Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 022, 46203-46214 [E9-21609]
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Federal Register / Vol. 74, No. 172 / Tuesday, September 8, 2009 / Notices
Drug Court Team Questionnaire
This questionnaire will be
administered to key drug court
personnel (e.g., judge, drug court
manager and treatment provider) during
the three annual site visits to the drug
court. This instrument consists of 15
open-ended questions, and will ask
respondents about their role and
involvement in the drug court process,
perceptions of drug courts, and the role
of treatment and coercion in drug courts
(subject to OMB approval).
Drug Court Client Focus Group
Questions for Guided Discussion
Focus groups will be conducted
during the annual site visits to each
drug court. During the focus groups,
drug court clients will be asked 12
open-ended questions about their
experiences in the drug court program
and current efforts towards recovery.
Drug court participants will be involved
in focus groups on 1 to 3 occasions.
Procedural Justice Questionnaire
This instrument contains 13 items
and asks drug court clients about their
perceptions regarding fair treatment by
the judge and drug court team during
the drug court process. It is
hypothesized that participants who
Correctional Mental Health Screener
for Men
perceive the judge and drug court team
as fair will be more compliant with the
drug court program, more likely to
graduate, and have better substance use
and criminal behavior outcomes (e.g.,
reduced substance use, fewer arrests).
This questionnaire will be administered
to drug court participants once, during
the 6-month post-discharge interview.
A mental health screener for men
(CMHS–M) will be administered to
gather data on drug court participants’
mental health. Many drug court clients
have co-occurring disorders (i.e.,
substance use and mental health
disorders). The information gathered
during this portion of the in-person drug
court client interviews will provide a
post-discharge indicator of mental
health status and will be used as a
moderator variable when assessing
client outcomes such as drug use and
arrest. This questionnaire will be
administered to drug court participants
once, during the 6-month post-discharge
interview. The CMHS–M contains
twelve questions and the two
instruments have six items in common.
Correctional Mental Health Screener
for Women
A mental health screener for women
(CMHS–W) will be administered to
gather data on drug court participants’
mental health. Many drug court clients
have co-occurring disorders (i.e.,
substance use and mental health
disorders). The information gathered
during this portion of the in-person drug
court client interviews will provide a
post-discharge indicator of mental
health status and will be used as a
moderator variable when assessing
client outcomes such as drug use and
arrest. This questionnaire will be
administered to drug court participants
once, during the 6-month post-discharge
interview. The CMHS–W contains eight
questions, and six items are common
between the men and women’s versions
of the instrument.
Treatment Satisfaction Index
The Treatment Satisfaction Index will
ask drug court participants about their
satisfaction with treatment received
during the drug court program. This 19item questionnaire will be administered
to drug court participants once, during
the 6-month post-discharge interview.
The estimated response burden for
this data collection is provided in the
table below:
ANNUALIZED ESTIMATES OF HOUR BURDEN
Number of
respondents
Responses
per
respondent
Total
responses
Hours per
response
Total hour
burden
240
3
720
.5
120
600
816
816
408
408
816
1
1
1
1
1
1
600
816
816
408
408
816
1.0
.5
.09
.08
.08
.08
600
408
73
33
33
65
Total ..............................................................................
jlentini on DSKJ8SOYB1PROD with NOTICES
Drug court team questionnaire ............................................
Drug court clients focus group questions for guided discussion .............................................................................
Drug court clients—interviews .............................................
Procedural justice questionnaire ..........................................
Correctional mental health screener—women ....................
Correctional mental health screener—men .........................
Treatment satisfaction index ................................................
1,656
........................
2,136
........................
1,128
The estimates in this table reflect the
maximum burden for participation in
the Adult Treatment Drug Court CrossSite Evaluation. Burden for drug court
personnel is aggregated to reflect total
burden over the three-year study period.
The drug court personnel questionnaire
will be administered three times; once
during each of three study years. Burden
for the drug court clients is annualized.
Focus groups and interviews are onetime events. Some drug court clients
will participate in both a focus group
and 6-month post-discharge interview.
Written comments and
recommendations concerning the
proposed information collection should
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be sent by October 8, 2009 to: SAMHSA
Desk Officer, Human Resources and
Housing Branch, Office of Management
and Budget, New Executive Office
Building, Room 10235, Washington, DC
20503; due to potential delays in OMB’s
receipt and processing of mail sent
through the U.S. Postal Service,
respondents are encouraged to submit
comments by fax to: 202–395–5806.
Dated: August 28, 2009.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. E9–21511 Filed 9–4–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2004–N–0451] (formerly
Docket No. 2004N–0226)
Food and Drug Administration
Modernization Act of 1997:
Modifications to the List of Recognized
Standards, Recognition List Number:
022
AGENCY:
ACTION:
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Food and Drug Administration,
HHS.
E:\FR\FM\08SEN1.SGM
Notice.
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Federal Register / Vol. 74, No. 172 / Tuesday, September 8, 2009 / Notices
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: 022’’ (Recognition List
Number: 022), 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 of ‘‘Modifications to the
List of Recognized Standards,
Recognition List Number: 022’’ to the
Division of Small Manufacturers,
International and Consumer Assistance,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave, Bldg. 66,
rm. 4613, Silver Spring, MD 20993–
0002. Send two self-addressed adhesive
labels to assist that office in processing
your requests, or fax your request to
301–847–8149. 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.access
data.fda.gov/scripts/cdrh/cfdocs/
cfTopic/cdrhnew.cfm. See section VI of
this document for electronic access to
the searchable database for the current
list of FDA recognized consensus
standards, including Recognition List
Number: 022 modifications and other
standards related information.
FOR FURTHER INFORMATION CONTACT:
Carol L. Herman, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 3632, Silver Spring,
MD 20993–0002, 301–796–6574.
SUPPLEMENTARY INFORMATION:
TABLE 1.—FEDERAL REGISTER
CITATION—Continued
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
of the act 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.
Modifications to the initial list of
recognized standards, as published in
the Federal Register, are identified in
table 1 of this document.
TABLE 1.—FEDERAL REGISTER
CITATION
February 25, 1998
(63 FR 9561)
May 27, 2005 (70
FR 30756)
October 16, 1998
(63 FR 55617)
November 8, 2005
(70 FR 67713)
July 12, 1999 (64
FR 37546)
March 31, 2006 (71
FR 16313)
November 15, 2000
(65 FR 69022)
June 23, 2006 (71
FR 36121)
May 7, 2001 (66 FR
23032)
November 3, 2006
(71 FR 64718)
January 14, 2002
(67 FR 1774)
May 21, 2007 (72
FR 28500)
October 2, 2002 (67
FR 61893)
September 12, 2007
(72 FR 52142)
April 28, 2003 (68
FR 22391)
December 19, 2007
(72 FR 71924)
March 8, 2004 (69
FR 10712)
September 9, 2008
(73 FR 52358)
June 18, 2004 (69
FR 34176)
March, 18, 2009 (74
FR 11586)
October 4, 2004 (69
FR 59240)
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: 022
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: 022’’ to
identify these current modifications.
In table 2 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 2.
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Old Recognition
No.
Replacement
Recognition
No.
Standard
Change
CGA C–9:2004 (Reaffirmed 2008) Standard Color Marking of Compressed
Gas Containers for Medical Use
Withdrawn and replaced with
newer version
A. Anesthesia
1–37
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1–80
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TABLE 2.—Continued
Old Recognition
No.
1–68
Replacement
Recognition
No.
1–81
Standard
Change
CGA V–5:2008 Diameter-Index Safety System Noninterchangeable Low
Pressure Connections for Medical Gas Applications
Withdrawn and replaced with
newer version
1–51
ASTM F1100–90 (1997) Standard Specification for Ventilators Intended for
Use in Critical Care
Withdrawn
1–59
ASTM F1456–01 Standard Specification for Minimum Performance and
Safety Requirements for Capnometers
Withdrawn
2–64
ANSI/AAMI/ISO 10993–5:1999 Biological Evaluation of Medical Devices—
Part 5: Tests for In Vitro Cytotoxicity
Contact person, Extent of recognition and Relevant guidance
2–82
ASTM F2147–01 Standard Practice for Guinea Pig: Split Adjuvant and
Closed Patch Testing for Contact Allergens
Contact person and Extent of
recognition
B. Biocompatibility
2–83
2–136
ASTM E1262–88 (Reapproved 2008) Standard Guide for Performance of
Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl
Transferase Gene Mutation Assay
Withdrawn and replaced with
newer version
2–84
2–137
ASTM E1263–97 (Reapproved 2008) Standard Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow Erythrocytes
Withdrawn and replaced with
newer version
2–85
2–138
ASTM E1280–97 (Reapproved 2008) Standard Guide for Performing the
Mouse Lymphoma Assay for Mammalian Cell Mutagenicity
Withdrawn and replaced with
newer version
ISO 10993–10:2002 Biological Evaluation of Medical Devices—Part 10:
Tests for Irritation and Delayed-type Hypersensitivity
Extent of recognition and Relevant guidance
2–87
2–90
2–139
ASTM E1397–91 (Reapproved 2008) Standard Practice for In Vitro Rat
Hepatocyte DNA Repair Assay
Withdrawn and replaced with
newer version
2–91
2–140
ASTM E1398–91 (Reapproved 2008) Standard Practice for In Vivo Rat
Hepatocyte DNA Repair Assay
Withdrawn and replaced with
newer version
2–93
ASTM F763–04 Standard Practice for Short-Term Screening of Implant Materials
Extent of recognition and
Contact person
2–94
ASTM F981–04 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Bone
Extent of recognition and
Contact person
2–95
2–141
ASTM F1984–99 (Reapproved 2008) Standard Practice for Testing for
Whole Complement Activation in Serum by Solid Materials
Withdrawn and replaced with
newer version
2–97
2–142
ASTM F1983–99 (Reapproved 2008) Standard Practice for Assessment of
Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications
Withdrawn and replaced with
newer version
ANSI/AAMI/ISO 10993–1:2003 Biological Evaluation of Medical Devices—
Part 1: Evaluation and Testing
Title, Extent of recognition,
Relevant guidance and
Contact person
ASTM F1904–98 (Reapproved 2008) Standard Practice for Testing the Biological Responses to Particles in vivo
Withdrawn and replaced with
newer version
ASTM E1372–95 (Reapproved 2003) Standard Test Method for Conducting
a 90-Day Oral Toxicity Study in Rats
Contact person
ASTM F619–03 (Reapproved 2008) Standard Practice for Extraction of
Medical Plastics
Withdrawn and replaced with
newer version
2–108
ASTM F1905–98(2003) Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity
Contact person and Extent of
recognition
2–114
ASTM F1877–05 Standard Practice for Characterization of Particles
Extent of recognition and
Contact person
2–98
2–99
2–143
2–100
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2–106
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2–144
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TABLE 2.—Continued
Old Recognition
No.
Replacement
Recognition
No.
2–115
Standard
Change
ASTM F895–84 (Reapproved 2006) Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
Extent of recognition, Relevant guidance and Contact
person
ASTM F1439–03 (Reapproved 2008) Standard Guide for Performance of
Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
Withdrawn and replaced with
newer version
2–118
ANSI/AAMI/ISO 10993–11:2006 Biological Evaluation of Medical Devices—
Part 11: Tests for Systemic Toxicity
Extent of recognition, Relevant guidance and Contact
person
2–119
ASTM F813–07 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
Contact person
ASTM F2148–07Ö1 Standard Practice for Evaluation of Delayed Contact
Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
Withdrawn and replaced with
newer version
2–122
ASTM F719–81 (Reapproved 2007)Ö1 Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation
Contact person and Relevant
guidance
2–124
ASTM F750–87 (Reapproved 2007)Ö1 Standard Practice for Evaluating
Material Extracts by Systemic Injection in the Mouse
Extent of recognition, Relevant guidance and Contact
person
2–125
ASTM F749–98 (Reapproved 2007)Ö1 Standard Practice for Evaluating
Material Extracts by Intracutaneous Injection in the Rabbit
Extent of recognition, Relevant guidance and Contact
person
2–126
ASTM F748–06 Standard Practice for Selecting Generic Biological Test
Methods for Materials and Devices
Extent of recognition, Relevant guidance and Contact
person
2–116
2–121
2–145
2–146
2–128
2–147
USP 32–NF26 Biological Tests <87> 2009 Biological Reactivity Test, In
Vitro—Direct Contact Test
Withdrawn and replaced with
newer version
2–129
2–148
USP 32–NF26 Biological Tests <88> Biological Reactivity Test, In Vitro—
Elution Test
Withdrawn and replaced with
newer version
2–130
2–149
USP 32–NF26 Biological Tests <88> Biological Reactivity Tests, In Vivo
Procedure—Preparation of Sample
Withdrawn and replaced with
newer version
2–131
2–150
USP 32–NF26 Biological Tests <88> Biological Reactivity Test, In Vivo,
Classification of Plastics—Intracutaneous Test
Withdrawn and replaced with
newer version
2–132
2–151
USP 32–NF26 Biological Tests <88> Biological Reactivity Tests, In Vivo,
Classification of Plastics—Systemic Injection Test
Withdrawn and replaced with
newer version
2–133
ASTM F1408–97 (Reapproved 2008) Standard Practice for Subcutaneous
Screening Test for Implant Materials
Contact person
2–134
ASTM F2065–00 (2006) Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials
Contact person
2–135
AAMI/ANSI/ISO 10993–12:2007 Biological Evaluation of Medical Devices—
Part 12: Sample Preparation and Reference Materials
Extent of recognition, Relevant guidance and Contact
person
C. Dental/ENT
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4–69
4–178
ISO 6872:2008 Dentistry—Ceramic Materials
Withdrawn and replaced with
newer version
4–73
4–179
ISO 7405: 2008 Dentistry—Evaluation of Biocompatibility of Medical Devices Used in Dentistry
Withdrawn and replaced with
newer version
ANSI ASA S3.46–1997 (R 2007) Methods of Measurement of Real-Ear
Performance Characteristics of Hearing Aids
Reaffirmation
4–175
D. General
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TABLE 2.—Continued
Old Recognition
No.
Replacement
Recognition
No.
Standard
Change
5–12
5–47
ISO 10012:2003 Measurement Management Systems—Requirements for
Measurement Processes and Measuring Equipment
Withdrawn and replaced with
newer version
5–15
5–48
ANSI/ASQ Z1.9–2008 Sampling Procedures and Tables for Inspection by
Variables for Percent Nonconforming
Withdrawn and replaced with
newer version
5–27
IEC 60601–1–1 Ed. 2.0 2000 Medical Electrical Equipment—Part 1–1: General Requirements for Safety—Collateral Standard: Safety requirements
for Medical Electrical Systems
Title
5–36
ISO/TR 16142:2006 Medical Devices—Guidance on the Selection of Standards in Support of Recognized Essential Principles of Safety and Performance of Medical Devices
Title
5–41
IEC 60601–1–4 (2000) Consol. Ed. 1.1 Medical Electrical Equipment—Part
1–4: General Requirements for Safety—Collateral Standard: Programmable Electrical Medical Systems
Title
IEC 60601–1–8, Ed. 1 Medical Electrical Equipment—Part 1–8: General
Requirements for Safety—Collateral Standard: Alarm Systems—Requirements, Tests and Guidelines—General Requirements and Guidelines for
Alarm Systems in Medical Equipment
Withdrawn and re-recognized
previous version
5–44
5–49
E. General Hospital/General Plastic Surgery
ISO 8536–7:2009 Infusion Equipment for Medical Use—Part 7: Caps Made
of Aluminum-plastics Combinations for Infusion Bottles
Withdrawn and replaced with
newer version
6–112
ANSI/AAMI PB70:2003 Liquid Barrier Performance and Classification of
Protective Apparel and Drapes Intended for Use in Health Care Facilities
Contact person
6–118
ASTM F2196–02 Standard Specification for Circulating Liquid and Forced
Air Patient Temperature Management Devices
CFR citation and product
code
6–144
ASTM D5712—05Ö1 Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified
Lowry Method
Title and Contact person
6–145
ASTM D3578–05Ö1 Standard Specification for Rubber Examination Gloves
Title and Contact person
6–147
ASTM D6978–05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
Contact person and Relevant
guidance
6–149
ASTM D7160–05 Standard Practice for Determination of Expiration Dating
for Medical Gloves
Contact person
6–150
ASTM D7161–05 Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse
Conditions
Contact person
6–165
ASTM D6977–04Ö1 Standard Specification for Polychloroprene Examination Gloves for Medical Application
Title and Contact person
6–167
ASTM D6319–00a (Reapproved 2005)Ö1 Standard Specification for Nitrile
Examination Gloves for Medical Application
Title and Contact person
6–168
ASTM D3577–09Ö1 Standard Specification for Rubber Surgical Gloves
Withdrawn and replaced with
newer version
6–175
ASTM D5151–06 Standard Test Method for Detection of Holes in Medical
Gloves
Contact person
6–178
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6–63
ASTM D6124–06 Standard Test Method for Residual Powder on Medical
Gloves
Contact person
6–183
ASTM D5250–06Ö1 Standard Specification for Poly(vinyl chloride) Gloves
for Medical Application
Title and Contact person
ASTM F1670–08 Standard Test Method for Resistance of Materials Used in
Protective Clothing to Penetration by Synthetic Blood
Withdrawn and replaced with
newer version
6–186
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6–216
6–217
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Federal Register / Vol. 74, No. 172 / Tuesday, September 8, 2009 / Notices
TABLE 2.—Continued
Old Recognition
No.
Replacement
Recognition
No.
Standard
Change
6–205
6–218
USP 32:2009 Nonabsorbable Surgical Suture
Withdrawn and replaced with
newer version
6–206
6–219
USP 32<11>:2009 Sterile Sodium Chloride for Irrigation
Withdrawn and replaced with
newer version
6–207
6–220
USP 32:2009 Absorbable Surgical Suture
Withdrawn and replaced with
newer version
6–208
6–221
USP 32<881>:2009 Tensile Strength
Withdrawn and replaced with
newer version
6–209
6–222
USP 32<861>:2009 Sutures—Diameter
Withdrawn and replaced with
newer version
6–210
6–223
USP 32<871>:2009 Sutures Needle Attachment
Withdrawn and replaced with
newer version
6–211
6–224
USP 32<11>:2009 Sterile Water for Irrigation
Withdrawn and replaced with
newer version
6–212
6–225
USP 32<11>:2009 Heparin Lock Flush Solution
Withdrawn and replaced with
newer version
6–213
6–226
USP 32<11>:2009 Sodium Chloride Injection
Withdrawn and replaced with
newer version
F. In Vitro Diagnostics
7–156
7–195
CLSI M02–A10, Performance Standards for Antimicrobial Disk Susceptibility
Tests
Withdrawn and replaced with
newer version
7–158
7–196
CLSI M07–A8, Methods for Dilution Antimicrobial Susceptibility Tests for
Bacteria that Grow Aerobically
Withdrawn and replaced with
newer version
7–160
7–197
CLSI M35–A2, Abbreviated Identification of Bacteria and Yeast
Withdrawn and replaced with
newer version
7–78
7–198
CLSI M23–A3, Development of In Vitro Susceptibility Testing Criteria and
Quality Control Parameters
Withdrawn and replaced with
newer version
7–177
7–199
CLSI M100–S19 Performance Standards for Antimicrobial Susceptibility
Testing
Withdrawn and replaced with
newer version
7–161
7–200
CLSI M48–A, Laboratory Detection and Identification of Mycobacteria
Withdrawn and replaced with
newer version
7–102
NCCLS H1–A5, Tubes and Additives for Venous Blood Specimen Collection
Contact Person
7–101
NCCLS H51–A, Assays of vonWillebrand Factor Antigen and Ristocetin Cofactor Activity
Contact Person
7–165
CLSI H20–A2, Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods
Contact Person
7–201
CLSI H3–A6, Procedures for the Collection of Diagnostic Blood Specimens
by Venipuncture
Withdrawn and replaced with
newer version
7–81
7–202
CLSI C28–A3 Defining, Establishing, and Verifying Reference Intervals in
the Clinical Laboratory
Withdrawn and replaced with
newer version
7–144
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7–103
7–203
CLSI H04–A6, Procedures and Devices for the Collection of Diagnostic
Capillary Blood Specimens
Withdrawn and replaced with
newer version
8–163
ASTM F1586–08 Standard Specification for Wrought Nitrogen Strengthened
21 Chromium-10Nickel-3Manganese-2.5Molybdenum Stainless Steel Bar
for Surgical Implants (UNS S31675)
Withdrawn and replaced with
newer version
G. Materials
8–32
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TABLE 2.—Continued
Old Recognition
No.
Replacement
Recognition
No.
Standard
Change
8–164
ASTM F136–08Ö1 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant
Applications (UNS R56401)
Withdrawn and replaced with
newer version
8–49
8–165
ASTM F1058–08 Standard Specification for Wrought 40Cobalt20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire and Strip for Surgical Implant Applications (UNS R30003 and UNS R30008)
Withdrawn and replaced with
newer version
8–50
8–166
ASTM F1091–08 Standard Specification for Wrought Cobalt-20 Chromium15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R30605)
Withdrawn and replaced with
newer version
8–52
8–167
ASTM F1350–08 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)
Withdrawn and replaced with
newer version
8–53
8–168
ASTM F1472–08Ö1 Standard Specification for Wrought Titanium
-6Aluminum -4Vanadium Alloy for Surgical Implant Applications (UNS
R56400)
Withdrawn and replaced with
newer version
8–76
8–169
ASTM F138–08 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants
(UNS S31673)
Withdrawn and replaced with
newer version
8–79
8–170
ASTM F961–08 Standard Specification for 35Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants (UNS
R30035)
Withdrawn and replaced with
newer version
8–81
8–171
ASTM F1609–08 Standard Specification for Calcium Phosphate Coatings
for Implantable Materials
Withdrawn and replaced with
newer version
8–86
8–172
ASTM F1926/F1926M–08 Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Granules, Fabricated Forms,
and Coatings
Withdrawn and replaced with
newer version
8–94
8–173
ASTM F601–03 (Reapproved 2008) Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
Withdrawn and replaced with
newer version
8–95
8–174
ASTM F629–02 (Reapproved 2007)Ö1 Standard Practice for Radiography
of Cast Metallic Surgical Implants
Withdrawn and replaced with
newer version
8–110
8–175
ASTM F1377–08 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)
Withdrawn and replaced with
newer version
8–118
8–176
ASTM F2503–08 Standard Practice for Marking Medical Devices and Other
Items for Safety in the Magnetic Resonance Environment
Withdrawn and replaced with
newer version
8–133
8–177
ASTM F2129–08 Standard Test Method for Conducting Cyclic
Potentiodynamic Polarization Measurements to Determine the Corrosion
Susceptibility of Small Implant Devices
Withdrawn and replaced with
newer version
8–143
8–178
ASTM F648–07Ö1 Standard Specification for Ultra-High-Molecular-Weight
Polyethylene Powder and Fabricated Form for Surgical Implants
Withdrawn and replaced with
newer version
8–144
8–179
ASTM F754–08 Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular
Molding Powders
Withdrawn and replaced with
newer version
8–146
8–180
ASTM F2066–08 Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)
Withdrawn and replaced with
newer version
8–148
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8–44
8–181
ASTM F899–09 Standard Specification for Wrought Stainless Steels for
Surgical Instruments
Withdrawn and replaced with
newer version
8–152
8–182
ASTM F1537–08 Standard Specification for Wrought Cobalt-28-Chromium6-Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538,
and UNS R31539)
Withdrawn and replaced with
newer version
8–160
8–183
ASTM F560–08 Standard Specification for Unalloyed Tantalum for Surgical
Implant Applications (UNS R05200, UNS R05400)
Withdrawn and replaced with
newer version
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TABLE 2.—Continued
Old Recognition
No.
Replacement
Recognition
No.
Standard
Change
8–161
8–184
ASTM F2516–07Ö2 Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials
Withdrawn and replaced with
newer version
8–162
8–185
ASTM F451–08 Standard Specification for Acrylic Bone Cement
Withdrawn and replaced with
newer version
ISO 4074:2002/Cor.1:2003(E):, Natural Latex Rubber Condoms—Requirements and Test Methods, Technical Corrigendum 1
Relevant guidance
ASTM D6324–08 Standard Test Methods for Male Condoms Made from
Polyurethane
Withdrawn and replaced with
newer version
9–43
ISO 16038:2005 Rubber condoms—Guidance on the Use of ISO 4074 in
the Quality Management of Natural Rubber Latex Condoms
Relevant guidance
9–56
ASTM D3492–08 Standard Specification for Rubber Contraceptives (Male
Condoms)
Relevant guidance
9–57
ISO 4074:2002/Cor.2:2008(E) Natural Latex Rubber Condoms—Requirements and Test Methods, Technical Corrigendum 2
Relevant guidance
H. OB-GYN/Gastroenterology
9–34
9–41
9–58
I. Orthopedics
11–172
11–211
ASTM F1798–97 (Reapproved 2008) Standard Guide for Evaluating the
Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
Withdrawn and replaced with
newer version
11–178
11–212
ASTM F1440–92 (Reapproved 2008) Standard Practice for Cyclic Fatigue
Testing of Metallic Stemmed Hip Arthroplasty Femoral Components Without Torsion
Withdrawn and replaced with
newer version
11–192
11–213
ASTM F1223–08 Standard Test Method for Determination of Total Knee
Replacement Constraint
Withdrawn and replaced with
newer version
11–198
11–214
ASTM F0382–99 (Reapproved 2008) Standard Specification and Test
Method for Metallic Bone Plates
Withdrawn and replaced with
newer version
11–204
11–215
ASTM F897–02 (Reapproved 2007) Standard Test Method for Measuring
Fretting Corrosion of Osteosynthesis Plates and Screws
Withdrawn and replaced with
newer version
11–205
11–216
ASTM F1264–03 (Reapproved 2007)Ö1 Standard Specification and Test
Methods for Intramedullary Fixation Devices
Withdrawn and replaced with
newer version
11–209
11–217
ASTM F2083–08Ö1 Standard Specification for Total Knee Prosthesis
Withdrawn and replaced with
newer version
12–17
12–192
NEMA MS 8–2008 Characterization of the Specific Absorption Rate for
Magnetic Resonance Imaging Systems
Withdrawn and replaced with
new version
12–48
12–193
AIUM AOL 2008 Acoustic Output Labeling Standard for Diagnostic
Ultrasound Equipment Revision 1- A Standard for How Manufacturers
Should Specify Acoustic Output Data
Withdrawn and replaced with
newer version
12–58
12–194
ANSI/HPS N43.6–2007 Sealed Radioactive Sources—Classification
Withdrawn and replaced with
newer version
12–69
12–195
NEMA MS 6–2008 Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging
Withdrawn and replaced with
newer version
12–95
12–196
NEMA MS 2–2008 Determination of Two-Dimensional Geometric Distortion
in Diagnostic Magnetic Resonance Images
Withdrawn and replaced with
newer version
NEMA UD 3–2004 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
Contact person
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J. Radiology
12–100
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TABLE 2.—Continued
Old Recognition
No.
Replacement
Recognition
No.
Standard
Change
12–105
NEMA UD 2–2004 Acoustic Output Measurement Standard for Diagnostic
Ultrasound Equipment Version 3
Contact person
12–139
AIUM AOMS–2004 Acoustic Output Measurement Standard for Diagnostic
Ultrasound Equipment
Title and Contact person
12–140
AIUM RTD1–2004 Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Revision 1
Title and Contact person
12–146
IEC 60601–2–17 (2004) Medical Electrical Equipment—Part 2–17: Particular Requirements for the Safety of Automatically-controlled
Brachytherapy Afterloading Equipment
Title
12–147
IEC 60601–2–5: (2000) Medical Electrical Equipment—Part 2–5: Particular
Requirements for the Safety of Ultrasonic Physiotherapy Equipment Ed.
2.0
Title
IEC 60601–2–22 (1995) Medical Electrical Equipment—Part 2–22: Particular Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment—Edition
2.0
Withdrawn and re-recognized
previous version
IEC 60601–2–45 Ed. 2.0, (2001), Medical electrical equipment—Part 2–45:
Particular requirements for the safety of mammographic X-ray equipment
and mammographic stereotactic devices
Title
12–169
12–197
12–178
12–182
12–198
IEC 60601–2–37 (2004), (2005) Amendment 2, Medical Electrical Equipment—Part 2–37: Particular Requirements for the Safety of Ultrasonic
Medical Diagnostic and Monitoring Equipment
Withdrawn and re-recognized
previous version
12–185
12–199
IEC 60601–1–3: 1994 Medical Electrical Equipment—Part 1: General Requirements for Safety 3. Collateral Standard: General Requirements for
Radiation Protection in Diagnostic X-ray Equipment—First Edition
Withdrawn and re-recognize
previous version
12–186
12–200
IEC 60601–2–29 (1999) Medical Electrical Equipment Part 2–29: Particular
Requirements for the Safety of Radiotherapy Simulators—Second Edition
Withdrawn and re-recognized
previous version
CLSI LIS01–A2 Specification for Low-Level Protocol to Transfer Messages
Between Clinical Laboratory Instruments and Computer Systems
Withdrawn and replaced with
newer version
14–55
ANSI/AAMI/ISO 14160:1998/(R) 2008 Sterilization of Single-use Medical
Devices Incorporating Materials of Animal Origin—Validation and Routine
Control of Sterilization by Liquid Chemical Sterilants
Reaffirmation
14–88
ANSI/AAMI/ ISO 14937:2000 Sterilization of Health Care Products—General Requirements for Characterization of a Sterilizing Agent and the Development, Validation, and Routine Control of a Sterilization Process for
Medical Devices.
Contact person
14–116
ANSI/AAMI ST72:2002 Bacterial Endotoxins—Test Methodologies, Routine
Monitoring, and Alternatives to Batch Testing
Relevant guidance and Extent
of recognition
14–135
ANSI/AAMI ST63:2002 Sterilization of Health Care Products—Requirements for the Development, Validation, and Routine Control of an Industrial Sterilization Process for Medical Devices—Dry Heat
Relevant Guidance
14–164
ANSI/AAMI ST81:2004 Sterilization of Medical Devices—Information to be
Provided by the Manufacturer for the Processing of Resterilizable Medical
Devices
Contact Person
14–195
ANSI/AAMI/ISO 11140–1:2005 Sterilization of Health Care Products—
Chemical Indicators—Part 1: General Requirements
Relevant Guidance, Extent of
Recognition and Contact
person
K. Software/Informatics
13–16
13–29
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L. Sterility
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TABLE 2.—Continued
Old Recognition
No.
14–220
Replacement
Recognition
No.
14–263
Standard
Change
ANSI/AAMI ST79:2006/A1:2008 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities
Withdrawn and replaced with
newer version
14–223
ANSI/AAMI/ISO 11138–1:2006 Sterilization of Health Care Products—Biological Indicators—Part 1: General Requirements
Relevant Guidance
14–224
ANSI/AAMI/ISO 11137–1:2006 Sterilization of Health Care Products—Radiation—Part 1: Requirements for Development, Validation, and Routine
Control of a Sterilization Process for Medical Devices
Relevant Guidance
14–225
ANSI/AAMI/ISO 11137–2:2006 Sterilization of Health Care Products—Radiation—Part 2: Establishing the Sterilization Dose
Relevant Guidance
14–226
ANSI/AAMI/ISO 11137–3:2006 Sterilization of Health Care Products—Radiation—Part 3: Guidance on Dosimetric Aspects
Relevant Guidance
14–228
ANSI/AAMI/ISO 11135–1:2007 Sterilization of Health Care Products—Ethylene oxide—Part 1: Requirements for Development, Validation, and Routine Control of a Sterilization Process for Medical Devices
Relevant Guidance
14–261
ANSI/AAMI/ISO 17665–1:2006 Sterilization of Health Care Products—Moist
Heat—Part 1: Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices
Relevant Guidance
14–119
ANSI/AAMI ST55:2003/(R)2008 Table-top Steam Sterilizers
Reaffirmation
14–71
14–264
ANSI/AAMI ST8:2008 Hospital Steam Sterilizers
Withdrawn and replaced with
newer version
14–249
14–265
USP 32:2009 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
Withdrawn and replaced with
newer version
14–250
14–266
USP 32:2009 <71> Sterility Tests
Withdrawn and replaced with
newer version
14–251
14–267
USP 32:2009 <85> Bacterial Endotoxins Test
Withdrawn and replaced with
newer version
14–252
14–268
USP 32:2009 <151> Pyrogen Test (USP Rabbit Test)
Withdrawn and replaced with
newer version
14–253
14–269
USP 32:2009 <161> Transfusion and Infusion Assemblies and Similar Medical Devices
Withdrawn and replaced with
newer version
14–254
14–270
USP 32:2009 Biological Indicator for Steam Sterilization—Self Contained
Withdrawn and replaced with
newer version
14–246
14–271
USP 32:2009 Biological Indicator for Dry-Heat Sterilization, Paper Carrier
Withdrawn and replaced with
newer version
14–247
14–272
USP 32:2009 Biological Indicator for Ethylene Oxide Sterilization, Paper
Carrier
Withdrawn and replaced with
newer version
14–248
14–273
USP 32:2009 Biological Indicator for Steam Sterilization, Paper Carrier
Withdrawn and replaced with
newer version
ANSI/AAMI/ISO 11140–5:2007 Sterilization of Health Care Products—
Chemical Indicators—Part 5: Class 2 Indicators for Bowie and Dick-type
Air Removal Tests
Contact person and Relevant
guidance
14–238
jlentini on DSKJ8SOYB1PROD with NOTICES
14–171
14–274
ANSI/AAMI/ISO 15882:2008 Chemical Indicators—Guidance on the Selection, Use, and Interpretation of Results
Withdrawn and replaced with
newer version
14–49
14–275
ANSI/AAMI ST41:2008 Ethylene oxide Sterilization in Health Care Facilities:
Safety and Effectiveness
Withdrawn and replaced with
newer version
ANSI/AAMI ST67:2003/(R) 2008 Sterilization of Health Care Products—Requirements for Products Labeled ‘‘STERILE’’
Reaffirmation and Relevant
guidance
14–136
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Federal Register / Vol. 74, No. 172 / Tuesday, September 8, 2009 / Notices
III. Listing of New Entries
In table 3 of this document, FDA
provides the listing of new entries and
consensus standards added as
modifications to the list of recognized
46213
standards under Recognition List
Number: 022.
TABLE 3.
Recognition No.
Title of Standard
Reference No. & Date
A. Biocompatibility
2–152
Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Delayed-type
Hypersensitivity Amendment 1
ISO 10993 10:2002/
Amd.1:2006(E)
5–46
Sampling Procedures for Inspection by Attributes—Part 1: Sampling Schemes Indexed by
Acceptance Quality Limit (AQL) for Lot-by-lot Inspection
ISO 2859–1:1999/Cor 1:2001
5–50
Medical Devices—Application of Usability Engineering to Medical Devices
IEC 62366:2007
B. General
C. In Vitro Diagnostics
7–204
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
CLSI M27–A3
8–186
Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene
(UHMWPE) Used in Orthopedic and Spinal Devices
ASTM F 2759—09
8–187
Implants for Surgery—Hydroxyapatite—Part 1: Ceramic Hydroxyapatite
ISO 13779–1:2008(E)
8–188
Implants for Surgery—Hydroxyapatite—Part 2: Coatings of Hydroxyapatite
ISO 13779–2:2008(E)
Implants for Surgery—Active Implantable Medical Devices Part 3: Implantable
Neurostimulators (Neurology)
ISO 14708–3 2008–11–15
D. Materials
E. Neurology
17–8
F. OB-GYN/Gastroenterology
9–59
Hemodialysis Systems
ANSI/AAMI RD5:2003/(R)
2008
Implants for surgery—Wear of Total Knee-joint Prostheses—Part 3: Loading and Displacement Parameters for Wear-testing Machines with Displacement Control and Corresponding Environmental Conditions for Test
ISO 14243–3:2004 Technical
Corrigendum 1
14–276
Sterilization of Health Care Products—Moist Heat—Part 2: Guidance on the Application of
ISO 17665–1
ISO/TS 17665–2:2009
14–277
Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
USP32:2009 <62>
14–278
Biological Evaluation of Medical Devices—Part 7: Ethylene Oxide Sterilization Residuals
ANSI/AAMI/ISO 10993–
7:2008
15–14
Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds
ASTM F2603–06
15–15
Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy
ASTM F2259–03 (Reapproved 2008)
G. Orthopedics
11–218
H. Sterility
jlentini on DSKJ8SOYB1PROD with NOTICES
I. Tissue Engineering
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.access
data.fda.gov/scripts/cdrh/cfdocs/
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cfStandards/search.cfm. FDA will
incorporate the modifications and minor
revisions described in this document
into the database and, upon publication
in the Federal Register, this recognition
of consensus standards will be effective.
FDA will announce additional
modifications and minor revisions to
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the list of recognized consensus
standards, as needed, in the Federal
Register once a year, or more often, if
necessary.
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Federal Register / Vol. 74, No. 172 / Tuesday, September 8, 2009 / Notices
V. Recommendation of Standards for
Recognition by FDA
Any person may recommend
consensus standards as candidates for
recognition under the new provision of
section 514 of the act by submitting
such recommendations, with reasons for
the recommendation, to the contact
person (See FOR FURTHER INFORMATION
CONTACT). To be properly considered
such recommendations should contain,
at a minimum, the following
information: (1) Title of the standard; (2)
any reference number and date; (3)
name and address of the national or
international standards development
organization; (4) a proposed list of
devices for which a declaration of
conformity to this standard should
routinely apply; and (5) a brief
identification of the testing or
performance or other characteristics of
the device(s) that would be addressed
by a declaration of conformity.
VI. Electronic Access
You may obtain a copy of ‘‘Guidance
on the Recognition and Use of
Consensus Standards’’ by using the
Internet. CDRH maintains a site on the
Internet for easy access to information
including text, graphics, and files that
you may download to a personal
computer with access to the Internet.
Updated on a regular basis, the CDRH
home page includes the guidance as
well as the current list of recognized
standards and other standards related
documents. After publication in the
Federal Register, this document
announcing ‘‘Modification to the List of
Recognized Standards, Recognition List
Number: 022’’ 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.
This Federal Register document on
modifications in FDA’s recognition of
consensus standards is available at
https://www.fda.gov/cdrh/fedregin.html.
jlentini on DSKJ8SOYB1PROD with NOTICES
VII. Submission of Comments and
Effective Date
Interested persons may submit to the
contact person (see FOR FURTHER
INFORMATION CONTACT) written or
electronic comments regarding this
document. Two copies of any mailed
comments are to be submitted, except
that individuals may submit one paper
copy. Comments are to be identified
with the docket number found in
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17:32 Sep 04, 2009
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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:
022. These modifications to the list or
recognized standards are effective upon
publication of this document in the
Federal Register.
Dated: August 26, 2009.
Catherine M. Cook,
Associate Director for Regulation and Policy.
[FR Doc. E9–21609 Filed 9–4–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention (CDC)
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel: Capacity Building
Assistance (CBA) To Improve the
Delivery and Effectiveness of Human
Immunodeficiency Virus (HIV)
Prevention Services for High-Risk and/
or Racial/Ethnicity Minority
Populations, Program Announcement
Number PS09–906, Initial Review
August 28, 2009.
Correction: This notice was published
in the Federal Register on August 6,
2009, Volume 74, Number 150, page
39333. The date on the original notice
has changed.
DATES:
CONTACT PERSON FOR MORE INFORMATION:
Monica Farmer, M.Ed., Public Health
Analyst, Strategic Science and Program
Unit, Office of the Director,
Coordinating Center for Infectious
Diseases, CDC, 1600 Clifton Road, NE.,
Mailstop E–60, Atlanta, GA 30333.
Telephone (404) 498–2277.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both CDC
and the Agency for Toxic Substances
and Disease Registry.
Dated: August 25, 2009.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E9–21510 Filed 9–4–09; 8:45 am]
BILLING CODE 4163–18–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
2009 Parenteral Drug Association and
Food and Drug Administration Joint
Regulatory Conference
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of meeting.
SUMMARY: The Food and Drug
Administration (FDA) in co-sponsorship
with the Parenteral Drug Association
(PDA), is announcing a conference
entitled ‘‘Securing the Future of Medical
Product Quality: A 2020 Vision.’’ The
workshop helps to achieve objectives set
forth in the FDA Modernization Act of
1997, which include working closely
with stakeholders and maximizing the
availability and clarity of information to
stakeholders and the public.
Date and Time: The conference will
be held on Monday, September 14, 2009
from 8 a.m. to 6 p.m.; Tuesday,
September 15, 2009 from 7:15 a.m. to
5:45 p.m.; and Wednesday, September
16 from 7:15 a.m. to 1:15 p.m.
Location: The public workshop will
be held at the Renaissance Hotel, 999
9th St., Washington, D.C., 20001; 1–
202–898–9000; FAX: 1–202–289–0947.
Contact: Regarding the conference:
Wanda Neal, Parenteral Drug
Association, PDA Global Headquarters,
Bethesda Towers, 4350 East-West Hwy.,
suite 200, Bethesda, MD 20814.
Regarding this document: Ken Nolan,
Office of External Relations, Food and
Drug Administration, 5600 Fishers
Lane, rm. 15–05, Rockville, MD 20857,
301–827–3376.
Registration: You are encouraged to
register at your earliest convenience.
The PDA registration fees cover the cost
of facilities, materials, and breaks. Seats
are limited; please submit your
registration as soon as possible.
Conference space will be filled in order
of receipt of registration. Those accepted
in to the conference will receive
confirmation. Registration will close
after applicable conference is filled.
Onsite registration will be available on
a space-available basis on the day of the
public conference, beginning at 7 a.m.
on Monday, September 14, 2009.
The cost of registration is as follows:
PDA Members .........
PDA Non-members
Government ............
PDA Member Academic/Health Authority.
E:\FR\FM\08SEN1.SGM
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$1850.00
$2099.00
$700.00
$700.00
]]>Agencies
[Federal Register Volume 74, Number 172 (Tuesday, September 8, 2009)]
[Notices]
[Pages 46203-46214]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-21609]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2004-N-0451] (formerly Docket No. 2004N-0226)
Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 022
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 46204]]
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: 022'' (Recognition List Number: 022), 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 of ``Modifications
to the List of Recognized Standards, Recognition List Number: 022'' to
the Division of Small Manufacturers, International and Consumer
Assistance, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave, Bldg. 66, rm. 4613, Silver
Spring, MD 20993-0002. Send two self-addressed adhesive labels to
assist that office in processing your requests, or fax your request to
301-847-8149. 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.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/cdrhnew.cfm. See section VI of this
document for electronic access to the searchable database for the
current list of FDA recognized consensus standards, including
Recognition List Number: 022 modifications and other standards related
information.
FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 3632, Silver Spring, MD 20993-0002, 301-
796-6574.
SUPPLEMENTARY INFORMATION:
I. Background
Section 204 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended
section 514 of the act 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.
Modifications to the initial list of recognized standards, as
published in the Federal Register, are identified in table 1 of this
document.
Table 1.--Federal Register Citation
February 25, 1998 (63 FR 9561) May 27, 2005 (70 FR 30756)
------------------------------------------------------------------------
October 16, 1998 (63 FR 55617) November 8, 2005 (70 FR 67713)
------------------------------------------------------------------------
July 12, 1999 (64 FR 37546) March 31, 2006 (71 FR 16313)
------------------------------------------------------------------------
November 15, 2000 (65 FR 69022) June 23, 2006 (71 FR 36121)
------------------------------------------------------------------------
May 7, 2001 (66 FR 23032) November 3, 2006 (71 FR 64718)
------------------------------------------------------------------------
January 14, 2002 (67 FR 1774) May 21, 2007 (72 FR 28500)
------------------------------------------------------------------------
October 2, 2002 (67 FR 61893) September 12, 2007 (72 FR 52142)
------------------------------------------------------------------------
April 28, 2003 (68 FR 22391) December 19, 2007 (72 FR 71924)
------------------------------------------------------------------------
March 8, 2004 (69 FR 10712) September 9, 2008 (73 FR 52358)
------------------------------------------------------------------------
June 18, 2004 (69 FR 34176) March, 18, 2009 (74 FR 11586)
------------------------------------------------------------------------
October 4, 2004 (69 FR 59240) ...................................
------------------------------------------------------------------------
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: 022
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: 022'' to identify these current
modifications.
In table 2 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 2.
----------------------------------------------------------------------------------------------------------------
Replacement
Old Recognition No. Recognition No. Standard Change
----------------------------------------------------------------------------------------------------------------
A. Anesthesia
----------------------------------------------------------------------------------------------------------------
1-37 1-80 CGA C-9:2004 (Reaffirmed 2008) Standard Withdrawn and replaced
Color Marking of Compressed Gas with newer version
Containers for Medical Use
----------------------------------------------------------------------------------------------------------------
[[Page 46205]]
1-68 1-81 CGA V-5:2008 Diameter-Index Safety System Withdrawn and replaced
Noninterchangeable Low Pressure with newer version
Connections for Medical Gas Applications
----------------------------------------------------------------------------------------------------------------
1-51 ..................... ASTM F1100-90 (1997) Standard Withdrawn
Specification for Ventilators Intended
for Use in Critical Care
----------------------------------------------------------------------------------------------------------------
1-59 ..................... ASTM F1456-01 Standard Specification for Withdrawn
Minimum Performance and Safety
Requirements for Capnometers
----------------------------------------------------------------------------------------------------------------
B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-64 ..................... ANSI/AAMI/ISO 10993-5:1999 Biological Contact person, Extent
Evaluation of Medical Devices--Part 5: of recognition and
Tests for In Vitro Cytotoxicity Relevant guidance
----------------------------------------------------------------------------------------------------------------
2-82 ..................... ASTM F2147-01 Standard Practice for Guinea Contact person and
Pig: Split Adjuvant and Closed Patch Extent of recognition
Testing for Contact Allergens
----------------------------------------------------------------------------------------------------------------
2-83 2-136 ASTM E1262-88 (Reapproved 2008) Standard Withdrawn and replaced
Guide for Performance of Chinese Hamster with newer version
Ovary Cell/Hypoxanthine Guanine
Phosphoribosyl Transferase Gene Mutation
Assay
----------------------------------------------------------------------------------------------------------------
2-84 2-137 ASTM E1263-97 (Reapproved 2008) Standard Withdrawn and replaced
Guide for Conduct of Micronucleus Assays with newer version
in Mammalian Bone Marrow Erythrocytes
----------------------------------------------------------------------------------------------------------------
2-85 2-138 ASTM E1280-97 (Reapproved 2008) Standard Withdrawn and replaced
Guide for Performing the Mouse Lymphoma with newer version
Assay for Mammalian Cell Mutagenicity
----------------------------------------------------------------------------------------------------------------
2-87 ..................... ISO 10993-10:2002 Biological Evaluation of Extent of recognition
Medical Devices--Part 10: Tests for and Relevant guidance
Irritation and Delayed-type
Hypersensitivity
----------------------------------------------------------------------------------------------------------------
2-90 2-139 ASTM E1397-91 (Reapproved 2008) Standard Withdrawn and replaced
Practice for In Vitro Rat Hepatocyte DNA with newer version
Repair Assay
----------------------------------------------------------------------------------------------------------------
2-91 2-140 ASTM E1398-91 (Reapproved 2008) Standard Withdrawn and replaced
Practice for In Vivo Rat Hepatocyte DNA with newer version
Repair Assay
----------------------------------------------------------------------------------------------------------------
2-93 ..................... ASTM F763-04 Standard Practice for Short- Extent of recognition
Term Screening of Implant Materials and Contact person
----------------------------------------------------------------------------------------------------------------
2-94 ..................... ASTM F981-04 Standard Practice for Extent of recognition
Assessment of Compatibility of and Contact person
Biomaterials for Surgical Implants with
Respect to Effect of Materials on Muscle
and Bone
----------------------------------------------------------------------------------------------------------------
2-95 2-141 ASTM F1984-99 (Reapproved 2008) Standard Withdrawn and replaced
Practice for Testing for Whole Complement with newer version
Activation in Serum by Solid Materials
----------------------------------------------------------------------------------------------------------------
2-97 2-142 ASTM F1983-99 (Reapproved 2008) Standard Withdrawn and replaced
Practice for Assessment of Compatibility with newer version
of Absorbable/Resorbable Biomaterials for
Implant Applications
----------------------------------------------------------------------------------------------------------------
2-98 ..................... ANSI/AAMI/ISO 10993-1:2003 Biological Title, Extent of
Evaluation of Medical Devices--Part 1: recognition, Relevant
Evaluation and Testing guidance and Contact
person
----------------------------------------------------------------------------------------------------------------
2-99 2-143 ASTM F1904-98 (Reapproved 2008) Standard Withdrawn and replaced
Practice for Testing the Biological with newer version
Responses to Particles in vivo
----------------------------------------------------------------------------------------------------------------
2-100 ..................... ASTM E1372-95 (Reapproved 2003) Standard Contact person
Test Method for Conducting a 90-Day Oral
Toxicity Study in Rats
----------------------------------------------------------------------------------------------------------------
2-106 2-144 ASTM F619-03 (Reapproved 2008) Standard Withdrawn and replaced
Practice for Extraction of Medical with newer version
Plastics
----------------------------------------------------------------------------------------------------------------
2-108 ..................... ASTM F1905-98(2003) Standard Practice for Contact person and
Selecting Tests for Determining the Extent of recognition
Propensity of Materials to Cause
Immunotoxicity
----------------------------------------------------------------------------------------------------------------
2-114 ..................... ASTM F1877-05 Standard Practice for Extent of recognition
Characterization of Particles and Contact person
----------------------------------------------------------------------------------------------------------------
[[Page 46206]]
2-115 ..................... ASTM F895-84 (Reapproved 2006) Standard Extent of recognition,
Test Method for Agar Diffusion Cell Relevant guidance and
Culture Screening for Cytotoxicity Contact person
----------------------------------------------------------------------------------------------------------------
2-116 2-145 ASTM F1439-03 (Reapproved 2008) Standard Withdrawn and replaced
Guide for Performance of Lifetime with newer version
Bioassay for the Tumorigenic Potential of
Implant Materials
----------------------------------------------------------------------------------------------------------------
2-118 ..................... ANSI/AAMI/ISO 10993-11:2006 Biological Extent of recognition,
Evaluation of Medical Devices--Part 11: Relevant guidance and
Tests for Systemic Toxicity Contact person
----------------------------------------------------------------------------------------------------------------
2-119 ..................... ASTM F813-07 Standard Practice for Direct Contact person
Contact Cell Culture Evaluation of
Materials for Medical Devices
----------------------------------------------------------------------------------------------------------------
2-121 2-146 ASTM F2148-071 Standard Practice for Withdrawn and replaced
Evaluation of Delayed Contact with newer version
Hypersensitivity Using the Murine Local
Lymph Node Assay (LLNA)
----------------------------------------------------------------------------------------------------------------
2-122 ..................... ASTM F719-81 (Reapproved 2007)1 Standard Contact person and
Practice for Testing Biomaterials in Relevant guidance
Rabbits for Primary Skin Irritation
----------------------------------------------------------------------------------------------------------------
2-124 ..................... ASTM F750-87 (Reapproved 2007)1 Standard Extent of recognition,
Practice for Evaluating Material Extracts Relevant guidance and
by Systemic Injection in the Mouse Contact person
----------------------------------------------------------------------------------------------------------------
2-125 ..................... ASTM F749-98 (Reapproved 2007)1 Standard Extent of recognition,
Practice for Evaluating Material Extracts Relevant guidance and
by Intracutaneous Injection in the Rabbit Contact person
----------------------------------------------------------------------------------------------------------------
2-126 ..................... ASTM F748-06 Standard Practice for Extent of recognition,
Selecting Generic Biological Test Methods Relevant guidance and
for Materials and Devices Contact person
----------------------------------------------------------------------------------------------------------------
2-128 2-147 USP 32-NF26 Biological Tests <87> 2009 Withdrawn and replaced
Biological Reactivity Test, In Vitro-- with newer version
Direct Contact Test
----------------------------------------------------------------------------------------------------------------
2-129 2-148 USP 32-NF26 Biological Tests <88> Withdrawn and replaced
Biological Reactivity Test, In Vitro-- with newer version
Elution Test
----------------------------------------------------------------------------------------------------------------
2-130 2-149 USP 32-NF26 Biological Tests <88> Withdrawn and replaced
Biological Reactivity Tests, In Vivo with newer version
Procedure--Preparation of Sample
----------------------------------------------------------------------------------------------------------------
2-131 2-150 USP 32-NF26 Biological Tests <88> Withdrawn and replaced
Biological Reactivity Test, In Vivo, with newer version
Classification of Plastics--
Intracutaneous Test
----------------------------------------------------------------------------------------------------------------
2-132 2-151 USP 32-NF26 Biological Tests <88> Withdrawn and replaced
Biological Reactivity Tests, In Vivo, with newer version
Classification of Plastics--Systemic
Injection Test
----------------------------------------------------------------------------------------------------------------
2-133 ..................... ASTM F1408-97 (Reapproved 2008) Standard Contact person
Practice for Subcutaneous Screening Test
for Implant Materials
----------------------------------------------------------------------------------------------------------------
2-134 ..................... ASTM F2065-00 (2006) Standard Practice for Contact person
Testing for Alternative Pathway
Complement Activation in Serum by Solid
Materials
----------------------------------------------------------------------------------------------------------------
2-135 ..................... AAMI/ANSI/ISO 10993-12:2007 Biological Extent of recognition,
Evaluation of Medical Devices--Part 12: Relevant guidance and
Sample Preparation and Reference Contact person
Materials
----------------------------------------------------------------------------------------------------------------
C. Dental/ENT
----------------------------------------------------------------------------------------------------------------
4-69 4-178 ISO 6872:2008 Dentistry--Ceramic Materials Withdrawn and replaced
with newer version
----------------------------------------------------------------------------------------------------------------
4-73 4-179 ISO 7405: 2008 Dentistry--Evaluation of Withdrawn and replaced
Biocompatibility of Medical Devices Used with newer version
in Dentistry
----------------------------------------------------------------------------------------------------------------
4-175 ..................... ANSI ASA S3.46-1997 (R 2007) Methods of Reaffirmation
Measurement of Real-Ear Performance
Characteristics of Hearing Aids
----------------------------------------------------------------------------------------------------------------
D. General
----------------------------------------------------------------------------------------------------------------
[[Page 46207]]
5-12 5-47 ISO 10012:2003 Measurement Management Withdrawn and replaced
Systems--Requirements for Measurement with newer version
Processes and Measuring Equipment
----------------------------------------------------------------------------------------------------------------
5-15 5-48 ANSI/ASQ Z1.9-2008 Sampling Procedures and Withdrawn and replaced
Tables for Inspection by Variables for with newer version
Percent Nonconforming
----------------------------------------------------------------------------------------------------------------
5-27 ..................... IEC 60601-1-1 Ed. 2.0 2000 Medical Title
Electrical Equipment--Part 1-1: General
Requirements for Safety--Collateral
Standard: Safety requirements for Medical
Electrical Systems
----------------------------------------------------------------------------------------------------------------
5-36 ..................... ISO/TR 16142:2006 Medical Devices-- Title
Guidance on the Selection of Standards in
Support of Recognized Essential
Principles of Safety and Performance of
Medical Devices
----------------------------------------------------------------------------------------------------------------
5-41 ..................... IEC 60601-1-4 (2000) Consol. Ed. 1.1 Title
Medical Electrical Equipment--Part 1-4:
General Requirements for Safety--
Collateral Standard: Programmable
Electrical Medical Systems
----------------------------------------------------------------------------------------------------------------
5-44 5-49 IEC 60601-1-8, Ed. 1 Medical Electrical Withdrawn and re-
Equipment--Part 1-8: General Requirements recognized previous
for Safety--Collateral Standard: Alarm version
Systems--Requirements, Tests and
Guidelines--General Requirements and
Guidelines for Alarm Systems in Medical
Equipment
----------------------------------------------------------------------------------------------------------------
E. General Hospital/General Plastic Surgery
----------------------------------------------------------------------------------------------------------------
6-63 6-216 ISO 8536-7:2009 Infusion Equipment for Withdrawn and replaced
Medical Use--Part 7: Caps Made of with newer version
Aluminum-plastics Combinations for
Infusion Bottles
----------------------------------------------------------------------------------------------------------------
6-112 ..................... ANSI/AAMI PB70:2003 Liquid Barrier Contact person
Performance and Classification of
Protective Apparel and Drapes Intended
for Use in Health Care Facilities
----------------------------------------------------------------------------------------------------------------
6-118 ..................... ASTM F2196-02 Standard Specification for CFR citation and
Circulating Liquid and Forced Air Patient product code
Temperature Management Devices
----------------------------------------------------------------------------------------------------------------
6-144 ..................... ASTM D5712--051 Standard Test Method for Title and Contact
Analysis of Aqueous Extractable Protein person
in Natural Rubber and Its Products Using
the Modified Lowry Method
----------------------------------------------------------------------------------------------------------------
6-145 ..................... ASTM D3578-051 Standard Specification for Title and Contact
Rubber Examination Gloves person
----------------------------------------------------------------------------------------------------------------
6-147 ..................... ASTM D6978-05 Standard Practice for Contact person and
Assessment of Resistance of Medical Relevant guidance
Gloves to Permeation by Chemotherapy
Drugs
----------------------------------------------------------------------------------------------------------------
6-149 ..................... ASTM D7160-05 Standard Practice for Contact person
Determination of Expiration Dating for
Medical Gloves
----------------------------------------------------------------------------------------------------------------
6-150 ..................... ASTM D7161-05 Standard Practice for Contact person
Determination of Real Time Expiration
Dating of Mature Medical Gloves Stored
Under Typical Warehouse Conditions
----------------------------------------------------------------------------------------------------------------
6-165 ..................... ASTM D6977-041 Standard Specification for Title and Contact
Polychloroprene Examination Gloves for person
Medical Application
----------------------------------------------------------------------------------------------------------------
6-167 ..................... ASTM D6319-00a (Reapproved 2005)1 Standard Title and Contact
Specification for Nitrile Examination person
Gloves for Medical Application
----------------------------------------------------------------------------------------------------------------
6-168 ..................... ASTM D3577-091 Standard Specification for Withdrawn and replaced
Rubber Surgical Gloves with newer version
----------------------------------------------------------------------------------------------------------------
6-175 ..................... ASTM D5151-06 Standard Test Method for Contact person
Detection of Holes in Medical Gloves
----------------------------------------------------------------------------------------------------------------
6-178 ..................... ASTM D6124-06 Standard Test Method for Contact person
Residual Powder on Medical Gloves
----------------------------------------------------------------------------------------------------------------
6-183 ..................... ASTM D5250-061 Standard Specification for Title and Contact
Poly(vinyl chloride) Gloves for Medical person
Application
----------------------------------------------------------------------------------------------------------------
6-186 6-217 ASTM F1670-08 Standard Test Method for Withdrawn and replaced
Resistance of Materials Used in with newer version
Protective Clothing to Penetration by
Synthetic Blood
----------------------------------------------------------------------------------------------------------------
[[Page 46208]]
6-205 6-218 USP 32:2009 Nonabsorbable Surgical Suture Withdrawn and replaced
with newer version
----------------------------------------------------------------------------------------------------------------
6-206 6-219 USP 32<11>:2009 Sterile Sodium Chloride Withdrawn and replaced
for Irrigation with newer version
----------------------------------------------------------------------------------------------------------------
6-207 6-220 USP 32:2009 Absorbable Surgical Suture Withdrawn and replaced
with newer version
----------------------------------------------------------------------------------------------------------------
6-208 6-221 USP 32<881>:2009 Tensile Strength Withdrawn and replaced
with newer version
----------------------------------------------------------------------------------------------------------------
6-209 6-222 USP 32<861>:2009 Sutures--Diameter Withdrawn and replaced
with newer version
----------------------------------------------------------------------------------------------------------------
6-210 6-223 USP 32<871>:2009 Sutures Needle Attachment Withdrawn and replaced
with newer version
----------------------------------------------------------------------------------------------------------------
6-211 6-224 USP 32<11>:2009 Sterile Water for Withdrawn and replaced
Irrigation with newer version
----------------------------------------------------------------------------------------------------------------
6-212 6-225 USP 32<11>:2009 Heparin Lock Flush Withdrawn and replaced
Solution with newer version
----------------------------------------------------------------------------------------------------------------
6-213 6-226 USP 32<11>:2009 Sodium Chloride Injection Withdrawn and replaced
with newer version
----------------------------------------------------------------------------------------------------------------
F. In Vitro Diagnostics
----------------------------------------------------------------------------------------------------------------
7-156 7-195 CLSI M02-A10, Performance Standards for Withdrawn and replaced
Antimicrobial Disk Susceptibility Tests with newer version
----------------------------------------------------------------------------------------------------------------
7-158 7-196 CLSI M07-A8, Methods for Dilution Withdrawn and replaced
Antimicrobial Susceptibility Tests for with newer version
Bacteria that Grow Aerobically
----------------------------------------------------------------------------------------------------------------
7-160 7-197 CLSI M35-A2, Abbreviated Identification of Withdrawn and replaced
Bacteria and Yeast with newer version
----------------------------------------------------------------------------------------------------------------
7-78 7-198 CLSI M23-A3, Development of In Vitro Withdrawn and replaced
Susceptibility Testing Criteria and with newer version
Quality Control Parameters
----------------------------------------------------------------------------------------------------------------
7-177 7-199 CLSI M100-S19 Performance Standards for Withdrawn and replaced
Antimicrobial Susceptibility Testing with newer version
----------------------------------------------------------------------------------------------------------------
7-161 7-200 CLSI M48-A, Laboratory Detection and Withdrawn and replaced
Identification of Mycobacteria with newer version
----------------------------------------------------------------------------------------------------------------
7-102 ..................... NCCLS H1-A5, Tubes and Additives for Contact Person
Venous Blood Specimen Collection
----------------------------------------------------------------------------------------------------------------
7-101 ..................... NCCLS H51-A, Assays of vonWillebrand Contact Person
Factor Antigen and Ristocetin Cofactor
Activity
----------------------------------------------------------------------------------------------------------------
7-165 ..................... CLSI H20-A2, Reference Leukocyte (WBC) Contact Person
Differential Count (Proportional) and
Evaluation of Instrumental Methods
----------------------------------------------------------------------------------------------------------------
7-103 7-201 CLSI H3-A6, Procedures for the Collection Withdrawn and replaced
of Diagnostic Blood Specimens by with newer version
Venipuncture
----------------------------------------------------------------------------------------------------------------
7-81 7-202 CLSI C28-A3 Defining, Establishing, and Withdrawn and replaced
Verifying Reference Intervals in the with newer version
Clinical Laboratory
----------------------------------------------------------------------------------------------------------------
7-144 7-203 CLSI H04-A6, Procedures and Devices for Withdrawn and replaced
the Collection of Diagnostic Capillary with newer version
Blood Specimens
----------------------------------------------------------------------------------------------------------------
G. Materials
----------------------------------------------------------------------------------------------------------------
8-32 8-163 ASTM F1586-08 Standard Specification for Withdrawn and replaced
Wrought Nitrogen Strengthened 21 Chromium- with newer version
10Nickel-3Manganese-2.5Molybdenum
Stainless Steel Bar for Surgical Implants
(UNS S31675)
----------------------------------------------------------------------------------------------------------------
[[Page 46209]]
8-44 8-164 ASTM F136-081 Standard Specification for Withdrawn and replaced
Wrought Titanium-6 Aluminum-4 Vanadium with newer version
ELI (Extra Low Interstitial) Alloy for
Surgical Implant Applications (UNS
R56401)
----------------------------------------------------------------------------------------------------------------
8-49 8-165 ASTM F1058-08 Standard Specification for Withdrawn and replaced
Wrought 40Cobalt-20Chromium-16Iron- with newer version
15Nickel-7Molybdenum Alloy Wire and Strip
for Surgical Implant Applications (UNS
R30003 and UNS R30008)
----------------------------------------------------------------------------------------------------------------
8-50 8-166 ASTM F1091-08 Standard Specification for Withdrawn and replaced
Wrought Cobalt-20 Chromium-15 Tungsten-10 with newer version
Nickel Alloy Surgical Fixation Wire (UNS
R30605)
----------------------------------------------------------------------------------------------------------------
8-52 8-167 ASTM F1350-08 Standard Specification for Withdrawn and replaced
Wrought 18 Chromium-14 Nickel-2.5 with newer version
Molybdenum Stainless Steel Surgical
Fixation Wire (UNS S31673)
----------------------------------------------------------------------------------------------------------------
8-53 8-168 ASTM F1472-081 Standard Specification for Withdrawn and replaced
Wrought Titanium -6Aluminum -4Vanadium with newer version
Alloy for Surgical Implant Applications
(UNS R56400)
----------------------------------------------------------------------------------------------------------------
8-76 8-169 ASTM F138-08 Standard Specification for Withdrawn and replaced
Wrought 18 Chromium-14 Nickel-2.5 with newer version
Molybdenum Stainless Steel Bar and Wire
for Surgical Implants (UNS S31673)
----------------------------------------------------------------------------------------------------------------
8-79 8-170 ASTM F961-08 Standard Specification for Withdrawn and replaced
35Cobalt-35 Nickel-20 Chromium-10 with newer version
Molybdenum Alloy Forgings for Surgical
Implants (UNS R30035)
----------------------------------------------------------------------------------------------------------------
8-81 8-171 ASTM F1609-08 Standard Specification for Withdrawn and replaced
Calcium Phosphate Coatings for with newer version
Implantable Materials
----------------------------------------------------------------------------------------------------------------
8-86 8-172 ASTM F1926/F1926M-08 Standard Test Method Withdrawn and replaced
for Evaluation of the Environmental with newer version
Stability of Calcium Phosphate Granules,
Fabricated Forms, and Coatings
----------------------------------------------------------------------------------------------------------------
8-94 8-173 ASTM F601-03 (Reapproved 2008) Standard Withdrawn and replaced
Practice for Fluorescent Penetrant with newer version
Inspection of Metallic Surgical Implants
----------------------------------------------------------------------------------------------------------------
8-95 8-174 ASTM F629-02 (Reapproved 2007)1 Standard Withdrawn and replaced
Practice for Radiography of Cast Metallic with newer version
Surgical Implants
----------------------------------------------------------------------------------------------------------------
8-110 8-175 ASTM F1377-08 Standard Specification for Withdrawn and replaced
Cobalt-28 Chromium-6 Molybdenum Powder with newer version
for Coating of Orthopedic Implants (UNS
R30075)
----------------------------------------------------------------------------------------------------------------
8-118 8-176 ASTM F2503-08 Standard Practice for Withdrawn and replaced
Marking Medical Devices and Other Items with newer version
for Safety in the Magnetic Resonance
Environment
----------------------------------------------------------------------------------------------------------------
8-133 8-177 ASTM F2129-08 Standard Test Method for Withdrawn and replaced
Conducting Cyclic Potentiodynamic with newer version
Polarization Measurements to Determine
the Corrosion Susceptibility of Small
Implant Devices
----------------------------------------------------------------------------------------------------------------
8-143 8-178 ASTM F648-071 Standard Specification for Withdrawn and replaced
Ultra-High-Molecular-Weight Polyethylene with newer version
Powder and Fabricated Form for Surgical
Implants
----------------------------------------------------------------------------------------------------------------
8-144 8-179 ASTM F754-08 Standard Specification for Withdrawn and replaced
Implantable Polytetrafluoroethylene with newer version
(PTFE) Sheet, Tube, and Rod Shapes
Fabricated from Granular Molding Powders
----------------------------------------------------------------------------------------------------------------
8-146 8-180 ASTM F2066-08 Standard Specification for Withdrawn and replaced
Wrought Titanium-15 Molybdenum Alloy for with newer version
Surgical Implant Applications (UNS
R58150)
----------------------------------------------------------------------------------------------------------------
8-148 8-181 ASTM F899-09 Standard Specification for Withdrawn and replaced
Wrought Stainless Steels for Surgical with newer version
Instruments
----------------------------------------------------------------------------------------------------------------
8-152 8-182 ASTM F1537-08 Standard Specification for Withdrawn and replaced
Wrought Cobalt-28-Chromium-6-Molybdenum with newer version
Alloys for Surgical Implants (UNS R31537,
UNS R31538, and UNS R31539)
----------------------------------------------------------------------------------------------------------------
8-160 8-183 ASTM F560-08 Standard Specification for Withdrawn and replaced
Unalloyed Tantalum for Surgical Implant with newer version
Applications (UNS R05200, UNS R05400)
----------------------------------------------------------------------------------------------------------------
[[Page 46210]]
8-161 8-184 ASTM F2516-072 Standard Test Method for Withdrawn and replaced
Tension Testing of Nickel-Titanium with newer version
Superelastic Materials
----------------------------------------------------------------------------------------------------------------
8-162 8-185 ASTM F451-08 Standard Specification for Withdrawn and replaced
Acrylic Bone Cement with newer version
----------------------------------------------------------------------------------------------------------------
H. OB-GYN/Gastroenterology
----------------------------------------------------------------------------------------------------------------
9-34 ..................... ISO 4074:2002/Cor.1:2003(E):, Natural Relevant guidance
Latex Rubber Condoms--Requirements and
Test Methods, Technical Corrigendum 1
----------------------------------------------------------------------------------------------------------------
9-41 9-58 ASTM D6324-08 Standard Test Methods for Withdrawn and replaced
Male Condoms Made from Polyurethane with newer version
----------------------------------------------------------------------------------------------------------------
9-43 ..................... ISO 16038:2005 Rubber condoms--Guidance on Relevant guidance
the Use of ISO 4074 in the Quality
Management of Natural Rubber Latex
Condoms
----------------------------------------------------------------------------------------------------------------
9-56 ..................... ASTM D3492-08 Standard Specification for Relevant guidance
Rubber Contraceptives (Male Condoms)
----------------------------------------------------------------------------------------------------------------
9-57 ..................... ISO 4074:2002/Cor.2:2008(E) Natural Latex Relevant guidance
Rubber Condoms--Requirements and Test
Methods, Technical Corrigendum 2
----------------------------------------------------------------------------------------------------------------
I. Orthopedics
----------------------------------------------------------------------------------------------------------------
11-172 11-211 ASTM F1798-97 (Reapproved 2008) Standard Withdrawn and replaced
Guide for Evaluating the Static and with newer version
Fatigue Properties of Interconnection
Mechanisms and Subassemblies Used in
Spinal Arthrodesis Implants
----------------------------------------------------------------------------------------------------------------
11-178 11-212 ASTM F1440-92 (Reapproved 2008) Standard Withdrawn and replaced
Practice for Cyclic Fatigue Testing of with newer version
Metallic Stemmed Hip Arthroplasty Femoral
Components Without Torsion
----------------------------------------------------------------------------------------------------------------
11-192 11-213 ASTM F1223-08 Standard Test Method for Withdrawn and replaced
Determination of Total Knee Replacement with newer version
Constraint
----------------------------------------------------------------------------------------------------------------
11-198 11-214 ASTM F0382-99 (Reapproved 2008) Standard Withdrawn and replaced
Specification and Test Method for with newer version
Metallic Bone Plates
----------------------------------------------------------------------------------------------------------------
11-204 11-215 ASTM F897-02 (Reapproved 2007) Standard Withdrawn and replaced
Test Method for Measuring Fretting with newer version
Corrosion of Osteosynthesis Plates and
Screws
----------------------------------------------------------------------------------------------------------------
11-205 11-216 ASTM F1264-03 (Reapproved 2007)1 Standard Withdrawn and replaced
Specification and Test Methods for with newer version
Intramedullary Fixation Devices
----------------------------------------------------------------------------------------------------------------
11-209 11-217 ASTM F2083-081 Standard Specification for Withdrawn and replaced
Total Knee Prosthesis with newer version
----------------------------------------------------------------------------------------------------------------
J. Radiology
----------------------------------------------------------------------------------------------------------------
12-17 12-192 NEMA MS 8-2008 Characterization of the Withdrawn and replaced
Specific Absorption Rate for Magnetic with new version
Resonance Imaging Systems
----------------------------------------------------------------------------------------------------------------
12-48 12-193 AIUM AOL 2008 Acoustic Output Labeling Withdrawn and replaced
Standard for Diagnostic Ultrasound with newer version
Equipment Revision 1- A Standard for How
Manufacturers Should Specify Acoustic
Output Data
----------------------------------------------------------------------------------------------------------------
12-58 12-194 ANSI/HPS N43.6-2007 Sealed Radioactive Withdrawn and replaced
Sources--Classification with newer version
----------------------------------------------------------------------------------------------------------------
12-69 12-195 NEMA MS 6-2008 Determination of Signal-to- Withdrawn and replaced
Noise Ratio and Image Uniformity for with newer version
Single-Channel Non-Volume Coils in
Diagnostic MR Imaging
----------------------------------------------------------------------------------------------------------------
12-95 12-196 NEMA MS 2-2008 Determination of Two- Withdrawn and replaced
Dimensional Geometric Distortion in with newer version
Diagnostic Magnetic Resonance Images
----------------------------------------------------------------------------------------------------------------
12-100 ..................... NEMA UD 3-2004 Standard for Real Time Contact person
Display of Thermal and Mechanical
Acoustic Output Indices on Diagnostic
Ultrasound Equipment
----------------------------------------------------------------------------------------------------------------
[[Page 46211]]
12-105 ..................... NEMA UD 2-2004 Acoustic Output Measurement Contact person
Standard for Diagnostic Ultrasound
Equipment Version 3
----------------------------------------------------------------------------------------------------------------
12-139 ..................... AIUM AOMS-2004 Acoustic Output Measurement Title and Contact
Standard for Diagnostic Ultrasound person
Equipment
----------------------------------------------------------------------------------------------------------------
12-140 ..................... AIUM RTD1-2004 Standard for Real-Time Title and Contact
Display of Thermal and Mechanical person
Acoustic Output Indices on Diagnostic
Ultrasound Equipment Revision 1
----------------------------------------------------------------------------------------------------------------
12-146 ..................... IEC 60601-2-17 (2004) Medical Electrical Title
Equipment--Part 2-17: Particular
Requirements for the Safety of
Automatically-controlled Brachytherapy
Afterloading Equipment
----------------------------------------------------------------------------------------------------------------
12-147 ..................... IEC 60601-2-5: (2000) Medical Electrical Title
Equipment--Part 2-5: Particular
Requirements for the Safety of Ultrasonic
Physiotherapy Equipment Ed. 2.0
----------------------------------------------------------------------------------------------------------------
12-169 12-197 IEC 60601-2-22 (1995) Medical Electrical Withdrawn and re-
Equipment--Part 2-22: Particular recognized previous
Requirements for Basic Safety and version
Essential Performance of Surgical,
Cosmetic, Therapeutic and Diagnostic
Laser Equipment--Edition 2.0
----------------------------------------------------------------------------------------------------------------
12-178 ..................... IEC 60601-2-45 Ed. 2.0, (2001), Medical Title
electrical equipment--Part 2-45:
Particular requirements for the safety of
mammograph
