[Federal Register Volume 70, Number 215 (Tuesday, November 8, 2005)]
[Notices]
[Pages 67713-67724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-22267]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0226]


Food and Drug Administration Modernization Act of 1997: 
Modifications to the List of Recognized Standards, Recognition List 
Number: 013

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing a 
publication containing modifications the agency is making to the list 
of standards FDA recognizes for use in premarket reviews (FDA 
recognized consensus standards). This publication entitled 
``Modifications to the List of Recognized Standards, Recognition List 
Number: 013'' (Recognition List Number: 013), will assist manufacturers 
who elect to declare conformity with consensus standards to meet 
certain requirements for medical devices.

DATES: Submit written or electronic comments concerning this document 
at any time. See section VII of this document for the effective date of 
the recognition of standards announced in this document.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of ``Modifications to the List of Recognized Standards, 
Recognition List Number: 013'' to the Division of Small Manufacturers, 
International and Consumer Assistance, Center for Devices and 
Radiological Health (HFZ-220), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive 
labels to assist that office in processing your requests, or FAX your 
request to 301-443-8818. Submit written comments concerning this 
document, or recommendations for additional standards for recognition, 
to the contact person (see FOR FURTHER INFORMATION CONTACT). Submit 
electronic comments by e-mail: [email protected]. This document 
may also be accessed on FDA's Internet site at http://www.fda.gov/cdrh/fedregin.html. See section VI of this document for electronic access to 
the searchable

[[Page 67714]]

database for the current list of FDA recognized consensus standards, 
including Recognition List Number: 013 modifications and other 
standards related information.

FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices 
and Radiological Health (HFZ-84), Food and Drug Administration, 12720 
Twinbrook Pkwy., MD 20857, 301-827-0021.



I. Background

    Section 204 of the Food and Drug Administration Modernization Act 
of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended 
section 514 allows FDA to recognize consensus standards developed by 
international and national organizations for use in satisfying portions 
of device premarket review submissions or other requirements.
    In a notice published in the Federal Register of February 25, 1998 
(63 FR 9561), FDA announced the availability of a guidance entitled 
``Recognition and Use of Consensus Standards.'' The notice described 
how FDA would implement its standard recognition program and provided 
the initial list of recognized standards.
    In Federal Register notices published on October 16, 1998 (63 FR 
55617), July 12, 1999 (64 FR 37546), November 15, 2000 (65 FR 69022), 
May 7, 2001 (66 FR 23032), January 14, 2002 (67 FR 1774), October 2, 
2002 (67 FR 61893), April 28, 2003 (68 FR 22391), March 8, 2004 (69 FR 
10712), June 18, 2004 (69 FR 34176), and October 4, 2004 (69 FR 59240), 
FDA modified its initial list of FDA recognized consensus standards. 
These notices describe the addition, withdrawal, and revision of 
certain standards recognized by FDA. The agency maintains ``hypertext 
markup language'' (HTML) and ``portable document format'' (PDF) 
versions of the list of ``FDA Recognized Consensus Standards.'' Both 
versions are publicly accessible at the agency's Internet site. See 
section VI of this document for electronic access information. 
Interested persons should review the supplementary information sheet 
for the standard to understand fully the extent to which FDA recognizes 
the standard.

II. Modifications to the List of Recognized Standards, Recognition List 
Number: 013

    FDA is announcing the addition, withdrawal, correction, and 
revision of certain consensus standards the agency will recognize for 
use in satisfying premarket reviews and other requirements for devices. 
FDA will incorporate these modifications in the list of FDA Recognized 
Consensus Standards in the agency's searchable database. FDA will use 
the term ``Recognition List Number: 013'' to identify these current 
modifications.
    In table 1 of this document, FDA describes the following 
modifications: (1) The withdrawal of standards and their replacement by 
others, (2) the correction of errors made by FDA in listing previously 
recognized standards, and (3) the changes to the supplementary 
information sheets of recognized standards that describe revisions to 
the applicability of the standards.
    In section III of this document, FDA lists modifications the agency 
is making that involve the initial addition of standards not previously 
recognized by FDA.

                                Table 1.
------------------------------------------------------------------------
                                                        Replacement Item
 Old Item No.          Standard             Change            No.
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
52             ASTM F1463-93 (1999),    Withdrawn      .................
                Standard Specification
                for Alarm Signals in
                Medical Equipment Used
                in Anesthesia and
                Respiratory Care
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
1              ASTM E1262-88 (2003),    Withdrawn and              83
                Standard Guide for       replaced
                Performance of the       with newer
                Chinese Hamster Ovary    version
                Cell/Hypoxanthine
                Guanine Phosphoribosyl
                Transferase Gene
                Mutation Assay
------------------------------------------------------------------------
2              ASTM E1263-97 (2003),    Withdrawn and              84
                Standard Guide for       replaced
                Conduct of               with newer
                Micronucleus Assays in   version
                Mammalian Bone Marrow
                Erythrocytes
------------------------------------------------------------------------
3              ASTM E1280-97 (2003),    Withdrawn and              85
                Standard Guide for       replaced
                Performing the Mouse     with newer
                Lymphoma Assay for       version
                Mammalian Cell
                Mutagenicity
------------------------------------------------------------------------
19             AAMI/ANSI/ISO10993-10:   Withdrawn and              86
                2002(E), Biological      replaced
                Evaluation of Medical    with newer
                Devices--Part 10:        version
                Tests for Irritation
                and Sensitization
------------------------------------------------------------------------
20             AAMI/ANSI/ISO10993-10:    Withdrawn                 87
                2002(E), Biological      and replaced
                Evaluation of Medical    with newer
                Devices--Part 10:        version
                Tests for Irritation
                and Sensitization--
                Maximization
                Sensitization Test
------------------------------------------------------------------------
21             AAMI/ANSI/ISO10993-      Extent of      .................
                11:1993, Biological      Recognition
                Evaluation of Medical    and Relevant
                Devices--Part 11:        Guidance
                Tests for Systemic
                Toxicity
------------------------------------------------------------------------
28             AAMI/ANSI/ISO10993-       Withdrawn                 88
                12:2002(E), Biological   and replaced
                Evaluation of Medical    with newer
                Devices--Part 12:        version
                Sample Preparation and
                Reference Materials
------------------------------------------------------------------------
34             ASTM F749-98 (2002)e2,   Withdrawn and              89
                Standard Practice for    replaced
                Evaluating Material      with newer
                Extracts by              version
                Intracutaneous
                Injection in the
                Rabbit
------------------------------------------------------------------------

[[Page 67715]]

 
37             ASTM E1397-91 (2003),    Withdrawn and              90
                Standard Practice for    replaced
                the In Vitro Rat         with newer
                Hepatocyte DNA Repair    version
                Assay
------------------------------------------------------------------------
38             ASTM E1398-91 (2003),    Withdrawn and              91
                Standard Practice for    replaced
                the In Vivo Rat          with newer
                Hepatocyte DNA Repair    version
                Assay
------------------------------------------------------------------------
39             ASTM F748-04, Standard   Withdrawn and              92
                Practice for Selecting   replaced
                Generic Biological       with newer
                Test Methods for         version
                Materials and Devices
------------------------------------------------------------------------
40             ASTM F763-04, Standard   Withdrawn and              93
                Practice for Short-      replaced
                Term Screening of        with newer
                Implant Materials        version
------------------------------------------------------------------------
41             ASTM F981-04, Standard   Withdrawn and              94
                Practice for             replaced
                Assessment of            with newer
                Compatibility of         version
                Biomaterials for
                Surgical Implants with
                Respect to Effect of
                Materials on Muscle
                and Bone
------------------------------------------------------------------------
42             ASTM F1984-99 (2003),    Withdrawn and              95
                Standard Practice for    replaced
                Testing for Whole        with newer
                Complement Activation    version
                in Serum by Solid
                Materials
------------------------------------------------------------------------
43             ASTM F1903-98 (2003),    Withdrawn and              96
                Standard Practice for    replaced
                Testing for Biological   with newer
                Responses to Particles   version
                In Vitro
------------------------------------------------------------------------
45             ASTM F1983-99 (2003),    Withdrawn and              97
                Standard Practice for    replaced
                Assessment of            with newer
                Compatibility of         version
                Absorbable/Resorbable
                Biomaterials for
                Implant Applications
------------------------------------------------------------------------
51             AAMI/ANSI/ISO10993-1:    Withdrawn and              98
                2003(E), Biological      replaced
                Evaluation of Medical    with newer
                Devices--Part 1:         version
                Evaluation and Testing
------------------------------------------------------------------------
52             ASTM F1904-98e1 (2003),  Withdrawn and              99
                Standard Practice for    replaced
                Testing for Biological   with newer
                Responses to Particles   version
                In Vivo
------------------------------------------------------------------------
53             ASTM E1372-95 (2003),    Withdrawn and             100
                Standard Test Method     replaced
                for Conducting a 90-     with newer
                Day Oral Toxicity        version
                Study in Rats
------------------------------------------------------------------------
70             ASTM F750-87 (2002)e1,   Relevant       .................
                Standard Practice for    guidance
                Evaluating Material
                Extracts by Systemic
                Injection in the Mouse
------------------------------------------------------------------------
74             USP 28-NF21Biological     Withdrawn                101
                Tests <87>, Biological   and replaced
                Reactivity Test, In      with newer
                Vitro--Direct Contact    version
                Test
------------------------------------------------------------------------
75             USP 28-NF21Biological    Withdrawn and             102
                Tests <87>, Biological   replaced
                Reactivity Test, In      with newer
                Vitro--Elution Test      version
------------------------------------------------------------------------
76             USP 28-NF21Biological    Withdrawn and             103
                Tests <88>, Biological   replaced
                Reactivity Test, In      with newer
                Vivo Procedure--         version
                Preparation of Sample
------------------------------------------------------------------------
77             USP 28-NF21Biological     Withdrawn                104
                Tests <88>, Biological   and replaced
                Reactivity Test, In      with newer
                Vitro, Classification    version
                of Plastics--
                Intracutaneous Test
------------------------------------------------------------------------
78             USP 28-NF21Biological    Withdrawn and             105
                Tests <88>, Biological   replaced
                Reactivity Test, In      with newer
                Vitro, Classification    version
                of Plastics--Systemic
                Injection Test
------------------------------------------------------------------------
79             ASTM F619-03, Standard   Withdrawn and             106
                Practice for             replaced
                Extraction of Medical    with newer
                Plastics                 version
------------------------------------------------------------------------
80             ASTM F1877 (2003)e1,      Withdrawn                107
                Standard Practice for    and replaced
                Characterization of      with newer
                Particles                version
------------------------------------------------------------------------
81             ASTM F1905 (2003)e1,     Withdrawn and             108
                Standard Practice for    replaced
                Selecting Tests for      with newer
                Determining the          version
                Propensity of
                Materials to Cause
                Immunotoxicity
------------------------------------------------------------------------
B. Cardiovascular/Neurology
------------------------------------------------------------------------
4              ANSI/AAMI SP10:2002--    Withdrawn and              53
                Manual, Electronic, or   replaced
                Automated                with newer
                Sphygmomanometers        version
------------------------------------------------------------------------
5              ANSI/AAMI/ISO 7198:1998/ Withdrawn and              54
                2001(R) 2004,            replaced
                Cardiovascular           with newer
                Implants--Tubular        version
                vascular prostheses
------------------------------------------------------------------------

[[Page 67716]]

 
14             ASTM F1830:05,           Withdrawn and              55
                Recommended Practice     replaced
                for Selection of Blood   with newer
                for In Vitro Hemolytic   version
                Evaluation of Blood
                Pumps
------------------------------------------------------------------------
15             ASTM F1841:05,           Withdrawn and              56
                Recommended Practice     replaced
                for Assessment of        with newer
                Hemolysis in             version
                Continuous Flow Blood
                Pumps
------------------------------------------------------------------------
48             ASTM F2129:04, Test      Withdrawn and              57
                Method for Conducting    replaced
                Cyclic Potentiodynamic   with newer
                Polarization             version
                Measurements to
                Determine the
                Corrosion
                Susceptibility of
                Small Implant Devices
------------------------------------------------------------------------
C. Dental/Ear, Nose, and Throat
------------------------------------------------------------------------
29             IEC 60601-2-18:2000      Withdrawn and             122
                Amendment 1, Medical     replaced
                Electrical Equipment--   with newer
                Part 2: Particular       version
                Requirements for the
                Safety of Endoscopic
                Equipment
------------------------------------------------------------------------
40             ANSI/ASA S3.6-2004,      Withdrawn and             123
                Specification for        replaced
                Audiometers              with newer
                                         version
------------------------------------------------------------------------
41             ANSI/ASA S3.22:2003,     Withdrawn and             124
                Specification of         replaced
                Hearing Aid              with newer
                Characteristics          version
------------------------------------------------------------------------
61             ISO 1562:2004,           Withdrawn and             125
                Dentistry--Casting       replaced
                gold alloys              with newer
                                         version
------------------------------------------------------------------------
82             ISO 10477:2004,          Withdrawn and             126
                Dentistry--Polymer-      replaced
                based crown and bridge   with newer
                materials                version
------------------------------------------------------------------------
D. General
------------------------------------------------------------------------
16             ASTM D903:1993, Test     Contact        .................
                Methods for Peel or      person
                Stripping Strength of
                Adhesive Bonds
------------------------------------------------------------------------
28             IEC 60601-1-2, (Second   Extent of      .................
                Edition), Medical        recognition
                Electrical Equipment--
                Part 1-2: General
                Requirements for
                Safety--Collateral
                Standard:
                Electromagnetic
                Compatibility--Require
                ments and Tests
------------------------------------------------------------------------
30             AAMI/IEC 60601-1-2,      Title and      .................
                Medical Electrical       extent of
                Equipment--Part 1-2:     recognition
                General Requirements
                for Safety--Collateral
                standard:
                Electromagnetic
                Compatibility--Require
                ments and Tests
                (Edition 2:2001)
------------------------------------------------------------------------
2              IEC 60601-1, Medical     Withdrawn      .................
                Electrical Equipment--
                Part 1: General
                Requirements for
                Safety
------------------------------------------------------------------------
4              IEC 60601-1, Medical     Contact        .................
                Electrical Equipment--   person,
                Part 1: General          devices
                Requirements for         affected and
                Safety, 1988;            extent of
                Amendment 1, l991-11,    recognition
                Amendment 2, 1995-03
------------------------------------------------------------------------
E. General Hospital/General Plastic Surgery
------------------------------------------------------------------------
18             ISO 8537:1991 Sterile    Contact        .................
                Single-Use Syringes,     person
                With or Without
                Needle, for Insulin
------------------------------------------------------------------------
38             ASTM F1671-03: Standard  Withdrawn and             130
                Test Method for          replaced
                Resistance of            with newer
                Materials Used in        version
                Protective Clothing to
                Penetration by Blood-
                Borne Pathogens Using
                Phi-X174 Bacteriophage
                Penetration as a Test
                System.
------------------------------------------------------------------------
48             ASTM D6499-03 Standard   Withdrawn and             131
                Test Method for the      replaced
                Immunological            with newer
                Measurement of           version
                Antigenic Protein in
                Natural Rubber and its
                Products
------------------------------------------------------------------------
31 Ophthalmic  ISO 11810-1:2005:        Transferred               132
89 Radiology    Lasers and Laser-        from
                Related Equipment--      Ophthalmic
                Test Method and          and
                Classification for the   Radiology
                Laser-Resistance of
                Surgical Drapes and/or
                Patient-Protective
                Covers--Part 1:
                Primary Ignition and
                Penetration
------------------------------------------------------------------------
97             USP 28: 2005             Withdrawn and             133
                Nonabsorbable Surgical   replaced
                Suture                   with newer
                                         version
------------------------------------------------------------------------

[[Page 67717]]

 
98             USP 28<11>: 2005         Withdrawn and             134
                Sterile Sodium           replaced
                Chloride for             with newer
                Irrigation               version
------------------------------------------------------------------------
99             USP 28: 2005 Absorbable  Withdrawn and             135
                Surgical Suture          replaced
                                         with newer
                                         version
------------------------------------------------------------------------
100            USP 28<881>: 2005        Withdrawn and             136
                Tensile Strength         replaced
                                         with newer
                                         version
------------------------------------------------------------------------
101            USP 28<861>: 2005        Withdrawn and             137
                Sutures--Diameter        replaced
                                         with newer
                                         version
------------------------------------------------------------------------
102            USP 28<871>: 2005        Withdrawn and             138
                Sutures Needle           replaced
                Attachment               with newer
                                         version
------------------------------------------------------------------------
103            USP 28<11>: 2005         Withdrawn and             139
                Sterile Water for        replaced
                Irrigation               with newer
                                         version
------------------------------------------------------------------------
104            USP 28<11>: 2005         Withdrawn and             140
                Heparin Lock Flush       replaced
                Solution                 with newer
                                         version
------------------------------------------------------------------------
105            USP 28<11>: 2005 Sodium  Withdrawn and             141
                Chloride Injection       replaced
                                         with newer
                                         version
------------------------------------------------------------------------
11             ISO 594-1:1986 Conical   Title and      .................
                Fittings With a 6%       contact
                (Luer) Taper for         person
                Syringes, Needles, and
                Certain Other Medical
                Equipment--Part 1:
                General Requirements
------------------------------------------------------------------------
13             ISO 595-1:1986 Reusable  Title and      .................
                All-Glass or Metal-and-  contact
                Glass Syringes for       person
                Medical Use--Part 1:
                Dimensions
------------------------------------------------------------------------
14             ISO 595-2:1987 Reusable  Title and      .................
                All-Glass or Metal-and-  contact
                Glass Syringes for       person
                Medical Use--Part 2:
                Design, Performance
                Requirements and Tests
------------------------------------------------------------------------
15             ISO 7864:1993 Sterile    Contact        .................
                Hypodermic Needles for   person
                Single Use
------------------------------------------------------------------------
16             ISO 7886-1:1993 Sterile  Title and      .................
                Hypodermic Syringes      contact
                for Single Use--Part     person
                1: Syringes for Manual
                Use
------------------------------------------------------------------------
62             ISO 8536-6:1995          Title and      .................
                Infusion Equipment for   contact
                Medical Use--Part 6:     person
                Freeze Drying Closures
                for Infusion Bottles
------------------------------------------------------------------------
63             ISO 8536-7-1999:         Contact        .................
                Infusion Equipment for   Person
                Medical Use--Part 7:
                Caps Made of Aluminum-
                Plastics Combinations
                for Infusion Bottles
------------------------------------------------------------------------
64             ISO 8536-3-1999:         Title and      .................
                Infusion Equipment for   contact
                Medical Use--Part 3:     person
                Aluminum Caps for
                Infusion Bottles
------------------------------------------------------------------------
66             ISO 8536-1-2000:         Title and      .................
                Infusion equipment for   Contact
                medical use--Part 1:     Person
                Infusion glass bottles
------------------------------------------------------------------------
68             ISO 7886-2-1996:         Title and                   ;
                Sterile Hypodermic       contact
                Syringes for Single      person
                Use--Part 2: Syringes
                for Use With Power-
                Driven Syringe Pumps
------------------------------------------------------------------------
69             ISO 9626-1991:           Title and      .................
                Stainless Steel Needle   contact
                Tubing for the           person
                Manufacture of Medical
                Devices
------------------------------------------------------------------------
70             ASTM E825-98 (2003)      Contact        .................
                Standard Specification   person
                for Phase Change-Type
                Disposable Fever
                Thermometer for
                Intermittent
                Determination of Human
                Temperature
------------------------------------------------------------------------
111            IEC 60601-2-38 Medical   Contact        .................
                Electrical Equipment--   person
                Part 2: Particular
                Requirements for the
                Safety of Electrically
                Operated Hospital Beds
------------------------------------------------------------------------
119            AAMI BF7: (R2002) Blood  Contact        .................
                Transfusion Micro-       person
                Filters
------------------------------------------------------------------------
120            ASTM F1054-01: Standard  Contact        .................
                Specification for        person
                Conical Fittings
------------------------------------------------------------------------

[[Page 67718]]

 
121            ISO 8536-2-2001:         Contact        .................
                Infusion Equipment for   person
                Medical Use--Part 2:
                Closures for Infusion
                Bottles
------------------------------------------------------------------------
122            ISO 8536-5-2004:         Title and      .................
                Infusion Equipment for   contact
                Medical Use--Part 5:     person
                Burette Infusion Sets
                for Single Use,
                Gravity Feed
------------------------------------------------------------------------
126            ISO 8536-4-2004:         Contact        .................
                Infusion Equipment for   person
                Medical Use--Part 4:
                Infusion Sets for
                Single Use, Gravity
                Feed
------------------------------------------------------------------------
127            ISO 1135-4-2004:         Contact        .................
                Transfusion Equipment    person
                for Medical Use--Part
                4: Transfusion Sets
                for Single Use
------------------------------------------------------------------------
129            ISO 594-2:1998 Conical   Contact        .................
                Fittings With a 6%       person
                (Luer) Taper for
                Syringes, Needles, and
                Certain Other Medical
                Equipment--Part 2:
                Lock Fittings
------------------------------------------------------------------------
F. In Vitro Diagnostic
------------------------------------------------------------------------
65             CLSI EP5-A2, Evaluation  Withdrawn and             110
                of Precision             replaced
                Performance of           with new
                Quantitative             version
                Measurement Methods;
                Approved Guideline--
                Second Edition
------------------------------------------------------------------------
54             CLSI D12-A2,             Product codes  .................
                Immunoprecipitin
                Analyses: Procedures
                for Evaluating the
                Performance of
                Materials--Second
                Edition; Approved
                Guideline
------------------------------------------------------------------------
G. Materials
------------------------------------------------------------------------
9              ASTM F563-00: Standard   Withdrawn      .................
                Specification for
                Wrought Cobalt-20
                Nickel-20 Chromium-3.5
                Molybdenum-3.5
                Tungsten-5 Iron Alloy
                for Surgical Implant
                Applications (UNS
                R30563)
------------------------------------------------------------------------
13             ASTM F648-04: Standard   Withdrawn and             106
                Specification for        replaced
                Ultra-High-Molecular-    with newer
                Weight Polyethylene      version
                Powder and Fabricated
                Form for Surgical
                Implants
------------------------------------------------------------------------
16             ASTM F746-04: Standard   Withdrawn and             107
                Test Method for          replaced
                Pitting or Crevice       with newer
                Corrosion of Metallic    version
                Surgical Implant
                Materials
------------------------------------------------------------------------
25             ASTM F1295-05: Standard  Withdrawn and             108
                Specification for        replaced
                Wrought Titanium-6       with newer
                Aluminum-7 Niobium       version
                Alloy for Surgical
                Implant Applications
                (UNS R56700)
------------------------------------------------------------------------
34             ASTM F1659-95: Standard  Withdrawn      .................
                Test Method for
                Bending and Shear
                Fatigue Testing of
                Calcium Phosphate
                Coatings on Solid
                Metallic Substrates
------------------------------------------------------------------------
72             ASTM F2213-04: Standard  Title          .................
                Test Method for
                Measurement of
                Magnetically Induced
                Torque on Passive
                Implants in the
                Magnetic Resonance
                Environment
------------------------------------------------------------------------
73             ASTM F561-05, Practice   Withdrawn and             109
                for Retrieval and        replaced
                Analysis of Implanted    with newer
                Medical Devices, and     version
                Associated Tissues
------------------------------------------------------------------------
74             ASTM F1377-04: Standard  Withdrawn and             110
                Specification for        replaced
                Cobalt-28 Chromium-6     with newer
                Molybdenum Powder for    version
                Coating of Orthopedic
                Implants (UNS R30075)
------------------------------------------------------------------------
75             ASTM F1160-05: Standard  Withdrawn and             111
                Test Method for Shear    replaced
                and Bending Fatigue      with newer
                Testing of Calcium       version
                Phosphate and Metallic
                Medical and Composite
                Calcium Phosphate/
                Metallic Coatings
------------------------------------------------------------------------
80             ASTM F1088-04a:          Title          .................
                Standard Specification
                for Beta-Tricalcium
                Phosphate for Surgical
                Implantation
------------------------------------------------------------------------
83             ASTM F1044-05: Standard  Withdrawn and             112
                Test Method for Shear    replaced
                Testing of Calcium       with newer
                Phosphate Coatings and   version
                Metallic Coatings
------------------------------------------------------------------------
84             ASTM F1147-05: Standard  Withdrawn and             113
                Test Method for          replaced
                Tension Testing of       with newer
                Calcium Phosphate and    version
                Metal Coatings
------------------------------------------------------------------------

[[Page 67719]]

 
90             ASTM F2255-05: Standard  Withdrawn and             114
                Test Method for          replaced
                Strength Properties of   with newer
                Tissue Adhesives in      version
                Lap Shear by Tension
                Loading
------------------------------------------------------------------------
91             ASTM F2256-05: Standard  Withdrawn and             115
                Test Method for          replaced
                Strength Properties of   with newer
                Tissue Adhesives in T-   version
                Peel by Tension
                Loading
------------------------------------------------------------------------
92             ASTM F2258-05: Standard  Withdrawn and             116
                Test Method for          replaced
                Strength Properties of   with newer
                Tissue Adhesives in      version
                Tension
------------------------------------------------------------------------
93             ASTM F86-04: Standard    Withdrawn and             117
                Practice for Surface     replaced
                Preparation and          with newer
                Marking of Metallic      version
                Surgical Implants
------------------------------------------------------------------------
H. OB-GYN/Gastroenterology
------------------------------------------------------------------------
1              AAMI RD5:1992:           Withdrawn      .................
                Hemodialysis systems
------------------------------------------------------------------------
17             ASTM D3492-03: Standard  Withdrawn and              32
                Specification for        replaced
                Rubber Contraceptives    with newer
                (Male Condoms)           version
------------------------------------------------------------------------
24             ASTM F623-99e1:          Withdrawn and              33
                Standard Performance     replaced
                Specification for        with newer
                Foley Catheter           version
------------------------------------------------------------------------
26             ISO 4074:2002/           Withdrawn and              34
                Cor.1:2003(E): Natural   replaced
                Latex Rubber Condoms--   with newer
                Requirements and Test    version
                Methods, Technical
                Corrigendum 1
------------------------------------------------------------------------
27             ASTM D6324-99a           Withdrawn and              35
                (Reapproved 2004):       replaced
                Standard Test Methods    with newer
                for Male Condoms Made    version
                From Synthetic
                Materials
------------------------------------------------------------------------
I. Ophthalmic
------------------------------------------------------------------------
31             ISO 11810:2002, Optics   Withdrawn      .................
                and Optical              newer
                Instruments--Lasers      version
                and Laser-Related        recognized
                Equipment--Test Method   under
                for the Laser-           General
                Resistance of Surgical   Hospital/
                Drapes and/or Patient-   General
                Protective Covers        Plastic
                                         Surgery
------------------------------------------------------------------------
J. Orthopedic
------------------------------------------------------------------------
126            ASTM F366-04: Standard   Withdrawn and             180
                Specification for        replaced
                Fixation Pins and        with newer
                Wires                    version
------------------------------------------------------------------------
159            ASTM F1717-04: Standard  Withdrawn and             181
                Test Methods for         replaced
                Spinal Implant           with newer
                Constructs in a          version
                Vertebrectomy Model
------------------------------------------------------------------------
173            ASTM F1800-04: Standard  Withdrawn and             182
                Test Method for Cyclic   replaced
                Fatigue Testing of       with newer
                Metal Tibial Tray        version
                Components of Total
                Knee Joint
                Replacements
------------------------------------------------------------------------
K. Radiology
------------------------------------------------------------------------
1              ANSI PH 2.43-1982:       Contact        .................
                Method for               person
                Sensitometry/Medical X-
                Ray Screen-Film
------------------------------------------------------------------------
2              ANSI IT 1.48-1997        Title and      .................
                Photography (Films)--    contact
                Medical Hard Copy        person
                Imaging Film-
                Dimensions and
                Specifications
------------------------------------------------------------------------
5              ANSI PH 2.50-1983:       Contact        .................
                Method/Sensitometry      person
                Direct Exposure
                Medical/Dental
------------------------------------------------------------------------
6              IEC 60806 (R1984)        Title and      .................
                Determination of the     contact
                Maximum Symmetrical      person
                Radiation Field From a
                Rotating Anode X-ray
                Tube for Medical
                Diagnosis
------------------------------------------------------------------------
8              IEC 60336 (R1993)        Title          .................
                Medical Electrical
                Equipment--X-ray Tube
                Assemblies for Medical
                Diagnosis--Characteris
                tics of Focal Spots
------------------------------------------------------------------------
23             NEMA XR 10-1986 (R2003)  Reaffirmation  .................
                Measurement of the
                Maximum Symmetrical
                Radiation Field from a
                Rotating Anode X-Ray
                Tube Used for Medical
                Diagnosis
------------------------------------------------------------------------

[[Page 67720]]

 
34             IEC 60601-2-7-1998       Tile and       .................
                Medical Electrical       contact
                Equipment--Part 2-7:     person
                Particular
                Requirements for the
                Safety of High-Voltage
                Generators of
                Diagnostic X-ray
                Generators
------------------------------------------------------------------------
37             IEC 60601-2-11-2004      133
                Amendment 1--Medical
                electrical equipment--
                Part 2-11: Particular
                requirements for the
                Safety of Gamma Beam
                Therapy Equipment
                Withdrawn and Replaced
                With Newer Version
------------------------------------------------------------------------
52             UL 544 (1998): Standard  Contact        .................
                for Medical and Dental   person
                Equipment--Ed. 4.0
------------------------------------------------------------------------
56             IEC 61674-1997 Medical   Withdrawn      .................
                Electrical Equipment--
                Dosimeters With
                Ionization Chambers
                and/or Semi-Conductor
                Detectors as Used in X-
                ray Diagnostic Imaging
------------------------------------------------------------------------
57             IEC 60731-1997 Medical   Title and      .................
                Electrical Equipment--   devices
                Dosimeters With          affected
                Ionization Chambers as
                Used in Radiotherapy
------------------------------------------------------------------------
61             UL 122 (1999): Standard  Contact        .................
                for Photographic         person
                Equipment--Ed. 4.0
------------------------------------------------------------------------
62             UL 187 (1998): Standard  Contact        .................
                for X-Ray Equipment--    person
                Ed. 7.0
------------------------------------------------------------------------
79             NEMA XR 7-1995 (R2000)   Title and      .................
                High-Voltage X-Ray       contact
                Cable Assemblies and     person
                Receptacles
------------------------------------------------------------------------
80             NEMA XR 9-1984 (R1994,   Contact        .................
                R2000) Power Supply      person
                Guidelines for X-Ray
                Machines
------------------------------------------------------------------------
81             NEMA XR 13-1990 (R1995,  Contact        .................
                R2000) Mechanical        person
                Safety Standard for
                Power Driven Motions
                of Electromedical
                Equipment
------------------------------------------------------------------------
82             NEMA XR 14-1990 (R1995,  Contact        .................
                R2000) Recommended       Person
                Practices for Load
                Bearing Mechanical
                Assemblies Used in
                Diagnostic Imaging
------------------------------------------------------------------------
89             ISO 11810:2002 Optics    Withdrawn      .................
                and Optical              Newer
                Instruments--Lasers      version
                and Laser-Related        recognized
                Equipment--Test Method   under
                for the Laser-           General
                Resistance of Surgical   Hospital/
                Drapes and/or Patient-   General
                Protective Covers        Plastic
                                         Surgery
------------------------------------------------------------------------
107            ISO 11146-1:2005 Lasers  Withdrawn and             134
                and Laser-Related        replaced
                Equipment--Test          with newer
                Methods for Laser Beam   version
                Widths, Divergence
                Angles and Beam
                Propagation Ratios--
                Part 1: Stigmatic and
                Simple Astigmatic
                Beams
------------------------------------------------------------------------
119            NEMA PS 3.1--3.18        Title          .................
                Digital Imaging and
                Communications in
                Medicine (DICOM) Set
------------------------------------------------------------------------
126            IEC 60601-2-28-1993      Title and      .................
                Medical Electrical       contact
                Equipment--Part 2:       person
                Particular
                Requirements for the
                Safety of X-ray Source
                Assemblies and X-ray
                Tube Assemblies for
                Medical Diagnosis--Ed.
                1.0
------------------------------------------------------------------------
127            IEC 60601-2-32-1994      Title and      .................
                Medical Electrical       contact
                Equipment--Part 2:       person
                Particular
                Requirements for the
                Safety of Associated
                Equipment of X-ray
                Equipment--Ed. 1.0
------------------------------------------------------------------------
129            NEMA NU 1-2001 (Errata   Title          .................
                2004): Performance
                Measurements of
                Scintillation Cameras
------------------------------------------------------------------------
131            IEC 61217-2002           Title          .................
                Radiotherapy
                Equipment--Coordinates
                Movements and Scales
                Consolidated Ed. 1.1
------------------------------------------------------------------------
132            IEC 60731-2002           Title and      .................
                Amendment 1--Medical     devices
                Electrical Equipment--   affected
                Dosimeters With
                Ionization Chambers as
                Used in Radiotherapy
------------------------------------------------------------------------
L. Sterility
------------------------------------------------------------------------
48             ANSI/AAMI ST40:2004,     Withdrawn and             152
                Table-Top Dry Heat       replaced
                (Heated Air)             with newer
                Sterilization and        version
                Sterility Assurance in
                Dental and Medical
                Facilities, 2ed
------------------------------------------------------------------------

[[Page 67721]]

 
52             ANSI/AAMI ST59:1999,     Title,         .................
                Sterilization of         relevant
                Health Care Products--   guidance,
                Biological Indicators    and contact
                Part 1: General          person
------------------------------------------------------------------------
70             ANSI/AAMI/ISO            Contact        .................
                14161:2000,              Person
                Sterilization of
                Health Care Products--
                Biological Indicators--
                Guidance for the
                Selection, Use, and
                Interpretation of
                Results, 2ed.
------------------------------------------------------------------------
71             ANSI/AAMI ST8:2001,      Contact        .................
                Hospital Steam           Person
                Sterilizers
------------------------------------------------------------------------
77             ANSI/AAMI ST24:1999,     Title and      .................
                Automatic, General       contact
                Purpose Ethylene Oxide   person
                Sterilizers and
                Ethylene Oxide
                Sterilant Sources
                Intended for Use in
                Health Care
                Facilities, 3ed.
------------------------------------------------------------------------
116            ANSI/AAMI ST72:2002,     Relevant       .................
                Bacterial Endotoxins--   guidance
                Test Methodologies,
                Routine Monitoring,
                and Alternatives to
                Batch Testing
------------------------------------------------------------------------
117            ANSI/AAMI ST35:2003,     Relevant       .................
                Safe Handling and        guidance and
                Biological               contact
                Decontamination of       person
                Medical Devices in
                Health Care Facilities
                and in Nonclinical
                Settings
------------------------------------------------------------------------
119            ANSI/AAMI ST55:2003,     Correct title  .................
                Table-Top Steam          and contact
                Sterilizers, 2ed.        person
------------------------------------------------------------------------
124            USP 28:2005, Biological  Withdrawn and             153
                Indicator for Dry Heat   replaced
                Sterilization, Paper     with newer
                Carrier                  version
------------------------------------------------------------------------
125            USP 28:2005, Biological  Withdrawn and             154
                Indicator for Ethylene   replaced
                Oxide Sterilization,     with newer
                Paper Carrier            version
------------------------------------------------------------------------
126            USP 28:2005, Biological  Withdrawn and             155
                Indicator for Steam      replaced
                Sterilization, Paper     with newer
                Carrier                  version
------------------------------------------------------------------------
127            USP28:2005, <61>         Withdrawn and             156
                Microbial Limits Test    replaced
                                         with newer
                                         version
------------------------------------------------------------------------
128            USP 28:2005, <71>,       Withdrawn and             157
                Microbiological Tests,   replaced
                Sterility Tests          with newer
                                         version
------------------------------------------------------------------------
129            USP28:2005, <85>,        Withdrawn and             158
                Biological Tests and     replaced
                Assays, Bacterial        with newer
                Endotoxin Test (LAL)     version
------------------------------------------------------------------------
130            USP28:2005 <151>,        Withdrawn and             159
                Pyrogen Test (USP        replaced
                Rabbit Test)             with newer
                                         version
------------------------------------------------------------------------
131            USP28:2005 <1211>,        Withdrawn                160
                Sterilization and        and replaced
                Sterility Assurance of   with newer
                Compendial Articles      version
------------------------------------------------------------------------
132            USP28:2005 <161>,        Withdrawn and             161
                Transfusion and          replaced
                Infusion Assemblies      with newer
                and Similar Medical      version
                Devices
------------------------------------------------------------------------
133            USP 28:2005, Biological  Withdrawn and             162
                Indicator for Steam      replaced
                Sterilization--Self-     with newer
                Contained                version
------------------------------------------------------------------------

III. Listing of New Entries

    The listing of new entries and consensus standards added as 
modifications to the list of recognized standards under Recognition 
List Number: 013, follows:

------------------------------------------------------------------------
   Item No.           Title of Standard          Reference No. and Date
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
65             Medical Electrical Equipment--   ISO 21647:2005
                Particular Requirements for
                the Basic Safety and Essential
                Performance of Respiratory Gas
                Monitors
------------------------------------------------------------------------
66             Medical Electrical Equipment--   ISO 9919:2005
                Particular Requirements for
                the Basic Safety and Essential
                Performance of Pulse Oximeter
                Equipment for Medical Use
------------------------------------------------------------------------

[[Page 67722]]

 
B. Dental/Ear, Nose, Throat
------------------------------------------------------------------------
127            Root Canal Files, Type H         ANSI/ADA Specification
                (Hedstrom)                       No. 58:2004
------------------------------------------------------------------------
128            Dentistry--Elastomeric           ISO/4823:2000 Technical
                Impression Materials             Corrigendum 1:2004
------------------------------------------------------------------------
129            Dentistry--Elastomeric           ANSI/ADA Specification
                Impression Materials             No. 19:2000 Technical
                                                 Corrigendum 1:2004
------------------------------------------------------------------------
C. General
------------------------------------------------------------------------
34             Medical Electrical Equipment--   IEC 60601-1-2:2004
                Part 1-2: General Requirements
                for Safety--Collateral
                Standard: Electromagnetic
                Compatibility--Requirements
                and tests (Edition 2:2001 with
                Amendment 1:2004; Edition 2.1
                (Edition 2:2001 Consolidated
                With Amendment 1:2004))
------------------------------------------------------------------------
35             Medical Electrical Equipment--   AAMI/IEC 60601-1-2:2001
                Part 1-2: General Requirements
                for Safety--Collateral
                standard: Electromagnetic
                Compatibility--Requirements
                and Tests (Edition 2:2001 with
                Amendment 1:2004)
------------------------------------------------------------------------
D. General Hospital/General Plastic Surgery
------------------------------------------------------------------------
142            Medical Electrical Equipment--   ANSI/AAMI II36:2004
                Part 2: Particular
                Requirements for Safety of
                Baby Incubators
------------------------------------------------------------------------
143            Medical Electrical Equipment--   ANSI/AAMI II51:2004
                Part 2: Particular
                Requirements for Safety of
                Transport Incubators
------------------------------------------------------------------------
E. In Vitro Diagnostic
------------------------------------------------------------------------
109            Laboratory Automation: Data      CLSI AUTO7-A:2004
                Content for Specimen
                Identification; Approved
                Standard
------------------------------------------------------------------------
111            Collection, Transport, and       CLSI H21-A4:2003
                Processing of Blood Specimens
                for Testing Plasma-Based
                Coagulation Assays; Approved
                Guideline--Fourth Edition
------------------------------------------------------------------------
112            Point-of-Care Monitoring of      CLSI H49-A:2004
                Anticoagulation Therapy;
                Approved Guideline
------------------------------------------------------------------------
113            Assessing the Quality of         CLSI I/LA23-A:2004
                Immunoassay Systems:
                Radioimmunoassays, and Enzyme,
                Fluorescence, and Luminescence
                Immunoassays; Approved
                Guideline
------------------------------------------------------------------------
114            Standard Specification for Low-  CLSI LIS01-A:2003
                Level Protocol to Transfer
                Messages Between Clinical
                Laboratory Instruments and
                Computer Systems
------------------------------------------------------------------------
115            Standard Specification for       CLSI LIS02-A2:2004
                Transferring Information
                Between Clinical Instruments
                and Computer Systems; Approved
                Standard--Second Edition
------------------------------------------------------------------------
116            Standard Guide for Selection of  CLSI LIS03-A:2003
                a Clinical Laboratory
                Information Management System
------------------------------------------------------------------------
117            Standard Guide for               CLSI LIS04-A:2003
                Documentation of Clinical
                Laboratory Computer Systems
------------------------------------------------------------------------
118            Standard Specification for       CLSI LIS05-A:2003
                Transferring Clinical
                Observations Between
                Independent Computer Systems
------------------------------------------------------------------------
119            Standard Practice for Reporting  CLSI LIS06-A:2003
                Reliability of Clinical
                Laboratory Information Systems
------------------------------------------------------------------------
120            Standard Specification for Use   CLSI LIS07-A:2003
                of Bar Codes on Specimen Tubes
                in the Clinical Laboratory
------------------------------------------------------------------------
121            Standard Guide for Functional    CLSI LIS08-A:2003
                Requirements of Clinical
                Laboratory Information
                Management Systems
------------------------------------------------------------------------
122            Standard Guide for Coordination  CLSI LIS09-A:2003
                of Clinical Laboratory
                Services Within the Electronic
                Health Record Environment and
                Networked Architectures
------------------------------------------------------------------------

[[Page 67723]]

 
123            Nucleic Acid Sequencing Methods  CLSI MM9-A:2004
                in Diagnostic Laboratory
                Medicine
------------------------------------------------------------------------
F. Materials
------------------------------------------------------------------------
118            Standard Practice for Marking    ASTM F2503-05
                Medical Devices and Other
                Items for Safety in the
                Magnetic Resonance Environment
------------------------------------------------------------------------
G. OB-GYN/Gastroenterology
------------------------------------------------------------------------
36             Mechanical contraceptives--      ISO 8009:2004(E)
                Reusable Natural and Silicone
                Rubber Contraceptive
                Diaphragms--Requirements and
                Tests
------------------------------------------------------------------------
H. Radiology
------------------------------------------------------------------------
135            Medical electrical equipment--   IEC 60601-2-5:2000
                Part 2-5: Particular
                Requirements for the Safety of
                Ultrasonic Physiotherapy
                Equipment Ed. 2.0
------------------------------------------------------------------------
I. Sterility
------------------------------------------------------------------------
163            Sterilization of Medical         ANSI/AAMI/ISO 11737-
                Devices--Microbiological         3:2004
                methods--Part 3: Guidance on
                Evaluation and Interpretation
                of Bioburden Data
------------------------------------------------------------------------
164            Sterilization of Medical         ANSI/AAMI ST81:2004
                Devices--Information To Be
                Provided by the Manufacturer
                for the Processing of
                Resterilizable Medical Devices
------------------------------------------------------------------------
165            Cleanrooms and Associated        ISO 14644-5:2004
                Controlled Environments--Part
                5: Operations
------------------------------------------------------------------------
166            Cleanrooms and Associated        ISO 14644-7:2004
                Controlled Environments--Part
                7: Separative Devices (Clean
                Air Hoods, Gloveboxes,
                Isolators and Mini-
                Environments)
------------------------------------------------------------------------
J. Tissue Engineering
------------------------------------------------------------------------
6              Standard Guide for Assessing     ASTM F2450-04
                Microstructure of Polymeric
                Scaffolds for Use in Tissue
                Engineered Medical Products
------------------------------------------------------------------------
7              Standard Guide for               ASTM F2315-03
                Immobilization or
                Encapsulation of Living Cells
                or Tissue in Alginate Gels
------------------------------------------------------------------------

IV. List of Recognized Standards

    FDA maintains the agency's current list of FDA recognized consensus 
standards in a searchable database that may be accessed directly at 
FDA's Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA will incorporate the modifications 
and minor revisions described in this notice into the database and, 
upon publication in the Federal Register, this recognition of consensus 
standards will be effective. FDA will announce additional modifications 
and minor revisions to the list of recognized consensus standards, as 
needed, in the Federal Register once a year, or more often, if 
necessary.

V. Recommendation of Standards for Recognition by FDA

    Any person may recommend consensus standards as candidates for 
recognition under the new provision of section 514 of the act by 
submitting such recommendations, with reasons for the recommendation, 
to the contact person (see FOR FURTHER INFORMATION CONTACT). To be 
properly considered such recommendations should contain, at a minimum, 
the following information: (1) Title of the standard, (2) any reference 
number and date, (3) name and address of the national or international 
standards development organization, (4) a proposed list of devices for 
which a declaration of conformity to this standard should routinely 
apply, and (5) a brief identification of the testing or performance or 
other characteristics of the device(s) that would be addressed by a 
declaration of conformity.

VI. Electronic Access

    In order to receive ``Guidance on the Recognition and Use of 
Consensus Standards'' on your FAX machine, call the Center for Devices 
and Radiological Health (CDRH) Facts-On-Demand system at 800-899-0381 
or 301-827-0111 from a touch-tone telephone. Press 1 to enter the 
system. At the second voice prompt press 1 to order a document. Enter 
the document number 321 followed by the pound sign. Follow the 
remaining voice prompts to complete your request.
    You may also obtain a copy of ``Guidance on the Recognition and Use 
of Consensus Standards'' by using the Internet. CDRH maintains a site 
on the Internet for easy access to information including text, 
graphics, and files that you may download to a personal computer with 
access to the Internet. Updated on a regular basis, the CDRH home page 
includes the guidance as well as the current list of recognized 
standards and other standards related documents. After publication in 
the Federal Register, this notice announcing ``Modifications to the 
List of Recognized Standards, Recognition List Number: 013'' will be 
available on the CDRH home page. You may access the CDRH home page at 
http://www.fda.gov/cdrh.
    You may access ``Guidance on the Recognition and Use of Consensus 
Standards,'' and the searchable database for ``FDA Recognized Consensus 
Standards'' through the hyperlink at http://www.fda.gov/cdrh/stdsprog.html.

[[Page 67724]]

    This Federal Register document on modifications in FDA's 
recognition of consensus standards is available at http://www.fda.gov/cdrh/fedregin.html.

VII. Submission of Comments and Effective Date

    Interested persons may submit to the contact person (see FOR 
FURTHER INFORMATION CONTACT) written or electronic comments regarding 
this document. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with the docket number found 
in brackets in the heading of this document. FDA will consider any 
comments received in determining whether to amend the current listing 
of modifications to the list of recognized standards, Recognition List 
Number: 013. These modifications to the list or recognized standards 
are effective upon publication of this notice in the Federal Register.

    Dated: October 10, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-22267 Filed 11-7-05; 8:45 am]
BILLING CODE 4160-01-S