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 Department of Health and Human Services Food and Drug Administration [Docket No. 2004N-0226]
 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: 017” (Recognition List Number: 017), 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: 017” 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 240-276-3151. Submit written comments concerning this document, or recommendations for additional standards for recognition, to the contact person (see 
                        **FOR FURTHER INFORMATION CONTACT**
                        ). Submit electronic comments by e-mail: 
                        *standards@cdrh.fda.gov*. This document may also be accessed on FDA's Internet site at 
                        *http://www.accessdata.fda.gov/​scripts/​cdrh/​cfdocs/​cfTopic/​cdrhnew.cfm*. See section VI of this document for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 017 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 Road, Rockville, MD 20850, 240-276-0533. 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 “Guidance on the 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 CiteOctober 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)
 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: 017 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: 017 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.
                    ( print page 28501) **Table 2.**
Old Item No.
Standard
Change
Replacement Item No.A. Anesthesia19
ISO 8382:1988: Resuscitators Intended for Use With Humans
Withdrawn
7148
ASTM F1246-91(2005): Standard Specification for Electrically Powered Home Care Ventilators, Part 1—Positive-Pressure Ventilators and Ventilator Circuits
Withdrawn and replaced with newer version
70B. Biocompatibility57
ASTM F895-84(2006): Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
Withdrawn and replaced with newer version
11572
ASTM F1439-03: Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
Withdrawn and replaced with newer version
11686
AAMI/ANSI/ISO 10993-10:2002(E): Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Sensitization
Withdrawn—duplicate
8787
AAMI/ANSI/ISO 10993-10:2002: Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Delayed-type Hypersensitivity
Title99
ASTM F1904-98(2003): Standard Practice for Testing the Biological Responses to Particles In Vivo
TitleC. Dental/Ear, Nose, and Throat (ENT)60
ANSI/ADA Specification No. 96:2000: Dental Water-Based Cements
Withdrawn and replaced with newer version
14372
ISO 6877-2006: Dentistry—Root-canal Obturating Points
Withdrawn and replaced with newer version
13785
ANSI/ADA Specification No. 15:2000, Synthetic Polymer Teeth
Withdrawn and replaced with newer version
13891
ANSI/ADA Specification No. 80:2001, Dental Materials—Determination of Color Stability
Title114
ANSI/ADA Specification No. 48:2004, Visible Light Curing Units
Withdrawn and replaced with newer version
139D. General2
IEC 60601-1, Medical Electrical Equipment—Part 1:General Requirements for Safety
Contact Person11
ISO 2859/1995, Sampling Procedures and Tables for Inspection By Attributes
Contact Person12
ISO 10012/1993, Quality Assurance Requirements for Measuring Equipment Part 1: Metrological Confirmation System for Measuring Equipment
Contact Person14
ANSI Z1.4/1993, Inspection by Attributes
Contact Person15
ANSI Z1.9/1993, Inspection by Variables
Contact Person18
ASTM D-4332/1991, Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
Contact Person19
ASTM E-876/1995, Standard Practice for Use of Statistics in the Evaluation of Spectrometric Data
Contact Person20
ASTM F-1140/1988, Standard Test Method for Failure Resistance of Unrestrained and Nonrigid Packages for Medical Applications
Contact Person27
IEC 60601-1-1:2000, Medical Electrical Equipment—Part 1: General Requirement for Safety; Safety Requirements for Medical Electrical Systems
Contact Person( print page 28502)28
IEC 60601-1-2, (Second Edition, 2001), Medical Electrical Equipment—Part 1-2: General Requirements for Safety; Electromagnetic Compatibility—Requirements and Tests
Extent of Recognition29
AAMI/ANSI HE74-2001, Human Factors Design Process for Medical Devices
Contact Person31
ISO 15223, Medical Devices—Symbols to be Used With Medical Device Labels, Labeling and Information to be Supplied
Contact Person32
EN 980:1996+1:1999+A2:2001, Graphical Symbols for use in the Labeling of Medical Devices
Contact Person35
AAMI/ANSI/IEC 60601-1-2, Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral standard: Electromagnetic Compatibility—Requirements and Tests (Edition 2:2001 with Amendment 1:2004) (AAMI/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.)
Standard OrganizationsE. General Hospital/General Plastic Surgery114
ISO 11608-1:2000 Pen-injectors for Medical Use—Part 1: Pen-injectors—Requirements and Test Methods
Contact Person115
ISO 11608-2:2000 Pen-injectors for Medical Use—Part 2: Needles—Requirements and Test Methods
Contact Person116
ISO 11608-3:2000 Pen-injectors for Medical Use—Part 3: Finished Cartridges—Requirements and Test Methods
Contact Person66 and 162
ISO 8536-1:2006 Infusion Equipment for Medical Use—Part 1: Infusion Glass Bottles
Withdrawn and replaced with newer version
17253
ASTM D5151-99 (2006) Standard Test Method for Detection of Holes in Medical Gloves
Withdrawn and replaced with newer version
17577
ASTM F1862-05 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
Withdrawn and replaced with newer version
18180
ASTM E1112-00 (2006) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
Withdrawn and replaced with newer version
17784
ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves
Withdrawn and replaced with newer version
178161
ISO 10555-1:1995/ Amendment 1:1999, Amendment 2:2004 Sterile, Single-use Intravascular Catheters—Part 1: General Requirements
Title85
ASTM 5250-06 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
Withdrawn and replaced with newer version
183E. In Vitro Diagnostics91
CLSI EP7-A2, Interference Testing in Clinical Chemistry; Approved Guidelines—Second Edition
Withdrawn and replaced with newer version
127F. Materials1
ASTM F67-06: Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
Withdrawn and replaced with newer version
1292
ASTM F75-01: Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
Contact Person3
ASTM F90-01: Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)
Contact Person( print page 28503)10
ASTM F603-00: Standard Specification for High-Purity Dense Aluminum Oxide for Surgical Implant Application
Contact Person11
ASTM F620-06: Standard Specification for Alpha Plus Beta Titanium Alloy Forgings for Surgical Implants
Withdrawn and replaced with newer version
13015
ASTM F745-00: Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications
Contact Person26
ASTM F1314-01: Standard Specification for Wrought Nitrogen Strengthened 22 Chromium—13 Nickel—5 Manganese—2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)
Contact Person27
ASTM F1341-99: Standard Specification for Unalloyed Titanium Wire UNS R50250, UNS R50400, UNS R50550, UNS R50700, for Surgical Implant Applications
Withdrawn30
ASTM F1537-00: Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloy for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
Contact Person32
ASTM F1586-02: Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-10 Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675)
Contact Person37
ASTM F1813-01: Standard Specification for Wrought Titanium—12 Molybdenum—6 Zirconium—2 Iron Alloy for Surgical Implant (UNS R58120)
Contact Person41
ASTM F2066-01: Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)
Contact Person43
ASTM F2146-01: Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)
Contact Person44
ASTM F136-02a: Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
Contact Person45
ASTM F562-02: Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
Contact Person46
ASTM F621-02: Standard Specification for Stainless Steel Forgings for Surgical Implants
Contact Person47
ASTM F799-06: Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
Withdrawn and replaced with newer version
13148
ASTM F899-02: Standard Specification for Stainless Steel for Surgical Instruments
Contact Person49
ASTM F1058-02: Standard Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire and Strip for Surgical Implant Applications (UNS R30003 and UNS R30008)
Contact Person50
ASTM F1091-02: Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R30605)
Contact Person52
ASTM F1350-02: Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)
Contact Person53
ASTM F1472-02a: Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
Contact Person( print page 28504)54
ASTM F1580-01: Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants
Contact Person56
ISO 5832-1:1997: Implants for Surgery—Metallic materials—Part 1: Wrought Stainless Steel
Contact Person57
ISO 5832-2:1999: Implants for Surgery—Metallic Materials—Part 2: Unalloyed Titanium
Contact Person58
ISO 5832-3:1996: Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminium 4-Vanadium Alloy
Contact Person59
ISO 5832-4:1996: Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum Casting Alloy
Contact Person61
ISO 5832-6:1997: Implants for Surgery—Metallic Materials—Part 6: Wrought Cobalt-nickel-chromium-Molybdenum alloy
Contact Person62
ISO 5832-9:1992: Implants for Surgery—Metallic Materials—Part 9: Wrought High Nitrogen Stainless Steel
Contact Person63
ISO 5832-11:1994: Implants for Surgery—Metallic Materials—Part 11: Wrought Titanium 6-aluminium 7 niobium Alloy
Contact Person64
ISO 5832-12:1996: Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum Alloy
Contact Person66
ISO 6474:1994: Implants for Surgery—Ceramic Materials Based on High Purity Alumina
Contact Person68
ISO 13782:1996: Implants for Surgery—Metallic Materials—Unalloyed Tantalum for Surgical Implant Applications
Contact Person76
ASTM F138-03: Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
Contact Person77
ASTM F139-03: Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)
Contact Person79
ASTM F961-03: Standard Specification for Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants [UNS R30035]
Contact Person80
ASTM F1088-04ae1: Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
Withdrawn and replaced with newer version
13281
ASTM F1609-03: Standard Specification for Calcium Phosphate Coatings for Implantable Materials
Contact Person82
ASTM F1713-03: Standard Specification for Wrought Titanium-13 Niobium-13 Zirconium Alloy for Surgical Implant Applications
Contact Person85
ASTM F1854-01: Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
Contact Person86
ASTM F1926-03: Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Coatings
Contact Person87
ASTM F1978-00e1: Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser
Contact Person88
ASTM F2024-00: Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
Contact Person89
ASTM F1873-98: Standard Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant Applications
Contact Person( print page 28505)94
ASTM F601-03: Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
Contact Person95
ASTM F629-02: Standard Practice for Radiography of Cast Metallic Surgical Implants
Contact Person97
ASTM F2129-06: Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
Withdrawn and replaced with newer version
13398
ASTM F451-99ae1: Standard Specification for Acrylic Bone Cement
Contact Person102
ASTM F2082-06: Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery
Withdrawn and replaced with newer version
134103
ASTM F1801-97(2004): Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials
Contact Person and Type of Standard104
ASTM F1108-04: Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
Contact Person106
ASTM F648-04: Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
Contact Person107
ASTM F746-04: Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
Contact Person108
ASTM F1295-05: Standard Specification for Wrought Titanium-6 Aluminum-7 Niobium Alloy for Surgical Implant Applications (UNS R56700)
Contact Person110
ASTM F1377-04: Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)
Contact Person111
ASTM F1160-05: Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
Contact Person112
ASTM F1044-05: Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
Contact Person113
ASTM F1147-05: Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coatings
Contact Person114
ASTM F2255-05: Standard Test Method for Strength Properties of Tissue Adhesives in Lap Shear by Tension Loading
Contact Person115
ASTM F2256-05: Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading
Contact Person116
ASTM F2258-05: Standard Test Method for Strength Properties of Tissue Adhesives in Tension
Contact Person117
ASTM F86-04: Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
Contact Person119
ASTM F688-05: Standard Specification for Wrought Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)
Contact Person120
ASTM F560-05: Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
Contact Person121
ASTM F2005-05: Standard Terminology for Nickel-Titanium Shape Memory Alloys
Contact Person122
ASTM F2063-05: Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
Contact Person( print page 28506)123
ISO 5832-5:2005: Implants for Surgery—Metallic Materials—Part 5: Wrought Cobalt-chromium-tungsten-nickel Alloy
Contact Person125
ASTM F2004-05: Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
Contact Person126
ASTM F561-05a: Practice for Retrieval and Analysis of Implanted Medical Devices, and Associated Tissues
Contact Person127
ISO 5834-2:1998: Implants for Surgery—Ultra-High-Molecular-Weight Polyethylene—Part 2: Moulded Forms
Contact PersonG. OB-GYN/Gastroenterology35
ASTM D6324-05 Standard Test Methods for Male Condoms Made from Synthetic Materials
Withdrawn and replaced with newer version
41H. Ophthalmic3
ISO 9340:1996 Optics and Optical Instruments—Contact lenses—Determination of Strains for Rigid Contact Lenses
Withdrawn12
ISO 11980:1997 Ophthalmic Optics—Contact Lenses and Contact Lens Care Products—Guidance for Clinical Investigations
Contact Person13
ISO 10942:2006 Ophthalmic Instruments—Direct Ophthalmoscopes
Withdrawn and replaced with newer version
3715
ISO 9394:1998 Ophthalmic Optics—Contact Lenses and Contact Lens Care Products—Determination of Biocompatibility By Ocular Study Using Rabbit Eyes
Contact Person18
ISO 10943:2006 Ophthalmic Instruments—Indirect Ophthalmoscopes
Withdrawn and replaced with newer version
3820
ISO 11979-1:2006 Ophthalmic implants—Intraocular Lenses—Part 1: Vocabulary
Withdrawn and replaced with newer version
4023
ISO 11981:1999 Ophthalmic Optics—Contact Lenses And Contact Lens Care Products—Determination of Physical Compatibility of Contact Lens Care Products With Contact Lenses
Contact Person24
ISO 11986:1999 Ophthalmic Optics—Contact Lenses and Contact Lens Care Products—Guidelines for Determination of Preservative Uptake and Release
Contact Person34
ANSI Z80.20-2004 Ophthalmics—Contact Lenses—Standard Terminology, Tolerances, Measurements and Physicochemical Properties
Contact PersonI. Orthopedic/Physical Medicine73
ISO 5838-1:1995: Implants for Surgery—Skeletal Pins and Wires—Part 1: Material and Mechanical Requirements
Contact Person74
ISO 5838-2:1991: Implants for Surgery—Skeletal Pins and Wires—Part 2: Steinmann Skeletal Pins—Dimensions
Contact Person75
ISO 5838-3:1993: Implants for Surgery—Skeletal Pins and Wires—Part 3: Kirschner Skeletal Wires
Contact Person79
ISO 7206-8:1995: Implants for Surgery—Partial and Total Hip Joint Prostheses—Part 8: Endurance Performance of Stemmed Femoral Components With Application of Torsion
Contact Person80
ISO 8828:1988: Implants for Surgery—Guidance on Care and Handling of Orthopaedic Implants
Contact Person81
ISO 9583:1993: Implants for Surgery—Non-destructive Testing—Liquid Penetrant Inspection of Metallic Surgical Implants
Contact Person( print page 28507)82
ISO 9584:1993: Implants for Surgery—Non-destructive Testing—Radiographic Examination of Cast Metallic Surgical Implants
Contact Person83
ISO 13402:1995: Surgical and Dental Hand Instruments—Determination of Resistance Against Autoclaving, Corrosion and Thermal Exposure
Contact Person121
ISO 7207-1:1994: Implants for Surgery—Components for Partial and Total Knee Joint Prostheses—Part 1: Classification, Definitions and Designation of Dimensions
Contact Person155
ISO 7207-2:1998: Implants for Surgery—Components for Partial and Total Knee Joint Prostheses—Part 2: Articulating Surfaces Made of Metal, Ceramic and Plastics Materials
Contact Person163
ASTM F543-02e1, Standard Specification and Test Methods for Metallic Medical Bone Screws
Withdrawn and replaced with newer version
202166
ASTM F897-02: Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
Contact Person167
ASTM F1089-02: Standard Test Method for Corrosion of Surgical Instruments
Contact Person168
ASTM F1781-03: Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
Contact Person171
ASTM F1814-97a(2003): Standard Guide for Evaluating Modular Hip and Knee Joint Components
Contact Person172
ASTM F1798-97(2003): Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
Contact Person175
ASTM F1582-98(2003): Standard Terminology Relating to Spinal Implants
Contact Person177
ASTM F1264-03: Standard Specification and Test Methods for Intramedullary Fixation Devices
Contact Person178
ASTM F1440-92(2002): Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components Without Torsion
Contact Person179
ASTM F2068-03: Standard Specification for Femoral Prostheses—Metallic Implants
Contact Person180
ASTM F366-04: Standard Specification for Fixation Pins and Wires
Contact Person181
ASTM F1717-04: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
Contact Person182
ASTM F1800-04: Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
Contact Person183
ASTM F1875-98(2004): Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-bore and Cone Taper Interface
Contact Person185
ASTM F2267-04: Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression
Contact Person186
ASTM F2077-03: Test Methods for Intervertebral Body Fusion Devices
Contact Person187
ASTM F2193-02: Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
Contact Person188
ISO 14243-1:2002: Implants for Surgery—Wear of Total Knee-joint Prostheses—Part 1: Loading and Displacement Parameters for Wear-testing Machines with Load Control and Corresponding Environmental Conditions for Test
Contact Person( print page 28508)189
ISO 14243-2:2000: Implants for Surgery—Wear of Total Knee-joint Prostheses—Part 2: Methods of Measurement
Contact Person190
ISO 14243-3:2004: Implants for Surgery—Wear of Total Knee-joint Prostheses—Part 3: Loading and Displacement Parameters for Wear-Testing Machines with Displacement Control and Corresponding Environmental Conditions for Test
Contact Person191
ISO 14879-1:2000: Implants for Surgery—Total Knee-joint Prostheses—Part 1: Determination of Endurance Properties of Knee Tibial Trays
Contact Person192
ASTM F1223-05: Standard Test Method for Determination of Total Knee Replacement Constraint
Contact PersonJ. Radiology34
IEC 60601-2-7 (1998) Medical Electrical Equipment—Part 2-7: Particular Requirements for the Safety of High-Voltage Generators of Diagnostic X-ray Generators
Contact Person68
NEMA MS 4-2006 Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
Withdrawn and replaced with newer version
151101
ANSI / IESNA RP-27.1-05 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems—General Requirements
Withdrawn and replaced with newer version
153104
IEC 60601-2-33 (2006), Medical Electrical Equipment—Part 2-33: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis
Withdrawn and replaced with newer version
161111
ISO 11554:2006 Optics and Photonics—Lasers and Laser-Related equipment—Test Methods for Laser Beam Power, Energy and Temporal Characteristics
Withdrawn and replaced with newer version
155K. Software1
ISO/IEC 12207:1995 Information Technology—Software Life Cycle Processes
Withdrawn3
IEEE/EIA 12207.0-1996 Industry Implementation of International Standard ISO/IEC 12207:1995(ISO/IEC 12207) Standard for Information Technology—Software Life Cycle Processes
Withdrawn5
IEEE 1074-1997 Standard for Developing a Software Project Life Cycle Process
Withdrawn6
IEEE 1012-2004 Standard for Software Verification and Validation
Withdrawn7
AAMI / ANSI SW68:2001 Medical Device Software—Software Life Cycle Processes
WithdrawnL. Sterility67
ASTM F1140-2005, Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages for Medical Applications
Withdrawn and replaced with newer version
19668
ASTM F1585:2000, Standard Guide for Integrity Testing of Porous Barrier Medical Packages
Withdrawn69
ASTM F1608:2004, Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method
Withdrawn and replaced with newer version
19789
ASTM F2054-05, Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
Withdrawn and replaced with newer version
198121
ASTM D4169-05, Standard Practice for Performance Testing of Shipping Containers and Systems
Withdrawn and replaced with newer version
199122
ASTM F88-2006, Standard Test Method for Seal Strength of Flexible Barrier Materials
Withdrawn and replaced with newer version
200( print page 28509)M. Tissue Engineering1
ASTM F2064-00(2006): Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for use in Biomedical and Tissue-Engineered Medical Products Application
Withdrawn and replaced with newer version
8
 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: 017. **Table 3.**
Item No.
Title of Standard
Reference No. & DateA. Anesthesia71
Lung Ventilators for Medical use—Particular Requirements for Basic Safety and Essential Performance—Part 5: Gas-powered Emergency Resuscitators
ISO 10651-5:2006B. Cardiovascular/Neurology59
Implants for surgery—Cardiac Pacemakers—Part 3: Low-profile Connectors (IS-1) for Implantable Pacemakers
ISO 5841-3:2000C. Dental/ENT140
Dental Base Metal Casting Alloys—Part 2: Nickel-based Alloys
ISO 6871-2:1994/Amd 1:2005141
Dental Base Metal Casting Alloys—Part 1: Cobalt-based Alloys
ISO 6871-1:1994142
Dental Base Metal Casting Alloys—Part 1: Cobalt-based Alloys
ISO 6871-1:1994/Amd 1:2005D. General36
Technical Information Report: Medical Devices—Guidance on the Selection of Standards in Support of Recognized Essential Principles of Safety and Performance of Medical Devices, Second Edition
ANSI/AAMI/ISO TIR 16142:2006E. General Hospital/General Plastic Surgery170
Sterile hypodermic syringes for single use—Part 1: Syringes for Manual Use
ISO 7886-1:1993/ Corrigendum 1:1995171
Sterile, Single-use Intravascular Catheters- Part 3: Central Venous Catheters
ISO 10555-3:1996/ Corrigendum 1:2002173
Infusion Equipment for Medical Use—Part 2: Closures for Infusion Bottles
ISO 8536-2:2001/ Corrigendum 1:2003174
Pen-injectors for Medical Use—Part 4: Requirements and Test Methods for Electronic and Electromechanical Pen-injectors
ISO 11608-4:2006176
Standard Guide for Assessment of Medical Gloves
ASTM D7103-06179
Needle-free Injectors for Medical Use—Requirements and Test Methods
ISO 21649:2006180
Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
ASTM F2407-06182
Medical Electrical Equipment— Part 2-38: Particular Requirements for the Safety of Electrically Operated Hospital Beds
IEC 60601-2-38 1996/Amendment 1:1999F. In Vitro Diagnostic128
Evaluation of Matrix Effects; Approved Guideline—Second Edition
CLSI EP14-A2 2005129
Quality Control of Microbiological Transport Systems
CLSI M40-A 2003G. Materials135
Standard Test Method for Burst Strength of Surgical Sealants
ASTM F2392-04136
Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants
ASTM F2458-05( print page 28510)H. OB-GYN/Gastroenterology42
Medical electrical equipment—Part 2: Particular Requirements for the Safety of Endoscopic Equipment
IEC 60601-2-18 (1996) Amendment 1 200043
Rubber Condoms—Guidance on the Use of ISO 4074 in the Quality Management of Natural Rubber Latex Condoms
ISO 16038:2005I. Ophthalmic43
Ophthalmic Implants—Intraocular lenses—Part 8: Fundamental Requirements
ISO 11979-8:2006J. Radiology150
Information Technology—Digital Compression and Coding of Continuous-tone Still Images—Part 1: Requirements and Guidelines
IEC / ISO 10918-1:1994 Technical Corrigendum 1:2005152
Medical Electrical Equipment—Part 2-1: Particular Requirements for the Safety of Electron Accelerators in the Range 1 MeV to 50 MeV
IEC 60601-2-1 (1998-06), Amendment 1 2002154
Lasers and Laser-related Equipment—Determination of Laser-induced Damage Threshold of Optical Surfaces—Part 3: Assurance of Laser Power (energy) Handling Capabilities
ISO 11254-3:2006156
Lasers and Laser-related Equipment—Test Methods for Laser Beam Parameters—Beam Positional Stability
ISO 11670:2003 Technical Corrigendum 1:2004157
Optics and Optical Instruments—Lasers and Laser-related Equipment—Test Methods for Laser Beam Power (energy) Density Distribution
ISO 13694:2000 Technical Corrigendum 1:2005158
Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging
NEMA MS 10-2006159
Determination of Gradient-Induced Electric Fields In Diagnostic Magnetic Resonance Imaging
NEMA MS 11-2006160
Quantification and Mapping of Geometric Distortion for Special Applications
NEMA MS 12-2006
 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 You may obtain a copy of “Guidance on the Recognition and Use of Consensus Standards” by using the Internet. CDRH maintains a site on the Internet for easy access to information including text, graphics, and files that you may download to a personal computer with access to the Internet. Updated on a regular basis, the CDRH home page includes the guidance as well as the current list of recognized standards and other standards related documents. After publication in the 
                    **Federal Register**
                    , this notice announcing “Modifications to the List of Recognized Standards, Recognition List Number: 017” 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. Two copies of any mailed comments are to be submitted, except that individuals may submit one paper copy. Comments are to be identified 
                    ( print page 28511)
                    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: 017. These modifications to the list or recognized standards are effective upon publication of this notice in the 
                    **Federal Register**
                    . Dated: May 10, 2007. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health.


[FR Doc. E7-9718 Filed 5-18-07; 8:45 am] BILLING CODE 4160-01-S