masker presently classified into class II
(special controls: labeling) to designate
a special control for these devices. The
draft guidance is neither final, nor is it
in effect at this time.
VerDate Aug<31>2005
16:11 Nov 07, 2005
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DATES:
Elsewhere in this issue of the Federal
Register, FDA is publishing a proposed
rule to amend the classification
regulations for tinnitus masker devices
presently classified into class II (special
controls: labeling) to designate a special
control for the devices. The draft
guidance document describes a means
by which the device may comply with
the requirement of special controls for
class II devices. Following the effective
date of a final rule based on the
proposed rule, any firm submitting a
510(k) premarket notification for the
device will need to address the issues
covered in the special control guidance.
However, the firm need only show that
its device meets the recommendations
of the guidance or in some other way
provides equivalent assurances of safety
and effectiveness.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on tinnitus masker devices. It does not
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create or confer any rights for or on any
person and does not operate to bind
FDA or the public. An alternative
approach may be used if such an
approach satisfies the requirements of
the applicable statute and regulations.
III. Electronic Access
To receive ‘‘Class II Special Controls
Guidance Document: Tinnitus Masker
Devices’’ by fax, call the CDRH FactsOn-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 (1555) followed by the pound
sign (#). Follow the remaining voice
prompts to complete your request.
Persons interested in obtaining a copy
of the draft guidance may also do so by
using the Internet. CDRH maintains an
entry on the Internet for easy access to
information including text, graphics,
and files that may be downloaded to a
personal computer with Internet access.
Updated on a regular basis, the CDRH
home page includes device safety alerts,
Federal Register reprints, information
on premarket submissions (including
lists of approved applications and
manufacturers’ addresses), small
manufacturer’s assistance, information
on video conferencing and electronic
submissions, Mammography Matters,
and other device-oriented information.
The CDRH Web site may be accessed at
https://www.fda.gov/cdrh. A search
capability for all CDRH guidance
documents is available at https://
www.fda.gov/cdrh/guidance.html.
Guidance documents are also available
on the Division of Dockets Management
Internet site at https://www.fda.gov/
ohrms/dockets.
IV. Paperwork Reduction Act of 1995
This draft guidance contains
information collection provisions that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(the PRA) (44 U.S.C. 3501–3520). The
collections of information addressed in
the draft guidance document have been
approved by OMB in accordance with
the PRA under the regulations
governing premarket notification
submissions (21 CFR part 807, subpart
E), under OMB control number 0910–
0120. The labeling provisions addressed
in the draft guidance have been
approved by OMB under OMB control
number 0910–0485.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES), written or electronic
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]]>Agencies
[Federal Register Volume 70, Number 215 (Tuesday, November 8, 2005)]
[Notices]
[Pages 67713-67724]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-22267]
-----------------------------------------------------------------------
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: standards@cdrh.fda.gov. This document
may also be accessed on FDA's Internet site at https://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
