[Federal Register Volume 73, Number 175 (Tuesday, September 9, 2008)]
[Notices]
[Pages 52358-52385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-20939]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2004-N-0451] (formerly FDA-2004-N-0226)
Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 020
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a
publication containing modifications the agency is making to the list
of standards FDA recognizes for use in premarket reviews (FDA
recognized consensus standards). This publication, entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 020'' (Recognition List Number: 020), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.
DATES: Effective September 9, 2008. Submit written or electronic
comments concerning this document at any time.
ADDRESSES: Submit written requests for single copies of
``Modifications to the List of Recognized Standards, Recognition List
Number: 020'' to the Division of Small Manufacturers, International and
Consumer Assistance, Center for Devices and Radiological Health (CDRH)
(HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville,
MD 20850. Send two self-addressed adhesive labels to assist that office
in processing your requests, or fax your request to 240-276-3151.
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 to
[email protected]. This document may also be accessed on FDA's
Internet site at http://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: 020
modifications and other standards related information.
FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices
and Radiological Health (HFZ-84), Food and Drug Administration, 7520
Standish Pl., Rockville, MD 20855, 240-276-8714.
SUPPLEMENTARY INFORMATION:
I. Background
Section 204 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended
section 514 allows FDA to recognize consensus standards developed by
international and national organizations for use in satisfying portions
of device premarket review submissions or other requirements.
In a notice published in the Federal Register of February 25, 1998
(63 FR 9561), FDA announced the availability of a guidance entitled
``Recognition and Use of Consensus Standards.'' The document 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
[[Page 52359]]
the Federal Register, are identified in table 1 of this document.
Table 1.--Previous Publications of Standard Recognition Lists
October 16, 1998 October 4, 2004
(63 FR 55617) (69 FR 59240)
July 12, 1999 May 27, 2005
(64 FR 37546) (70 FR 30756)
November 15, 2000 November 8, 2005
(65 FR 69022) (70 FR 67713)
May 7, 2001 March 31, 2006
(66 FR 23032) (71 FR 16313)
January 14, 2002 June 23, 2006
(67 FR 1774) (71 FR 36121)
October 2, 2002 November 3, 2006
(67 FR 61893) (71 FR 64718)
April 28, 2003 May 21, 2007
(68 FR 22391) (72 FR 28500)
March 8, 2004 September 12, 2007
(69 FR 10712) (72 FR 52142)
June 18, 2004 December 19, 2007
(69 FR 34176) (72 FR 71924)
------------------------------------------------------------------------
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: 020
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.
In addition to these changes, FDA has also established a new internal
numbering system that assigns unique identification recognition
numbers. FDA believes this new numbering system will facilitate the use
of FDA Form 3654, ``Standards Data Report for 510(k)s,'' which was
implemented in November 2007. 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:
020'' 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.--Modifications to the List of Recognized Standards
------------------------------------------------------------------------
Old Replacement
Recognition Recognition Standard Change
No. No.
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
1-11 ............ IEC 60601-3-1:1996-08 Withdrawn
Medical Electrical
Equipment Part 3-1:
Essential Performance
Requirements for
Transcutaneous Oxygen and
Carbon Dioxide Partial
Pressure Monitoring
Equipment
------------------------------------------------------------------------
1-46 ............ ISO 5367:2000 Breathing Relevant
Tubes Intended for Use guidance and
With Anaesthetic Extent of
Apparatus and Ventilators recognition
------------------------------------------------------------------------
1-51 ............ ASTM F1101-90(1997) Withdrawn
Standard Specification
for Ventilators Intended
for Use During Anesthesia
------------------------------------------------------------------------
1-62 ............ ISO 5356-1:2004 Relevant
Anaesthetic and guidance
Respiratory Equipment--
Conical Connectors: Part
1: Cones and Sockets
------------------------------------------------------------------------
1-66 ............ ISO 9919:2005: Medical Relevant
Electrical Equipment-- guidance
Particular Requirements
for the Basic Safety and
Essential Performance of
Pulse Oximeter Equipment
for Medical Use
------------------------------------------------------------------------
1-68 ............ CGA V-5:2005 Diameter- Relevant
Index Safety System guidance
(Noninterchangeable Low
Pressure Connections for
Medical Gas Applications)
------------------------------------------------------------------------
1-72 ............ ISO 10651-5:2006 Lung Relevant
Ventilators for Medical guidance, Code
Use--Particular of Federal
Requirements for Basic Regulations
Safety and Essential (CFR) Citation
Performance--Part 5: Gas- and Product
powered Emergency Codes
Resuscitators
------------------------------------------------------------------------
1-73 ............ ISO 10651-4:2002 Lung Relevant
Ventilators--Part 4: guidance
Particular Requirements
for Operator Powered
Resuscitators
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
2-21 2-118 ANSI/AAMI/ISO 10993-11: Withdrawn and
2006 Biological replaced with
Evaluation of Medical newer version
Devices--Part 11: Tests
for System Toxicity
------------------------------------------------------------------------
2-56 2-119 ASTM F813-07 Standard Withdrawn and
Practice for Direct replaced with
Contact Cell Culture newer version
Evaluation of Materials
for Medical Devices
------------------------------------------------------------------------
[[Page 52360]]
2-63 2-120 ANSI/AAMI/ISO 10993-6: Withdrawn and
2007 Biological replaced with
Evaluation of Medical newer version
Devices--Part 6: Tests
for Local Effects After
Implantation
------------------------------------------------------------------------
2-66 2-121 ASTM F2148-07e1 Standard Withdrawn and
Practice for Evaluation replaced with
of Delayed Contact newer version
Hypersensitivity Using
the Murine Local Lymph
Node Assay (LLNA)
------------------------------------------------------------------------
2-68 2-122 ASTM F719-81 (2007) e1 Withdrawn and
Standard Practice for replaced with
Testing Biomaterials in newer version
Rabbits for Primary Skin
Irritation
------------------------------------------------------------------------
2-69 2-123 ASTM F720-81 (2007) e1 Withdrawn and
Standard Practice for replaced with
Testing Guinea Pigs for newer version
Contact Allergens: Guinea
Pig Maximization Test
------------------------------------------------------------------------
2-70 2-124 ASTM F750-87 (2007) e1 Withdrawn and
Standard Practice for replaced with
Evaluating Material newer version
Extracts by Systemic
Injection in the Mouse
------------------------------------------------------------------------
2-89 2-125 ASTM F749-98 (2007) e1 Withdrawn and
Standard Practice for replaced with
Evaluating Material newer version
Extracts by
Intracutaneous Injection
in the Rabbit
------------------------------------------------------------------------
2-92 2-126 ASTM F748-06 Standard Withdrawn and
Practice for Selecting replaced with
Generic Biological Test newer version
Methods for Materials and
Devices
------------------------------------------------------------------------
2-95 ............ ASTM F1984-99(2003) Relevant
Standard Practice for guidance
Testing for Whole
Complement Activation in
Serum by Solid Materials
------------------------------------------------------------------------
2-109 2-128 USP 31-NF26 Biological Withdrawn and
Test <87> 2008 Biological replaced with
Reactivity Test, In newer version
Vitro--Direct Contact
Test
------------------------------------------------------------------------
2-110 2-129 USP 31-NF26 Biological Withdrawn and
Test <88> 2008 Biological replaced with
Reactivity Test, In newer version
Vitro--Elution Test
------------------------------------------------------------------------
2-111 2-130 USP 31-NF26 Biological Withdrawn and
Test <88> 2008 Biological replaced with
Reactivity Test, In newer version
Vitro, Procedure--
Preparation of Sample
------------------------------------------------------------------------
2-112 2-131 USP 31-NF26 Biological Withdrawn and
Test <88> 2008 Biological replaced with
Reactivity Test, In newer version
Vitro, Classification of
Plastics--Intracutaneous
Test
------------------------------------------------------------------------
2-113 2-132 USP 31-NF26Biological Test Withdrawn and
<88> 2008 Biological replaced with
Reactivity Test, In Vivo-- newer version
Classification of
Plastics--Systemic
Injection Test
------------------------------------------------------------------------
C. Cardiovascular/Neurology
------------------------------------------------------------------------
3-2 ............ ANSI/AAMI EC53:1995/ Reaffirmation
(R)2001--ECG Cables and
Leadwires
------------------------------------------------------------------------
3-3 ............ ANSI/AAMI NS28:1988/ Reaffirmation
(R)2006--Intracranial
Pressure Monitoring
Devices
------------------------------------------------------------------------
3-16 3-60 IEC 60601-2-10: Amendment Withdrawn and
1: 2001-09, Medical replaced with
Electrical Equipment-- newer version
Part 2-10: Particular
Requirements for the
Safety of Nerve and
Muscle Stimulators
------------------------------------------------------------------------
3-18 3-61 IEC 60601-2-27: 2005-08, Withdrawn and
Second Edition, Medical replaced with
Electrical Equipment-- newer version
Part 2-27: Particular
Requirements for the
Safety, Including
Essential Performance, of
Electrocardiographic
Monitoring Equipment
------------------------------------------------------------------------
3-20 3-62 IEC 60601-2-31: 2008-03, Withdrawn and
Edition 2.0, Medical replaced with
Electrical Equipment-- newer version
Part 2-31: Particular
Requirements for the
Basic Safety and
Essential Performance of
External Cardiac
Pacemakers with Internal
Power Source
------------------------------------------------------------------------
3-25 3-63 ISO 11318:2002, Second Withdrawn and
Edition, Cardiac replaced with
Defibrillators--Connector newer version
Assembly DF-1 for
Implantable
Defibrillators--Dimension
s and Test Requirements
------------------------------------------------------------------------
[[Page 52361]]
3-40 ............ ANSI/AAMI SP9:1994, Non- Withdrawn
automated
Sphygmomanometers
------------------------------------------------------------------------
3-41 ............ ANSI/AAMI EC11:1991/ Reaffirmation
(R)2007--Diagnostic
Electrocardiographic
Devices
------------------------------------------------------------------------
3-42 ............ ANSI/AAMI EC13:2002/ Reaffirmation
(R)2007--Cardiac
Monitors, Heart Rate
Meters, and Alarms
------------------------------------------------------------------------
3-43 3-65 ANSI/AAMI EC38:2007-- Withdrawn and
Medical Electrical replaced with
Equipment--Part 2-47: newer version
Particular Requirements
for the Safety, Including
Essential Performance, of
Ambulatory
Electrocardiographic
Systems
------------------------------------------------------------------------
3-44 ............ ANSI/AAMI BP22:1994/ Reaffirmation
(R)2006, Blood Pressure
Transducers
------------------------------------------------------------------------
3-45 ............ ANSI/AAMI EC57:1998/ Reaffirmation
(R)2003, Testing and
Reporting Performance
Results of Cardiac Rhythm
and ST Segment
Measurement Algorithms
------------------------------------------------------------------------
3-47 3-66 ASTM F2081-06, Standard Withdrawn and
Guide for replaced with
Characterization and newer version
Presentation of the
Dimensional Attributes of
Vascular Stents
------------------------------------------------------------------------
3-52 ............ ANSI/AAMI EC12:2000/ Reaffirmation
(R)2005, Disposable ECG
Electrodes
------------------------------------------------------------------------
3-57 3-67 ASTM F2129-06, Standard Withdrawn and
Test Method for replaced with
Conducting Cyclic newer version
Potentiodynamic
Polarization Measurements
to Determine the
Corrosion Susceptibility
of Small Implant Devices
------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat
------------------------------------------------------------------------
4-43 ............ ANSI/ADA Specification No. Type of
5-Dental Casting standard, and
Alloys:1997 Relevant
guidance
------------------------------------------------------------------------
4-50 ............ ANSI/ADA Specification No. Title and
18-Alginate Impression Relevant
Materials:1992 guidance
------------------------------------------------------------------------
4-52 4-147 ANSI/ADA Specification No. Withdrawn and
27-Resin-Based Filling replaced with
Materials: 2005 newer year
------------------------------------------------------------------------
4-62 ............ ISO 1563:1990 Dental Relevant
Alginate Impression guidance and
Material Extent of
recognition
------------------------------------------------------------------------
4-63 ............ ISO 1564:1995 Dental Relevant
Aqueous Impression guidance
Materials Based on Agar
------------------------------------------------------------------------
4-65 4-151 ISO 3336:1993, Dentistry-- Withdrawn and
Synthetic Polymer Teeth replaced with
newer version
------------------------------------------------------------------------
4-66 ............ ISO 4049:1988, Dentistry-- Withdrawn--newer
Resin-Based Filling version
Materials previously
recognized
------------------------------------------------------------------------
4-67 ............ ISO 6871-1:1994, Dental Withdrawn--newer
Base Metal Casting Alloys version
Part 1: Cobalt-based previously
Alloys--TECHNICAL recognized
CORRIGENDUM 1:1998
------------------------------------------------------------------------
4-68 ............ ISO 6871-2:1994, Dental Withdrawn--newer
Base Metal Casting Alloys version
Part 2: Nickel-Based previously
Alloys recognized
------------------------------------------------------------------------
4-69 ............ ISO 6872:1995/Amendment Date of standard
1:1997 Dental Ceramic and Extent of
recognition
------------------------------------------------------------------------
4-73 ............ ISO 7405:1997 Dentistry-- Extent of
Preclinical Evaluation of recognition and
Biocompatibility of Contact person
Medical Devices Used in
Dentistry--Test Methods
for Dental Materials
------------------------------------------------------------------------
4-75 ............ ISO 7785-1:1997 Dental Relevant
Handpieces--Part 1: High- guidance and
Speed Air Turbine Extent of
Handpieces recognition
------------------------------------------------------------------------
[[Page 52362]]
4-76 ............ ISO 7785-2:1995 Dental Relevant
Handpieces--Part 2: guidance and
Straight and Geared Angle Extent of
Handpieces recognition
------------------------------------------------------------------------
4-78 ............ ISO 9168:1991 Dental Relevant
Handpieces--Hose guidance and
Connectors Extent of
recognition
------------------------------------------------------------------------
4-83 ............ ISO 11498:1997 Dental Relevant
Handpieces--Dental Low- guidance and
Voltage Electrical Motors Extent of
recognition
------------------------------------------------------------------------
4-84 ............ ISO 13294:1997 Dental Relevant
Handpieces--Dental Air- guidance and
Motors Extent of
recognition
------------------------------------------------------------------------
4-88 4-148 ANSI/ADA Specification No. Withdrawn and
78-Endodontic Obturating replaced with
Cones: 2005 newer version
------------------------------------------------------------------------
4-89 ............ ANSI/ADA Specification No. Reaffirmation
53-Polymer-Based Crowns and Relevant
and Bridge Resins: 1999 guidance
(Reaffirmed 2005)
------------------------------------------------------------------------
4-90 ............ ANSI/ASA S3.39:1987 Reaffirmation
(R2007), Specifications and Type of
for Instruments to standard
Measure Aural Acoustic
Impedance and Admittance
(Aural Acoustic
Immittance)
------------------------------------------------------------------------
4-91 ............ ANSI/ADA Specification No. Relevant
80-Dental Materials-- guidance
Determination of Color
Stability: 2001
------------------------------------------------------------------------
4-92 ............ ANSI/ADA Specification No. Reaffirmation
88-Dental Brazing Alloys: and Relevant
2000 (Reaffirmed 2006) guidance
------------------------------------------------------------------------
4-93 4-159 IEEE ANSI C63.19:2007 Withdrawn and
Methods of Measurement of replaced with
Compatibility Between newer version
Wireless Communications
Devices and Hearing Aids
------------------------------------------------------------------------
4-94 ............ ANSI/ADA Specification No. Reaffirmation,
14--Dental Base Metal Date of
Casting Alloys: 1982 standard, Type
(Reaffirmed 1998) of standard,
Offices,
Relevant
guidance
------------------------------------------------------------------------
4-95 ............ ANSI/ADA Specification Withdrawn--newer
No.17:1999, Dental Base version
Temporary Relining Resin previously
recognized
------------------------------------------------------------------------
4-96 ............ ANSI/ADA Specification No. Reaffirmation
30--Dental Zinc Oxide-- and Relevant
Eugenol and Zinc Oxide-- guidance
Non-Eugenol Cements: 2000
(Reaffirmed 2005)
------------------------------------------------------------------------
4-97 ............ ANSI/ADA Specification No. Reaffirmation,
57--Endodontic Sealing Offices and
Material: 2000 Type of
(Reaffirmed 2006) standard
------------------------------------------------------------------------
4-98 ............ ANSI/ADA Specification No. Withdrawn--newer
96:2000, Dental-Water- version
Based Cements previously
recognized
------------------------------------------------------------------------
4-99 ............ ISO 4049: 2000 Dentistry-- Relevant
Polymer-based Filling, guidance, Type
Restorative and Luting of standard and
Materials Extent of
recognition
------------------------------------------------------------------------
4-100 4-133 ISO 6876:2001, Dental Root Withdrawn
Canal Sealing Materials (duplicate)
------------------------------------------------------------------------
4-101 ............ ISO 8891:1998, Dental Withdrawn--newer
Casting Alloys With Noble version
Metal Content of At Least previously
25% but Less Than 75% recognized
------------------------------------------------------------------------
4-102 4-152 ISO 9693:1999, Metal- Withdrawn and
Ceramic Dental replaced with
Restorative Systems newer version
------------------------------------------------------------------------
4-104 4-149 ANSI/ADA Specification No. Withdrawn and
39--Pit and Fissure replaced with
Sealants: 2006 newer version
------------------------------------------------------------------------
4-105 ............ ANSI/ADA Specification No. Type of standard
75--Resilient Lining and Relevant
Materials for Removable guidance
Dentures--Part 1: Short-
Term Materials: 1997
(Reaffirmed 2003)
------------------------------------------------------------------------
4-107 ............ ISO 9917-2:1998 Dental Devices
Water-Based Cements--Part affected, Type
2: Light-Activated of standard,
Cements Relevant
guidance and
Extent of
recognition
------------------------------------------------------------------------
[[Page 52363]]
4-109 ............ ISO 13716:1999 Dentistry-- Type of
Reversible-Irreversible standard,
Hydrocolloid Impression Relevant
Material Systems guidance,
Extent of
recognition and
Code of Federal
Regulations
(CFR) citation
------------------------------------------------------------------------
4-110 ............ ANSI/ADA Specification No. Type of standard
11--Agar Impression and Relevant
Materials: 1997 guidance
------------------------------------------------------------------------
4-111 ............ ANSI/ADA Specification No. Reaffirmation,
13--Denture Cold-Curing Date of
Repair Resins: 1981 standard, Type
(Reaffirmed 2006) of standard and
Relevant
guidance
------------------------------------------------------------------------
4-112 ............ ANSI/ADA Specification No. Reaffirmation,
16--Dental Impression Date of
Paste--Zinc Oxide-Eugenol standard, Type
Type: 1961 (Reaffirmed of standard and
1999) Relevant
guidance
------------------------------------------------------------------------
4-113 ............ ANSI/ADA Specification No. Reaffirmation,
20--Dental Duplicating Date of
Material: 1972 standard, Type
(Reaffirmed 1995) of standard and
Relevant
guidance
------------------------------------------------------------------------
4-115 4-153 ISO 9917-1:2007 Dentistry-- Withdrawn and
Water-Based Cements--Part replaced with a
1: Powder/Liquid Acid- newer year
Base Cements
------------------------------------------------------------------------
4-117 ............ ANSI/ADA Specification No. Type of standard
12--Denture Base
Polymers: 2002
------------------------------------------------------------------------
4-119 ............ ANSI/ADA Specification No. Reaffirmation,
82--Dental Reversible/ Date of
Irreversible Hydrocolloid standard, Type
Impression Material of standard and
Systems: 1998 (Reaffirmed Relevant
2003) guidance
------------------------------------------------------------------------
4-120 ............ ISO 10139-2:1999 Type of
Dentistry--Soft Lining standard,
Materials for Removable Relevant
Dentures--Part 2: guidance and
Materials for Long-Term Extent of
Use recognition
------------------------------------------------------------------------
4-121 ............ ISO 7494-2:2003 Dentistry-- Type of standard
Dental Units--Part 2: and Extent of
Water and Air Supply recognition
------------------------------------------------------------------------
4-125 ............ ISO 1562:2004, Dentistry-- Withdrawn--newer
Casting Gold Alloys version
previously
recognized
------------------------------------------------------------------------
4-126 ............ ISO 10477:2004 Dentistry-- Extent of
Polymer-Based Crown and recognition and
Bridge Materials Relevant
guidance
------------------------------------------------------------------------
4-127 ............ ANSI/ADA Specification No. Type of standard
58--Root Canal Files, and Extent of
Type H (Hedstrom): 2004 recognition
------------------------------------------------------------------------
4-128 ............ ISO 4823:2000,, Dentistry-- Withdrawn
Elastomeric Impression
Materials and Technical
Corrigendum 1:2004
------------------------------------------------------------------------
4-129 4-150 ANSI/ADA Specification No. Withdrawn and
19--Dental Elastomeric replaced with
Impression Material: 2004 newer version
------------------------------------------------------------------------
4-130 ............ ANSI/ADA Specification No. Reaffirmation,
17--Denture Base Processes
Temporary Relining impacted,
Resins: 1983 (Reaffirmed Extent of
2006) recognition,
CFR citations
and Relevant
guidance
------------------------------------------------------------------------
4-131 ............ ISO 3107: 2004 Dentistry-- Processes
Zinc Oxide/Eugenol and impacted and
Zinc Oxide/Non-eugenol Relevant
Cements Technical guidance
Corrigendum 1:2006-Third
Edition
------------------------------------------------------------------------
4-132 ............ ISO 6874:2005 Dentistry-- Extent of
Polymer-Based Pit and recognition and
Fissure Sealants Relevant
guidance
------------------------------------------------------------------------
4-133 ............ ISO 6876:2001 Dental Root Processes
Canal Sealing Materials impacted and
Extent of
recognition
------------------------------------------------------------------------
4-134 ............ ISO 7494-1:2004 Dentistry-- Extent of
Dental Units--Part 1: recognition
General Requirements and
Test Methods
------------------------------------------------------------------------
4-135 ............ ISO 10139-1:2005 Relevant
Dentistry--Soft Lining guidance and
Materials for Removable Extent of
Dentures--Part 1: recognition
Materials for Short-term
Use
------------------------------------------------------------------------
[[Page 52364]]
4-136 ............ ASTM F2504-05 Standard Relevant
Practice for Describing guidance
System Output of
Implantable Middle Ear
Hearing Devices
------------------------------------------------------------------------
4-137 ............ ISO 6877:2006 Dentistry-- Extent of
Root-Canal Obturating recognition
Points
------------------------------------------------------------------------
4-139 ............ ANSI/ADA Specification No. Relevant
48--Visible Light Curing guidance
Units: 2004
------------------------------------------------------------------------
4-140 ............ ISO 6871-2:1994/Amd Withdrawn--newer
1:2005, Dental Base Metal version
Casting Alloys--Part 2: previously
Nickel-Based Alloys recognized
------------------------------------------------------------------------
4-141 ............ ISO 6871-1:1994, Dental Withdrawn--newer
Base Metal Casting version
Alloys--Part 1: Cobalt- previously
Based Alloys recognized
------------------------------------------------------------------------
4-142 ............ ISO 6871-1:1994/Amd Withdrawn--newer
1:2005, Dental Base Metal version
Casting Alloys--Part 1: previously
Cobalt-Based Alloys recognized
------------------------------------------------------------------------
4-143 ............ ANSI/ADA Specification Reaffirmation,
No.96, Dental-Water-Based Type of
Cements standard and
Relevant
guidance
------------------------------------------------------------------------
4-145 ............ ISO 22803:2004 Dentistry-- Relevant
Membrane Materials for guidance and
Guided Tissue Devices
Regeneration in Oral and affected
Maxillofacial Surgery--
Contents of a Technical
File
------------------------------------------------------------------------
4-146 ............ ISO 22674:2006 Dentistry-- Devices affected
Metallic Materials for and Processes
Fixed and Removable impacted
Restorations and
Appliances
------------------------------------------------------------------------
E. General
------------------------------------------------------------------------
5-7 12-185 IEC 60601-1-3(1994-07) Transferred
Medical Electrical
Equipment--Part 1:
General Requirements for
Safety; General
Requirements for
Radiation Protection in
Diagnostic X-Ray
Equipment
------------------------------------------------------------------------
5-8 5-41 IEC 60601-1-4:2000 Medical Withdrawn and
Electrical Equipment-- replaced with
Part 1-4: General newer version
Requirements for Safety--
Collateral Standard:
Programmable Electrical
Medical Systems, Edition
1.1
------------------------------------------------------------------------
5-16 5-42 ASTM D903-98(2004) Withdrawn and
Standard Test Methods for replaced with
Peel or Stripping newer version
Strength of Adhesive
Bonds
------------------------------------------------------------------------
5-19 ............ ASTM E876/1995 Standard Withdrawn
Practice for Use of
Statistics in the
Evaluation of
Spectrometric Data
------------------------------------------------------------------------
5-25 5-43 ANSI/ESD S20.20-2007 Withdrawn and
Standard for the replaced with
Development of an newer version
Electrostatic Discharge
Control Program for
Protection of Electrical
and Electronic Parts,
Assemblies and Equipment
(Excluding Electrically
Initiated Explosive
Devices)
------------------------------------------------------------------------
5-28 ............ IEC 60601-1-2, (Second Extent of
Edition, 2001) Medical recognition
Electrical Equipment--
Part 1-2: General
Requirements for Safety--
Collateral Standard:
Electromagnetic
Compatibility--Requiremen
ts and Tests
------------------------------------------------------------------------
5-30 ............ AAMI/ANSI/IEC 60601-1-2 Type of standard
Medical Electrical and Extent of
Equipment--Part 1-2: recognition
General Requirements for
Safety--Collateral
Standard: Electromagnetic
Compatibility--Requiremen
ts and Tests (AAMI/ANSI/
IEC 60601-1-2:2001 is the
U.S. version of IEC 60601-
1-2:2001 with identical
requirements for
electromagnetic
compatibility (EMC) of
medical electrical
equipment.)
------------------------------------------------------------------------
5-33 5-44 IEC 60601-1-8:2006 Medical Withdrawn and
Electrical Equipment-- replaced with
Part 1-8: General newer version
Requirements for Basic
Safety and Essential
Performance--Collateral
Standard: General
Requirements, Tests and
Guidance for Alarm
Systems in Medical
Electrical Equipment and
Medical Electrical
Systems, Second Edition
------------------------------------------------------------------------
[[Page 52365]]
5-34 ............ IEC 60601-1-2 Medical Extent of
Electrical Equipment-- recognition
Part 1-2: General
Requirements for Safety--
Collateral Standard:
Electromagnetic
Compatibility--Requiremen
ts and Tests (Edition
2:2001 with Amendment
1:2004; Edition 2.1
(Edition 2:2001
consolidated with
Amendment 1:2004))
------------------------------------------------------------------------
5-35 ............ AAMI/ANSI/IEC 60601-1-2 Type of standard
Medical Electrical and Extent of
Equipment--Part 1-2: recognition
General Requirements for
Safety--Collateral
standard: Electromagnetic
Compatibility--Requiremen
ts and Tests (Edition
2:2001 with Amendment
1:2004) (AAMI/ANSI/IEC
60601-1-2:2001 with
Amendment 1:2004 is the
U.S. version of IEC 60601-
1-2:2001 with Amendment
1:2004, with identical
requirements for
electromagnetic
compatibility (EMC) of
medical electrical
equipment)
------------------------------------------------------------------------
5-36 ............ ANSI/AAMI/ISO TIR CFR Citations,
16142:2006: Technical Product codes
Information Report: and Relevant
Medical Devices--Guidance guidance
on the Selection of
Standards in Support of
Recognized Essential
Principles of Safety and
Performance of Medical
Devices, Second Edition
------------------------------------------------------------------------
F. General Hospital/General Plastic Surgery
------------------------------------------------------------------------
6-16 ............ ISO 7886-1:1993 Sterile Withdrawn
Hypodermic Syringes for
Single Use--Part 1:
Syringes for Manual Use
------------------------------------------------------------------------
6-117 ............ ASTM F2172-02: Standard Relevant
Specification for Blood/ guidance
Intravenous Fluid/
Irrigation Fluid Warmers
------------------------------------------------------------------------
6-118 ............ ASTM F2196-02 Standard Relevant
Specification for guidance,
Circulating Liquid and Contact person
Forced Air Patient
Temperature Management
Devices
------------------------------------------------------------------------
6-131 6-203 ASTM D6499-07 Standard Withdrawn and
Test Method for the replaced with
Immunological Measurement newer version
of Antigenic Protein in
Natural Rubber and Its
Products
------------------------------------------------------------------------
6-160 6-204 ISO 8537:2007 Sterile Withdrawn and
Single-Use Syringes, With replaced with
or Without Needle, for newer version
Insulin
------------------------------------------------------------------------
6-166 6-215 ASTM F2132-01(2008) Withdrawn and
Standard Specification replaced with
for Puncture Resistance newer version
of Materials Used in
Containers for Discarded
Medical Needles and Other
Sharps
------------------------------------------------------------------------
6-167 ............ ASTM D6319-00a(2005) Relevant
Standard Specification guidance
for Nitrile Examination
Gloves for Medical
Application
------------------------------------------------------------------------
6-188 6-205 USP 31:2008 Nonabsorbable Withdrawn and
Surgical Suture replaced with
newer version
------------------------------------------------------------------------
6-189 6-206 USP 31<11>2008 Sterile Withdrawn and
Sodium Chloride for replaced with
Irrigation newer version
------------------------------------------------------------------------
6-190 6-207 USP 31:2008 Absorbable Withdrawn and
Surgical Suture replaced with
newer version
------------------------------------------------------------------------
6-191 6-208 USP 31<881>:2008 Tensile Withdrawn and
Strength replaced with
newer version
------------------------------------------------------------------------
6-192 6-209 USP 31<861>:2008 Sutures-- Withdrawn and
Diameter replaced with
newer version
------------------------------------------------------------------------
6-193 6-210 USP 31<871>:2008 Sutures Withdrawn and
Needle Attachment replaced with
newer version
------------------------------------------------------------------------
6-194 6-211 USP 31<11>: 2008 Sterile Withdrawn and
Water for Irrigation replaced with
newer version
------------------------------------------------------------------------
6-195 6-212 USP 31<11>: 2008 Heparin Withdrawn and
Lock Flush Solution replaced with
newer version
------------------------------------------------------------------------
[[Page 52366]]
6-196 6-213 USP 31<11>: 2008 Sodium Withdrawn and
Chloride Injection replaced with
newer version
------------------------------------------------------------------------
6-198 ............ ASTM F2100-07 Standard Relevant
Specification for guidance
Performance of Materials
Used in Medical Face
Masks
------------------------------------------------------------------------
6-201 ............ ISO 8536-4:2007 Infusion Relevant
Equipment for Medical guidance
Use--Part 4: Infusion
Sets for Single Use,
Gravity Feed
------------------------------------------------------------------------
G. In Vitro Diagnostic
------------------------------------------------------------------------
7-6 7-131 CLSI ILA18-A2 Withdrawn and
Specifications for replaced with
Immunological Testing for newer version
Infectious Diseases
------------------------------------------------------------------------
7-11 7-132 CLSI MM03-A2 Molecular Withdrawn and
Diagnostic Methods for replaced with
Infectious Diseases newer version
------------------------------------------------------------------------
7-12 ............ CLSI/NCCLS C12-A Withdrawn
Definitions of Quantities
and Conventions Related
to Blood pH and Gas
Analysis; Approved
Standard (1994)
------------------------------------------------------------------------
7-13 ............ CLSI/NCCLS C21-A Withdrawn
Performance
Characteristics for
Devices Measuring PO2 and
PCO2 in Blood Samples;
Approved Standard (1992)
------------------------------------------------------------------------
7-15 ............ CLSI/NCCLS C25-A Withdrawn
Fractional Oxyhemoglobin,
Oxygen Content and
Saturation, and Related
Quantities in Blood:
Terminology, Measurement,
and Reporting; Approved
Guideline (1997)
------------------------------------------------------------------------
7-16 ............ CLSI/NCCLS C27-A Blood Gas Withdrawn
Preanalytical
Considerations: Specimen
Collection, Calibration,
and Controls; Approved
Guideline (1993)
------------------------------------------------------------------------
7-18 7-133 CLSI C30-A2, Point-of Care Withdrawn and
Blood Glucose Testing in replaced with
Acute and Chronic Care newer version
Facilities
------------------------------------------------------------------------
7-21 ............ CLSI C42-A, Erythrocyte Contact person
Protoporphyrin Testing;
Approved Guideline (1996)
------------------------------------------------------------------------
7-22 7-134 CLSI GP20-A2 Fine-Needle Withdrawn and
Aspiration Biopsy (FNAB) replaced with
Techniques newer versions
------------------------------------------------------------------------
7-25 ............ NCCLS H8-A2 Detection of Withdrawn
Abnormal Hemoglobin Using
Cellulose Acetate
Electrophoresis--Second
Edition; Approved
Standard (1994)
------------------------------------------------------------------------
7-26 ............ NCCLS H9-A Chromatographic Withdrawn
(Microcolumn)
Determination of
Hemoglobin A2; Approved
Standard (1989)
------------------------------------------------------------------------
7-27 ............ NCCLS H10-A2 Solubility Withdrawn
Test to Confirm the
Presence of Sickling
Hemoglobins--Second
Edition; Approved
Standard (1995)
------------------------------------------------------------------------
7-29 ............ NCCLS H14-A2 Devices for Withdrawn
Collection of Skin
Puncture Blood Specimens--
Second Edition; Approved
Guideline (1990)
------------------------------------------------------------------------
7-34 7-135 CLSI H44-A2 Methods for Withdrawn and
Reticulocyte Counting replaced with
(Flow Cytometry and newer version
Supravital Dyes)
------------------------------------------------------------------------
7-35 ............ CLSI H47-A One-Stage Contact person
Prothrombin Time (PT)
Test and Activated
Partial Thromboplastin
Time (APTT) Test;
Approved Guideline (1996)
------------------------------------------------------------------------
7-36 7-136 CLSI ILA02-A2 Quality Withdrawn and
Assurance of Laboratory replaced with
Tests for Autoantibodies newer version
to Nuclear Antigens
------------------------------------------------------------------------
7-37 ............ CLSI ILA06-A Detection and Contact person
Quantitation of Rubella
IgG Antibody
------------------------------------------------------------------------
[[Page 52367]]
7-38 ............ CLSI/NCCLS I/LA10-A Withdrawn
Choriogonadotropin
Testing: Nomenclature,
Reference Preparations,
Assay Performance, and
Clinical Application;
Approved Guideline (1996)
------------------------------------------------------------------------
7-39 ............ CLSI/NCCLS I/LA17-A Withdrawn
Assessing the Quality of
Systems for Alpha-
Fetoprotein (AFP) Assays
Used in Prenatal
Screening and Diagnosis
of Neural Tube Defects;
Approved Guideline (1997)
------------------------------------------------------------------------
7-40 ............ NCCLS I/LA18-A Withdrawn
Specifications for
Immunological Testing for
Infectious Diseases;
Approved Guideline (1994)
------------------------------------------------------------------------
7-41 ............ CLSI ILA19-A Primary Contact person
Reference Preparations
Used to Standardize
Calibration of
Immunochemical Assays for
Serum Prostate Specific
Antigen (PSA); Approved
Guideline (1997)
------------------------------------------------------------------------
7-42 ............ CLSI ILA20-A Evaluation Contact person
Methods and Analytical
Performance
Characteristics of
Immunological Assays for
Human Immunoglobulin E
(IgE) Antibodies of
Defined Allergen
Specificities; Approved
Guideline (1997)
------------------------------------------------------------------------
7-43 7-137 CLSI LA04-A5 Blood Withdrawn and
Collection on Filter replaced with
Paper for Newborn newer version
Screening Programs
------------------------------------------------------------------------
7-46 7-138 CLSI M27-A2, Reference Withdrawn and
Method for Broth Dilution replaced with
Antifungal Susceptibility newer version
Testing of Yeasts
------------------------------------------------------------------------
7-49 ............ CLSI H26-A Performance Contact person
Goals for the Internal
Quality Control of
Multichannel Hematology
Analyzers; Approved
Standard
------------------------------------------------------------------------
7-50 ............ NCCLS D11-A2 Glossary and Withdrawn
Guidance for
Immunodiagnostic
Procedures, Reagents, and
Reference Materials--
Second Edition, Approved
Guideline
------------------------------------------------------------------------
7-51 7-139 CLSI GP27-A2 Using Withdrawn and
Proficiency Testing to replaced with
Improve the Clinical newer version
Laboratory
------------------------------------------------------------------------
7-52 ............ CLSI / NCCLS NRSCL 8-A Withdrawn
Terminology and
Definitions for use in
NCCLS Documents; Approved
Standard
------------------------------------------------------------------------
7-53 7-140 CLSI GP22-A2 Continuous Withdrawn and
Quality Improvement replaced with
newer version
------------------------------------------------------------------------
7-55 7-141 CLSI H18-A3 Procedures for Withdrawn and
the Handling and replaced with
Processing of Blood newer version
Specimens
------------------------------------------------------------------------
7-58 7-142 CLSI H11-A4 Procedures for Withdrawn and
the Collection of replaced with
Arterial Blood Specimens newer version
------------------------------------------------------------------------
7-59 13-9 CLSI / NCCLS AUTO2-A Transferred
Laboratory Automation:
Bar Codes for Specimen
Container Identification;
Approved Standard
------------------------------------------------------------------------
7-60 13-10 NCCLS AUTO1-A Laboratory Transferred
Automation: Specimen
Container/Specimen
Carrier; Approved
Standard
------------------------------------------------------------------------
7-61 13-11 NCCLS AUTO3-A Laboratory Transferred
Automation:
Communications with
Automated Clinical
Laboratory Systems,
Instruments, Devices, and
Information Systems;
Approved Standard
------------------------------------------------------------------------
7-62 13-12 NCCLS AUTO4-A Laboratory Transferred
Automation: Systems
Operational Requirements,
Characteristics, and
Information Elements;
Approved Standard
------------------------------------------------------------------------
7-63 13-13 NCCLS AUTO5-A Laboratory Transferred
Automation:
Electromechanical
Interfaces; Approved
Standard
------------------------------------------------------------------------
7-64 13-14 NCCLS POCT1-A Point-of- Transferred
Care Connectivity;
Approved Standard
------------------------------------------------------------------------
[[Page 52368]]
7-67 7-143 CLSI EP14-A2 Evaluation of Withdrawn and
Matrix Effects replaced with
newer version
------------------------------------------------------------------------
7-68 13-15 NCCLS GP19-A2 Laboratory Transferred
Instruments and Data
Management Systems:
Design of Software User
Interfaces and End-User
Software Systems
Validation, Operation,
and Monitoring; Approved
Guideline--Second Edition
------------------------------------------------------------------------
7-70 7-144 CLSI H4-A5 Procedures and Withdrawn and
Devices for the replaced with
Collection of Diagnostic newer version
Blood Specimens by Skin
Puncture
------------------------------------------------------------------------
7-72 7-145 CLSI H42-A2 Enumeration of Withdrawn and
Immunologically Defined replaced with
Cell Populations by Flow newer version
Cytometry
------------------------------------------------------------------------
7-74 7-146 NCCLS M6-A2 Protocols for Withdrawn and
Evaluating Dehydrated replaced with
Mueller-Hinton Agar newer version
------------------------------------------------------------------------
7-77 7-147 CLSI M22-A3 Quality Withdrawn and
Control for Commercially replaced with
Prepared Microbiological newer version
Culture Media
------------------------------------------------------------------------
7-79 7-148 CLSI M28-A2 Procedures for Withdrawn and
the Recovery and replaced with
Identification of newer version
Parasites From the
Intestinal Tract
------------------------------------------------------------------------
7-80 ............ CLSI MM01-A2 Molecular Withdrawn
Diagnostic Methods for
Genetic Diseases
------------------------------------------------------------------------
7-83 ............ NCCLS C46-A Blood Gas and Withdrawn
pH Analysis and Related
Measurements; Approved
Guideline
------------------------------------------------------------------------
7-85 7-149 CLSI C24-A3 Statistical Withdrawn and
Quality Control for replaced with
Quantitative Measurement newer version
Procedures
------------------------------------------------------------------------
7-90 7-150 CLSI H43-A2 Clinical Flow Withdrawn and
Cytometric Analysis of replaced with
Neoplastic Hematolymphoid newer version
Cells
------------------------------------------------------------------------
7-93 ............ NCCLS EP10-A2, Preliminary Withdrawn
Evaluation of
Quantitative Clinical
Laboratory Methods;
Approved Guideline
------------------------------------------------------------------------
7-94 7-152 CLSI EP12-A2 User Protocol Withdrawn and
for Evaluation of replaced with
Qualitative Test newer version
Performance
------------------------------------------------------------------------
7-95 7-153 CLSI EP15-A2 User Withdrawn and
Verification of replaced with
Performance for Precision newer version
and Trueness
------------------------------------------------------------------------
7-98 7-154 CLSI MM02-A2 Immunoglobin Withdrawn and
and T-Cell Receptor Gene replaced with
Rearrangement Assays newer version
------------------------------------------------------------------------
7-99 ............ CLSI MM5-A Nucleic Acid Contact person
Amplification Assays for
Molecular Hematopathology
------------------------------------------------------------------------
7-103 7-155 CLSI H03-A6 Procedures for Withdrawn and
the Collection of replaced with
Diagnostic Blood newer version
Specimens by Venipunture
------------------------------------------------------------------------
7-106 7-156 CLSI M02-A9 Performance Withdrawn and
Standards for replaced with
Antimicrobial Disk newer version
Susceptibility Tests
------------------------------------------------------------------------
7-107 7-157 CLSI M11-A7 Methods for Withdrawn and
Antimicrobial replaced with
Susceptibility Testing of newer version
Anaerobic Bacteria
------------------------------------------------------------------------
7-108 7-158 CLSI M7-A7 Methods for Withdrawn and
Antimicrobial replaced with
Susceptibility Tests of newer version
Anaerobic Bacteria
------------------------------------------------------------------------
7-109 ............ CLSI AUTO7-A Laboratory Withdrawn
Automation: Data Content
for Specimen
Identification; Approved
Standard
------------------------------------------------------------------------
7-111 7-159 CLSI H21-A5 Collection, Withdrawn and
Transport, and Processing replaced with
of Blood Specimens for newer version
Testing Plasma-Based
Coagulation Assays and
Molecular Hemostasis
Assays
------------------------------------------------------------------------
[[Page 52369]]
7-114 13-16 CLSI LIS01-A Standard Transferred
Specification for Low-
Level Protocol to
Transfer Messages Between
Clinical Laboratory
Instruments and Computer
Systems
------------------------------------------------------------------------
7-115 13-17 CLSI LIS02-A2 Standard Transferred
Specification for
Transferring Information
Between Clinical
Instruments and Computer
Systems; Approved
Standard-Second Edition
------------------------------------------------------------------------
7-116 13-18 CLSI LIS03-A Standard Transferred
Guide for Selection of a
Clinical Laboratory
Information Management
System
------------------------------------------------------------------------
7-117 13-19 CLSI LIS04-A Standard Transferred
Guide for Documentation
of Clinical Laboratory
Computer Systems
------------------------------------------------------------------------
7-118 13-20 CLSI LIS05-A, Standard Transferred
Specification for
Transferring Clinical
Observations Between
Independent Computer
Systems
------------------------------------------------------------------------
7-119 13-21 CLSI LIS06-A Standard Transferred
Practice for Reporting
Reliability of Clinical
Laboratory Information
Systems
------------------------------------------------------------------------
7-120 13-22 CLSI LIS07-A Standard Transferred
Specification for Use of
Bar Codes on Specimen
Tubes in the Clinical
Laboratory
------------------------------------------------------------------------
7-121 13-23 CLSI LIS08-A Standard Transferred
Guide for Functional
Requirements of Clinical
Laboratory Information
Management Systems
------------------------------------------------------------------------
7-122 13-24 CLSI LIS09-A Standard Transferred
Guide for Coordination of
Clinical Laboratory
Services within the
Electronic Health Record
Environment and Networked
Architectures
------------------------------------------------------------------------
7-125 ............ CLSI/NCCLS M28-A2 Volume Withdrawn
25, No. 16 Procedures for
the Recovery and
Identification of
Parasites From the
Intestinal Tract;
Approved Guideline
------------------------------------------------------------------------
H. Materials
------------------------------------------------------------------------
8-32 ............ ASTM F1586-02: Standard Contact person
Specification for Wrought
Nitrogen Strengthened 21
Chromium-10 Nickel-3
Manganese-2.5 Molybdenum
Stainless Steel Bar for
Surgical Implants (UNS
S31675)
------------------------------------------------------------------------
8-44 ............ ASTM F0136-02a: Standard Contact person
Specification for Wrought
Titanium-6 Aluminum-4
Vanadium ELI (Extra Low
Interstitial) Alloy for
Surgical Implant
Applications (UNS R56401)
------------------------------------------------------------------------
8-46 8-154 ASTM F0621-08: Standard Withdrawn and
Specification for replaced with
Stainless Steel Forgings newer year
for Surgical Implants version
------------------------------------------------------------------------
8-50 ............ ASTM F1091-02: Standard Contact person
Specification for Wrought
Cobalt-20 Chromium-15
Tungsten-10 Nickel Alloy
Surgical Fixation Wire
(UNS R30605)
------------------------------------------------------------------------
8-52 ............ ASTM F1350-02: Standard Contact person
Specification for Wrought
18 Chromium-14 Nickel-2.5
Molybdenum Stainless
Steel Surgical Fixation
Wire (UNS S31673)
------------------------------------------------------------------------
8-53 ............ ASTM F1472-02a: Standard Contact person
Specification for Wrought
Titanium -6Aluminum -
4Vanadium Alloy for
Surgical Implant
Applications (UNS R56400)
------------------------------------------------------------------------
8-54 8-155 ASTM F1580-07 Standard Withdrawn and
Specification for replaced with
Titanium and Titanium-6 newer year
Aluminum-4 Vanadium Alloy version
Powders for Coatings of
Surgical Implants
------------------------------------------------------------------------
8-57 ............ ISO 5832-2:1999, Implants Contact person
for Surgery--Metallic
Materials--Part 2:
Unalloyed Titanium
------------------------------------------------------------------------
8-58 ............ ISO 5832-3:1996, Implants Contact person
for Surgery--Metallic
Materials--Part 3:
Wrought Titanium 6-
Aluminium 4-Vanadium
Alloy
------------------------------------------------------------------------
[[Page 52370]]
8-59 ............ ISO 5832-4:1996, Implants Contact person
for Surgery--Metallic
Materials--Part 4: Cobalt-
Chromium-Molybdenum
Casting Alloy
------------------------------------------------------------------------
8-61 ............ ISO 5832-6:1997, Implants Contact person
for Surgery--Metallic
Materials--Part 6:
Wrought Cobalt-Nickel-
Chromium-Molybdenum Alloy
------------------------------------------------------------------------
8-63 ............ ISO 5832-11:1994, Implants Contact person
for Surgery--Metallic
Materials--Part 11:
Wrought Titanium 6-
Aluminium 7-Niobium Alloy
------------------------------------------------------------------------
8-76 ............ ASTM F138-03: Standard Contact person
Specification for Wrought
18 Chromium-14 Nickel-2.5
Molybdenum Stainless
Steel Bar and Wire for
Surgical Implants (UNS
S31673)
------------------------------------------------------------------------
8-77 8-156 ASTM F0139-08, Standard Withdrawn and
Specification for Wrought replaced with
18 Chromium-14 Nickel-2.5 newer year
Molybdenum Stainless version
Steel Sheet and Strip for
Surgical Implants (UNS
S31673)
------------------------------------------------------------------------
8-79 ............ ASTM F0961-03, Standard Contact person
Specification for Cobalt-
35 Nickel-20 Chromium-10
Molybdenum Alloy Forgings
for Surgical Implants
[UNS R30035]
------------------------------------------------------------------------
8-81 ............ ASTM F1609-03 Standard Contact person
Specification for Calcium
Phosphate Coatings for
Implantable Materials
------------------------------------------------------------------------
11-81 8-157 ISO 9583:1993 Implants for Transferred
Surgery--Non-Destructive
Testing--Liquid Penetrant
Inspection of Metallic
Surgical Implants
------------------------------------------------------------------------
8-82 8-158 ASTM F1713-08 Standard Withdrawn and
Specification for Wrought replaced with
Titanium-13 Niobium-13 newer year
Zirconium Alloy for version
Surgical Implant
Applications (UNS R58130)
------------------------------------------------------------------------
11-82 8-159 ISO 9584:1993 Implants for Transferred
Surgery--Non-Destructive
Testing--Radiographic
Examination of Cast
Metallic Surgical
Implants
------------------------------------------------------------------------
8-86 ............ ASTM F1926-03 Standard Relevant
Test Method for guidance
Evaluation of the
Environmental Stability
of Calcium Phosphate
Coatings
------------------------------------------------------------------------
8-88 ............ ASTM F2024-00 Standard Relevant
Practice for X-Ray guidance
Diffraction Determination
of Phase Content of
Plasma-Sprayed
Hydroxyapatite Coatings
------------------------------------------------------------------------
8-98 8-162 ASTM F451-99a(2007)e1 Withdrawn and
Standard Specification replaced with
for Acrylic Bone Cement newer year
version
------------------------------------------------------------------------
8-104 ............ ASTM F1108-04 Standard Contact person
Specification for
Titanium-6Aluminum-4Vanad
ium Alloy Castings for
Surgical Implants (UNS
R56406)
------------------------------------------------------------------------
8-108 ............ ASTM F1295-05 Standard Contact person
Specification for Wrought
Titanium-6 Aluminum-7
Niobium Alloy for
Surgical Implant
Applications (UNS R56700)
------------------------------------------------------------------------
8-110 ............ ASTM F1377-04 Standard Contact person
Specification for Cobalt-
28 Chromium-6 Molybdenum
Powder for Coating of
Orthopedic Implants (UNS
R30075)
------------------------------------------------------------------------
8-112 ............ ASTM F1044-05 Standard Relevant
Test Method for Shear guidance
Testing of Calcium
Phosphate Coatings and
Metallic Coatings
------------------------------------------------------------------------
8-113 ............ ASTM F1147-05 Standard Relevant
Test Method for Tension guidance
Testing of Calcium
Phosphate and Metal
Coatings
------------------------------------------------------------------------
8-119 ............ ASTM F688-05 Standard Contact person
Specification for Wrought
Cobalt-35 Nickel-20
Chromium-10 Molybdenum
Alloy Plate, Sheet, and
Foil for Surgical
Implants (UNS R30035)
------------------------------------------------------------------------
[[Page 52371]]
8-120 8-160 ASTM F0560-07 Standard Withdrawn and
Specification for replaced with
Unalloyed Tantalum for newer year
Surgical Implant version
Applications (UNS R05200,
UNS R05400)
------------------------------------------------------------------------
8-123 ............ ISO 5832-5:2005 Implants Contact person
for Surgery--Metallic
Materials--Part 5:
Wrought Cobalt-Chromium-
Tungsten-Nickel Alloy
------------------------------------------------------------------------
8-127 ............ ISO 5834-2:2006 Implants Relevant
for Surgery--Ultra-high- guidance
molecular-weight
polyethylene--Part 2:
Moulded Forms
------------------------------------------------------------------------
8-129 ............ ASTM F67-06 Standard Contact person
Specification for
Unalloyed Titanium for
Surgical Implant
Applications (UNS R50250,
UNS R50400, UNS R50550,
UNS R50700)
------------------------------------------------------------------------
8-130 ............ ASTM F620-06 Standard Contact person
Specification for Alpha
Plus Beta Titanium Alloy
Forgings for Surgical
Implants
------------------------------------------------------------------------
8-131 ............ ASTM F799-06 Standard Contact person
Specification for Cobalt-
28 Chromium-6 Molybdenum
Alloy Forgings for
Surgical Implants (UNS
R31537, R31538, R31539)
------------------------------------------------------------------------
8-132 ............ ASTM F1088-04ae1 Standard Contact person
Specification for Beta-
Tricalcium Phosphate for
Surgical Implantation
------------------------------------------------------------------------
8-137 ............ ASTM F0075-07 Standard Contact person
Specification for Cobalt-
28 Chromium-6 Molybdenum
Alloy Castings and
Casting Alloy for
Surgical Implants (UNS
R30075)
------------------------------------------------------------------------
8-138 ............ ASTM F0745-07 Standard Contact person
Specification for 18
Chromium-12.5 Nickel-2.5
Molybdenum Stainless
Steel for Cast and
Solution-Annealed
Surgical Implant
Applications
------------------------------------------------------------------------
8-139 ............ ASTM F1314-07 Standard Contact person
Specification for Wrought
Nitrogen Strengthened 22
Chromium - 13 Nickel - 5
Manganese - 2.5
Molybdenum Stainless
Steel Alloy Bar and Wire
for Surgical Implants
(UNS S20910)
------------------------------------------------------------------------
8-142 ............ ASTM F1978-00(2007)e2 Relevant
Standard Test Method for guidance
Measuring Abrasion
Resistance of Metallic
Thermal Spray Coatings by
Using the Taber Abraser
------------------------------------------------------------------------
8-144 ............ ASTM F0754-00 Standard Contact person
Specification for
Implantable
Polytetrafluoroethylene
(PTFE) Polymer Fabricated
in Sheet, Tube and Rod
Shapes
------------------------------------------------------------------------
8-145 ............ ASTM F0090-07 Standard Contact person
Specification for Wrought
Cobalt-20 Chromium-15
Tungsten-10 Nickel Alloy
for Surgical Implant
Applications (UNS R30605)
------------------------------------------------------------------------
8-147 ............ ASTM F0562-07 Standard Contact person
Specification for Wrought
35Cobalt-35Nickel-20Chrom
ium-10Molybdenum Alloy
for Surgical Implant
Applications (UNS R30035)
------------------------------------------------------------------------
8-149 ............ ISO 5832-1:2007 Implants Contact person
for Surgery--Metallic
Materials--Part 1:
Wrought Stainless Steel
------------------------------------------------------------------------
8-150 ............ ISO 5832-9:2007 Implants Contact person
for Surgery--Metallic
Materials--Part 9:
Wrought High Nitrogen
Stainless Steel
------------------------------------------------------------------------
8-151 ............ ISO 5832-12:2007 Implants Contact person
for Surgery--Metallic
Materials--Part 12:
Wrought Cobalt-Chromium-
Molybdenum Alloy
------------------------------------------------------------------------
8-152 ............ ASTM F1537-07 Standard Contact person
Specification for Wrought
Cobalt-28Chromium-6Molybd
enum Alloys for Surgical
Implants (UNS R31537, UNS
R31538, and UNS R31539)
------------------------------------------------------------------------
I. OB-GYN/Gastroenterology
------------------------------------------------------------------------
[[Page 52372]]
9-4 ............ IEC 60601-2-16 (1998) Relevant
Medical Electrical guidance and
Equipment--Part 2-16: Contact person
Particular Requirements
for the Safety of
Haemodialysis,
Haemodiafiltration and
Haemofiltration Equipment
------------------------------------------------------------------------
9-6 ............ IEC 60601-2-36 (1997) Title, Relevant
Medical Electrical guidance, CFR
Equipment--Part 2-36: Citation, and
Particular Requirements Product Codes
for the Safety of
Equipment for
Extracorporeally Induced
Lithotripsy
------------------------------------------------------------------------
9-7 ............ IEC 61846 (1998) Relevant
Ultrasonics--Pressure guidance, CFR
Pulse Lithotripters-- Citation, and
Characteristics of Fields Product Codes
------------------------------------------------------------------------
9-21 ............ ISO 8600-4:1997 Optics and Relevant
Optical Instruments-- guidance
Medical Endoscopes and
Certain Accessories--Part
4: Determination of
Maximum Width of
Insertion Portion
------------------------------------------------------------------------
9-23 ............ ASTM F1518-00 Standard Relevant
Practice for Cleaning and guidance, CDRH
Disinfection of Flexible Office and
Fiberoptic and Video Division
Endoscopes Used in the associated with
Examination of the Hollow recognized
Viscera standard
------------------------------------------------------------------------
9-25 ............ AAMI / ANSI HF18:2001 Withdrawn
Electrosurgical Devices
------------------------------------------------------------------------
9-28 9-47 ANSI/AAMI RD16:2007 Withdrawn and
Cardiovascular Implants replaced with
and Artificial Organs-- newer version
Hemodialyzers,
Hemodiafilters,
Hemofilters, and
Hemoconcentrators
------------------------------------------------------------------------
9-29 9-48 AAMI / ANSI RD17 :2007 Withdrawn and
Cardiovascular Implants replaced with
and artificial organs-- newer version
Extracorporeal Blood
Circuit for
Hemodialyzers,
Hemodiafilters, and
Hemofilters
------------------------------------------------------------------------
9-32 ............ ASTM D3492-03 Standard Relevant
Specification for Rubber guidance
Contraceptives (Male
Condoms)
------------------------------------------------------------------------
9-34 ............ ISO 4074:2002/ Relevant
Cor.1:2003(E) Natural guidance
Latex Rubber Condoms--
Requirements and Test
Methods, Technical
Corrigendum 1
------------------------------------------------------------------------
9-37 ............ ISO 8600-1:2005 Optics and Relevant
Photonics--Medical guidance
Endoscopes and
Endotherapy Devices--Part
1: General Requirements
ISO 8600-1:2005
------------------------------------------------------------------------
9-38 ............ ISO 8600-3:1997 Amendment Relevant
1 2003, Optics and guidance
Optical Instruments--
Medical Endoscopes and
Endoscopic Accessories
Part 3: Determination of
Field of View and
Direction of View of
Endoscopes with Optics
------------------------------------------------------------------------
9-39 ............ ISO 8600-5:2005 Optics and Relevant
Photonics--Medical guidance
Endoscopes and
Endotherapy Devices--Part
5: Determination of
Optical Resolution of
Rigid Endoscopes with
Optics
------------------------------------------------------------------------
9-40 ............ ISO 8600-6:2005 Optics and Relevant
Photonics--Medical guidance
Endoscopes and
Endotherapy Devices--Part
6: Vocabulary
------------------------------------------------------------------------
9-41 ............ ASTM D6324-05 Standard Relevant
Test Methods for Male guidance
Condoms Made from
Synthetic Materials
------------------------------------------------------------------------
9-42 ............ IEC 60601-2-18 (1996) Relevant
Amendment 1 2000 Medical guidance
electrical equipment--
Part 2: Particular
Requirements for the
Safety of Endoscopic
Equipment
------------------------------------------------------------------------
9-43 ............ ISO 16038:2005 Rubber Relevant
Condoms--Guidance on the guidance
Use of ISO 4074 in the
Quality Management of
Natural Rubber Latex
Condoms
------------------------------------------------------------------------
J. Ophthalmic
------------------------------------------------------------------------
10-21 ............ ISO 11979-2:1999 Withdrawn
Ophthalmic Implants--
Intraocular Lenses--Part
2: Optical Properties and
Test Methods
------------------------------------------------------------------------
[[Page 52373]]
10-23 ............ ISO 11981:1999 Ophthalmic Withdrawn
Optics--Contact Lenses
and Contact Lens Care
Products--Determination
of Physical Compatibility
of Contact Lens Care
Products With Contact
Lenses
------------------------------------------------------------------------
10-42 ............ ISO 11979-2:1999/ Extent of
Corrigendum1:2003 recognition and
Ophthalmic Implants-- Process
Intraocular Lenses--Part impacted
2: Optical Properties and
Test Methods
------------------------------------------------------------------------
10-44 ............ ISO 11981:1999/ Relevant
Corrigendum1:2005 guidance and
Ophthalmic Optics-- Process
Contact Lenses and impacted
Contact Lens Car
Products--Determination
of Physical Compatibility
of Contact Lens Care
Products with Contact
Lenses
------------------------------------------------------------------------
K. Orthopedic
------------------------------------------------------------------------
11-73 ............ ISO 5838-1:1995 Implants Type of standard
for Surgery--Skeletal and Contact
Pins and Wires--Part 1: person
Material and Mechanical
Requirements
------------------------------------------------------------------------
11-74 ............ ISO 5838-2:1991 Implants Type of standard
for Surgery--Skeletal and Contact
Pins and Wires--Part 2: person
Steinmann Skeletal Pins--
Dimensions
------------------------------------------------------------------------
11-75 ............ ISO 5838-3:1993 Implants Type of standard
for Surgery--Skeletal and Contact
Pins and Wires--Part 3: person
Kirschner Skeletal Wires
------------------------------------------------------------------------
11-79 ............ ISO 7206-8:1995 Implants Type of
for Surgery--Partial and standard, CFR
Total Hip Joint Citation,
Prostheses--Part 8: Product codes
Endurance Performance of and Relevant
Stemmed Femoral guidance
Components with
Application of Torsion
------------------------------------------------------------------------
11-80 ............ ISO 8828:1988 Implants for Contact person
Surgery--Guidance on Care Processes
and Handling of Impacted
Orthopaedic Implants
------------------------------------------------------------------------
11-81 8-157 ISO 9583:1993 Implants for Transferred
Surgery--Non-Destructive
Testing--Liquid Penetrant
Inspection of Metallic
Surgical Implants
------------------------------------------------------------------------
11-82 8-159 ISO 9584:1993 Implants for Transferred
Surgery--Non-Destructive
Testing--Radiographic
Examination of Cast
Metallic Surgical
Implants
------------------------------------------------------------------------
11-155 ............ ISO 7207-2:1998 Implants Type of standard
for Surgery--Components and Relevant
for Partial and Total guidance
Knee Joint Prostheses--
Part 2: Articulating
Surfaces Made of Metal,
Ceramic and Plastics
Materials
------------------------------------------------------------------------
11-164 11-203 ASTM F1541-02(2007) Withdrawn and
Standard Specification replaced with
and Test Methods for newer version
External Skeletal
Fixation Devices
------------------------------------------------------------------------
11-166 11-204 ASTM F0897-02(2007) Withdrawn and
Standard Test Method for replaced with
Measuring Fretting newer version
Corrosion of
Osteosynthesis Plates and
Screws
------------------------------------------------------------------------
11-168 ............ ASTM F1781-03 Standard Type of standard
Specification for
Elastomeric Flexible
Hinge Finger Total Joint
Implants
------------------------------------------------------------------------
11-171 ............ ASTM F1814-97a(2003) Type of standard
Standard Guide for and Relevant
Evaluating Modular Hip guidance
and Knee Joint Components
------------------------------------------------------------------------
11-172 ............ ASTM F1798-97(2003) Type of standard
Standard Guide for and Relevant
Evaluating the Static and guidance
Fatigue Properties of
Interconnection
Mechanisms and
Subassemblies Used in
Spinal Arthrodesis
Implants
------------------------------------------------------------------------
11-175 ............ ASTM F1582-98(2003) Type of
Standard Terminology standard, CFR
Relating to Spinal Citation,
Implants Product codes
and Relevant
guidance
------------------------------------------------------------------------
11-177 11-205 ASTM F1264-03(2007) Withdrawn and
Standard Specification replaced with
and Test Methods for newer version
Intramedullary Fixation
Devices
------------------------------------------------------------------------
[[Page 52374]]
11-178 ............ ASTM F1440-92(2002) Processes
Standard Practice for impacted, Type
Cyclic Fatigue Testing of of standard,
Metallic Stemmed Hip CFR Citation,
Arthroplasty Femoral Product codes
Components Without and Relevant
Torsion guidance
------------------------------------------------------------------------
11-179 ............ ASTM F2068-03 Standard Processes
Specification for Femoral impacted, Type
Prostheses--Metallic of standard,
Implants CFR Citation,
Product codes
and Relevant
guidance
------------------------------------------------------------------------
11-180 ............ ASTM F0366-04 Standard Type of standard
Specification for and Contact
Fixation Pins and Wires person
------------------------------------------------------------------------
11-181 ............ ASTM F1717-04 Standard Type of standard
Test Methods for Spinal and Relevant
Implant Constructs in a guidance
Vertebrectomy Model
------------------------------------------------------------------------
11-182 11-206 ASTM F1800-07 Standard Withdrawn and
Test Method for Cyclic replaced with
Fatigue Testing of Metal newer version
Tibial Tray Components of
Total Knee Joint
Replacements
------------------------------------------------------------------------
11-183 ............ ASTM F1875-98(2004) Type of
Standard Practice for standard, CFR
Fretting Corrosion Citations,
Testing of Modular Product codes
Implant Interfaces: Hip and Relevant
Femoral Head-Bore and guidance
Cone Taper Interface
------------------------------------------------------------------------
11-184 ............ ISO 8827:1988 Implants for Type of standard
surgery--Staples with and Contact
Parallel Legs for person
Orthopaedic Use--General
Requirements
------------------------------------------------------------------------
11-185 ............ ASTM F2267-04 Standard CFR Citations,
Test Method for Measuring Product codes
Load Induced Subsidence and Relevant
of an Intervertebral Body guidance
Fusion Device Under
Static Axial Compression
------------------------------------------------------------------------
11-186 ............ ASTM F2077-03 Test Methods Type of
for Intervertebral Body standard, CFR
Fusion Devices Citations,
Product codes
and Relevant
guidance
------------------------------------------------------------------------
11-187 11-207 ASTM F2193-02(2007) Withdrawn and
Standard Specifications replaced with
and Test Methods for newer version
Components Used in the
Surgical Fixation of the
Spinal Skeletal System
------------------------------------------------------------------------
11-188 ............ ISO 14243-1:2002 Implants Type of
for Surgery--Wear of standard, CFR
Total Knee-Joint Citations and
Prostheses--Part 1: Product codes
Loading and Displacement
Parameters for Wear-
Testing Machines With
Load Control and
Corresponding
Environmental Conditions
for Test
------------------------------------------------------------------------
11-189 ............ ISO 14243-2:2000 Implants Type of
for Surgery--Wear of standard,
Total Knee-Joint Extent of
Prostheses--Part 2: recognition,
Methods of Measurement CFR Citations
and Product
codes
------------------------------------------------------------------------
11-190 ............ ISO 14243-3:2004 Implants Type of
for Surgery--Wear of standard, CFR
Total Knee-Joint Citations and
Prostheses--Part 3: Product codes
Loading and Displacement
Parameters for Wear-
Testing Machines With
Displacement Control and
Corresponding
Environmental Conditions
for Test
------------------------------------------------------------------------
11-191 ............ ISO 14879-1:2000 Implants Type of standard
for Surgery--Total Knee-
Joint Prostheses--Part 1:
Determination of
Endurance Properties of
Knee Tibial Trays
------------------------------------------------------------------------
11-192 ............ ASTM F1223-05 Standard Type of standard
Test Method for CFR Citations
Determination of Total and Product
Knee Replacement codes
Constraint
------------------------------------------------------------------------
11-194 11-208 ISO 14630:2008 Non-Active Withdrawn and
Surgical Implants-- replaced with
General Requirements--3d newer version
Edition
------------------------------------------------------------------------
11-195 ............ ASTM F1612-95(2005) Type of
Standard Practice for standard, CFR
Cyclic Fatigue Testing of Citations,
Metallic Stemmed Hip Product codes
Arthroplasty Femoral and Relevant
Components with Torsion guidance
------------------------------------------------------------------------
11-196 ............ ASTM F1672-95(2005) Type of standard
Standard Specification and Relevant
for Resurfacing Patellar guidance
Prosthesis
------------------------------------------------------------------------
[[Page 52375]]
11-197 ............ ASTM F0983-86(2005) Contact person
Standard Practice for and Processes
Permanent Marking of impacted
Orthopaedic Implant
Components
------------------------------------------------------------------------
11-198 ............ ASTM F0382-99(2003)e1 Type of standard
Standard Specification and Contact
and Test Method for person
Metallic Bone Plates
------------------------------------------------------------------------
11-199 ............ ASTM F0565-04 Standard Contact person
Practice for Care and and Processes
Handling of Orthopedic impacted
Implants and Instruments
------------------------------------------------------------------------
11-200 11-209 ASTM F2083-07 Standard Withdrawn and
Specification for Total replaced with
Knee Prosthesis newer version
------------------------------------------------------------------------
11-201 ............ ASTM F0564-02(2006) Contact person
Standard Specification
and Test Methods for
Metallic Bone Staples
------------------------------------------------------------------------
11-202 11-210 ASTM F0543-07 Standard Withdrawn and
Specification and Test replaced with
Methods for Metallic newer version
Medical Bone Screws
------------------------------------------------------------------------
L. Physical Medicine
------------------------------------------------------------------------
16-19 ............ ISO 7176-4:1997 Contact person
Wheelchairs--Part 4: and Type of
Energy Consumption of standard
Electric Wheelchairs and
Scooters for
Determination of
Theoretical Distance
Range
------------------------------------------------------------------------
16-20 ............ ISO 7176-5:1986 Contact person
Wheelchairs--Part 5: and Type of
Determination of Overall standard
Dimensions, Mass and
Turning Space
------------------------------------------------------------------------
16-23 ............ ISO 7176-10:1988 Contact person
Wheelchairs--Part 10: and Type of
Determination of Obstacle- standard
Climbing Ability of
Electric Wheelchairs
------------------------------------------------------------------------
16-24 ............ ISO 7176-11:1992 Contact person
Wheelchairs--Part 11: and Type of
Test Dummies standard
------------------------------------------------------------------------
16-25 ............ ISO 7176-13:1989 Contact person
Wheelchairs--Part 13: and Type of
Determination of standard
Coefficient of Friction
of Test Surfaces
------------------------------------------------------------------------
16-26 ............ ISO 7176-14:1997 Contact person
Wheelchairs--Part 14: and Type of
Power and Control Systems standard
for Electric Wheelchairs--
Requirements and Test
Methods
------------------------------------------------------------------------
16-27 ............ ISO 7176-15:1996 Contact person
Wheelchairs--Part 15: and Type of
Requirements for standard
Information Disclosure,
Documentation and
Labeling
------------------------------------------------------------------------
16-28 ............ ISO 7176-16: 1997 Contact person
Wheelchairs--Part 16: and Type of
Resistance to Ignition of standard
Upholstered Parts--
Requirements and Test
Methods
------------------------------------------------------------------------
16-29 ............ ISO 7176-6:2001 Contact person
Wheelchairs--Part 6: and Type of
Determination of Maximum standard
Speed, Acceleration and
Deceleration of Electric
Wheelchairs
------------------------------------------------------------------------
16-30 ............ ISO 7176-9:2001 Contact person
Wheelchairs--Part 9: and Type of
Climatic Tests for standard
Electric Wheelchairs
------------------------------------------------------------------------
16-31 ............ ANSI/RESNA WC/Volume 1- Contact person
1998 Section 1: and Type of
Determination of Static standard
Stability
------------------------------------------------------------------------
16-32 ............ ANSI/RESNA WC/Volume 2- Contact person
1998 Section 2: and Type of
Determination of Dynamic standard
Stability of Electric
Wheelchairs
------------------------------------------------------------------------
16-33 ............ ANSI/RESNA WC/Volume 2- Contact person
1998 Section 3: Test and Type of
Methods and Requirements standard
for the Effectiveness of
Brakes
------------------------------------------------------------------------
16-34 ............ ANSI/RESNA WC/Volume 2- Contact person
1998 Section 4: and Type of
Determination of Energy standard
Consumption of Electric
Wheelchairs
------------------------------------------------------------------------
16-35 ............ ANSI/RESNA WC/Volume 1- Contact person
1998 Section 5: and Type of
Determination of Overall standard
Dimensions, Mass, and
Turning Space--Wheelchair
------------------------------------------------------------------------
[[Page 52376]]
16-36 ............ ANSI/RESNA WC/Volume 2- Contact person
1998 Section 6: and Type of
Determination of Maximum standard
Speed, Acceleration, and
Retardation of Electric
Wheelchairs
------------------------------------------------------------------------
16-37 ............ ANSI/RESNA WC/Volume 1- Contact person
1998 Section 7: and Type of
Wheelchairs - standard
Determination of Seating
and Wheel Dimensions
------------------------------------------------------------------------
16-38 ............ ANSI/RESNA WC/Volume 1- Contact person
1998 Section 8: and Type of
Wheelchairs--Static, standard
Impact and Fatigue
Strength Tests
------------------------------------------------------------------------
16-39 ............ ANSI/RESNA WC/Volume 2 - Contact person
1998 Section 9: Climatic and Type of
Tests for Electric standard
Wheelchairs
------------------------------------------------------------------------
16-40 ............ ANSI/RESNA WC/Volume 2 - Contact person
1998 Section 10: and Type of
Determination of the standard
Obstacle-Climbing Ability
of Electric Wheelchairs
------------------------------------------------------------------------
16-41 ............ ANSI/RESNA WC/Volume 1 - Contact person
1998 Section 11: and Type of
Wheelchairs--Test Dummies standard
------------------------------------------------------------------------
16-42 ............ ANSI/RESNA WC/Volume 1 - Contact person
1998 Section 13: and Type of
Determination of standard
Coefficient of Friction
of Test Surfaces
------------------------------------------------------------------------
16-43 ............ ANSI/RESNA WC/Volume 2 - Contact person
1998 Section 14: and Type of
Wheelchairs--Testing of standard
Power and Control Systems
for Electric Wheelchairs
------------------------------------------------------------------------
16-44 ............ ANSI/RESNA WC/Volume 1 - Contact person
1998 Section 15: and Type of
Wheelchairs--Requirements standard
for Information
Disclosures,
Documentation and
Labeling
------------------------------------------------------------------------
16-45 ............ ANSI/RESNA WC/Volume 1 - Title change,
1998 Section 16: Contact person
Wheelchairs--Determinatio and Type of
n of Flammability standard
------------------------------------------------------------------------
16-46 ............ ANSI/RESNA WC/Volume 1 - Contact person
1998 Section 20: and Type of
Wheelchairs--Determinatio standard
n of the Performance of
Stand-Up Wheelchairs
------------------------------------------------------------------------
16-47 ............ ANSI/RESNA WC/Volume 1 - Contact person
1998 Section 22: and Type of
Wheelchairs--Set Up standard
Procedures
------------------------------------------------------------------------
16-48 ............ ANSI/RESNA WC/Volume 1 - Contact person
1998 Section 93: Maximum and Type of
Overall Dimensions standard
------------------------------------------------------------------------
16-49 ............ ANSI/RESNA WC/Volume 1 - Contact person
1998 Section 0: and Type of
Nomenclature, Terms, and standard
Definitions
------------------------------------------------------------------------
16-50 ............ ISO 7176-3:2003 Contact person
Wheelchairs--Part 3: and Type of
Determination of standard
Effectiveness of Brakes
------------------------------------------------------------------------
16-158 ............ ISO 7176-1:1999 Contact person
Wheelchairs--Part 1: and Type of
Determination of Static standard
Stability
------------------------------------------------------------------------
16-159 ............ ISO 7176-2:2001 Contact person
Wheelchairs--Part 2: and Type of
Determination of Dynamic standard
Stability of Electric
Wheelchairs
------------------------------------------------------------------------
M. Radiology
------------------------------------------------------------------------
12-17 ............ NEMA MS 8-1993 (2000), Relevant
Characterization of the guidance and
Specific Absorption Rate Contact person
for Magnetic Resonance
Imaging Systems
------------------------------------------------------------------------
12-61 12-177 UL 122 (2007): Standard Withdrawn and
for Photographic replaced with
Equipment--Ed. 5.0 newer version
------------------------------------------------------------------------
12-64 12-178 IEC 60601-2-45 Ed. 2.0, Withdrawn and
(2006) Medical Electrical replaced with
Equipment--Part 2-45: newer version
Particular Requirements
for the Safety of
Mammographic X-ray
Equipment and
Mammographic Stereotactic
Devices
------------------------------------------------------------------------
[[Page 52377]]
12-69 ............ NEMA MS 6-1991 (R2000) Relevant
Characterization of guidance,
Special Purpose Coils for Contact person
Diagnostic Magnetic and CFR
Resonance Images Citations
------------------------------------------------------------------------
12-95 ............ NEMA MS 2-2003 Relevant
Determination of Two- guidance and
Dimensional Geometric Contact person
Distortion in Diagnostic
Magnetic Resonance Images
------------------------------------------------------------------------
12-96 ............ NEMA MS 3-2003 Relevant
Determination of Image guidance and
Uniformity in Diagnostic Contact person
Magnetic Resonance Images
------------------------------------------------------------------------
12-97 ............ NEMA MS-1-2001 Relevant
Determination of Signal- guidance,
to-Noise Ratio (SNR) in Contact person
Diagnostic Magnetic and CFR
Resonance Imaging Citations
------------------------------------------------------------------------
12-103 12-179 ANSI / IESNA RP-27.3-2007 Withdrawn and
Recommended Practice for replaced with
Photobiological Safety newer version
for Lamps--Risk Group
Classification and
Labeling
------------------------------------------------------------------------
12-120 ............ IEC 60601-2-44 (2002-11): Relevant
Medical Electrical guidance and
Equipment--Part 2-44: CFR Citations
Particular Requirements
for the Safety of X-ray
Equipment for Computed
Tomography--Ed. 2.1
------------------------------------------------------------------------
12-123 12-180 IEC 61689:2007 Withdrawn and
Ultrasonics--Physiotherap replaced with
y Systems--Field newer version
Specifications and
Methods of Measurement in
the Frequency Range 0,5
MHz to 5 MHz Ed. 2.0
------------------------------------------------------------------------
12-125 ............ NEMA MS 5-2003 Relevant
Determination of Slice guidance and
Thickness in Diagnostic Contact person
Magnetic Resonance
Imaging
------------------------------------------------------------------------
12-129 12-181 NU 1-2007 Performance Withdrawn and
Measurements of Gamma replaced with
Cameras newer version
------------------------------------------------------------------------
12-131 12-184 IEC 61217 2002 Withdrawn and
Consolidated Ed. 1.1, replaced with
2007 Amendment 2 Ed. 1.0 newer version
Radiotherapy Equipment--
Coordinates, Movements,
and Scales
------------------------------------------------------------------------
12-150 ............ IEC / ISO 10918-1:1994 Relevant
Technical Corrigendum guidance,
1:2005 Information Contact person,
Technology--Digital CFR Citations,
Compression and Coding of Product code,
Continuous-Tone Still and Devices
Images--Part 1: affected
Requirements
------------------------------------------------------------------------
12-151 ............ NEMA MS 4 (2006) Acoustic Relevant
Noise Measurement guidance,
Procedure for Diagnosing Contact person
Magnetic Resonance and CFR
Imaging Devices Citations
------------------------------------------------------------------------
12-158 ............ NEMA MS 10-2006 Relevant
Determination of Local guidance,
Specific Absorption Rate Contact person
(SAR) in Diagnostic and CFR
Magnetic Resonance Citations
Imaging
------------------------------------------------------------------------
12-159 ............ NEMA MS 11-2006 Relevant
Determination of Gradient- guidance,
Induced Electric Fields Contact person
in Diagnostic Magnetic and CFR
Resonance Imaging Citations
------------------------------------------------------------------------
12-160 ............ NEMA MS 12-2006 Relevant
Quantification and guidance,
Mapping of Geometric Contact person
Distortion for Special and CFR
Applications Citations
------------------------------------------------------------------------
12-161 ............ IEC 60601-2-33 (2006), Relevant
Medical Electrical guidance and
Equipment--Part 2-33: Contact person
Particular Requirements
for the Safety of
Magnetic Resonance
Equipment for Medical
Diagnosis
------------------------------------------------------------------------
12-164 12-182 IEC 60601-2-37:2007 Withdrawn and
Medical Electrical replaced with
Equipment--Part 2-37: newer version
Particular Requirements
for the Basic Safety and
Essential Performance of
Ultrasonic Medical
Diagnostic and Monitoring
Equipment
------------------------------------------------------------------------
12-165 ............ NEMA XR 22-2006 ``Quality Relevant
Control Manual'' Template guidance
for Manufacturers of
Displays and Workstations
Labeled for Final
Interpretation in Full-
Field Digital Mammography
------------------------------------------------------------------------
12-166 ............ NEMA XR 23-2006 ``Quality Relevant
Control Manual'' Template guidance
for Manufacturers of
Hardcopy Output Devices
Labeled for Final
Interpretation in Full-
Field Digital Mammography
------------------------------------------------------------------------
12-168 ............ IEC 60825-1 Ed. 2.0 (2007) Contact person
Safety of Laser Products-- and Processes
Part 1: Equipment impacted
Classification, and
Requirements
------------------------------------------------------------------------
[[Page 52378]]
12-169 ............ IEC 60601-2-22 Ed. 3.0 Contact person,
(2007) Medical Electrical Processes
Equipment--Part 2-22: impacted and
Particular Requirements Title
for Basic Safety and
Essential Performance of
Surgical, Cosmetic,
Therapeutic and
Diagnostic Laser
Equipment
------------------------------------------------------------------------
12-170 12-183 NEMA PS 3.1 - 3.18 (2008) Withdrawn and
Digital Imaging and replaced with
Communications in newer versions
Medicine (DICOM) Set
------------------------------------------------------------------------
5-7 12-185 IEC 60601-1-3 2008 Edition Transferred
2.0 Medical Electrical
Equipment--Part 1-
3:General Requirements
for Basic Safety and
Essential Performance--
Collateral Standard:
Radiation Protection in
Diagnostic X-ray
Equipment
------------------------------------------------------------------------
N. Software/Informatics
------------------------------------------------------------------------
13-4 ............ ANSI/UL 1998, Software in CFR Citations,
Programmable Components Product codes,
Relevant
guidance and
Extent of
recognition
------------------------------------------------------------------------
13-5 ............ IEEE 1074:1997, Standard Withdrawn
for Developing Software
Life Cycle Processes
------------------------------------------------------------------------
13-8 ............ IEC 62304 Ed. 1.0, Medical CFR Citations,
Device Software--Software Product codes,
Life Cycle Processes Relevant
guidance, and
Extent of
recognition
------------------------------------------------------------------------
7-59 13-9 CLSI AUTO2-A2 Laboratory Transferred
Automation: Bar Codes for
Specimen Container
Identification; Approved
Standard
------------------------------------------------------------------------
7-60 13-10 CLSI AUTO1-A Laboratory Transferred
Automation: Specimen
Container/Specimen
Carrier; Approved
Standard
------------------------------------------------------------------------
7-61 13-11 CLSI AUTO3-A Laboratory Transferred
Automation:
Communications with
Automated Clinical
Laboratory Systems,
Instruments, Devices, and
Information Systems;
Approved Standard
------------------------------------------------------------------------
7-62 13-12 CLSI AUTO4-A Laboratory Transferred
Automation: Systems
Operational Requirements,
Characteristics, and
Information Elements;
Approved Standard
------------------------------------------------------------------------
7-63 13-13 CLSI AUTO5-A Laboratory Transferred
Automation:
Electromechanical
Interfaces; Approved
Standard
------------------------------------------------------------------------
7-64 13-14 CLSI POCT1-A2 Point-of- Transferred
Care Connectivity;
Approved Standard
------------------------------------------------------------------------
7-68 13-15 CLSI GP19-A2 Laboratory Transferred
Instruments and Data
Management Systems:
Design of Software User
Interfaces and End-User
Software Systems
Validation, Operation,
and Monitoring; Approved
Guideline--Second Edition
------------------------------------------------------------------------
7-114 13-16 CLSI LIS01-A Standard Transferred
Specification for Low-
Level Protocol to
Transfer Messages Between
Clinical Laboratory
Instruments and Computer
Systems
------------------------------------------------------------------------
7-115 13-17 CLSI LIS02-A2 Standard Transferred
Specification for
Transferring Information
Between Clinical
Instruments and Computer
Systems; Approved
Standard-Second Edition
------------------------------------------------------------------------
7-116 13-18 CLSI LIS03-A Standard Transferred
Guide for Selection of a
Clinical Laboratory
Information Management
System
------------------------------------------------------------------------
7-117 13-19 CLSI LIS04-A Standard Transferred
Guide for Documentation
of Clinical Laboratory
Computer Systems
------------------------------------------------------------------------
7-118 13-20 CLSI LIS05-A Standard Transferred
Specification for
Transferring Clinical
Observations Between
Independent Computer
Systems
------------------------------------------------------------------------
7-119 13-21 CLSI LIS06-A Standard Transferred
Practice for Reporting
Reliability of Clinical
Laboratory Information
Systems
------------------------------------------------------------------------
[[Page 52379]]
7-120 13-22 CLSI LIS07-A Standard Transferred
Specification for Use of
Bar Codes on Specimen
Tubes in the Clinical
Laboratory
------------------------------------------------------------------------
7-121 13-23 CLSI LIS08-A Standard Transferred
Guide for Functional
Requirements of Clinical
Laboratory Information
Management Systems
------------------------------------------------------------------------
7-122 13-24 CLSI LIS09-A Standard Transferred
Guide for Coordination of
Clinical Laboratory
Services within the
Electronic Health Record
Environment and Networked
Architectures
------------------------------------------------------------------------
O. Sterility
------------------------------------------------------------------------
14-24 ............ AAMI/ANSI/ISO 11134:1993 Withdrawn
Sterilization of Health
Care Products--
Requirements for
Validation and Routine
Control-Industrial Moist
Heat Sterilization
------------------------------------------------------------------------
14-53 ............ AAMI/ANSI ST66:1996 Withdrawn
Sterilization of Health
Care Products--Chemical
Indicators--Part 2:
Indicators for Air
Removal Test Sheets and
Packs
------------------------------------------------------------------------
14-54 ............ AAMI/ANSI/ISO 11737-2:1998 CFR Citations,
Sterilization of Medical Product codes
Devices--Microbiological and Devices
Methods--Part 2: Tests of affected
Sterility Performed in
the Validation of a
Sterilization Process
------------------------------------------------------------------------
14-55 ............ AAMI/ANSI/ISO 14160:1998 Relevant
Sterilization of Single- guidance
Use Medical Devices
Incorporating Materials
of Animal Origin--
Validation and Routine
Control of Sterilization
by Liquid Chemical
Sterilants
------------------------------------------------------------------------
14-60 ............ ASTM F1327:1998 Standard Withdrawn
Terminology Relating to
Barrier Materials for
Medical Packaging
------------------------------------------------------------------------
14-63 ............ ASTM F1886: 1998 (2004) CFR Citations
Standard Test Method for and Product
Determining Integrity of codes
Seals for Medical
Packaging by Visual
Inspection
------------------------------------------------------------------------
14-64 ............ ASTM F1929:1998 (2004) CFR Citations
Standard Test Method for and Product
Detecting Seal Leaks in codes
Porous Medical Packaging
by Dye Penetration
------------------------------------------------------------------------
14-70 ............ AAMI/ANSI/ISO 14161:2000 CFR Citations,
Sterilization of Health Product codes
Care Products--Biological and Devices
Indicators--Guidance for affected
the Selection, Use and
Interpretation of
Results, 2ed.
------------------------------------------------------------------------
14-76 ............ AAMI/ANSI/ISO 10993-7:1995 CFR Citations,
(R) 2001 Biological Product codes
Evaluation of Medical and Contact
Devices--Part 7: Ethylene person
Oxide Sterilization
Residuals
------------------------------------------------------------------------
14-88 ............ AAMI/ANSI/ISO 14937:2000 CFR Citations
Sterilization of Health and Product
Care Products--General codes
Requirements for
Characterization of a
Sterilizing Agent and the
Development, Validation,
and Routine Control of a
Sterilization Process for
Medical Devices
------------------------------------------------------------------------
14-90 14-256 ASTM F2095-07 Standard Withdrawn and
Test Methods for Pressure replaced with
Decay Leak Test for newer version
Nonporous Flexible
Packages With and Without
Restraining Plates
------------------------------------------------------------------------
14-116 ............ AAMI ST72:2002 Bacterial CFR Citations,
endotoxins--Test Product codes,
Methodologies, Routine Type of
Monitoring, and standard,
Alternatives to Batch Guidance and
Testing Extent of
recognition
------------------------------------------------------------------------
14-120 ............ ASTM D3078:2002 Standard CFR Citations,
Test Method for Product codes
Determination of Leaks in and Type of
Flexible Packaging by standard
Bubble Emission
------------------------------------------------------------------------
14-123 ............ ASTM F2096-04 Standard CFR Citations,
Test Method for Detecting Product codes,
Gross Leaks in Medical CDRH Office and
Packaging by Internal Division
Pressurization (Bubble associated with
Test) recognized
standard
------------------------------------------------------------------------
[[Page 52380]]
14-135 ............ AAMI/ANSI ST63:2002 CFR Citations,
Sterilization of Health Product codes
Care Products-- and Type of
Requirements for the standard
Development, Validation
and Routine Control of an
Industrial Sterilization
Process for Medical
Devices--Dry Heat
------------------------------------------------------------------------
14-136 ............ AAMI/ANSI ST67:2003 CFR Citations,
Sterilization of Health Product codes
Care Products-- and Guidance
Requirements for Products
Labeled 'Sterile' 1st
Edition
------------------------------------------------------------------------
14-138 ............ ISO 13408-2:2003 Aseptic CFR Citations,
Processing of Health Care Product codes,
Products--Part 2: Type of
Filtration standard and
Guidance
------------------------------------------------------------------------
14-139 ............ ISO 14644-1:1999 CFR Citations,
Cleanrooms and Associated Product codes
Controlled Environments-- and Type of
Part 1: Classification of standard
Air Cleanliness
------------------------------------------------------------------------
14-140 ............ ISO 14644-2:2000 CFR Citations,
Cleanrooms and Associated Product codes
Controlled Environments-- and Type of
Part 2: Specification for standard
Testing and Monitoring to
Prove Continued
Compliance With ISO 14644-
1
------------------------------------------------------------------------
14-141 ............ ISO 14644-4:2001 CFR Citations,
Cleanrooms and Associated Product codes
Controlled Environments-- and Type of
Part 4: Design, standard
Construction and Startup
------------------------------------------------------------------------
14-142 ............ ISO 14698-1:2003 CFR Citations,
Cleanrooms and Associated Product codes
Controlled Environments-- and Type of
Biocontamination Control-- standard
Part 1: General
Principles and Methods
------------------------------------------------------------------------
14-143 ............ ISO 14698-2:2003 CFR Citations,
Cleanrooms and Associated Product codes
Controlled Environments-- and Type of
Biocontamination Control-- standard
Part 2: Evaluation and
Interpretation of
Biocontamination Data
------------------------------------------------------------------------
14-148 ............ ASTM F2250-03 Standard CFR Citations,
Practice for Evaluation Product codes
of Chemical Resistance of and Type of
Printed Inks and Coatings standard
on Flexible Packaging
Materials
------------------------------------------------------------------------
14-149 ............ ASTM F2251-03e1 Standard CFR Citations,
Test Method for Thickness Product codes
Measurement of Flexible and Type of
Packaging Material standard
------------------------------------------------------------------------
14-150 ............ ASTM F2252-03 Standard CFR Citations,
Practice for Evaluating Product codes
Ink or Coating Adhesion and Type of
to Flexible Packaging standard
Materials Using Tape
------------------------------------------------------------------------
14-164 ............ AAMI/ANSI ST81:2004 CFR Citations,
Sterilization of Medical Product codes,
Devices--Information to and Devices
be Provided by the affected
Manufacturer for the
Processing of
Resterilizable Devices
------------------------------------------------------------------------
14-165 ............ ISO 14644-5:2004 CFR Citations,
Cleanrooms and Associated Product codes
Controlled Environments-- and Type of
Part 5: Operations standard
------------------------------------------------------------------------
14-166 ............ ISO 14644-7:2004 CFR Citations,
Cleanrooms and Associated Product codes
Controlled Environments-- and Type of
Part 7: Separative standard
Devices (Clean Air Hoods,
Gloveboxes, Isolators and
Mini-Environments)
------------------------------------------------------------------------
14-168 14-245 ASTM F2338-07 Standard Withdrawn and
Test Method for replaced with
Nondestructive Detection newer version
of Leaks in Packages by
Vacuum Decay Method
------------------------------------------------------------------------
14-169 ............ ASTM F2391-05 Standard CFR Citations,
Test Method for Measuring Product codes
Package and Seal and Type of
Integrity Using Helium as standard
Tracer Gas
------------------------------------------------------------------------
14-170 ............ ASTM F2475-05 Standard CFR Citations,
Guide for Product codes
Biocompatibility and Type of
Evaluation of Medical standard
Device Packaging
Materials
------------------------------------------------------------------------
14-191 ............ ISO 13408-4:2005 Aseptic CFR Citations,
Processing of Health care Product codes,
Products--Part 4: Clean- Type of
in-Place Technologies standard and
Relevant
guidance
------------------------------------------------------------------------
14-193 ............ AAMI/ANSI/ISO 11607-1:2006 CFR Citations,
Packaging for terminally Product codes,
Sterilized Medical Devices
Devices--Part 1: affected and
Requirements for Relevant
Materials, Sterile guidance
Barrier Systems and
Packaging Systems, 3d ed.
------------------------------------------------------------------------
[[Page 52381]]
14-194 ............ AAMI/ANSI/ISO 11607-2:2006 CFR Citations,
Packaging for Terminally Product codes,
Sterilized Medical Devices
Devices--Part 2: affected and
Validation Requirements Relevant
for Forming, Sealing and guidance
Assembly Processes, 1st
ed.
------------------------------------------------------------------------
14-197 ............ ASTM F1608:00(2004) CFR Citations
Standard Test Method for and Product
Microbial Ranking of codes
Porous Packaging
Materials (Exposure
Chamber Method)
------------------------------------------------------------------------
14-199 ............ ASTM D4169-05 Standard Related CFR
Practice for Performance Citations and
Testing of Shipping Product codes
Containers and Systems
------------------------------------------------------------------------
14-202 14-246 USP 31:2008 Biological Withdrawn and
Indicator for Dry-Heat replaced with
Sterilization, Paper newer version
Carrier
------------------------------------------------------------------------
14-203 14-247 USP 31:2008 Biological Withdrawn and
Indicator for Ethylene replaced with
Oxide Sterilization, newer version
Paper Carrier.
------------------------------------------------------------------------
14-204 14-248 USP 31:2008 Biological Withdrawn and
Indicator for Steam replaced with
Sterilization, Paper newer version
Carrier
------------------------------------------------------------------------
14-205 14-249 USP 31:2008 <61> Microbial Withdrawn and
Limits Test replaced with
newer version
------------------------------------------------------------------------
14-206 14-250 USP 31:2008 <71> Withdrawn and
Microbiological Tests, replaced with
Sterility Tests newer version
------------------------------------------------------------------------
14-207 14-251 USP 31:2008 <85> Withdrawn and
Biological Tests and replaced with
Assays, Bacterial newer version
Endotoxin Test (LAL)
------------------------------------------------------------------------
14-208 14-252 USP 31:2008 <151> Pyrogen Withdrawn and
Test (USP Rabbit Test) replaced with
newer version
------------------------------------------------------------------------
14-209 14-253 USP 31:2008 <161> Withdrawn and
Transfusion and Infusion replaced with
Assemblies and Similar newer version
Medical Devices
------------------------------------------------------------------------
14-210 14-254 USP 31:2008 Biological Withdrawn and
Indicator for Steam replaced with
Sterilization--Self newer version
Contained
------------------------------------------------------------------------
14-220 ............ AAMI/ANSI ST79:2006 Type of Standard
Comprehensive Guide to
Steam Sterilization and
Sterility Assurance in
Health Care Facilities
------------------------------------------------------------------------
14-221 ............ AAMI/ANSI/ISO TIR CFR Citations,
11139:2006 Sterilization Product codes,
of Health Care Products-- Title, Devices
Vocabulary affected, and
Type of
standard
------------------------------------------------------------------------
14-222 ............ AAMI/ANSI/ISO 18472:2006 Type of standard
Sterilization of Health
Care Products--Biological
and Chemical Indicators--
Test Equipment
------------------------------------------------------------------------
14-223 ............ ANSI/AAMI/ISO 11138-1:2006 Type of
Sterilization of Health standard,
Care Products--Biological Guidance and
Indicators--Part 1: Extent of
General Requirements recognition
------------------------------------------------------------------------
14-224 ............ AAMI/ANSI/ISO 11137-1:2006 CFR Citations,
Sterilization of Health Product codes,
Care Products--Radiation-- and Type of
Part 1: Requirements for standard
Development, Validation,
and Routine Control of a
Sterilization Process for
Medical Devices
------------------------------------------------------------------------
14-225 ............ AAMI/ANSI/ISO 11137-2:2006 CFR Citations,
Sterilization of Health Product codes
Care Products--Radiation-- and Type of
Part 2: Establishing the standard
Sterilization Dose
------------------------------------------------------------------------
14-226 ............ AAMI/ANSI/ISO 11137-3:2006 CFR Citations,
Sterilization of Health Product codes
Care Products--Radiation-- and Type of
Part 3: Guidance on standard
Dosimetric Aspects
------------------------------------------------------------------------
[[Page 52382]]
14-227 ............ AAMI/ANSI/ISO 11737-1:2006 CFR Citations,
Sterilization of Medical Product codes,
Devices-Microbiological Devices
Methods-Part 1: affected, CDRH
Determination of the Office and
Population of Division
Microorganisms on associated with
Products, 2d, ed. recognized
standard
------------------------------------------------------------------------
14-228 ............ ANSI/AAMI/ISO 11135-1:2007 CFR Citations,
Sterilization of Health Product codes,
Care Products--Ethylene Devices
Oxide--Part 1: affected, and
Requirements for the Type of
Development, Validation, standard
and Routine Control of a
Sterilization Process for
Medical Devices
------------------------------------------------------------------------
14-229 ............ ASTM F1980-07 Standard CFR Citations
Guide for Accelerated and Product
Aging of Sterile Barrier codes
Systems for Medical
Devices
------------------------------------------------------------------------
14-230 ............ ASTM F2203-02(2007) CFR Citations,
Standard Test Method for Product codes
Linear Measurement Using and Type of
Precision Steel Rule standard
------------------------------------------------------------------------
14-231 ............ ASTM F2217-02(2007) CFR Citations,
Standard Practice for Product codes
Coating/Adhesive Weight and Type of
Determination standard
------------------------------------------------------------------------
14-232 ............ ASTM F2227-02(2007) CFR Citations,
Standard Test Method for Product codes
Non-Destructive Detection and Type of
of Leaks in Non-Sealed standard
and Empty Medical
Packaging Trays by CO2
Tracer Gas Method
------------------------------------------------------------------------
14-233 ............ ASTM F2228-02(2007) CFR Citations,
Standard Test Method for Product codes
Non-Destructive Detection and Type of
of Leaks in Medical standard
Packaging Which
Incorporates Porous
Barrier Material by CO2
Tracer Gas Method
------------------------------------------------------------------------
14-234 ............ ASTM F2097-07 Standard CFR Citations,
Guide for Design and Product codes
Evaluation of Primary and Type of
Flexible Packaging for standard
Medical Products
------------------------------------------------------------------------
14-235 ............ ASTM F1140-07 Standard CFR Citations,
Test Methods for Internal Product codes
Pressurization Failure and Type of
Resistance of standard
Unrestrained Packages
------------------------------------------------------------------------
14-236 ............ ASTM F2054-07 Standard CFR Citations,
Test Method for Burst Product codes
Testing of Flexible and Type of
Package Seals Using standard
Internal Air
Pressurization Within
Restraining Plates
------------------------------------------------------------------------
14-237 ............ ASTM F88-07 Standard Test CFR Citations,
Method for Seal Strength Product codes
of Flexible Barrier and Type of
Materials standard
------------------------------------------------------------------------
14-239 ............ ISO 13408-3:2006 Aseptic CFR Citations
Processing of Health Care and Product
Products--Part 3: codes
Lyophilization
------------------------------------------------------------------------
14-240 ............ ISO 13408-5:2006 Aseptic CFR Citations
Processing of Health Care and Product
Products--Part 5: codes
Sterilization-in-Place
------------------------------------------------------------------------
14-241 ............ ISO 13408-6:2005 Aseptic CFR Citations
Processing of Health Care and Product
Products--Part 6: codes
Isolator Systems
------------------------------------------------------------------------
14-242 ............ ISO 14644-3:2005 CFR Citations
Cleanrooms and Associated and Product
Controlled Environments-- codes
Part 3: Test Methods
------------------------------------------------------------------------
14-243 ............ ISO 14644-6:2007 CFR Citations
Cleanrooms and Associated and Product
Controlled Environments-- codes
Part 6: Vocabulary
------------------------------------------------------------------------
14-244 ............ ISO 14644-8:2006 CFR Citations
Cleanrooms and Associated and Product
Controlled Environments-- codes
Part 8: Classification of
Airborne Molecular
Contamination
------------------------------------------------------------------------
P. Tissue Engineering
------------------------------------------------------------------------
15-12 ............ ASTM F2103-01(2007)e1 CFR Citations
Standard Guide for and Product
Characterization and codes, Relevant
Testing of Chitosan Salts guidance, Type
as Starting Materials of standard and
Intended for Use in CDRH Office and
Biomedical and Tissue- Division
Engineered Medical associated with
Product Applications recognized
standard
------------------------------------------------------------------------
[[Page 52383]]
15-5 ............ ASTM F2347-03, Standard CFR Citations
Guide for and Product
Characterization and codes, Relevant
Testing of Hyaluronan as guidance, Type
Starting Materials of standard and
Intended for Use in CDRH Office and
Biomedical and Tissue Division
Engineered Medical associated with
Product Applications recognized
standard
------------------------------------------------------------------------
15-6 ............ ASTM F2450-04, Standard CFR Citations
Guide for Assessing and Product
Microstructure of codes, Relevant
Polymeric Scaffolds for guidance, Type
Use in Tissue Engineered of standard and
Medical Products CDRH Office and
Division
associated with
recognized
standard
------------------------------------------------------------------------
15-7 ............ ASTM F2315-03, Standard CFR Citations
Guide for Immobilization and Product
or Encapsulation of codes, Relevant
Living Cells or Tissue in guidance, Type
Alginate Gels of standard and
CDRH Office and
Division
associated with
recognized
standard
------------------------------------------------------------------------
15-8 ............ ASTM F2064-00(2006), CFR Citations
Standard Guide for and Product
Characterization and codes, Relevant
Testing of Alginates as guidance, Type
Starting Materials of standard and
Intended for use in CDRH Office and
Biomedical and Tissue- Division
Engineered Medical associated with
Products Application recognized
standard
------------------------------------------------------------------------
15-9 ............ ASTM F2311-06, Standard CFR Citations
Guide for Classification and Product
of Therapeutic Skin codes, Relevant
Substitutes guidance, Type
of standard and
CDRH Office and
Division
associated with
recognized
standard
------------------------------------------------------------------------
15-10 ............ ASTM F2451-05, Standard CFR Citations
Guide for in vivo and Product
Assessment of Implantable codes, Relevant
Devices Intended to guidance, Type
Repair or Regenerate of standard and
Articular Cartilage CDRH Office and
Division
associated with
recognized
standard
------------------------------------------------------------------------
15-11 ............ ASTM F2212-02(2007)e1, CFR Citations
Standard Guide for and Product
Characterization of Type codes, Relevant
I Collagen as a Starting guidance, Type
Material for Surgical of standard and
Implants and Substrates CDRH Office and
for Tissue Engineered Division
Medical Products associated with
recognized
standard
------------------------------------------------------------------------
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 standards under Recognition List Number: 020.
Table 3.--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
Recognition Reference No. and
No. Title of Standard Date
------------------------------------------------------------------------
A. Biocompatibility
------------------------------------------------------------------------
2-127 Biological Evaluation of Medical ANSI/AAMI BE
Devices--Part 10: Tests for 78:2002/A1:2006
Irritation and Delayed-Type
Hypersensitivity--Amendment 1
------------------------------------------------------------------------
B. Cardiovascular/Neurology
------------------------------------------------------------------------
3-70 Manual, Electronic or Automated ANSI/AAMI
Sphygmomanometers SP10:2002/
A1:2003--Amendmen
t 1 to ANSI/AAMI
SP10:2002
------------------------------------------------------------------------
3-71 Manual, Electronic and Automated ANSI/AAMI
Sphygmomanometers SP10:2002/
A2:2006--Amendmen
t 2 to ANSI/AAMI
SP10:2002
------------------------------------------------------------------------
C. Dental/ Ear, Nose, and Throat
------------------------------------------------------------------------
4-151 Dentistry--Artificial Teeth for ISO 22112:2005
Dental Prostheses
------------------------------------------------------------------------
[[Page 52384]]
4-152 Metal-Ceramic Dental Restorative ISO 9693:1999/
Systems Amendment 1:2005
------------------------------------------------------------------------
4-154 Dentistry--Elastometric Impression ISO 4823:2000
Materials-Third Edition
------------------------------------------------------------------------
4-155 Dentistry--Elastomeric Impression ISO 4823:2000
Materials Technical Corrigendum 1- Technical
Third Edition Corrigendum
1:2004
------------------------------------------------------------------------
4-156 Dentistry--Elastomeric Impression ISO 4823:2000
Materials Amendment 1-Third Edition Amendment 1:2007
------------------------------------------------------------------------
4-157 Dentistry--Zinc Oxide/Eugenol and ISO 3107: 2004
Zinc Oxide/Non-eugenol Cements-
Third Edition
------------------------------------------------------------------------
4-158 Dentistry--Soft Lining Materials for ISO 10139-1:2005
Removable Dentures--Part 1: Technical
Materials for Short-Term Use Corrigendum
Technical Corrigendum 1 1:2006
------------------------------------------------------------------------
D. General Hospital/ General Plastic Surgery
------------------------------------------------------------------------
6-214 Standard Test Method for Human ASTM D6355-07
Repeat Insult Patch Testing of
Medical Gloves
------------------------------------------------------------------------
E. In Vitro Diagnostic
------------------------------------------------------------------------
7-160 Abbreviated Identification of CLSI M35-A,
Bacteria and Yeast; Approved
Guideline
------------------------------------------------------------------------
7-161 Laboratory Detection and CLSI M48-P
Identification of Mycobacteria;
Proposed Guideline.
------------------------------------------------------------------------
7-162 Point-of-Care Monitoring of CLSI H49-A
Anticoagulant Therapy; Approved
Guideline
------------------------------------------------------------------------
7-163 Body Fluid Analysis for Cellular CLSI H56-A
Composition
------------------------------------------------------------------------
7-164 Microwave Device Use in the CLSI GP28-A
Histology Laboratory; Approved
Guideline
------------------------------------------------------------------------
7-165 Reference Leukocyte (WBC) CLSI H20-A2
Differential Count (Proportional)
and Evaluation of Instrumental
Methods; Approved Standard-Second
Edition
------------------------------------------------------------------------
7-166 Fine Needle Aspiration Biopsy (FNAB) CLSI GP20-A2
Techniques; Approved Guideline--
Second Edition
------------------------------------------------------------------------
7-167 Nongynecologic Cytologic Specimens: CLSI GP23-A
Collection and Cytopreparatory
Techniques; Approved Guideline
------------------------------------------------------------------------
7-168 Reference Method for Broth Dilution CLSI M38-A
Antifungal Susceptibility Testing
of Filamentous Fungi; Approved
Standard
------------------------------------------------------------------------
F. Materials
------------------------------------------------------------------------
8-161 Standard Test Method for Tension ASTM F2516-07
Testing of Nickel-Titanium
Superelastic Materials
------------------------------------------------------------------------
G. OB-GYN/Gastroenterology
------------------------------------------------------------------------
9-46 Medical Electrical Equipment--Part 2- ANSI/AAMI 60601-2-
2: Particular Requirements for the 2:2006
Safety of High Frequency Surgical
Equipment
------------------------------------------------------------------------
9-49 Concentrates for Hemodialysis AAMI / ANSI
RD61:2006
------------------------------------------------------------------------
9-50 Dialysate for Hemodialysis ANSI/AAMI
RD52:2004
------------------------------------------------------------------------
9-51 Cardiovascular Implants and ISO 8637:2004
Artificial Organs--Haemodialysers,
Haemodiafilters, Haemofilters and
Haemoconcentrators
------------------------------------------------------------------------
9-52 Cardiovascular Implants and ISO 8638:2004
Artificial Organs--Extracorporeal
Blood Circuit for Haemodialysers,
Haemodiafilters and Haemofilters
------------------------------------------------------------------------
9-53 Standard Practice for Reprocessing ASTM F1992-
of Reusable, Heat-Stable Endoscopic 99(2007)
Accessory Instruments (EAI) Used
with Flexible Endoscopes
------------------------------------------------------------------------
9-54 Standard Specification for Rubber ASTM D6976-08
Contraceptives--Vaginal Diaphragms
------------------------------------------------------------------------
H. Ophthalmic
------------------------------------------------------------------------
10-56 Ophthalmics Multifocal Intraocular ANSI Z80.12-2007
Lenses
------------------------------------------------------------------------
[[Page 52385]]
10-57 Phakic Intraocular Lenses ANSI Z80.13-2007
------------------------------------------------------------------------
I. Physical Medicine
------------------------------------------------------------------------
16-161 Safety Standard for Platform Lifts ASME A18.1-2005
and Stairway Chairlifts
------------------------------------------------------------------------
J. Sterility
------------------------------------------------------------------------
14-255 Standard Terminology Relating to ASTM F17-07a
Flexible Barrier Packaging
------------------------------------------------------------------------
IV. List of Recognized Standards
FDA maintains the agency's current list of FDA recognized consensus
standards in a searchable database that may be accessed directly at
FDA's Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA will incorporate the modifications
and minor revisions described in this notice into the database and,
upon publication in the Federal Register, this recognition of consensus
standards will be effective. FDA will announce additional modifications
and minor revisions to the list of recognized consensus standards, as
needed, in the Federal Register once a year, or more often, if
necessary.
V. Recommendation of Standards for Recognition by FDA
Any person may recommend consensus standards as candidates for
recognition under the new provision of section 514 of the act by
submitting such recommendations, with reasons for the recommendation,
to the contact person (see FOR FURTHER INFORMATION CONTACT). To be
properly considered such recommendations should contain, at a minimum,
the following information: (1) Title of the standard, (2) any reference
number and date, (3) name and address of the national or international
standards development organization, (4) a proposed list of devices for
which a declaration of conformity to this standard should routinely
apply, and (5) a brief identification of the testing or performance or
other characteristics of the device(s) that would be addressed by a
declaration of conformity.
VI. Electronic Access
Persons interested in obtaining a copy of ``Guidance on the
Recognition and Use of Consensus Standards'' by using the Internet.
CDRH maintains an entry on the Internet for easy access to information
including text, graphics, and files that may be downloaded to a
personal computer with Internet access. Updated on a regular basis, the
CDRH home page includes device safety alerts, Federal Register
reprints, information on premarket submissions [including lists of
approved applications and manufacturers' addresses], small
manufacturer's assistance, information on video conferencing and
electronic submissions, Mammography Matters, and other device-oriented
information. The CDRH Web site may be accessed at http://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available at http://www.regulations.gov.
This Federal Register document on modifications in FDA's
recognition of consensus standards is available at http://www.fda.gov/cdrh/fedregin.html.
VII. Submission of Comments and Effective Date
Interested persons may submit to the contact person (see FOR
FURTHER INFORMATION CONTACT) written or electronic comments regarding
this document. Two copies of any mailed comments are to be submitted,
except that individuals may submit one paper copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. FDA will consider any comments received in determining
whether to amend the current listing of modifications to the list of
recognized standards, Recognition List Number: 020. These modifications
to the list or recognized standards are effective upon publication of
this notice in the Federal Register.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.
Dated: August 27, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-20939 Filed 9-8-08; 8:45 am]
BILLING CODE 4160-01-S