[Federal Register Volume 72, Number 176 (Wednesday, September 12, 2007)]
[Notices]
[Pages 52142-52153]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-18021]


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

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: 018

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: 018'' (Recognition List Number: 018), will assist manufacturers 
who elect to declare conformity with consensus standards to meet 
certain requirements for medical devices.

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

ADDRESSES: Submit written requests for single copies of ``Modifications 
to the List of Recognized Standards, Recognition List Number: 018'' to 
the Division of Small Manufacturers,

[[Page 52143]]

International and Consumer Assistance, Center for Devices and 
Radiological Health (HFZ-220), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive 
labels to assist that office in processing your requests, or FAX your 
request to 301-443-8818. Submit written comments concerning this 
document, or recommendations for additional standards for recognition, 
to the contact person (see FOR FURTHER INFORMATION CONTACT). Submit 
electronic comments by e-mail: standards@cdrh.fda.hhs.gov. This 
document may also be accessed on FDA's Web 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: 018 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, 2098 
Gaither Rd., Rockville, MD 20850, 240-276-0533.

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 notice described 
how FDA would implement its standard recognition program and provided 
the initial list of recognized standards.
    Modifications to the initial list of recognized standards, as 
published in the Federal Register, are identified in table 1 of this 
document.

                                Table 1.
------------------------------------------------------------------------
                          Federal Register Cite
-------------------------------------------------------------------------
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)
------------------------------------------------------------------------
October 4, 2004 (69 FR 59240)
------------------------------------------------------------------------
May 27, 2005 (70 FR 30756)
------------------------------------------------------------------------
November 8, 2005 (70 FR 67713)
------------------------------------------------------------------------
March 31, 2006 (71 FR 16313)
------------------------------------------------------------------------
June 23, 2006 (71 FR 36121)
------------------------------------------------------------------------
November 3, 2006 (71 FR 64718)
------------------------------------------------------------------------
May 21, 2007 (72 FR 28500)
------------------------------------------------------------------------

    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: 018

    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: 018'' 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.
------------------------------------------------------------------------
  Old
  Item                Standard                   Change      Replacement
  No.                                                         Item No.
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
3        ASTM F1161-88, Standard             Withdrawn      ............
          Specification for Minimum
          Performance and Safety
          Requirements for Components and
          Systems of Anesthesia Gas
          Machines
------------------------------------------------------------------------
15       ISO 5361-4:1987, Tracheal Tubes--   Contact        ............
          Part 4: Cole Type                   person
------------------------------------------------------------------------
35       ISO 5361:1999, Anaesthetic and      Contact        ............
          Respiratory Equipment--Tracheal     person
          Tubes and Connectors
------------------------------------------------------------------------
36       ISO 5366-3:2001, Anaesthetic and    Contact        ............
          Respiratory Equipment--             person
          Tracheostomy Tubes--Part 3:
          Pediatric Tracheostomy Tubes
------------------------------------------------------------------------
42       ISO 5360:2006, Anaesthetic          Withdrawn and            74
          Vaporizers--Agent Specific          replaced
          Filling Systems                     with newer
                                              version
------------------------------------------------------------------------

[[Page 52144]]

 
43       ISO 5362:2006, Anaesthetic          Withdrawn and            75
          Reservoir Bags                      replaced
                                              with newer
                                              version
------------------------------------------------------------------------
44       ISO 5366-1:2000, Anaesthetic and    Contact        ............
          Respiratory Equipment--             person
          Tracheostomy Tubes--Part 1: Tubes
          and Connectors for Use in Adults
------------------------------------------------------------------------
46       ISO 5367:2000, Breathing Tubes      Contact        ............
          Intended for Use With Anaesthetic   person
          Apparatus and Ventilators
------------------------------------------------------------------------
50       ASTM F920-93(1999): Standard        Withdrawn      ............
          Specification for Minimum
          Performance and Safety
          Requirements for Resuscitators
          Intended for Use with Humans
------------------------------------------------------------------------
55       ASTM F1054-01: Standard             Withdrawn      ............
          Specification for Conical
          Fittings
------------------------------------------------------------------------
61       IEC 60601-2-13(2003-05), Medical    Contact        ............
          Electrical Equipment--Part 2-13:    person
          Particular Requirements for the
          Safety and Essential Performance
          of Anaesthetic Systems
------------------------------------------------------------------------
62       ISO 5356-1:2004, Anaesthetic and    Contact        ............
          Respiratory Equipment--Conical      person
          Connectors: Part 1: Cones and
          Sockets
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
21       AAMI / ANSI / ISO 10993-11:1993,    Contact        ............
          Biological Evaluation of Medical    person
          Devices--Part 11: Tests for
          Systemic Toxicity
------------------------------------------------------------------------
63       AAMI / ANSI / ISO 10993-6:1995/(R)  Contact        ............
          2001, Biological Evaluation of      person
          Medical Devices--Part 6: Test for
          Local Effects After Implantation
------------------------------------------------------------------------
64       AAMI / ANSI / ISO 10993-5:1999,     Contact        ............
          Biological Evaluation of Medical    person
          Devices--Part 5: Tests for In
          Vitro Cytotoxicity
------------------------------------------------------------------------
68       ASTM F719-81(2002)e1: Standard      Contact        ............
          Practice for Testing Biomaterials   person
          in Rabbits for Primary Skin
          Irritation
------------------------------------------------------------------------
70       ASTM F750-87 (2002)e1: Standard     Contact        ............
          Practice for Evaluating Material    person
          Extracts by Systemic Injection in
          the Mouse
------------------------------------------------------------------------
71       ASTM F1408-02e1: Standard Practice  Contact        ............
          for Subcutaneous Screening Test     person
          for Implant Materials
------------------------------------------------------------------------
83       ASTM E1262-88(2003): Standard       Contact        ............
          Guide for Performance of the        person
          Chinese Hamster Ovary Cell/
          Hypoxanthine Guanine
          Phosphoribosyl Transferase Gene
          Mutation Assay
------------------------------------------------------------------------
84       ASTM E1263-97(2003): Standard       Contact        ............
          Guide for Conduct of Micronucleus   person
          Assays in Mammalian Bone Marrow
          Erythrocytes
------------------------------------------------------------------------
85       ASTM E1280-97 (2003): Standard      Contact        ............
          Guide for Performing the Mouse      person
          Lymphoma Assay for Mammalian Cell
          Mutagenicity
------------------------------------------------------------------------
87       AAMI / ANSI / ISO 10993-10:2002,    Contact        ............
          Biological Evaluation of Medical    person
          Devices--Part 10: Tests for
          Irritation and Sensitization
------------------------------------------------------------------------
88       AAMI / ANSI / ISO 10993-12:         Contact        ............
          2002(E), Biological Evaluation of   person
          Medical Devices--Part 12: Sample
          Preparation and Reference
          materials
------------------------------------------------------------------------
89       ASTM F749-98 (2002)e2: Standard     Contact        ............
          Practice for Evaluating Material    person
          Extracts by Intracutaneous
          Injection in the Rabbit
------------------------------------------------------------------------
90       ASTM E1397-91(2003): Standard       Contact        ............
          Practice for the in vitro Rat       person
          Hepatocyte DNA Repair Assay
------------------------------------------------------------------------
91       ASTM E1398-91(2003): Standard       Contact        ............
          Practice for the in vivo Rat        person
          Hepatocyte DNA Repair Assay
------------------------------------------------------------------------
92       ASTM F748-04: Standard Practice     Contact        ............
          for Selecting Generic Biological    person
          Test Methods for Materials and
          Devices
------------------------------------------------------------------------
93       ASTM F763-04: Standard Practice     Contact        ............
          for Short-Term Screening of         person
          Implant Materials
------------------------------------------------------------------------

[[Page 52145]]

 
94       ASTM F981-04: Standard Practice     Contact        ............
          for Assessment of Compatibility     person
          of Biomaterials for Surgical
          Implants with Respect to Effect
          of Materials on Muscle and Bone
------------------------------------------------------------------------
97       ASTM F1983-99(2003): Standard       Contact        ............
          Practice for Assessment of          person
          Compatibility of Absorbable/
          Resorbable Biomaterials for
          Implant Applications
------------------------------------------------------------------------
98       AAMI / ANSI / ISO 10993-1:2003(E),  Contact        ............
          Biological evaluation of medical    person
          devices--Part 1: Evaluation and
          Testing
------------------------------------------------------------------------
99       ASTM F1904-98(2003): Standard       Contact        ............
          Practice for Testing the            person
          Biological Responses to Particles
          In Vivo
------------------------------------------------------------------------
100      ASTM E1372-95(2003): Standard Test  Contact        ............
          Method for Conducting a 90-Day      person
          Oral Toxicity Study in Rats
------------------------------------------------------------------------
106      ASTM F619-03: Standard Practice     Contact        ............
          for Extraction of Medical           person
          Plastics
------------------------------------------------------------------------
109      USP 29-NF21 Biological Tests <87>,  Contact        ............
          Biological Reactivity Test, In      person
          Vitro--Direct Contact Test
------------------------------------------------------------------------
110      USP 29-NF21 Biological Tests <87>,  Contact        ............
          Biological Reactivity Test, In      person
          Vitro--Elution Test
------------------------------------------------------------------------
111      USP 29-NF21 Biological Tests <88>,  Contact        ............
          Biological Reactivity Tests, In     person
          Vivo, Procedure--Preparation of
          Sample
------------------------------------------------------------------------
112      USP 29-NF21 Biological Tests <88>,  Contact        ............
          Biological Reactivity Test, In      person
          Vitro, Classification of
          Plastics--Intracutaneous Test
------------------------------------------------------------------------
113      USP 29-NF21 Biological Tests <88>,  Contact        ............
          Biological Reactivity Tests, In     person
          Vivo, Classification of Plastics--
          Systemic Injection Test
------------------------------------------------------------------------
114      ASTM F1877-05: Standard Practice    Contact        ............
          for Characterization of Particles   person
------------------------------------------------------------------------
115      ASTM F895-84(2006): Standard Test   Contact        ............
          Method for Agar Diffusion cell      person
          Culture Screening for
          Cytotoxicity
------------------------------------------------------------------------
116      ASTM F1439-03: Standard Guide for   Contact        ............
          Performance of Lifetime Bioassay    person
          for the Tumorigenic Potential of
          Implant Materials
------------------------------------------------------------------------
C. General
------------------------------------------------------------------------
2        IEC 60601-1, Medical electrical     Withdrawn      ............
          equipment -- Part 1: General
          requirements for safety
------------------------------------------------------------------------
11       ISO 2859-1:1999: Sampling           Withdrawn and            37
          Procedures for Inspection By        replaced
          Attributes--Part 1: Sampling        with newer
          Schemes Indexed by Acceptance       year version
          Quality Limit (AQL)for Lot-by-Lot
          Inspection
------------------------------------------------------------------------
14       ANSI/ASQ Z1.4-2003: Sampling        Withdrawn and            38
          Procedures and Tables for           replaced
          Inspection by Attributes            with newer
                                              year version
------------------------------------------------------------------------
22       ISO 2768-1: 1989, General           Contact name   ............
          Tolerances--Part 1: Tolerances
          for Linear and Angular Dimensions
          Without Individual Tolerance
          Indications
------------------------------------------------------------------------
23       ISO 2768-2: 1989, General           Contact name   ............
          Tolerances--Part 2: Geometrical
          Tolerances for Features Without
          Individual Tolerance Indications
------------------------------------------------------------------------
24       IEC 60812, edition 2.0: 2006-01,    Withdrawn and            39
          Analysis Technique for System       replaced
          Reliability--Procedure for          with newer
          Failure Mode and Effects Analysis   year version
------------------------------------------------------------------------
26       ISO 14971:2007: Medical devices--   Withdrawn and            40
          Application of Risk Management to   replaced
          Medical Devices                     with newer
                                              year version
------------------------------------------------------------------------
28       IEC 60601-1-2, (Second Edition,     Extent of      ............
          2001), Medical Electrical           recognition
          Equipment--Part 1-2: General
          Requirements for Safety;
          Electromagnetic Compatibility--
          Requirements and Tests
------------------------------------------------------------------------

[[Page 52146]]

 
30       AAMI/ANSI/IEC 60601-1-2, Medical    Title change   ............
          Electrical Equipment--Part 1-2:    Type of
          General Requirements for Safety--   standard
          Collateral Standard:                Extent of
          Electromagnetic Compatibility--     recognition
          Requirements and Tests. (The 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.)
------------------------------------------------------------------------
34       IEC 60601-1-2, Medical Electrical   Extent of      ............
          Equipment--Part 1-2: General        recognition
          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       AAMI/ANSI/IEC 60601-1-2, Medical    Extent of      ............
          Electrical Equipment--Part 1-2:     recognition
          General Requirements for Safety--
          Collateral Standard:
          Electromagnetic Compatibility--
          Requirements and Tests (Edition
          2:2001 with Amendment 1:2004)
          (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.)
------------------------------------------------------------------------
D. General Hospital/ General Plastic Surgery
------------------------------------------------------------------------
18       ISO 8537:1991 Sterile Single-use    Withdrawn      ............
          Syringes, With or Without Needle,   duplicate
          for Insulin
------------------------------------------------------------------------
20       ISO 10555-1-1995 Sterile, Single-   Withdrawn      ............
          use Intravascular Catheters--Part   duplicate
          1: General Requirements
------------------------------------------------------------------------
46       IEC 60601-2-2 2006 Medical          Withdrawn and           197
          Electrical Equipment--Part 2-2:     replaced
          Particular Requirements for the     with newer
          Safety of High Frequency Surgical   version
          Equipment
------------------------------------------------------------------------
69       ISO 9626-1991: Stainless Steel      Withdrawn      ............
          Needle Tubing for the Manufacture   duplicate
          of Medical Devices
------------------------------------------------------------------------
72       ISO 10555-5 1996-06-15 Sterile,     Withdrawn      ............
          Single-use Intravascular            duplicate
          Catheters--Part 5: Over-needle
          Peripheral Catheters
------------------------------------------------------------------------
96       ASTM F2101-07 Standard Test Method  Withdrawn and           199
          for Evaluating the Bacterial        replaced
          Filtration Efficiency (BFE) of      with newer
          Medical Face Mask Materials,        version
          Using a Biological Aerosol of
          Staphylococcus Aureus
------------------------------------------------------------------------
113      ASTM F2100-07 Standard              Withdrawn and           198
          Specification for Performance of    replaced
          Materials Used in Medical Face      with newer
          Masks                               version
------------------------------------------------------------------------
108      ASTM F754-00 Standard               Transferred    ............
          Specification for Implantable       to materials
          Polytetrafluoroethylene (PTFE)
          Polymer Fabricated in Sheet, Tube
          and Rod Shapes
------------------------------------------------------------------------
109      ASTM F881-94(2006) Standard         Withdrawn and           185
          Specification for Silicone          replaced
          Elastomer Facial Implants           with newer
                                              version
------------------------------------------------------------------------
128      ASTM F1670-07 Standard Test Method  Withdrawn and           186
          for Resistance of Materials Used    replaced
          in Protective Clothing to           with newer
          Penetration by Synthetic Blood      version
------------------------------------------------------------------------
130      ASTM F1671-07 Standard Test Method  Withdrawn and           187
          for Resistance of Materials Used    replaced
          in Protective Clothing to           with newer
          Penetration by Blood-Borne          version
          Pathogens Using Phi-X174
          Bacteriophage Penetration as a
          Test System
------------------------------------------------------------------------
151      USP 30:2007 Nonabsorbable Surgical  Withdrawn and           188
          Suture                              replaced
                                              with newer
                                              version
------------------------------------------------------------------------
152      USP 30<11>: 2007 Sterile Sodium     Withdrawn and           189
          Chloride for Irrigation             replaced
                                              with newer
                                              version
------------------------------------------------------------------------
153      USP 30:2007 Absorbable Surgical     Withdrawn and           190
          Suture                              replaced
                                              with newer
                                              version
------------------------------------------------------------------------
154      USP 30<881>:2007 Tensile Strength   Withdrawn and           191
                                              replaced
                                              with newer
                                              version
------------------------------------------------------------------------
155      USP 30<861>:2007 Sutures--Diameter  Withdrawn and           192
                                              replaced
                                              with newer
                                              version
------------------------------------------------------------------------
156      USP 30<871>:2007 Sutures Needle     Withdrawn and           193
          Attachment                          replaced
                                              with newer
                                              version
------------------------------------------------------------------------

[[Page 52147]]

 
157      USP 30<11>: 2007 Sterile Water for  Withdrawn and           194
          Irrigation                          replaced
                                              with newer
                                              version
------------------------------------------------------------------------
158      USP 30<11>: 2007 Heparin Lock       Withdrawn and           195
          Flush Solution                      replaced
                                              with newer
                                              version
------------------------------------------------------------------------
159      USP 30<11>: 2007 Sodium Chloride    Withdrawn and           196
          Injection                           replaced
                                              with newer
                                              version
------------------------------------------------------------------------
181      ASTM F1862-07: Standard Test        Withdrawn and           184
          Method for Resistance of Medical    replaced
          Face Masks to Penetration by        with newer
          Synthetic Blood (Horizontal         version
          Projection of Fixed Volume at a
          Known Velocity)
------------------------------------------------------------------------
E. Materials
------------------------------------------------------------------------
2        ASTM F75-07: Standard               Withdrawn and           137
          Specification for Cobalt-28         replaced
          Chromium-6 Molybdenum Alloy         with newer
          Castings and Casting Alloy for      year version
          Surgical Implants (UNS R30075)
------------------------------------------------------------------------
15       ASTM F745-07: Standard              Withdrawn and           138
          Specification for 18 Chromium-      replaced
          12.5 Nickel-2.5 Molybdenum          with newer
          Stainless Steel for Cast and        year version
          Solution-Annealed Surgical
          Implant Applications
------------------------------------------------------------------------
26       ASTM F1314-07: Standard             Withdrawn and           139
          Specification for Wrought           replaced
          Nitrogen Strengthened 22            with newer
          Chromium--13 Nickel--5 Manganese--  year version
          2.5 Molybdenum Stainless Steel
          Alloy Bar and Wire for Surgical
          Implants (UNS S20910)
------------------------------------------------------------------------
37       ASTM F1813-06: Standard             Withdrawn and           140
          Specification for Wrought           replaced
          Titanium--12 Molybdenum--6          with newer
          Zirconium--2 Iron Alloy for         year version
          Surgical Implant (UNS R58120)
------------------------------------------------------------------------
43       ASTM F2146-07: Standard             Withdrawn and           141
          Specification for Wrought           replaced
          Titanium-3Aluminum-2.5Vanadium      with newer
          Alloy Seamless Tubing for           year version
          Surgical Implant Applications
          (UNS R56320)
------------------------------------------------------------------------
67       ISO 7153-1:1991/Amd. 1:1999,        Contact        ............
          Surgical Instruments--Metallic      person
          Materials--Part 1: Stainless
          Steel
------------------------------------------------------------------------
87       ASTM F1978-00(2007)e2: Standard     Withdrawn and           142
          Test Method for Measuring           replaced
          Abrasion Resistance of Metallic     with newer
          Thermal Spray Coatings by Using     year version
          the Taber Abraser
------------------------------------------------------------------------
89       ASTM F1873-98: Standard             Withdrawn      ............
          Specification for High-Purity
          Dense Yttria Tetragonal Zirconium
          Oxide Polycrystal (Y-TZP) for
          Surgical Implant Applications
------------------------------------------------------------------------
106      ASTM F648-07: Standard              Withdrawn and           143
          Specification for Ultra-High-       replaced
          Molecular-Weight Polyethylene       with newer
          Powder and Fabricated Form for      year version
          Surgical Implants
------------------------------------------------------------------------
128      ASTM F2213-06: Standard Test        Title          ............
          Method for Measurement of
          Magnetically Induced Torque on
          Medical Devices in the Magnetic
          Resonance Environment
------------------------------------------------------------------------
GH/GPS   ASTM F754-00: Standard              Transferred             144
 108      Specification for Implantable       from GH/GPS
          Polytetrafluoroethylene (PTFE)      to Materials
          Polymer Fabricated in Sheet,
          Tube, and Rod Shapes
------------------------------------------------------------------------
F. OB-GYN/Gastroenterology
------------------------------------------------------------------------
20       ISO 8600-3:1997 Amendment 1 2003,   Withdraw       ............
          Optics and Optical Instruments--    duplicate
          Medical Endoscopes and Endoscopic
          Accessories Part 3: Determination
          of Field of View and Direction of
          View of Endoscopes with Optics
------------------------------------------------------------------------
32       ASTM D3492-03 Standard              Extent of      ............
          Specification for Rubber            recognition,
          Contraceptives (Male Condoms)       processes
                                              impacted,
                                              relevant
                                              guidance
------------------------------------------------------------------------
33       ASTM F623-99(2006) Standard         Withdrawn and            44
          Performance Specification for       replaced
          Foley Catheter                      with newer
                                              version
------------------------------------------------------------------------
34       ISO 4074:2002/Cor.1:2003(E)         Extent of      ............
          Natural Latex Rubber Condoms--      recognition,
          Requirements and Test Methods,      relevant
          Technical Corrigendum 1             guidance
------------------------------------------------------------------------
G. Ophthalmic
------------------------------------------------------------------------
1        ISO 9338:1996 Optics and Optical    Withdrawn      ............
          Instruments--Contact Lenses--
          Determination of the Diameters
------------------------------------------------------------------------

[[Page 52148]]

 
2        ISO 9339-1:1996 Optics and Optical  Withdrawn      ............
          Instruments--Contact Lenses--
          Determination of the Thickness--
          Part 1: Rigid Contact Lenses
------------------------------------------------------------------------
4        ISO 9341:1996 Optics and Optical    Withdrawn      ............
          Instruments--Contact Lenses--
          Determination of Inclusions and
          Surface Imperfections for Rigid
          Contact Lenses
------------------------------------------------------------------------
7        ISO 9913-1:1996 Optics and Optical  Withdrawn      ............
          Instruments--Contact Lenses--Part
          1: Determination of Oxygen
          Permeability and Transmissibility
          with the FATT Method
------------------------------------------------------------------------
8        ISO 10338:1996 Optics and Optical   Withdrawn      ............
          Instruments--Contact Lenses--
          Determination of Curvature
------------------------------------------------------------------------
9        ISO 10339:1997 Ophthalmic Optics--  Withdrawn      ............
          Contact Lenses--Determination of
          Water Content of Hydrogel Lenses
------------------------------------------------------------------------
10       ISO 10340:1995 Optics and Optical   Withdrawn      ............
          Instruments--Contact Lenses--
          Method for Determining the
          Extractable Substances
------------------------------------------------------------------------
11       ISO 10344:1996 Optics and Optical   Withdrawn      ............
          Instruments--Contact Lenses--
          Saline Solution for Contact Lens
          Testing
------------------------------------------------------------------------
16       ISO 9913-2:2000 Optics and Optical  Withdrawn      ............
          Instruments--Contact Lenses--Part
          2: Determination of Oxygen
          Permeability and Transmissibility
          by the Coulometric Method
------------------------------------------------------------------------
17       ISO 10939:2007 Ophthalmic           Withdrawn and            35
          Instruments--Slit-lamp              replaced
          Microscopes                         with newer
                                              version
------------------------------------------------------------------------
19       ISO 11539:1999 Ophthalmic Optics--  Withdrawn      ............
          Contact Lenses--Classification of
          Contact Lenses and Contact Lens
          Materials
------------------------------------------------------------------------
22       ISO 11979-3:2006 Ophthalmic         Withdrawn and            36
          Implants--Intraocular Lenses--      replaced
          Part 3: Mechanical Properties and   with newer
          Test Methods                        version
------------------------------------------------------------------------
25       ISO 12865:2006 Ophthalmic           Withdrawn and            39
          Instruments--Retinoscopes           replaced
                                              with newer
                                              version
------------------------------------------------------------------------
27       ISO 11979-7:2006 Ophthalmic         Withdrawn and            41
          Implants--Intraocular Lenses--      replaced
          Part 7: Clinical Investigations     with newer
                                              version
------------------------------------------------------------------------
H. Orthopedic/ Physical Medicine
------------------------------------------------------------------------
121      ISO 7207-1:1994, Implants for       Withdrawn      ............
          Surgery--Components for Partial
          and Total Knee Joint Prostheses--
          Part 1: Classification,
          Definitions and Designation of
          Dimensions
------------------------------------------------------------------------
I. Radiology
------------------------------------------------------------------------
57 &     IEC 60731 (1997), (2002) Amendment  Withdrawn and           162
 132      1, Medical Electrical Equipment--   combine
          Dosimeters with Ionization
          Chambers as Used in Radiotherapy
------------------------------------------------------------------------
59       IEC 61168:1993, Radiotherapy        Contact        ............
          Simulators--Functional              person
          Performance Characteristics
------------------------------------------------------------------------
63       IEC 60601-2-43--Ed. 1.0, Medical    Contact        ............
          Electrical Equipment--Part 2-43:    person
          Particular Requirements for the
          Safety of X-ray Equipment for
          Interventional Procedures
------------------------------------------------------------------------
91       IEC 60601-2-8 (1997-08), Amendment  Withdrawn      ............
          1--Medical Electrical Equipment--   duplicate
          Part 2: Particular Requirements
          for the Safety of Therapeutic X-
          ray Equipment Operating in the
          Range of 10 kV to 1 MV
------------------------------------------------------------------------
103      ANSI / IESNA RP-27.3-1996,          Title          ............
          Recommended Practice for
          Photobiological Safety for Lamps--
          Risk Group Classification and
          Labeling
------------------------------------------------------------------------
130 &    IEC 60601-2-37 (2004), (2005)       Withdrawn and           164
 148      Amendment 2, Medical Electrical     combine
          Equipment--Part 2-37: Particular
          Requirements for the Safety of
          Ultrasonic Medical Diagnostic and
          Monitoring Equipment
------------------------------------------------------------------------
131      IEC 61217 2002:, Radiotherapy       Contact        ............
          Equipment--Coordinates,             person
          Movements, and Scales
          Consolidated Ed. 1.1
------------------------------------------------------------------------

[[Page 52149]]

 
133      IEC 60601-2-11 (1997), (2004)       Title          ............
          Amendment 1, Medical Electrical
          Equipment--Part 2-11: Particular
          Requirements for the Safety of
          gamma Beam Therapy Equipment
------------------------------------------------------------------------
145      IEC 61674 (1997), (2002) Amendment  Contact        ............
          1, Medical Electrical Equipment--   person
          Dosimeters with Ionization
          Chambers and/or Semi-conductor
          Detectors as Used in X-ray
          Diagnostic Imaging
------------------------------------------------------------------------
J. Sterility
------------------------------------------------------------------------
28       ANSI/AAMI/ISO 11737-1:2006,         Withdrawn and           227
          Sterilization of Medical Devices--  replaced
          Microbiological Methods--Part 1:    with newer
          Determination of a Population of    version
          Microorganisms on Products, 2nd
          ed.
------------------------------------------------------------------------
47       ANSI/AAMI ST37:1996, Flash          Withdrawn      ............
          Sterilization: Steam
          Sterilization of Patient Care
          Items for Immediate Use
------------------------------------------------------------------------
49       ANSI/AAMI ST41:1999/(R) 2005,       Reaffirmation  ............
          Ethylene Oxide Sterilization in
          Health Care Facilities: Safety
          and Effectiveness
------------------------------------------------------------------------
50       ANSI/AAMI ST42:1998, Steam          Withdrawn      ............
          Sterilization and Sterility
          Assurance Using Table-top
          Sterilizers in Office-based,
          Ambulatory-care Medical,
          Surgical, and Dental Facilities.
------------------------------------------------------------------------
52       ANSI/AAMI ST59:1999, Sterilization  Withdrawn      ............
          of Health Care Products--
          Biological Indicators--Part 1:
          General
------------------------------------------------------------------------
53       ANSI/AAMI ST66:1996, Sterilization  Contact        ............
          of Health Care Products--Chemical   person
          Indicators--Part 2: Indicators
          for Air Removal Test Sheets and
          Packs
------------------------------------------------------------------------
54       ANSI/AAMI/ISO 11737-2:1998,         Contact        ............
          Sterilization of Medical Devices--  person
          Microbiological Methods--Part 2:
          Tests of Sterility Performed in
          the Validation of a Sterilization
          Process
------------------------------------------------------------------------
60       ASTM F1327:1998, Standard           Contact        ............
          Terminology Relating to Barrier     person
          Materials for Medical Packaging
------------------------------------------------------------------------
63       ASTM F1886: 1998 (2004), Standard   Contact        ............
          Test Method for Determining         person
          Integrity of Seals for Medical
          Packaging by Visual Inspection
------------------------------------------------------------------------
64       ASTM F1929:1998 (2004), Standard    Contact        ............
          Test Method for Detecting Seal      person
          Leaks in Porous Medical Packaging
          by Dye Penetration
------------------------------------------------------------------------
72       ANSI/AAMI ST33:1996, Guidelines     Withdrawn      ............
          for the Selection and Use of
          Reusable Rigid Sterilization
          Container Systems for Ethylene
          Oxide Sterilization and Steam
          Sterilization in Health Care
          Facilities
------------------------------------------------------------------------
75       ANSI/AAMI/ISO 11137:1994,           Withdrawn      ............
          Sterilization of Health Care
          Products--Requirements for
          Validation and Routine Control--
          Radiation Sterilization and ANSI/
          AAMI/ISO 11137:1994 (Amendment
          1:2002)
------------------------------------------------------------------------
77       ANSI/AAMI ST24:1999/(R) 2005,       Reaffirmation  ............
          Automatic, General Purpose
          Ethylene Oxide Sterilizers and
          Ethylene Oxide Sterilant Sources
          Intended for use in Health Care
          Facilities, 3rd ed.
------------------------------------------------------------------------
86       ASTM F1980:2002, Standard Guide     Contact        ............
          for Accelerated Aging of Sterile    person
          Medical Device Packages
------------------------------------------------------------------------
88       ANSI/AAMI/ISO 14937:2000,           Extent of      ............
          Sterilization of Health Care        recognition
          Products--General Requirements
          for Characterization of a
          Sterilizing Agent and the
          Development, Validation, and
          Routine Control of a
          Sterilization Process for Medical
          Devices
------------------------------------------------------------------------
90       ASTM F2095-01, Standard Test        Contact        ............
          Methods for Pressure Decay Leak     person
          Test for Nonporous Flexible
          Packages With and Without
          Restraining Plates
------------------------------------------------------------------------
105      ANSI/AAMI ST46:2002, Steam          Withdrawn      ............
          Sterilization and Sterility
          Assurance in Health Care
          Facilities
------------------------------------------------------------------------
116      ANSI/AAMI ST72:2002, Bacterial      Contact        ............
          Endotoxins--Test Methodologies,     person
          Routine Monitoring, and
          Alternatives to Batch Testing
------------------------------------------------------------------------

[[Page 52150]]

 
117      ANSI/AAMI ST35:2003, Safe Handling  Extent of      ............
          and Biological Decontamination of   recognition
          Reusable Medical Devices in
          Health Care Facilities and in
          Nonclinical Settings
------------------------------------------------------------------------
120      ASTM D3078:2002, Standard Test      Contact        ............
          Method for Determination of Leaks   person
          in Flexible Packaging by Bubble
          Emission
------------------------------------------------------------------------
123      ASTM F2096-04, Standard Test        Contact        ............
          Method for Detecting Gross Leaks    person
          in Medical Packaging by Internal
          Pressurization (Bubble Test)
------------------------------------------------------------------------
134      ANSI/AAMI ST44:2002, Resistometers  Withdrawn      ............
          Used for Characterizing the
          Performance of Biological and
          Chemical Indicators
------------------------------------------------------------------------
135      ANSI/AAMI ST63:2002, Sterilization  Extent of      ............
          of Health Care Products--           recognition
          Requirements for the Development,
          Validation and Routine Control of
          an Industrial Sterilization
          Process for Medical Devices--Dry
          heat
------------------------------------------------------------------------
136      ANSI/AAMI ST67:2003, Sterilization  Contact        ............
          of Health Care Products--           person
          Requirements for Products Labeled
          `sterile'
------------------------------------------------------------------------
137      ANSI/AAMI/ISO TIR 11139:2006,       Withdrawn and           221
          Sterilization of Health Care        replaced
          Products--Vocabulary                with newer
                                              version
------------------------------------------------------------------------
144      ASTM F2203-02e1, Standard Test      Contact        ............
          Method for Linear Measurement       person
          Using Precision Steel Rule
------------------------------------------------------------------------
145      ASTM F2217-02, Standard Practice    Contact        ............
          for Coating/Adhesive Weight         person
          Determination
------------------------------------------------------------------------
146      ASTM F2227-02, Standard Test        Contact        ............
          Method of Leaks in Non-sealed and   person
          Empty Medical Packaging Trays by
          C02 Tracer Gas Method
------------------------------------------------------------------------
147      ASTM F2228-02, Standard Test        Contact        ............
          Method for Non-Destructive          person
          Detection of Leaks in Medical
          Packaging Which Incorporates
          Porous Barrier Material by C02
          Tracer Gas Method
------------------------------------------------------------------------
148      ASTM F2250-03, Standard Practice    Contact        ............
          for Evaluation of Chemical          person
          Resistance of Printed Inks and
          Coatings on Flexible Packaging
          Materials
------------------------------------------------------------------------
149      ASTM F2251-03e1, Standard Test      Contact        ............
          Method for Thickness Measurement    person
          of Flexible Packaging Material
------------------------------------------------------------------------
150      ASTM F2252-03, Standard Practice    Contact        ............
          for Evaluating Ink or Coating       person
          Adhesion to Flexible Packaging
          Materials Using Tape
------------------------------------------------------------------------
163      ANSI/AAMI/ISO 11737-3:2004,         Withdrawn      ............
          Sterilization of Medical Devices--
          Microbiological Methods--Part 3:
          Guidance on Evaluation and
          Interpretation of Bioburden Data
------------------------------------------------------------------------
167      ASTM F2097-05, Standard Guide for   Contact        ............
          Design and Evaluation of Primary    person
          Packaging for Medical Products
------------------------------------------------------------------------
168      ASTM F2338-05, Standard Test        Contact        ............
          Method for Nondestructive           person
          Detection of Leaks in Packages by
          Vacuum Decay Method
------------------------------------------------------------------------
169      ASTM F2391-05, Standard Test        Contact        ............
          Method for Measuring Package and    person
          Seal Integrity Using Helium as
          Tracer Gas
------------------------------------------------------------------------
170      ASTM F2475-05, Standard Guide for   Contact        ............
          Biocompatibility Evaluation of      person
          Medical Device Packaging
          Materials
------------------------------------------------------------------------
171      ANSI/AAMI/ISO 15882:2003, Chemical  Contact        ............
          Indicators--Guidance on the         person
          Selection, Use, and
          Interpretation of Results
------------------------------------------------------------------------
172      AOAC 6.2.01:2006, Official Method   Withdrawn and           211
          955.14, Testing Disinfectants       replaced
          Against Salmonella choleraesuis,    with newer
          Use-Dilution Method                 version
------------------------------------------------------------------------
173      AOAC 6.2.02:2006, Official Method   Withdrawn and           212
          991.47, Testing Disinfectants       replaced
          Against Salmonella choleraesuis,    with newer
          Hard Surface Carrier Test Method    version
------------------------------------------------------------------------
174      AOAC 6.2.03:2006, Official Method   Withdrawn and           213
          991.48, Testing Disinfectants       replaced
          Against Staphylococcus aureus,      with newer
          Hard Surface Carrier Test Method    version
------------------------------------------------------------------------

[[Page 52151]]

 
175      AOAC 6.2.04:2006, Official Method   Withdrawn and           214
          955.15, Testing Disinfectants       replaced
          Against Staphylococcus aureus,      with newer
          Use-Dilution Method                 version
------------------------------------------------------------------------
176      AOAC 6.2.05:2006, Official Method   Withdrawn and           215
          991.49, Testing Disinfectants       replaced
          Against Pseudomonas aeruginosa,     with newer
          Hard Surface Carrier Test Method    version
------------------------------------------------------------------------
177      AOAC 6.2.06:2006, Official Method   Withdrawn and           216
          964.02, Testing Disinfectants       replaced
          Against Pseudomonas aeruginosa,     with newer
          Use-Dilution Method                 version
------------------------------------------------------------------------
178      AOAC 6.3.02:2006, Official Method   Withdrawn and           217
          955.17, Fungicidal Activity of      replaced
          Disinfectants Using Trichophyton    with newer
          mentagrophytes                      version
------------------------------------------------------------------------
179      AOAC 6.3.05:2006, Official Method   Withdrawn and           218
          966.04, Sporicidal Activity of      replaced
          Disinfectants, Method I             with newer
                                              version
------------------------------------------------------------------------
180      AOAC 6.3.06:2006, Official Method   Withdrawn and           219
          965.12, Tuberculocidal Activity     replaced
          of Disinfectants                    with newer
                                              version
------------------------------------------------------------------------
181      ANSI/AAMI ST58:2005, Chemical       Title,         ............
          Sterilization and High-Level        Devices
          Disinfection in Health Care         affected and
          Facilities                          Relevant
                                              guidance
------------------------------------------------------------------------
182      USP 30:2007, Biological Indicator   Withdrawn and           202
          for Dry-Heat Sterilization, Paper   replaced
          Carrier                             with newer
                                              version
------------------------------------------------------------------------
183      USP 30:2007, Biological Indicator   Withdrawn and           203
          for Ethylene Oxide Sterilization,   replaced
          Paper Carrier                       with newer
                                              version
------------------------------------------------------------------------
184      USP 30:2007, Biological Indicator   Withdrawn and           204
          for Steam Sterilization, Paper      replaced
          Carrier                             with newer
                                              version
------------------------------------------------------------------------
185      USP 30:2007, <61> Microbial Limits  Withdrawn and           205
          Test                                replaced
                                              with newer
                                              version
------------------------------------------------------------------------
186      USP 30:2007, <71> Microbiological   Withdrawn and           206
          Tests, Sterility Tests              replaced
                                              with newer
                                              version
------------------------------------------------------------------------
187      USP 30:2007, <85> Biological Tests  Withdrawn and           207
          and Assays, Bacterial Endotoxin     replaced
          Test (LAL)                          with newer
                                              version
------------------------------------------------------------------------
188      USP 30:2007, <151> Pyrogen Test     Withdrawn and           208
          (USP Rabbit Test)                   replaced
                                              with newer
                                              version
------------------------------------------------------------------------
189      USP 30:2007, <161> Transfusion and  Withdrawn and           209
          Infusion Assemblies and Similar     replaced
          Medical Devices                     with newer
                                              version
------------------------------------------------------------------------
190      USP 30:2007, Biological Indicator   Withdrawn and           210
          for Steam Sterilization, Self-      replaced
          Contained                           with newer
                                              version
------------------------------------------------------------------------
193      ANSI/AAMI/ISO 11607-1:2006,         Contact        ............
          Packaging for Terminally            person
          Sterilized Medical Devices--Part
          1: Requirements for Materials,
          Sterile Barrier Systems and
          Packaging Systems, 3rd ed.
------------------------------------------------------------------------
194      ANSI/AAMI/ISO 11607-2:2006,         Contact        ............
          Packaging for Terminally            person
          Sterilized Medical Devices--Part
          2: Validation Requirements for
          Forming, Sealing and Assembly
          Processes, 1st ed.
------------------------------------------------------------------------
196      ASTM F1140-2005, Standard Test      Contact        ............
          Methods for Internal                person
          Pressurization Failure Resistance
          of Unrestrained Packages for
          Medical Applications
------------------------------------------------------------------------
197      ASTM F1608:2004, Standard Test      Contact        ............
          Method for Microbial Ranking of     person
          Porous Packaging Materials
          (Exposure Chamber Method)
------------------------------------------------------------------------
198      ASTM F2054-05, Standard Test        Contact        ............
          Method for Burst Testing of         person
          Flexible Package Seals Using
          Internal Air Pressurization
          Within Restraining Plates
------------------------------------------------------------------------
199      ASTM D4169-05, Standard Practice    Contact        ............
          for Performance Testing of          person
          Shipping Containers and Systems
------------------------------------------------------------------------
200      ASTM F88-2005, Standard Test        Contact        ............
          Method for Seal Strength of         person
          Flexible Barrier Materials
------------------------------------------------------------------------

[[Page 52152]]

 
K. Tissue Engineering
------------------------------------------------------------------------
3        ASTM F2212-02(2007)e1, Standard     Withdrawn and            11
          Guide for Characterization of       replaced
          Type I Collagen as Starting         with newer
          Material for Surgical Implants      version
          and Substrates for Tissue
          Engineered Medical Products
          (TEMPs)
------------------------------------------------------------------------

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: 018.

                                Table 3.
------------------------------------------------------------------------
                                                      Reference No. and
 Item No.              Title of Standard                     Date
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
72          Lung Ventilators for Medical Use--       ISO 10651-5:2006
             Particular Requirements for Basic
             Safety and Essential Performance--Part
             5: Gas-powered Emergency Resuscitators
------------------------------------------------------------------------
73          Lung Ventilators--Part 4: Particular     ISO 10651-4:2002
             Requirements for Operator Powered
             Resuscitators
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
117         Biological Evaluation of Medical         ANSI/AAMI/ISO 10993-
             Devices--Part 3: Tests for               3: 2003
             Genotoxicity, Carcinogenicity, and
             Reproductive Toxicity
------------------------------------------------------------------------
C. Dental/ ENT
------------------------------------------------------------------------
144         Dentistry-Mercury and Alloys for Dental  ISO 24234: 2004(E)
             Amalgam
------------------------------------------------------------------------
D. OB-GYN/Gastroenterology
------------------------------------------------------------------------
45          Standard Test Methods for Enteral        ASTM F2528-06
             Feeding Devices with a Retention
             Balloon
------------------------------------------------------------------------
E. Ophthalmic
------------------------------------------------------------------------
42          Ophthalmic Implants--Intraocular         ISO 11979-2:1999/
             lenses--Part 2: Optical Properties and   Corrigendum1:2003
             Test Methods
------------------------------------------------------------------------
43          Ophthalmic Optics--Contact Lenses and    ISO 11981:1999/
             Contact Lens Care Products--             Corrigendum1:2005
             Determination of Physical
             Compatibility of Contact Lens Care
             Products with Contact Lenses
------------------------------------------------------------------------
45          Ophthalmic Optics--Contact Lenses--Part  ISO 18369-2:2006
             2: Tolerances
------------------------------------------------------------------------
46          Ophthalmic Optics--Contact Lenses--Part  ISO 18369-3:2006
             3: Measurement Methods
------------------------------------------------------------------------
48          Ophthalmic Implants--Intraocular         ISO 11979-5:2006
             Lenses--Part 5: Biocompatibility
------------------------------------------------------------------------
49          Ophthalmic Implants--Intraocular         ISO 11979-9:2006
             Lenses--Part 9: Multifocal Intraocular
             Lenses
------------------------------------------------------------------------
50          Ophthalmic implants--Intraocular         ISO 11979-10:2006
             lenses--Part 10: Phakic Intraocular
             Lenses
------------------------------------------------------------------------
51          Ophthalmic Instruments--Fundamental      ISO 15004-2:2007
             Requirements and Test Methods Part 2:
             Light Hazard Protection
------------------------------------------------------------------------
F. Radiology
------------------------------------------------------------------------
165         ``Quality Control Manual'' Template for  NEMA XR 22-2006
             Manufacturers of Displays and
             Workstations Labeled for Final
             Interpretation in Full-field Digital
             Mammography
------------------------------------------------------------------------
166         ``Quality Control Manual'' Template for  NEMA XR 23-2006
             Manufacturers of Hardcopy Output
             Devices Labeled for Final
             Interpretation in Full-field Digital
             Mammography
------------------------------------------------------------------------
G. Sterility
------------------------------------------------------------------------
201         Containment Devices for Reusable         ANSI/AAMI ST77:2006
             Medical Device Sterilization
------------------------------------------------------------------------
220         Comprehensive Guide to Steam             ANSI/AAMI ST79:2006
             Sterilization and Sterility Assurance
             in Health Care Facilities
------------------------------------------------------------------------

[[Page 52153]]

 
222         Sterilization of Health Care Products--  ANSI/AAMI/ISO
             Biological and Chemical Indicators--     18472:2006
             Test Equipment
------------------------------------------------------------------------
223         Sterilization of Health Care Products--  ANSI/AAMI/ISO 11138-
             Biological Indicators--Part 1: General   1:2006
             Requirements
------------------------------------------------------------------------
224         Sterilization of Health Care Products--  ANSI/AAMI/ISO 11137-
             Radiation--Part 1: Requirements for      1:2006
             the Development, Validation and
             Routine Control of a Sterilization
             Process for Medical Devices
------------------------------------------------------------------------
225         Sterilization of Health Care Products--  ANSI/AAMI/ISO 11137-
             Radiation--Part 2: Establishing the      2:2006
             Sterilization Dose
------------------------------------------------------------------------
226         Sterilization of Health Care Products--  ANSI/AAMI/ISO 11137-
             Radiation--Part 3: Guidance on           3:2006
             Dosimetric Aspects
------------------------------------------------------------------------
H. Tissue Engineering
------------------------------------------------------------------------
9           Standard Guide for Classification of     ASTM F2311-06
             Therapeutic Skin Substitutes
------------------------------------------------------------------------
10          Standard Guide for in vivo Assessment    ASTM F2451-05
             of Implantable Devices Intended to
             Repair or Regenerate Articular
             Cartilage
------------------------------------------------------------------------

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 Web 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

    You may obtain a copy of ``Guidance on the Recognition and Use of 
Consensus Standards'' by using the Internet. The Center for Devices and 
Radiological Health (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 ``Modification to the List of Recognized Standards, 
Recognition List Number: 018'' 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.
    This Federal Register document on modifications in FDA's 
recognition of consensus standards is available at http://
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/cdrhnew.cfm.

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: 018. These modifications to the list or recognized standards 
are effective upon publication of this notice in the Federal Register.

    Dated: August 30, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-18021 Filed 9-11-07; 8:45 am]
BILLING CODE 4160-01-S