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Notice

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 017

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

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.

Start Further Info

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.

End Further Info

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 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)

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.Start Printed Page 28501

Table 2.

Old Item No.StandardChangeReplacement Item No.
A. Anesthesia
19ISO 8382:1988: Resuscitators Intended for Use With HumansWithdrawn71
48ASTM F1246-91(2005): Standard Specification for Electrically Powered Home Care Ventilators, Part 1—Positive-Pressure Ventilators and Ventilator CircuitsWithdrawn and replaced with newer version70
B. Biocompatibility
57ASTM F895-84(2006): Standard Test Method for Agar Diffusion Cell Culture Screening for CytotoxicityWithdrawn and replaced with newer version115
72ASTM F1439-03: Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant MaterialsWithdrawn and replaced with newer version116
86AAMI/ANSI/ISO 10993-10:2002(E): Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and SensitizationWithdrawn—duplicate87
87AAMI/ANSI/ISO 10993-10:2002: Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Delayed-type HypersensitivityTitle
99ASTM F1904-98(2003): Standard Practice for Testing the Biological Responses to Particles In VivoTitle
C. Dental/Ear, Nose, and Throat (ENT)
60ANSI/ADA Specification No. 96:2000: Dental Water-Based CementsWithdrawn and replaced with newer version143
72ISO 6877-2006: Dentistry—Root-canal Obturating PointsWithdrawn and replaced with newer version137
85ANSI/ADA Specification No. 15:2000, Synthetic Polymer TeethWithdrawn and replaced with newer version138
91ANSI/ADA Specification No. 80:2001, Dental Materials—Determination of Color StabilityTitle
114ANSI/ADA Specification No. 48:2004, Visible Light Curing UnitsWithdrawn and replaced with newer version139
D. General
2IEC 60601-1, Medical Electrical Equipment—Part 1:General Requirements for SafetyContact Person
11ISO 2859/1995, Sampling Procedures and Tables for Inspection By AttributesContact Person
12ISO 10012/1993, Quality Assurance Requirements for Measuring Equipment Part 1: Metrological Confirmation System for Measuring EquipmentContact Person
14ANSI Z1.4/1993, Inspection by AttributesContact Person
15ANSI Z1.9/1993, Inspection by VariablesContact Person
18ASTM D-4332/1991, Standard Practice for Conditioning Containers, Packages, or Packaging Components for TestingContact Person
19ASTM E-876/1995, Standard Practice for Use of Statistics in the Evaluation of Spectrometric DataContact Person
20ASTM F-1140/1988, Standard Test Method for Failure Resistance of Unrestrained and Nonrigid Packages for Medical ApplicationsContact Person
27IEC 60601-1-1:2000, Medical Electrical Equipment—Part 1: General Requirement for Safety; Safety Requirements for Medical Electrical SystemsContact Person
Start Printed Page 28502
28IEC 60601-1-2, (Second Edition, 2001), Medical Electrical Equipment—Part 1-2: General Requirements for Safety; Electromagnetic Compatibility—Requirements and TestsExtent of Recognition
29AAMI/ANSI HE74-2001, Human Factors Design Process for Medical DevicesContact Person
31ISO 15223, Medical Devices—Symbols to be Used With Medical Device Labels, Labeling and Information to be SuppliedContact Person
32EN 980:1996+1:1999+A2:2001, Graphical Symbols for use in the Labeling of Medical DevicesContact Person
35AAMI/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 Organizations
E. General Hospital/General Plastic Surgery
114ISO 11608-1:2000 Pen-injectors for Medical Use—Part 1: Pen-injectors—Requirements and Test MethodsContact Person
115ISO 11608-2:2000 Pen-injectors for Medical Use—Part 2: Needles—Requirements and Test MethodsContact Person
116ISO 11608-3:2000 Pen-injectors for Medical Use—Part 3: Finished Cartridges—Requirements and Test MethodsContact Person
66 and 162ISO 8536-1:2006 Infusion Equipment for Medical Use—Part 1: Infusion Glass BottlesWithdrawn and replaced with newer version172
53ASTM D5151-99 (2006) Standard Test Method for Detection of Holes in Medical GlovesWithdrawn and replaced with newer version175
77ASTM 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 version181
80ASTM E1112-00 (2006) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient TemperatureWithdrawn and replaced with newer version177
84ASTM D6124-06 Standard Test Method for Residual Powder on Medical GlovesWithdrawn and replaced with newer version178
161ISO 10555-1:1995/ Amendment 1:1999, Amendment 2:2004 Sterile, Single-use Intravascular Catheters—Part 1: General RequirementsTitle
85ASTM 5250-06 Standard Specification for Poly(vinyl chloride) Gloves for Medical ApplicationWithdrawn and replaced with newer version183
E. In Vitro Diagnostics
91CLSI EP7-A2, Interference Testing in Clinical Chemistry; Approved Guidelines—Second EditionWithdrawn and replaced with newer version127
F. Materials
1ASTM F67-06: Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)Withdrawn and replaced with newer version129
2ASTM F75-01: Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)Contact Person
3ASTM F90-01: Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)Contact Person
Start Printed Page 28503
10ASTM F603-00: Standard Specification for High-Purity Dense Aluminum Oxide for Surgical Implant ApplicationContact Person
11ASTM F620-06: Standard Specification for Alpha Plus Beta Titanium Alloy Forgings for Surgical ImplantsWithdrawn and replaced with newer version130
15ASTM F745-00: Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant ApplicationsContact Person
26ASTM 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 Person
27ASTM F1341-99: Standard Specification for Unalloyed Titanium Wire UNS R50250, UNS R50400, UNS R50550, UNS R50700, for Surgical Implant ApplicationsWithdrawn
30ASTM F1537-00: Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloy for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)Contact Person
32ASTM 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 Person
37ASTM F1813-01: Standard Specification for Wrought Titanium—12 Molybdenum—6 Zirconium—2 Iron Alloy for Surgical Implant (UNS R58120)Contact Person
41ASTM F2066-01: Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)Contact Person
43ASTM F2146-01: Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)Contact Person
44ASTM F136-02a: Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)Contact Person
45ASTM F562-02: Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)Contact Person
46ASTM F621-02: Standard Specification for Stainless Steel Forgings for Surgical ImplantsContact Person
47ASTM F799-06: Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)Withdrawn and replaced with newer version131
48ASTM F899-02: Standard Specification for Stainless Steel for Surgical InstrumentsContact Person
49ASTM 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 Person
50ASTM F1091-02: Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R30605)Contact Person
52ASTM F1350-02: Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)Contact Person
53ASTM F1472-02a: Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy for Surgical Implant Applications (UNS R56400)Contact Person
Start Printed Page 28504
54ASTM F1580-01: Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical ImplantsContact Person
56ISO 5832-1:1997: Implants for Surgery—Metallic materials—Part 1: Wrought Stainless SteelContact Person
57ISO 5832-2:1999: Implants for Surgery—Metallic Materials—Part 2: Unalloyed TitaniumContact Person
58ISO 5832-3:1996: Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminium 4-Vanadium AlloyContact Person
59ISO 5832-4:1996: Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum Casting AlloyContact Person
61ISO 5832-6:1997: Implants for Surgery—Metallic Materials—Part 6: Wrought Cobalt-nickel-chromium-Molybdenum alloyContact Person
62ISO 5832-9:1992: Implants for Surgery—Metallic Materials—Part 9: Wrought High Nitrogen Stainless SteelContact Person
63ISO 5832-11:1994: Implants for Surgery—Metallic Materials—Part 11: Wrought Titanium 6-aluminium 7 niobium AlloyContact Person
64ISO 5832-12:1996: Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum AlloyContact Person
66ISO 6474:1994: Implants for Surgery—Ceramic Materials Based on High Purity AluminaContact Person
68ISO 13782:1996: Implants for Surgery—Metallic Materials—Unalloyed Tantalum for Surgical Implant ApplicationsContact Person
76ASTM F138-03: Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)Contact Person
77ASTM F139-03: Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)Contact Person
79ASTM F961-03: Standard Specification for Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants [UNS R30035]Contact Person
80ASTM F1088-04ae1: Standard Specification for Beta-Tricalcium Phosphate for Surgical ImplantationWithdrawn and replaced with newer version132
81ASTM F1609-03: Standard Specification for Calcium Phosphate Coatings for Implantable MaterialsContact Person
82ASTM F1713-03: Standard Specification for Wrought Titanium-13 Niobium-13 Zirconium Alloy for Surgical Implant ApplicationsContact Person
85ASTM F1854-01: Standard Test Method for Stereological Evaluation of Porous Coatings on Medical ImplantsContact Person
86ASTM F1926-03: Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate CoatingsContact Person
87ASTM F1978-00e1: Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber AbraserContact Person
88ASTM F2024-00: Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite CoatingsContact Person
89ASTM F1873-98: Standard Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant ApplicationsContact Person
Start Printed Page 28505
94ASTM F601-03: Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical ImplantsContact Person
95ASTM F629-02: Standard Practice for Radiography of Cast Metallic Surgical ImplantsContact Person
97ASTM F2129-06: Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant DevicesWithdrawn and replaced with newer version133
98ASTM F451-99ae1: Standard Specification for Acrylic Bone CementContact Person
102ASTM F2082-06: Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free RecoveryWithdrawn and replaced with newer version134
103ASTM F1801-97(2004): Standard Practice for Corrosion Fatigue Testing of Metallic Implant MaterialsContact Person and Type of Standard
104ASTM F1108-04: Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)Contact Person
106ASTM F648-04: Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical ImplantsContact Person
107ASTM F746-04: Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant MaterialsContact Person
108ASTM F1295-05: Standard Specification for Wrought Titanium-6 Aluminum-7 Niobium Alloy for Surgical Implant Applications (UNS R56700)Contact Person
110ASTM F1377-04: Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)Contact Person
111ASTM F1160-05: Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic CoatingsContact Person
112ASTM F1044-05: Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic CoatingsContact Person
113ASTM F1147-05: Standard Test Method for Tension Testing of Calcium Phosphate and Metal CoatingsContact Person
114ASTM F2255-05: Standard Test Method for Strength Properties of Tissue Adhesives in Lap Shear by Tension LoadingContact Person
115ASTM F2256-05: Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension LoadingContact Person
116ASTM F2258-05: Standard Test Method for Strength Properties of Tissue Adhesives in TensionContact Person
117ASTM F86-04: Standard Practice for Surface Preparation and Marking of Metallic Surgical ImplantsContact Person
119ASTM F688-05: Standard Specification for Wrought Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)Contact Person
120ASTM F560-05: Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)Contact Person
121ASTM F2005-05: Standard Terminology for Nickel-Titanium Shape Memory AlloysContact Person
122ASTM F2063-05: Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical ImplantsContact Person
Start Printed Page 28506
123ISO 5832-5:2005: Implants for Surgery—Metallic Materials—Part 5: Wrought Cobalt-chromium-tungsten-nickel AlloyContact Person
125ASTM F2004-05: Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal AnalysisContact Person
126ASTM F561-05a: Practice for Retrieval and Analysis of Implanted Medical Devices, and Associated TissuesContact Person
127ISO 5834-2:1998: Implants for Surgery—Ultra-High-Molecular-Weight Polyethylene—Part 2: Moulded FormsContact Person
G. OB-GYN/Gastroenterology
35ASTM D6324-05 Standard Test Methods for Male Condoms Made from Synthetic MaterialsWithdrawn and replaced with newer version41
H. Ophthalmic
3ISO 9340:1996 Optics and Optical Instruments—Contact lenses—Determination of Strains for Rigid Contact LensesWithdrawn
12ISO 11980:1997 Ophthalmic Optics—Contact Lenses and Contact Lens Care Products—Guidance for Clinical InvestigationsContact Person
13ISO 10942:2006 Ophthalmic Instruments—Direct OphthalmoscopesWithdrawn and replaced with newer version37
15ISO 9394:1998 Ophthalmic Optics—Contact Lenses and Contact Lens Care Products—Determination of Biocompatibility By Ocular Study Using Rabbit EyesContact Person
18ISO 10943:2006 Ophthalmic Instruments—Indirect OphthalmoscopesWithdrawn and replaced with newer version38
20ISO 11979-1:2006 Ophthalmic implants—Intraocular Lenses—Part 1: VocabularyWithdrawn and replaced with newer version40
23ISO 11981:1999 Ophthalmic Optics—Contact Lenses And Contact Lens Care Products—Determination of Physical Compatibility of Contact Lens Care Products With Contact LensesContact Person
24ISO 11986:1999 Ophthalmic Optics—Contact Lenses and Contact Lens Care Products—Guidelines for Determination of Preservative Uptake and ReleaseContact Person
34ANSI Z80.20-2004 Ophthalmics—Contact Lenses—Standard Terminology, Tolerances, Measurements and Physicochemical PropertiesContact Person
I. Orthopedic/Physical Medicine
73ISO 5838-1:1995: Implants for Surgery—Skeletal Pins and Wires—Part 1: Material and Mechanical RequirementsContact Person
74ISO 5838-2:1991: Implants for Surgery—Skeletal Pins and Wires—Part 2: Steinmann Skeletal Pins—DimensionsContact Person
75ISO 5838-3:1993: Implants for Surgery—Skeletal Pins and Wires—Part 3: Kirschner Skeletal WiresContact Person
79ISO 7206-8:1995: Implants for Surgery—Partial and Total Hip Joint Prostheses—Part 8: Endurance Performance of Stemmed Femoral Components With Application of TorsionContact Person
80ISO 8828:1988: Implants for Surgery—Guidance on Care and Handling of Orthopaedic ImplantsContact Person
81ISO 9583:1993: Implants for Surgery—Non-destructive Testing—Liquid Penetrant Inspection of Metallic Surgical ImplantsContact Person
Start Printed Page 28507
82ISO 9584:1993: Implants for Surgery—Non-destructive Testing—Radiographic Examination of Cast Metallic Surgical ImplantsContact Person
83ISO 13402:1995: Surgical and Dental Hand Instruments—Determination of Resistance Against Autoclaving, Corrosion and Thermal ExposureContact Person
121ISO 7207-1:1994: Implants for Surgery—Components for Partial and Total Knee Joint Prostheses—Part 1: Classification, Definitions and Designation of DimensionsContact Person
155ISO 7207-2:1998: Implants for Surgery—Components for Partial and Total Knee Joint Prostheses—Part 2: Articulating Surfaces Made of Metal, Ceramic and Plastics MaterialsContact Person
163ASTM F543-02e1, Standard Specification and Test Methods for Metallic Medical Bone ScrewsWithdrawn and replaced with newer version202
166ASTM F897-02: Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and ScrewsContact Person
167ASTM F1089-02: Standard Test Method for Corrosion of Surgical InstrumentsContact Person
168ASTM F1781-03: Standard Specification for Elastomeric Flexible Hinge Finger Total Joint ImplantsContact Person
171ASTM F1814-97a(2003): Standard Guide for Evaluating Modular Hip and Knee Joint ComponentsContact Person
172ASTM F1798-97(2003): Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis ImplantsContact Person
175ASTM F1582-98(2003): Standard Terminology Relating to Spinal ImplantsContact Person
177ASTM F1264-03: Standard Specification and Test Methods for Intramedullary Fixation DevicesContact Person
178ASTM F1440-92(2002): Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components Without TorsionContact Person
179ASTM F2068-03: Standard Specification for Femoral Prostheses—Metallic ImplantsContact Person
180ASTM F366-04: Standard Specification for Fixation Pins and WiresContact Person
181ASTM F1717-04: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy ModelContact Person
182ASTM F1800-04: Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint ReplacementsContact Person
183ASTM F1875-98(2004): Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-bore and Cone Taper InterfaceContact Person
185ASTM F2267-04: Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial CompressionContact Person
186ASTM F2077-03: Test Methods for Intervertebral Body Fusion DevicesContact Person
187ASTM F2193-02: Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal SystemContact Person
188ISO 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 TestContact Person
Start Printed Page 28508
189ISO 14243-2:2000: Implants for Surgery—Wear of Total Knee-joint Prostheses—Part 2: Methods of MeasurementContact Person
190ISO 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 TestContact Person
191ISO 14879-1:2000: Implants for Surgery—Total Knee-joint Prostheses—Part 1: Determination of Endurance Properties of Knee Tibial TraysContact Person
192ASTM F1223-05: Standard Test Method for Determination of Total Knee Replacement ConstraintContact Person
J. Radiology
34IEC 60601-2-7 (1998) Medical Electrical Equipment—Part 2-7: Particular Requirements for the Safety of High-Voltage Generators of Diagnostic X-ray GeneratorsContact Person
68NEMA MS 4-2006 Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging DevicesWithdrawn and replaced with newer version151
101ANSI / IESNA RP-27.1-05 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems—General RequirementsWithdrawn and replaced with newer version153
104IEC 60601-2-33 (2006), Medical Electrical Equipment—Part 2-33: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical DiagnosisWithdrawn and replaced with newer version161
111ISO 11554:2006 Optics and Photonics—Lasers and Laser-Related equipment—Test Methods for Laser Beam Power, Energy and Temporal CharacteristicsWithdrawn and replaced with newer version155
K. Software
1ISO/IEC 12207:1995 Information Technology—Software Life Cycle ProcessesWithdrawn
3IEEE/EIA 12207.0-1996 Industry Implementation of International Standard ISO/IEC 12207:1995(ISO/IEC 12207) Standard for Information Technology—Software Life Cycle ProcessesWithdrawn
5IEEE 1074-1997 Standard for Developing a Software Project Life Cycle ProcessWithdrawn
6IEEE 1012-2004 Standard for Software Verification and ValidationWithdrawn
7AAMI / ANSI SW68:2001 Medical Device Software—Software Life Cycle ProcessesWithdrawn
L. Sterility
67ASTM F1140-2005, Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages for Medical ApplicationsWithdrawn and replaced with newer version196
68ASTM F1585:2000, Standard Guide for Integrity Testing of Porous Barrier Medical PackagesWithdrawn
69ASTM F1608:2004, Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber MethodWithdrawn and replaced with newer version197
89ASTM F2054-05, Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining PlatesWithdrawn and replaced with newer version198
121ASTM D4169-05, Standard Practice for Performance Testing of Shipping Containers and SystemsWithdrawn and replaced with newer version199
122ASTM F88-2006, Standard Test Method for Seal Strength of Flexible Barrier MaterialsWithdrawn and replaced with newer version200
Start Printed Page 28509
M. Tissue Engineering
1ASTM F2064-00(2006): Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for use in Biomedical and Tissue-Engineered Medical Products ApplicationWithdrawn and replaced with newer version8

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 StandardReference No. & Date
A. Anesthesia
71Lung Ventilators for Medical use—Particular Requirements for Basic Safety and Essential Performance—Part 5: Gas-powered Emergency ResuscitatorsISO 10651-5:2006
B. Cardiovascular/Neurology
59Implants for surgery—Cardiac Pacemakers—Part 3: Low-profile Connectors (IS-1) for Implantable PacemakersISO 5841-3:2000
C. Dental/ENT
140Dental Base Metal Casting Alloys—Part 2: Nickel-based AlloysISO 6871-2:1994/Amd 1:2005
141Dental Base Metal Casting Alloys—Part 1: Cobalt-based AlloysISO 6871-1:1994
142Dental Base Metal Casting Alloys—Part 1: Cobalt-based AlloysISO 6871-1:1994/Amd 1:2005
D. General
36Technical Information Report: Medical Devices—Guidance on the Selection of Standards in Support of Recognized Essential Principles of Safety and Performance of Medical Devices, Second EditionANSI/AAMI/ISO TIR 16142:2006
E. General Hospital/General Plastic Surgery
170Sterile hypodermic syringes for single use—Part 1: Syringes for Manual UseISO 7886-1:1993/ Corrigendum 1:1995
171Sterile, Single-use Intravascular Catheters- Part 3: Central Venous CathetersISO 10555-3:1996/ Corrigendum 1:2002
173Infusion Equipment for Medical Use—Part 2: Closures for Infusion BottlesISO 8536-2:2001/ Corrigendum 1:2003
174Pen-injectors for Medical Use—Part 4: Requirements and Test Methods for Electronic and Electromechanical Pen-injectorsISO 11608-4:2006
176Standard Guide for Assessment of Medical GlovesASTM D7103-06
179Needle-free Injectors for Medical Use—Requirements and Test MethodsISO 21649:2006
180Standard Specification for Surgical Gowns Intended for Use in Healthcare FacilitiesASTM F2407-06
182Medical Electrical Equipment— Part 2-38: Particular Requirements for the Safety of Electrically Operated Hospital BedsIEC 60601-2-38 1996/Amendment 1:1999
F. In Vitro Diagnostic
128Evaluation of Matrix Effects; Approved Guideline—Second EditionCLSI EP14-A2 2005
129Quality Control of Microbiological Transport SystemsCLSI M40-A 2003
G. Materials
135Standard Test Method for Burst Strength of Surgical SealantsASTM F2392-04
136Standard Test Method for Wound Closure Strength of Tissue Adhesives and SealantsASTM F2458-05
Start Printed Page 28510
H. OB-GYN/Gastroenterology
42Medical electrical equipment—Part 2: Particular Requirements for the Safety of Endoscopic EquipmentIEC 60601-2-18 (1996) Amendment 1 2000
43Rubber Condoms—Guidance on the Use of ISO 4074 in the Quality Management of Natural Rubber Latex CondomsISO 16038:2005
I. Ophthalmic
43Ophthalmic Implants—Intraocular lenses—Part 8: Fundamental RequirementsISO 11979-8:2006
J. Radiology
150Information Technology—Digital Compression and Coding of Continuous-tone Still Images—Part 1: Requirements and GuidelinesIEC / ISO 10918-1:1994 Technical Corrigendum 1:2005
152Medical Electrical Equipment—Part 2-1: Particular Requirements for the Safety of Electron Accelerators in the Range 1 MeV to 50 MeVIEC 60601-2-1 (1998-06), Amendment 1 2002
154Lasers and Laser-related Equipment—Determination of Laser-induced Damage Threshold of Optical Surfaces—Part 3: Assurance of Laser Power (energy) Handling CapabilitiesISO 11254-3:2006
156Lasers and Laser-related Equipment—Test Methods for Laser Beam Parameters—Beam Positional StabilityISO 11670:2003 Technical Corrigendum 1:2004
157Optics and Optical Instruments—Lasers and Laser-related Equipment—Test Methods for Laser Beam Power (energy) Density DistributionISO 13694:2000 Technical Corrigendum 1:2005
158Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance ImagingNEMA MS 10-2006
159Determination of Gradient-Induced Electric Fields In Diagnostic Magnetic Resonance ImagingNEMA MS 11-2006
160Quantification and Mapping of Geometric Distortion for Special ApplicationsNEMA 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 Start Printed Page 28511with 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.

Start Signature

Dated: May 10, 2007.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.

End Signature End Preamble

[FR Doc. E7-9718 Filed 5-18-07; 8:45 am]

BILLING CODE 4160-01-S