Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 017, 28500-28511 [E7-9718]

Download as PDF 28500 Federal Register / Vol. 72, No. 97 / Monday, May 21, 2007 / Notices Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: May 15, 2007. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E7–9737 Filed 5–18–07; 8:45 am] BILLING CODE 4160–01–S 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: 017 AGENCY: Food and Drug Administration, HHS. pwalker on PROD1PC71 with NOTICES 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 selfaddressed 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 VerDate Aug<31>2005 15:57 May 18, 2007 Jkt 211001 INFORMATION CONTACT). Submit electronic comments by e-mail: standards@cdrh.fda.gov. This document may also be accessed on FDA’s Internet site at https://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. PO 00000 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) Frm 00039 Fmt 4703 Sfmt 4703 TABLE 1.—Continued Federal Register Cite 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. E:\FR\FM\21MYN1.SGM 21MYN1 Federal Register / Vol. 72, No. 97 / Monday, May 21, 2007 / Notices 28501 TABLE 2. Old Item No. Standard Change Replacement Item No. A. Anesthesia 19 ISO 8382:1988: Resuscitators Intended for Use With Humans Withdrawn 71 48 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 70 B. Biocompatibility 57 ASTM F895–84(2006): Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity Withdrawn and replaced with newer version 115 72 ASTM F1439–03: Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials Withdrawn and replaced with newer version 116 86 AAMI/ANSI/ISO 10993–10:2002(E): Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Sensitization Withdrawn—duplicate 87 AAMI/ANSI/ISO 10993–10:2002: Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Delayed-type Hypersensitivity Title 99 ASTM F1904–98(2003): Standard Practice for Testing the Biological Responses to Particles In Vivo Title 87 C. Dental/Ear, Nose, and Throat (ENT) 60 ANSI/ADA Specification No. 96:2000: Dental Water-Based Cements Withdrawn and replaced with newer version 143 72 ISO 6877–2006: Dentistry—Root-canal Obturating Points Withdrawn and replaced with newer version 137 85 ANSI/ADA Specification No. 15:2000, Synthetic Polymer Teeth Withdrawn and replaced with newer version 138 91 ANSI/ADA Specification No. 80:2001, Dental Materials—Determination of Color Stability Title 114 ANSI/ADA Specification No. 48:2004, Visible Light Curing Units Withdrawn and replaced with newer version 2 IEC 60601–1, Medical Electrical Equipment—Part 1:General Requirements for Safety Contact Person 11 ISO 2859/1995, Sampling Procedures and Tables for Inspection By Attributes Contact Person 12 ISO 10012/1993, Quality Assurance Requirements for Measuring Equipment Part 1: Metrological Confirmation System for Measuring Equipment Contact Person 14 ANSI Z1.4/1993, Inspection by Attributes Contact Person 15 ANSI Z1.9/1993, Inspection by Variables Contact Person 18 ASTM D–4332/1991, Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing Contact Person 19 ASTM E–876/1995, Standard Practice for Use of Statistics in the Evaluation of Spectrometric Data Contact Person 20 ASTM F–1140/1988, Standard Test Method for Failure Resistance of Unrestrained and Nonrigid Packages for Medical Applications Contact Person 27 IEC 60601–1–1:2000, Medical Electrical Equipment—Part 1: General Requirement for Safety; Safety Requirements for Medical Electrical Systems Contact Person pwalker on PROD1PC71 with NOTICES D. General VerDate Aug<31>2005 15:57 May 18, 2007 Jkt 211001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\21MYN1.SGM 21MYN1 139 28502 Federal Register / Vol. 72, No. 97 / Monday, May 21, 2007 / Notices TABLE 2.—Continued Old Item No. Standard Change 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 Recognition 29 AAMI/ANSI HE74–2001, Human Factors Design Process for Medical Devices Contact Person 31 ISO 15223, Medical Devices—Symbols to be Used With Medical Device Labels, Labeling and Information to be Supplied Contact Person 32 EN 980:1996+1:1999+A2:2001, Graphical Symbols for use in the Labeling of Medical Devices Contact Person 35 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.) Replacement Item No. Standard Organizations E. General Hospital/General Plastic Surgery 114 ISO 11608–1:2000 Pen-injectors for Medical Use—Part 1: Peninjectors—Requirements and Test Methods Contact Person 115 ISO 11608–2:2000 Pen-injectors for Medical Use—Part 2: Needles—Requirements and Test Methods Contact Person 116 ISO 11608–3:2000 Pen-injectors for Medical Use—Part 3: Finished Cartridges—Requirements and Test Methods Contact Person 66 and 162 ISO 8536–1:2006 Infusion Equipment for Medical Use—Part 1: Infusion Glass Bottles Withdrawn and replaced with newer version 172 53 ASTM D5151–99 (2006) Standard Test Method for Detection of Holes in Medical Gloves Withdrawn and replaced with newer version 175 77 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 181 80 ASTM E1112–00 (2006) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature Withdrawn and replaced with newer version 177 84 ASTM D6124–06 Standard Test Method for Residual Powder on Medical Gloves Withdrawn and replaced with newer version 178 161 ISO 10555–1:1995/ Amendment 1:1999, Amendment 2:2004 Sterile, Single-use Intravascular Catheters—Part 1: General Requirements Title 85 ASTM 5250–06 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application Withdrawn and replaced with newer version 183 CLSI EP7–A2, Interference Testing in Clinical Chemistry; Approved Guidelines—Second Edition Withdrawn and replaced with newer version 127 1 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 129 2 ASTM F75–01: Standard Specification for Cobalt–28 Chromium–6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075) Contact Person 3 ASTM F90–01: Standard Specification for Wrought Cobalt–20 Chromium–15 Tungsten–10 Nickel Alloy for Surgical Implant Applications (UNS R30605) Contact Person E. In Vitro Diagnostics 91 pwalker on PROD1PC71 with NOTICES F. Materials VerDate Aug<31>2005 15:57 May 18, 2007 Jkt 211001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\21MYN1.SGM 21MYN1 Federal Register / Vol. 72, No. 97 / Monday, May 21, 2007 / Notices 28503 TABLE 2.—Continued Old Item No. Standard Change ASTM F603–00: Standard Specification for High-Purity Dense Aluminum Oxide for Surgical Implant Application Contact Person 11 ASTM F620–06: Standard Specification for Alpha Plus Beta Titanium Alloy Forgings for Surgical Implants Withdrawn and replaced with newer version 15 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 Person 26 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 Person 27 ASTM F1341–99: Standard Specification for Unalloyed Titanium Wire UNS R50250, UNS R50400, UNS R50550, UNS R50700, for Surgical Implant Applications Withdrawn 30 ASTM F1537–00: Standard Specification for Wrought Cobalt–28–Chromium–6–Molybdenum Alloy for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) Contact Person 32 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 Person 37 ASTM F1813–01: Standard Specification for Wrought Titanium—12 Molybdenum—6 Zirconium—2 Iron Alloy for Surgical Implant (UNS R58120) Contact Person 41 ASTM F2066–01: Standard Specification for Wrought Titanium–15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150) Contact Person 43 ASTM F2146–01: Standard Specification for Wrought Titanium– 3Aluminum–2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320) Contact Person 44 ASTM F136–02a: Standard Specification for Wrought Titanium–6 Aluminum–4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) Contact Person 45 ASTM F562–02: Standard Specification for Wrought 35Cobalt–35Nickel– 20Chromium–10Molybdenum Alloy for Surgical Implant Applications (UNS R30035) Contact Person 46 ASTM F621–02: Standard Specification for Stainless Steel Forgings for Surgical Implants Contact Person 47 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 48 ASTM F899–02: Standard Specification for Stainless Steel for Surgical Instruments Contact Person 49 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 Person 50 ASTM F1091–02: Standard Specification for Wrought Cobalt–20 Chromium–15 Tungsten–10 Nickel Alloy Surgical Fixation Wire (UNS R30605) Contact Person 52 pwalker on PROD1PC71 with NOTICES 10 ASTM F1350–02: Standard Specification for Wrought 18 Chromium–14 Nickel–2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673) Contact Person 53 ASTM F1472–02a: Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy for Surgical Implant Applications (UNS R56400) Contact Person Replacement Item No. VerDate Aug<31>2005 15:57 May 18, 2007 Jkt 211001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\21MYN1.SGM 21MYN1 130 131 28504 Federal Register / Vol. 72, No. 97 / Monday, May 21, 2007 / Notices TABLE 2.—Continued Old Item No. Standard Change ASTM F1580–01: Standard Specification for Titanium and Titanium–6 Aluminum–4 Vanadium Alloy Powders for Coatings of Surgical Implants Contact Person 56 ISO 5832–1:1997: Implants for Surgery—Metallic materials—Part 1: Wrought Stainless Steel Contact Person 57 ISO 5832–2:1999: Implants for Surgery—Metallic Materials—Part 2: Unalloyed Titanium Contact Person 58 ISO 5832–3:1996: Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6–Aluminium 4–Vanadium Alloy Contact Person 59 ISO 5832–4:1996: Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum Casting Alloy Contact Person 61 ISO 5832–6:1997: Implants for Surgery—Metallic Materials—Part 6: Wrought Cobalt-nickel-chromium-Molybdenum alloy Contact Person 62 ISO 5832–9:1992: Implants for Surgery—Metallic Materials—Part 9: Wrought High Nitrogen Stainless Steel Contact Person 63 ISO 5832–11:1994: Implants for Surgery—Metallic Materials—Part 11: Wrought Titanium 6–aluminium 7 niobium Alloy Contact Person 64 ISO 5832–12:1996: Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum Alloy Contact Person 66 ISO 6474:1994: Implants for Surgery—Ceramic Materials Based on High Purity Alumina Contact Person 68 ISO 13782:1996: Implants for Surgery—Metallic Materials—Unalloyed Tantalum for Surgical Implant Applications Contact Person 76 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 Person 77 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 Person 79 ASTM F961–03: Standard Specification for Cobalt–35 Nickel–20 Chromium–10 Molybdenum Alloy Forgings for Surgical Implants [UNS R30035] Contact Person 80 ASTM F1088–04ae1: Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation Withdrawn and replaced with newer version 81 ASTM F1609–03: Standard Specification for Calcium Phosphate Coatings for Implantable Materials Contact Person 82 ASTM F1713–03: Standard Specification for Wrought Titanium–13 Niobium–13 Zirconium Alloy for Surgical Implant Applications Contact Person 85 ASTM F1854–01: Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants Contact Person 86 ASTM F1926–03: Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Coatings Contact Person 87 pwalker on PROD1PC71 with NOTICES 54 ASTM F1978–00e1: Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser Contact Person 88 ASTM F2024–00: Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings Contact Person 89 ASTM F1873–98: Standard Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant Applications Contact Person Replacement Item No. VerDate Aug<31>2005 15:57 May 18, 2007 Jkt 211001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\21MYN1.SGM 21MYN1 132 Federal Register / Vol. 72, No. 97 / Monday, May 21, 2007 / Notices 28505 TABLE 2.—Continued Old Item No. Standard Change ASTM F601–03: Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants Contact Person 95 ASTM F629–02: Standard Practice for Radiography of Cast Metallic Surgical Implants Contact Person 97 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 98 ASTM F451–99ae1: Standard Specification for Acrylic Bone Cement Contact Person 102 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 103 ASTM F1801–97(2004): Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials Contact Person and Type of Standard 104 ASTM F1108–04: Standard Specification for Titanium–6Aluminum– 4Vanadium Alloy Castings for Surgical Implants (UNS R56406) Contact Person 106 ASTM F648–04: Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants Contact Person 107 ASTM F746–04: Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials Contact Person 108 ASTM F1295–05: Standard Specification for Wrought Titanium–6 Aluminum–7 Niobium Alloy for Surgical Implant Applications (UNS R56700) Contact Person 110 ASTM F1377–04: Standard Specification for Cobalt–28 Chromium–6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075) Contact Person 111 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 Person 112 ASTM F1044–05: Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings Contact Person 113 ASTM F1147–05: Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coatings Contact Person 114 ASTM F2255–05: Standard Test Method for Strength Properties of Tissue Adhesives in Lap Shear by Tension Loading Contact Person 115 ASTM F2256–05: Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading Contact Person 116 ASTM F2258–05: Standard Test Method for Strength Properties of Tissue Adhesives in Tension Contact Person 117 ASTM F86–04: Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants Contact Person 119 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 Person 120 pwalker on PROD1PC71 with NOTICES 94 ASTM F560–05: Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400) Contact Person 121 ASTM F2005–05: Standard Terminology for Nickel-Titanium Shape Memory Alloys Contact Person 122 ASTM F2063–05: Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants Contact Person Replacement Item No. VerDate Aug<31>2005 15:57 May 18, 2007 Jkt 211001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\21MYN1.SGM 21MYN1 133 134 28506 Federal Register / Vol. 72, No. 97 / Monday, May 21, 2007 / Notices TABLE 2.—Continued Old Item No. Standard Change 123 ISO 5832–5:2005: Implants for Surgery—Metallic Materials—Part 5: Wrought Cobalt-chromium-tungsten-nickel Alloy Contact Person 125 ASTM F2004–05: Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis Contact Person 126 ASTM F561–05a: Practice for Retrieval and Analysis of Implanted Medical Devices, and Associated Tissues Contact Person 127 ISO 5834–2:1998: Implants for Surgery—Ultra-High-Molecular-Weight Polyethylene—Part 2: Moulded Forms Replacement Item No. Contact Person G. OB-GYN/Gastroenterology 35 ASTM D6324–05 Standard Test Methods for Male Condoms Made from Synthetic Materials Withdrawn and replaced with newer version 41 H. Ophthalmic 3 ISO 9340:1996 Optics and Optical Instruments—Contact lenses—Determination of Strains for Rigid Contact Lenses Withdrawn 12 ISO 11980:1997 Ophthalmic Optics—Contact Lenses and Contact Lens Care Products—Guidance for Clinical Investigations Contact Person 13 ISO 10942:2006 Ophthalmic Instruments—Direct Ophthalmoscopes Withdrawn and replaced with newer version 15 ISO 9394:1998 Ophthalmic Optics—Contact Lenses and Contact Lens Care Products—Determination of Biocompatibility By Ocular Study Using Rabbit Eyes Contact Person 18 ISO 10943:2006 Ophthalmic Instruments—Indirect Ophthalmoscopes Withdrawn and replaced with newer version 38 20 ISO 11979–1:2006 Ophthalmic implants—Intraocular Lenses—Part 1: Vocabulary Withdrawn and replaced with newer version 40 23 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 Person 24 ISO 11986:1999 Ophthalmic Optics—Contact Lenses and Contact Lens Care Products—Guidelines for Determination of Preservative Uptake and Release Contact Person 34 ANSI Z80.20–2004 Ophthalmics—Contact Lenses—Standard Terminology, Tolerances, Measurements and Physicochemical Properties Contact Person I. Orthopedic/Physical Medicine ISO 5838–1:1995: Implants for Surgery—Skeletal Pins and Wires—Part 1: Material and Mechanical Requirements Contact Person 74 ISO 5838–2:1991: Implants for Surgery—Skeletal Pins and Wires—Part 2: Steinmann Skeletal Pins—Dimensions Contact Person 75 ISO 5838–3:1993: Implants for Surgery—Skeletal Pins and Wires—Part 3: Kirschner Skeletal Wires Contact Person 79 pwalker on PROD1PC71 with NOTICES 73 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 Person 80 ISO 8828:1988: Implants for Surgery—Guidance on Care and Handling of Orthopaedic Implants Contact Person 81 ISO 9583:1993: Implants for Surgery—Non-destructive Testing—Liquid Penetrant Inspection of Metallic Surgical Implants Contact Person VerDate Aug<31>2005 15:57 May 18, 2007 Jkt 211001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\21MYN1.SGM 21MYN1 37 Federal Register / Vol. 72, No. 97 / Monday, May 21, 2007 / Notices 28507 TABLE 2.—Continued Old Item No. Standard Change ISO 9584:1993: Implants for Surgery—Non-destructive Testing—Radiographic Examination of Cast Metallic Surgical Implants Contact Person 83 ISO 13402:1995: Surgical and Dental Hand Instruments—Determination of Resistance Against Autoclaving, Corrosion and Thermal Exposure Contact Person 121 ISO 7207–1:1994: Implants for Surgery—Components for Partial and Total Knee Joint Prostheses—Part 1: Classification, Definitions and Designation of Dimensions Contact Person 155 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 Person 163 ASTM F543–02e1, Standard Specification and Test Methods for Metallic Medical Bone Screws Withdrawn and replaced with newer version 166 ASTM F897–02: Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws Contact Person 167 ASTM F1089–02: Standard Test Method for Corrosion of Surgical Instruments Contact Person 168 ASTM F1781–03: Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants Contact Person 171 ASTM F1814–97a(2003): Standard Guide for Evaluating Modular Hip and Knee Joint Components Contact Person 172 ASTM F1798–97(2003): Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants Contact Person 175 ASTM F1582–98(2003): Standard Terminology Relating to Spinal Implants Contact Person 177 ASTM F1264–03: Standard Specification and Test Methods for Intramedullary Fixation Devices Contact Person 178 ASTM F1440–92(2002): Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components Without Torsion Contact Person 179 ASTM F2068–03: Standard Specification for Femoral Prostheses—Metallic Implants Contact Person 180 ASTM F366–04: Standard Specification for Fixation Pins and Wires Contact Person 181 ASTM F1717–04: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model Contact Person 182 ASTM F1800–04: Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements Contact Person 183 ASTM F1875–98(2004): Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-bore and Cone Taper Interface Contact Person 185 ASTM F2267–04: Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression Contact Person 186 ASTM F2077–03: Test Methods for Intervertebral Body Fusion Devices Contact Person 187 pwalker on PROD1PC71 with NOTICES 82 ASTM F2193–02: Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System Contact Person 188 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 Replacement Item No. VerDate Aug<31>2005 15:57 May 18, 2007 Jkt 211001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\21MYN1.SGM 21MYN1 202 28508 Federal Register / Vol. 72, No. 97 / Monday, May 21, 2007 / Notices TABLE 2.—Continued Old Item No. Standard Change Replacement Item No. 189 ISO 14243–2:2000: Implants for Surgery—Wear of Total Knee-joint Prostheses—Part 2: Methods of Measurement Contact Person 190 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 Person 191 ISO 14879–1:2000: Implants for Surgery—Total Knee-joint Prostheses— Part 1: Determination of Endurance Properties of Knee Tibial Trays Contact Person 192 ASTM F1223–05: Standard Test Method for Determination of Total Knee Replacement Constraint Contact Person 34 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 Person 68 NEMA MS 4–2006 Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices Withdrawn and replaced with newer version 151 101 ANSI / IESNA RP–27.1–05 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems—General Requirements Withdrawn and replaced with newer version 153 104 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 161 111 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 155 1 ISO/IEC 12207:1995 Information Technology—Software Life Cycle Processes Withdrawn 3 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 Withdrawn 5 IEEE 1074–1997 Standard for Developing a Software Project Life Cycle Process Withdrawn 6 IEEE 1012–2004 Standard for Software Verification and Validation Withdrawn 7 AAMI / ANSI SW68:2001 Medical Device Software—Software Life Cycle Processes Withdrawn 67 ASTM F1140–2005, Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages for Medical Applications Withdrawn and replaced with newer version 68 ASTM F1585:2000, Standard Guide for Integrity Testing of Porous Barrier Medical Packages Withdrawn 69 ASTM F1608:2004, Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method Withdrawn and replaced with newer version 197 89 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 198 121 ASTM D4169–05, Standard Practice for Performance Testing of Shipping Containers and Systems Withdrawn and replaced with newer version 199 122 ASTM F88–2006, Standard Test Method for Seal Strength of Flexible Barrier Materials Withdrawn and replaced with newer version 200 J. Radiology K. Software pwalker on PROD1PC71 with NOTICES L. Sterility VerDate Aug<31>2005 15:57 May 18, 2007 Jkt 211001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\21MYN1.SGM 21MYN1 196 28509 Federal Register / Vol. 72, No. 97 / Monday, May 21, 2007 / Notices TABLE 2.—Continued Old Item No. Standard Replacement Item No. Change M. Tissue Engineering 1 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 III. Listing of New Entries In table 3 of this document, FDA provides the listing of new entries and Withdrawn and replaced with newer version consensus standards added as modifications to the list of recognized 8 standards under Recognition List Number: 017. TABLE 3. Item No. Title of Standard Reference No. & Date A. Anesthesia 71 Lung Ventilators for Medical use—Particular Requirements for Basic Safety and Essential Performance—Part 5: Gas-powered Emergency Resuscitators ISO 10651–5:2006 B. Cardiovascular/Neurology 59 Implants for surgery—Cardiac Pacemakers—Part 3: Low-profile Connectors (IS–1) for Implantable Pacemakers ISO 5841–3:2000 C. Dental/ENT 140 Dental Base Metal Casting Alloys—Part 2: Nickel-based Alloys ISO 6871–2:1994/Amd 1:2005 141 Dental Base Metal Casting Alloys—Part 1: Cobalt-based Alloys ISO 6871–1:1994 142 Dental Base Metal Casting Alloys—Part 1: Cobalt-based Alloys ISO 6871–1:1994/Amd 1:2005 D. General 36 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 16142:2006 E. General Hospital/General Plastic Surgery 170 Sterile hypodermic syringes for single use—Part 1: Syringes for Manual Use ISO 7886–1:1993/ Corrigendum 1:1995 171 Sterile, Single-use Intravascular Catheters- Part 3: Central Venous Catheters ISO 10555–3:1996/ Corrigendum 1:2002 173 Infusion Equipment for Medical Use—Part 2: Closures for Infusion Bottles 174 Pen-injectors for Medical Use—Part 4: Requirements and Test Methods for Electronic and Electromechanical Pen-injectors 176 Standard Guide for Assessment of Medical Gloves 179 Needle-free Injectors for Medical Use—Requirements and Test Methods ISO 21649:2006 180 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities ASTM F2407–06 182 Medical Electrical Equipment— Part 2–38: Particular Requirements for the Safety of Electrically Operated Hospital Beds IEC 60601–2–38 1996/Amendment 1:1999 ISO 8536–2:2001/ Corrigendum 1:2003 ISO 11608–4:2006 ASTM D7103–06 F. In Vitro Diagnostic Evaluation of Matrix Effects; Approved Guideline—Second Edition 129 pwalker on PROD1PC71 with NOTICES 128 CLSI EP14–A2 2005 Quality Control of Microbiological Transport Systems CLSI M40–A 2003 G. Materials 135 Standard Test Method for Burst Strength of Surgical Sealants ASTM F2392–04 136 Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants ASTM F2458–05 VerDate Aug<31>2005 15:57 May 18, 2007 Jkt 211001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\21MYN1.SGM 21MYN1 28510 Federal Register / Vol. 72, No. 97 / Monday, May 21, 2007 / Notices TABLE 3.—Continued Item No. Title of Standard Reference No. & Date H. OB-GYN/Gastroenterology 42 Medical electrical equipment—Part 2: Particular Requirements for the Safety of Endoscopic Equipment IEC 60601–2–18 (1996) Amendment 1 2000 43 Rubber Condoms—Guidance on the Use of ISO 4074 in the Quality Management of Natural Rubber Latex Condoms ISO 16038:2005 I. Ophthalmic 43 Ophthalmic Implants—Intraocular lenses—Part 8: Fundamental Requirements ISO 11979–8:2006 J. Radiology 150 Information Technology—Digital Compression and Coding of Continuous-tone Still Images—Part 1: Requirements and Guidelines IEC / ISO 10918–1:1994 Technical Corrigendum 1:2005 152 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 2002 154 Lasers and Laser-related Equipment—Determination of Laser-induced Damage Threshold of Optical Surfaces—Part 3: Assurance of Laser Power (energy) Handling Capabilities ISO 11254–3:2006 156 Lasers and Laser-related Equipment—Test Methods for Laser Beam Parameters— Beam Positional Stability ISO 11670:2003 Technical Corrigendum 1:2004 157 Optics and Optical Instruments—Lasers and Laser-related Equipment—Test Methods for Laser Beam Power (energy) Density Distribution ISO 13694:2000 Technical Corrigendum 1:2005 158 Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging NEMA MS 10–2006 159 Determination of Gradient-Induced Electric Fields In Diagnostic Magnetic Resonance Imaging NEMA MS 11–2006 160 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 https:// 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. pwalker on PROD1PC71 with NOTICES 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 VerDate Aug<31>2005 15:57 May 18, 2007 Jkt 211001 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 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 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 https:// 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 https://www.fda.gov/cdrh/stdsprog.html. This Federal Register document on modifications in FDA’s recognition of consensus standards is available at https://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 E:\FR\FM\21MYN1.SGM 21MYN1 Federal Register / Vol. 72, No. 97 / Monday, May 21, 2007 / Notices 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: pwalker on PROD1PC71 with NOTICES SUMMARY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852–3804; telephone: 301/ 496–7057; fax: 301/402–0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. A Method With Increased Yield for Production of Polysaccharide-Protein Conjugate Vaccines Using Hydrazide Chemistry Description of Technology: Current methods for synthesis and manufacturing of polysaccharideprotein conjugate vaccines employ conjugation reactions with low efficiency (about twenty percent). This means that up to eighty percent of the added activated polysaccharide (PS) is lost. In addition, inclusion of a VerDate Aug<31>2005 15:57 May 18, 2007 Jkt 211001 chromatographic process for purification of the conjugates from unconjugated PS is required. The present invention utilizes the characteristic chemical property of hydrazide groups on one reactant to react with aldehyde groups or cyanate esters on the other reactant with an improved conjugate yield of at least sixty percent. With this conjugation efficiency the leftover unconjugated protein and polysaccharide would not need to be removed and thus the purification process of the conjugate product can be limited to diafiltration to remove the by-products of small molecules. The new conjugation reaction can be carried out within one or two days with reactant concentrations between 1 and 25 mg/mL at PS/protein ratios from 1:2 to 3:1, at temperatures between 4 and 40 degrees Centigrade, and in a pH range of 5.5 to 7.4, optimal conditions varying from PS to PS. Application: Cost effective and efficient manufacturing of conjugate vaccines. Inventors: Che-Hung Robert Lee and Carl E. Frasch (CBER/FDA). Patent Status: U.S. Patent Application No. 10/566,899 filed 01 Feb 2006, claiming priority to 06 Aug 2003 (HHS Reference No. E–301–2003/0–US–10); U.S. Patent Application No. 10/566,898 filed 01 Feb 2006, claiming priority to 06 Aug 2003 (HHS Reference No. E– 301–2003/1–US–02); International rights available. Licensing Status: Available for nonexclusive licensing. Licensing Contact: Peter A. Soukas, J.D.; 301/435–4646; soukasp@mail.nih.gov. A Method of Immunizing Humans Against Salmonella Typhi Using a VirEPA Conjugate Vaccine Description of Technology: This invention is a method of immunization against typhoid fever using a conjugate vaccine comprising the capsular polysaccharide of Salmonella typhi, Vi, conjugated through an adipic dihydrazide linker to nontoxic recombinant exoprotein A (rEPA) from Pseudomonas aeruginosa. The three licensed vaccines against typhoid fever, attenuated S. typhi Ty21a, killed whole cell vaccines and Vi polysaccharide, have limited efficacy, in particular for children under 5 years of age, which make an improved vaccine desirable. It is generally recognized that an effective vaccine against Salmonella typhi is one that increases serum antiVi IgG eight-fold six weeks after immunization. The conjugate vaccine of the invention increases anti-Vi IgG, 48- PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 28511 fold, 252-fold and 400-fold in adults, in 5–14 years-old and 2–4 years-old children, respectively. Thus this is a highly effective vaccine suitable for children and should find utility in endemic regions and as a traveler’s vaccine. The route of administration can also be combined with routine immunization. In 2–5 years old, the protection against typhoid fever is 90% for 4 years. In school age children and in adults the protection could mount to completer protection according to the immunogenicity data. Application: Immunization against Salmonella typhi for long term prevention of typhoid fever in all ages. Developmental Status: Conjugates have been synthesized and clinical studies have been performed. The synthesis of the conjugates is described by Kossaczka et al. in Infect Immun. 1997 June;65(7):2088–2093. Phase III clinical studies are described by Mai et al. in N Engl J Med. 2003 October 2; 349(14):1390–1391. Dosage studies are described by Canh et al. in Infect Immun. 2004 Nov;72(11):6586–6588. A safety and immunogenicity study in infants are underway. The aim is to administer the conjugate vaccine with routine infant immunization. Preliminary results show the vaccine is safe in 2 months old infants. Inventors: Zuzana Kossaczka, Shousun C. Szu, and John B. Robbins (NICHD). Patent Status: U.S. Patent 6,797,275 issued 28 Sep 2004 (HHS Reference No. E–020–1999/0–US–02); U.S. Patent Application No. 10/866,343 filed 10 Jun 2004 (HHS Reference No. E–020–1999/ 0–US–03); U.S. Patent Application No. 11/726,304 filed 20 Mar 2007 (HHS Reference No. E–020–1999/0–US–04). Licensing Status: Available for nonexclusive licensing. Licensing Contact: Peter A. Soukas, J.D.; 301/435–4646; soukasp@mail.nih.gov. Collaborative Research Opportunity: The National Institute of Child Health and Human Development, Laboratory of Developmental and Molecular Immunity, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize A Method of Immunizing Humans Against Salmonella Typhi Using a Vi-rEPA Conjugate Vaccine. Please contact John D. Hewes, Ph.D., at 301–435–3121 or hewesj@mail.nih.gov for more information. E:\FR\FM\21MYN1.SGM 21MYN1

Agencies

[Federal Register Volume 72, Number 97 (Monday, May 21, 2007)]
[Notices]
[Pages 28500-28511]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-9718]


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

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: 017

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 https://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 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.

[[Page 28501]]



                                Table 2.
------------------------------------------------------------------------
Old Item                                                   Replacement
   No.               Standard                Change          Item No.
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
19        ISO 8382:1988: Resuscitators   Withdrawn                    71
           Intended for Use With Humans
------------------------------------------------------------------------
48        ASTM F1246-91(2005): Standard  Withdrawn and                70
           Specification for              replaced with
           Electrically Powered Home      newer version
           Care Ventilators, Part 1--
           Positive-Pressure
           Ventilators and Ventilator
           Circuits
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
57        ASTM F895-84(2006): Standard   Withdrawn and               115
           Test Method for Agar           replaced with
           Diffusion Cell Culture         newer version
           Screening for Cytotoxicity
------------------------------------------------------------------------
72        ASTM F1439-03: Standard Guide  Withdrawn and               116
           for Performance of Lifetime    replaced with
           Bioassay for the Tumorigenic   newer version
           Potential of Implant
           Materials
------------------------------------------------------------------------
86        AAMI/ANSI/ISO 10993-           Withdrawn--dup               87
           10:2002(E): Biological         licate
           Evaluation of Medical
           Devices--Part 10: Tests for
           Irritation and Sensitization
------------------------------------------------------------------------
87        AAMI/ANSI/ISO 10993-10:2002:   Title           ...............
           Biological Evaluation of
           Medical Devices--Part 10:
           Tests for Irritation and
           Delayed-type
           Hypersensitivity
------------------------------------------------------------------------
99        ASTM F1904-98(2003): Standard  Title           ...............
           Practice for Testing the
           Biological Responses to
           Particles In Vivo
------------------------------------------------------------------------
C. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
60        ANSI/ADA Specification No.     Withdrawn and               143
           96:2000: Dental Water-Based    replaced with
           Cements                        newer version
------------------------------------------------------------------------
72        ISO 6877-2006: Dentistry--     Withdrawn and               137
           Root-canal Obturating Points   replaced with
                                          newer version
------------------------------------------------------------------------
85        ANSI/ADA Specification No.     Withdrawn and               138
           15:2000, Synthetic Polymer     replaced with
           Teeth                          newer version
------------------------------------------------------------------------
91        ANSI/ADA Specification No.     Title           ...............
           80:2001, Dental Materials--
           Determination of Color
           Stability
------------------------------------------------------------------------
114       ANSI/ADA Specification No.     Withdrawn and               139
           48:2004, Visible Light         replaced with
           Curing Units                   newer version
------------------------------------------------------------------------
D. General
------------------------------------------------------------------------
2         IEC 60601-1, Medical           Contact Person  ...............
           Electrical Equipment--Part
           1:General Requirements for
           Safety
------------------------------------------------------------------------
11        ISO 2859/1995, Sampling        Contact Person  ...............
           Procedures and Tables for
           Inspection By Attributes
------------------------------------------------------------------------
12        ISO 10012/1993, Quality        Contact Person  ...............
           Assurance Requirements for
           Measuring Equipment Part 1:
           Metrological Confirmation
           System for Measuring
           Equipment
------------------------------------------------------------------------
14        ANSI Z1.4/1993, Inspection by  Contact Person  ...............
           Attributes
------------------------------------------------------------------------
15        ANSI Z1.9/1993, Inspection by  Contact Person  ...............
           Variables
------------------------------------------------------------------------
18        ASTM D-4332/1991, Standard     Contact Person  ...............
           Practice for Conditioning
           Containers, Packages, or
           Packaging Components for
           Testing
------------------------------------------------------------------------
19        ASTM E-876/1995, Standard      Contact Person  ...............
           Practice for Use of
           Statistics in the Evaluation
           of Spectrometric Data
------------------------------------------------------------------------
20        ASTM F-1140/1988, Standard     Contact Person  ...............
           Test Method for Failure
           Resistance of Unrestrained
           and Nonrigid Packages for
           Medical Applications
------------------------------------------------------------------------
27        IEC 60601-1-1:2000, Medical    Contact Person  ...............
           Electrical Equipment--Part
           1: General Requirement for
           Safety; Safety Requirements
           for Medical Electrical
           Systems
------------------------------------------------------------------------

[[Page 28502]]

 
28        IEC 60601-1-2, (Second         Extent of       ...............
           Edition, 2001), Medical        Recognition
           Electrical Equipment--Part 1-
           2: General Requirements for
           Safety; Electromagnetic
           Compatibility--Requirements
           and Tests
------------------------------------------------------------------------
29        AAMI/ANSI HE74-2001, Human     Contact Person  ...............
           Factors Design Process for
           Medical Devices
------------------------------------------------------------------------
31        ISO 15223, Medical Devices--   Contact Person  ...............
           Symbols to be Used With
           Medical Device Labels,
           Labeling and Information to
           be Supplied
------------------------------------------------------------------------
32        EN 980:1996+1:1999+A2:2001,    Contact Person  ...............
           Graphical Symbols for use in
           the Labeling of Medical
           Devices
------------------------------------------------------------------------
35        AAMI/ANSI/IEC 60601-1-2,       Standard        ...............
           Medical Electrical             Organizations
           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.)
------------------------------------------------------------------------
E. General Hospital/General Plastic Surgery
------------------------------------------------------------------------
114       ISO 11608-1:2000 Pen-          Contact Person  ...............
           injectors for Medical Use--
           Part 1: Pen-injectors--
           Requirements and Test
           Methods
------------------------------------------------------------------------
115       ISO 11608-2:2000 Pen-          Contact Person  ...............
           injectors for Medical Use--
           Part 2: Needles--
           Requirements and Test
           Methods
------------------------------------------------------------------------
116       ISO 11608-3:2000 Pen-          Contact Person  ...............
           injectors for Medical Use--
           Part 3: Finished Cartridges--
           Requirements and Test
           Methods
------------------------------------------------------------------------
66 and    ISO 8536-1:2006 Infusion       Withdrawn and               172
 162       Equipment for Medical Use--    replaced with
           Part 1: Infusion Glass         newer version
           Bottles
------------------------------------------------------------------------
53        ASTM D5151-99 (2006) Standard  Withdrawn and               175
           Test Method for Detection of   replaced with
           Holes in Medical Gloves        newer version
------------------------------------------------------------------------
77        ASTM F1862-05 Standard Test    Withdrawn and               181
           Method for Resistance of       replaced with
           Medical Face Masks to          newer version
           Penetration by Synthetic
           Blood (Horizontal Projection
           of Fixed Volume at a Known
           Velocity)
------------------------------------------------------------------------
80        ASTM E1112-00 (2006) Standard  Withdrawn and               177
           Specification for Electronic   replaced with
           Thermometer for Intermittent   newer version
           Determination of Patient
           Temperature
------------------------------------------------------------------------
84        ASTM D6124-06 Standard Test    Withdrawn and               178
           Method for Residual Powder     replaced with
           on Medical Gloves              newer version
------------------------------------------------------------------------
161       ISO 10555-1:1995/ Amendment    Title           ...............
           1:1999, Amendment 2:2004
           Sterile, Single-use
           Intravascular Catheters--
           Part 1: General Requirements
------------------------------------------------------------------------
85        ASTM 5250-06 Standard          Withdrawn and               183
           Specification for Poly(vinyl   replaced with
           chloride) Gloves for Medical   newer version
           Application
------------------------------------------------------------------------
E. In Vitro Diagnostics
------------------------------------------------------------------------
91        CLSI EP7-A2, Interference      Withdrawn and               127
           Testing in Clinical            replaced with
           Chemistry; Approved            newer version
           Guidelines--Second Edition
------------------------------------------------------------------------
F. Materials
------------------------------------------------------------------------
1         ASTM F67-06: Standard          Withdrawn and               129
           Specification for Unalloyed    replaced with
           Titanium for Surgical          newer version
           Implant Applications (UNS
           R50250, UNS R50400, UNS
           R50550, UNS R50700)
------------------------------------------------------------------------
2         ASTM F75-01: Standard          Contact Person  ...............
           Specification for Cobalt-28
           Chromium-6 Molybdenum Alloy
           Castings and Casting Alloy
           for Surgical Implants (UNS
           R30075)
------------------------------------------------------------------------
3         ASTM F90-01: Standard          Contact Person  ...............
           Specification for Wrought
           Cobalt-20 Chromium-15
           Tungsten-10 Nickel Alloy for
           Surgical Implant
           Applications (UNS R30605)
------------------------------------------------------------------------

[[Page 28503]]

 
10        ASTM F603-00: Standard         Contact Person  ...............
           Specification for High-
           Purity Dense Aluminum Oxide
           for Surgical Implant
           Application
------------------------------------------------------------------------
11        ASTM F620-06: Standard         Withdrawn and               130
           Specification for Alpha Plus   replaced with
           Beta Titanium Alloy Forgings   newer version
           for Surgical Implants
------------------------------------------------------------------------
15        ASTM F745-00: Standard         Contact Person  ...............
           Specification for 18
           Chromium-12.5 Nickel-2.5
           Molybdenum Stainless Steel
           for Cast and Solution-
           Annealed Surgical Implant
           Applications
------------------------------------------------------------------------
26        ASTM F1314-01: Standard        Contact Person  ...............
           Specification for Wrought
           Nitrogen Strengthened 22
           Chromium--13 Nickel--5
           Manganese--2.5 Molybdenum
           Stainless Steel Alloy Bar
           and Wire for Surgical
           Implants (UNS S20910)
------------------------------------------------------------------------
27        ASTM F1341-99: Standard        Withdrawn       ...............
           Specification for Unalloyed
           Titanium Wire UNS R50250,
           UNS R50400, UNS R50550, UNS
           R50700, for Surgical Implant
           Applications
------------------------------------------------------------------------
30        ASTM F1537-00: Standard        Contact Person  ...............
           Specification for Wrought
           Cobalt-28-Chromium-6-Molybde
           num Alloy for Surgical
           Implants (UNS R31537, UNS
           R31538, and UNS R31539)
------------------------------------------------------------------------
32        ASTM F1586-02: Standard        Contact Person  ...............
           Specification for Wrought
           Nitrogen Strengthened 21
           Chromium-10 Nickel-3
           Manganese-2.5 Molybdenum
           Stainless Steel Bar for
           Surgical Implants (UNS
           S31675)
------------------------------------------------------------------------
37        ASTM F1813-01: Standard        Contact Person  ...............
           Specification for Wrought
           Titanium--12 Molybdenum--6
           Zirconium--2 Iron Alloy for
           Surgical Implant (UNS
           R58120)
------------------------------------------------------------------------
41        ASTM F2066-01: Standard        Contact Person  ...............
           Specification for Wrought
           Titanium-15 Molybdenum Alloy
           for Surgical Implant
           Applications (UNS R58150)
------------------------------------------------------------------------
43        ASTM F2146-01: Standard        Contact Person  ...............
           Specification for Wrought
           Titanium-3Aluminum-2.5Vanadi
           um Alloy Seamless Tubing for
           Surgical Implant
           Applications (UNS R56320)
------------------------------------------------------------------------
44        ASTM F136-02a: Standard        Contact Person  ...............
           Specification for Wrought
           Titanium-6 Aluminum-4
           Vanadium ELI (Extra Low
           Interstitial) Alloy for
           Surgical Implant
           Applications (UNS R56401)
------------------------------------------------------------------------
45        ASTM F562-02: Standard         Contact Person  ...............
           Specification for Wrought
           35Cobalt-35Nickel-20Chromium
           -10Molybdenum Alloy for
           Surgical Implant
           Applications (UNS R30035)
------------------------------------------------------------------------
46        ASTM F621-02: Standard         Contact Person  ...............
           Specification for Stainless
           Steel Forgings for Surgical
           Implants
------------------------------------------------------------------------
47        ASTM F799-06: Standard         Withdrawn and               131
           Specification for Cobalt-28    replaced with
           Chromium-6 Molybdenum Alloy    newer version
           Forgings for Surgical
           Implants (UNS R31537,
           R31538, R31539)
------------------------------------------------------------------------
48        ASTM F899-02: Standard         Contact Person  ...............
           Specification for Stainless
           Steel for Surgical
           Instruments
------------------------------------------------------------------------
49        ASTM F1058-02: Standard        Contact Person  ...............
           Specification for Wrought
           40Cobalt-20Chromium-16Iron-1
           5Nickel-7Molybdenum Alloy
           Wire and Strip for Surgical
           Implant Applications (UNS
           R30003 and UNS R30008)
------------------------------------------------------------------------
50        ASTM F1091-02: Standard        Contact Person  ...............
           Specification for Wrought
           Cobalt-20 Chromium-15
           Tungsten-10 Nickel Alloy
           Surgical Fixation Wire (UNS
           R30605)
------------------------------------------------------------------------
52        ASTM F1350-02: Standard        Contact Person  ...............
           Specification for Wrought 18
           Chromium-14 Nickel-2.5
           Molybdenum Stainless Steel
           Surgical Fixation Wire (UNS
           S31673)
------------------------------------------------------------------------
53        ASTM F1472-02a: Standard       Contact Person  ...............
           Specification for Wrought
           Titanium -6Aluminum -
           4Vanadium Alloy for Surgical
           Implant Applications (UNS
           R56400)
------------------------------------------------------------------------

[[Page 28504]]

 
54        ASTM F1580-01: Standard        Contact Person  ...............
           Specification for Titanium
           and Titanium-6 Aluminum-4
           Vanadium Alloy Powders for
           Coatings of Surgical
           Implants
------------------------------------------------------------------------
56        ISO 5832-1:1997: Implants for  Contact Person  ...............
           Surgery--Metallic materials--
           Part 1: Wrought Stainless
           Steel
------------------------------------------------------------------------
57        ISO 5832-2:1999: Implants for  Contact Person  ...............
           Surgery--Metallic Materials--
           Part 2: Unalloyed Titanium
------------------------------------------------------------------------
58        ISO 5832-3:1996: Implants for  Contact Person  ...............
           Surgery--Metallic Materials--
           Part 3: Wrought Titanium 6-
           Aluminium 4-Vanadium Alloy
------------------------------------------------------------------------
59        ISO 5832-4:1996: Implants for  Contact Person  ...............
           Surgery--Metallic Materials--
           Part 4: Cobalt-chromium-
           molybdenum Casting Alloy
------------------------------------------------------------------------
61        ISO 5832-6:1997: Implants for  Contact Person  ...............
           Surgery--Metallic Materials--
           Part 6: Wrought Cobalt-
           nickel-chromium-Molybdenum
           alloy
------------------------------------------------------------------------
62        ISO 5832-9:1992: Implants for  Contact Person  ...............
           Surgery--Metallic Materials--
           Part 9: Wrought High
           Nitrogen Stainless Steel
------------------------------------------------------------------------
63        ISO 5832-11:1994: Implants     Contact Person  ...............
           for Surgery--Metallic
           Materials--Part 11: Wrought
           Titanium 6-aluminium 7
           niobium Alloy
------------------------------------------------------------------------
64        ISO 5832-12:1996: Implants     Contact Person  ...............
           for Surgery--Metallic
           Materials--Part 12: Wrought
           Cobalt-chromium-molybdenum
           Alloy
------------------------------------------------------------------------
66        ISO 6474:1994: Implants for    Contact Person  ...............
           Surgery--Ceramic Materials
           Based on High Purity Alumina
------------------------------------------------------------------------
68        ISO 13782:1996: Implants for   Contact Person  ...............
           Surgery--Metallic Materials--
           Unalloyed Tantalum for
           Surgical Implant
           Applications
------------------------------------------------------------------------
76        ASTM F138-03: Standard         Contact Person  ...............
           Specification for Wrought 18
           Chromium-14 Nickel-2.5
           Molybdenum Stainless Steel
           Bar and Wire for Surgical
           Implants (UNS S31673)
------------------------------------------------------------------------
77        ASTM F139-03: Standard         Contact Person  ...............
           Specification for Wrought 18
           Chromium-14 Nickel-2.5
           Molybdenum Stainless Steel
           Sheet and Strip for Surgical
           Implants (UNS S31673)
------------------------------------------------------------------------
79        ASTM F961-03: Standard         Contact Person  ...............
           Specification for Cobalt-35
           Nickel-20 Chromium-10
           Molybdenum Alloy Forgings
           for Surgical Implants [UNS
           R30035]
------------------------------------------------------------------------
80        ASTM F1088-04ae1: Standard     Withdrawn and               132
           Specification for Beta-        replaced with
           Tricalcium Phosphate for       newer version
           Surgical Implantation
------------------------------------------------------------------------
81        ASTM F1609-03: Standard        Contact Person  ...............
           Specification for Calcium
           Phosphate Coatings for
           Implantable Materials
------------------------------------------------------------------------
82        ASTM F1713-03: Standard        Contact Person  ...............
           Specification for Wrought
           Titanium-13 Niobium-13
           Zirconium Alloy for Surgical
           Implant Applications
------------------------------------------------------------------------
85        ASTM F1854-01: Standard Test   Contact Person  ...............
           Method for Stereological
           Evaluation of Porous
           Coatings on Medical Implants
------------------------------------------------------------------------
86        ASTM F1926-03: Standard Test   Contact Person  ...............
           Method for Evaluation of the
           Environmental Stability of
           Calcium Phosphate Coatings
------------------------------------------------------------------------
87        ASTM F1978-00e1: Standard      Contact Person  ...............
           Test Method for Measuring
           Abrasion Resistance of
           Metallic Thermal Spray
           Coatings by Using the Taber
           Abraser
------------------------------------------------------------------------
88        ASTM F2024-00: Standard        Contact Person  ...............
           Practice for X-Ray
           Diffraction Determination of
           Phase Content of Plasma-
           Sprayed Hydroxyapatite
           Coatings
------------------------------------------------------------------------
89        ASTM F1873-98: Standard        Contact Person  ...............
           Specification for High-
           Purity Dense Yttria
           Tetragonal Zirconium Oxide
           Polycrystal (Y-TZP) for
           Surgical Implant
           Applications
------------------------------------------------------------------------

[[Page 28505]]

 
94        ASTM F601-03: Standard         Contact Person  ...............
           Practice for Fluorescent
           Penetrant Inspection of
           Metallic Surgical Implants
------------------------------------------------------------------------
95        ASTM F629-02: Standard         Contact Person  ...............
           Practice for Radiography of
           Cast Metallic Surgical
           Implants
------------------------------------------------------------------------
97        ASTM F2129-06: Standard Test   Withdrawn and               133
           Method for Conducting Cyclic   replaced with
           Potentiodynamic Polarization   newer version
           Measurements to Determine
           the Corrosion Susceptibility
           of Small Implant Devices
------------------------------------------------------------------------
98        ASTM F451-99ae1: Standard      Contact Person  ...............
           Specification for Acrylic
           Bone Cement
------------------------------------------------------------------------
102       ASTM F2082-06: Standard Test   Withdrawn and               134
           Method for Determination of    replaced with
           Transformation Temperature     newer version
           of Nickel-Titanium Shape
           Memory Alloys by Bend and
           Free Recovery
------------------------------------------------------------------------
103       ASTM F1801-97(2004): Standard  Contact Person  ...............
           Practice for Corrosion         and Type of
           Fatigue Testing of Metallic    Standard
           Implant Materials
------------------------------------------------------------------------
104       ASTM F1108-04: Standard        Contact Person  ...............
           Specification for Titanium-
           6Aluminum-4Vanadium Alloy
           Castings for Surgical
           Implants (UNS R56406)
------------------------------------------------------------------------
106       ASTM F648-04: Standard         Contact Person  ...............
           Specification for Ultra-High-
           Molecular-Weight
           Polyethylene Powder and
           Fabricated Form for Surgical
           Implants
------------------------------------------------------------------------
107       ASTM F746-04: Standard Test    Contact Person  ...............
           Method for Pitting or
           Crevice Corrosion of
           Metallic Surgical Implant
           Materials
------------------------------------------------------------------------
108       ASTM F1295-05: Standard        Contact Person  ...............
           Specification for Wrought
           Titanium-6 Aluminum-7
           Niobium Alloy for Surgical
           Implant Applications (UNS
           R56700)
------------------------------------------------------------------------
110       ASTM F1377-04: Standard        Contact Person  ...............
           Specification for Cobalt-28
           Chromium-6 Molybdenum Powder
           for Coating of Orthopedic
           Implants (UNS R30075)
------------------------------------------------------------------------
111       ASTM F1160-05: Standard Test   Contact Person  ...............
           Method for Shear and Bending
           Fatigue Testing of Calcium
           Phosphate and Metallic
           Medical and Composite
           Calcium Phosphate/Metallic
           Coatings
------------------------------------------------------------------------
112       ASTM F1044-05: Standard Test   Contact Person  ...............
           Method for Shear Testing of
           Calcium Phosphate Coatings
           and Metallic Coatings
------------------------------------------------------------------------
113       ASTM F1147-05: Standard Test   Contact Person  ...............
           Method for Tension Testing
           of Calcium Phosphate and
           Metal Coatings
------------------------------------------------------------------------
114       ASTM F2255-05: Standard Test   Contact Person  ...............
           Method for Strength
           Properties of Tissue
           Adhesives in Lap Shear by
           Tension Loading
------------------------------------------------------------------------
115       ASTM F2256-05: Standard Test   Contact Person  ...............
           Method for Strength
           Properties of Tissue
           Adhesives in T-Peel by
           Tension Loading
------------------------------------------------------------------------
116       ASTM F2258-05: Standard Test   Contact Person  ...............
           Method for Strength
           Properties of Tissue
           Adhesives in Tension
------------------------------------------------------------------------
117       ASTM F86-04: Standard          Contact Person  ...............
           Practice for Surface
           Preparation and Marking of
           Metallic Surgical Implants
------------------------------------------------------------------------
119       ASTM F688-05: Standard         Contact Person  ...............
           Specification for Wrought
           Cobalt-35 Nickel-20 Chromium-
           10 Molybdenum Alloy Plate,
           Sheet, and Foil for Surgical
           Implants (UNS R30035)
------------------------------------------------------------------------
120       ASTM F560-05: Standard         Contact Person  ...............
           Specification for Unalloyed
           Tantalum for Surgical
           Implant Applications (UNS
           R05200, UNS R05400)
------------------------------------------------------------------------
121       ASTM F2005-05: Standard        Contact Person  ...............
           Terminology for Nickel-
           Titanium Shape Memory Alloys
------------------------------------------------------------------------
122       ASTM F2063-05: Standard        Contact Person  ...............
           Specification for Wrought
           Nickel-Titanium Shape Memory
           Alloys for Medical Devices
           and Surgical Implants
------------------------------------------------------------------------

[[Page 28506]]

 
123       ISO 5832-5:2005: Implants for  Contact Person  ...............
           Surgery--Metallic Materials--
           Part 5: Wrought Cobalt-
           chromium-tungsten-nickel
           Alloy
------------------------------------------------------------------------
125       ASTM F2004-05: Standard Test   Contact Person  ...............
           Method for Transformation
           Temperature of Nickel-
           Titanium Alloys by Thermal
           Analysis
------------------------------------------------------------------------
126       ASTM F561-05a: Practice for    Contact Person  ...............
           Retrieval and Analysis of
           Implanted Medical Devices,
           and Associated Tissues
------------------------------------------------------------------------
127       ISO 5834-2:1998: Implants for  Contact Person  ...............
           Surgery--Ultra-High-
           Molecular-Weight
           Polyethylene--Part 2:
           Moulded Forms
------------------------------------------------------------------------
G. OB-GYN/Gastroenterology
------------------------------------------------------------------------
35        ASTM D6324-05 Standard Test    Withdrawn and                41
           Methods for Male Condoms       replaced with
           Made from Synthetic            newer version
           Materials
------------------------------------------------------------------------
H. Ophthalmic
------------------------------------------------------------------------
3         ISO 9340:1996 Optics and       Withdrawn       ...............
           Optical Instruments--Contact
           lenses--Determination of
           Strains for Rigid Contact
           Lenses
------------------------------------------------------------------------
12        ISO 11980:1997 Ophthalmic      Contact Person  ...............
           Optics--Contact Lenses and
           Contact Lens Care Products--
           Guidance for Clinical
           Investigations
------------------------------------------------------------------------
13        ISO 10942:2006 Ophthalmic      Withdrawn and                37
           Instruments--Direct            replaced with
           Ophthalmoscopes                newer version
------------------------------------------------------------------------
15        ISO 9394:1998 Ophthalmic       Contact Person  ...............
           Optics--Contact Lenses and
           Contact Lens Care Products--
           Determination of
           Biocompatibility By Ocular
           Study Using Rabbit Eyes
------------------------------------------------------------------------
18        ISO 10943:2006 Ophthalmic      Withdrawn and                38
           Instruments--Indirect          replaced with
           Ophthalmoscopes                newer version
------------------------------------------------------------------------
20        ISO 11979-1:2006 Ophthalmic    Withdrawn and                40
           implants--Intraocular          replaced with
           Lenses--Part 1: Vocabulary     newer version
------------------------------------------------------------------------
23        ISO 11981:1999 Ophthalmic      Contact Person  ...............
           Optics--Contact Lenses And
           Contact Lens Care Products--
           Determination of Physical
           Compatibility of Contact
           Lens Care Products With
           Contact Lenses
------------------------------------------------------------------------
24        ISO 11986:1999 Ophthalmic      Contact Person  ...............
           Optics--Contact Lenses and
           Contact Lens Care Products--
           Guidelines for Determination
           of Preservative Uptake and
           Release
------------------------------------------------------------------------
34        ANSI Z80.20-2004 Ophthalmics-- Contact Person  ...............
           Contact Lenses--Standard
           Terminology, Tolerances,
           Measurements and
           Physicochemical Properties
------------------------------------------------------------------------
I. Orthopedic/Physical Medicine
------------------------------------------------------------------------
73        ISO 5838-1:1995: Implants for  Contact Person  ...............
           Surgery--Skeletal Pins and
           Wires--Part 1: Material and
           Mechanical Requirements
------------------------------------------------------------------------
74        ISO 5838-2:1991: Implants for  Contact Person  ...............
           Surgery--Skeletal Pins and
           Wires--Part 2: Steinmann
           Skeletal Pins--Dimensions
------------------------------------------------------------------------
75        ISO 5838-3:1993: Implants for  Contact Person  ...............
           Surgery--Skeletal Pins and
           Wires--Part 3: Kirschner
           Skeletal Wires
------------------------------------------------------------------------
79        ISO 7206-8:1995: Implants for  Contact Person  ...............
           Surgery--Partial and Total
           Hip Joint Prostheses--Part
           8: Endurance Performance of
           Stemmed Femoral Components
           With Application of Torsion
------------------------------------------------------------------------
80        ISO 8828:1988: Implants for    Contact Person  ...............
           Surgery--Guidance on Care
           and Handling of Orthopaedic
           Implants
------------------------------------------------------------------------
81        ISO 9583:1993: Implants for    Contact Person  ...............
           Surgery--Non-destructive
           Testing--Liquid Penetrant
           Inspection of Metallic
           Surgical Implants
------------------------------------------------------------------------

[[Page 28507]]

 
82        ISO 9584:1993: Implants for    Contact Person  ...............
           Surgery--Non-destructive
           Testing--Radiographic
           Examination of Cast Metallic
           Surgical Implants
------------------------------------------------------------------------
83        ISO 13402:1995: Surgical and   Contact Person  ...............
           Dental Hand Instruments--
           Determination of Resistance
           Against Autoclaving,
           Corrosion and Thermal
           Exposure
------------------------------------------------------------------------
121       ISO 7207-1:1994: Implants for  Contact Person  ...............
           Surgery--Components for
           Partial and Total Knee Joint
           Prostheses--Part 1:
           Classification, Definitions
           and Designation of
           Dimensions
------------------------------------------------------------------------
155       ISO 7207-2:1998: Implants for  Contact Person  ...............
           Surgery--Components for
           Partial and Total Knee Joint
           Prostheses--Part 2:
           Articulating Surfaces Made
           of Metal, Ceramic and
           Plastics Materials
------------------------------------------------------------------------
163       ASTM F543-02e1, Standard       Withdrawn and               202
           Specification and Test         replaced with
           Methods for Metallic Medical   newer version
           Bone Screws
------------------------------------------------------------------------
166       ASTM F897-02: Standard Test    Contact Person  ...............
           Method for Measuring
           Fretting Corrosion of
           Osteosynthesis Plates and
           Screws
------------------------------------------------------------------------
167       ASTM F1089-02: Standard Test   Contact Person  ...............
           Method for Corrosion of
           Surgical Instruments
------------------------------------------------------------------------
168       ASTM F1781-03: Standard        Contact Person  ...............
           Specification for
           Elastomeric Flexible Hinge
           Finger Total Joint Implants
------------------------------------------------------------------------
171       ASTM F1814-97a(2003):          Contact Person  ...............
           Standard Guide for
           Evaluating Modular Hip and
           Knee Joint Components
------------------------------------------------------------------------
172       ASTM F1798-97(2003): Standard  Contact Person  ...............
           Guide for Evaluating the
           Static and Fatigue
           Properties of
           Interconnection Mechanisms
           and Subassemblies Used in
           Spinal Arthrodesis Implants
------------------------------------------------------------------------
175       ASTM F1582-98(2003): Standard  Contact Person  ...............
           Terminology Relating to
           Spinal Implants
------------------------------------------------------------------------
177       ASTM F1264-03: Standard        Contact Person  ...............
           Specification and Test
           Methods for Intramedullary
           Fixation Devices
------------------------------------------------------------------------
178       ASTM F1440-92(2002): Standard  Contact Person  ...............
           Practice for Cyclic Fatigue
           Testing of Metallic Stemmed
           Hip Arthroplasty Femoral
           Components Without Torsion
------------------------------------------------------------------------
179       ASTM F2068-03: Standard        Contact Person  ...............
           Specification for Femoral
           Prostheses--Metallic
           Implants
------------------------------------------------------------------------
180       ASTM F366-04: Standard         Contact Person  ...............
           Specification for Fixation
           Pins and Wires
------------------------------------------------------------------------
181       ASTM F1717-04: Standard Test   Contact Person  ...............
           Methods for Spinal Implant
           Constructs in a
           Vertebrectomy Model
------------------------------------------------------------------------
182       ASTM F1800-04: Standard Test   Contact Person  ...............
           Method for Cyclic Fatigue
           Testing of Metal Tibial Tray
           Components of Total Knee
           Joint Replacements
------------------------------------------------------------------------
183       ASTM F1875-98(2004): Standard  Contact Person  ...............
           Practice for Fretting
           Corrosion Testing of Modular
           Implant Interfaces: Hip
           Femoral Head-bore and Cone
           Taper Interface
------------------------------------------------------------------------
185       ASTM F2267-04: Standard Test   Contact Person  ...............
           Method for Measuring Load
           Induced Subsidence of an
           Intervertebral Body Fusion
           Device Under Static Axial
           Compression
------------------------------------------------------------------------
186       ASTM F2077-03: Test Methods    Contact Person  ...............
           for Intervertebral Body
           Fusion Devices
------------------------------------------------------------------------
187       ASTM F2193-02: Standard        Contact Person  ...............
           Specifications and Test
           Methods for Components Used
           in the Surgical Fixation of
           the Spinal Skeletal System
------------------------------------------------------------------------
188       ISO 14243-1:2002: Implants     Contact Person  ...............
           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
------------------------------------------------------------------------

[[Page 28508]]

 
189       ISO 14243-2:2000: Implants     Contact Person  ...............
           for Surgery--Wear of Total
           Knee-joint Prostheses--Part
           2: Methods of Measurement
------------------------------------------------------------------------
190       ISO 14243-3:2004: Implants     Contact Person  ...............
           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
------------------------------------------------------------------------
191       ISO 14879-1:2000: Implants     Contact Person  ...............
           for Surgery--Total Knee-
           joint Prostheses--Part 1:
           Determination of Endurance
           Properties of Knee Tibial
           Trays
------------------------------------------------------------------------
192       ASTM F1223-05: Standard Test   Contact Person  ...............
           Method for Determination of
           Total Knee Replacement
           Constraint
------------------------------------------------------------------------
J. Radiology
------------------------------------------------------------------------
34        IEC 60601-2-7 (1998) Medical   Contact Person  ...............
           Electrical Equipment--Part 2-
           7: Particular Requirements
           for the Safety of High-
           Voltage Generators of
           Diagnostic X-ray Generators
------------------------------------------------------------------------
68        NEMA MS 4-2006 Acoustic Noise  Withdrawn and               151
           Measurement Procedure for      replaced with
           Diagnosing Magnetic            newer version
           Resonance Imaging Devices
------------------------------------------------------------------------
101       ANSI / IESNA RP-27.1-05        Withdrawn and               153
           Recommended Practice for       replaced with
           Photobiological Safety for     newer version
           Lamps and Lamp Systems--
           General Requirements
------------------------------------------------------------------------
104       IEC 60601-2-33 (2006),         Withdrawn and               161
           Medical Electrical             replaced with
           Equipment--Part 2-33:          newer version
           Particular Requirements for
           the Safety of Magnetic
           Resonance Equipment for
           Medical Diagnosis
------------------------------------------------------------------------
111       ISO 11554:2006 Optics and      Withdrawn and               155
           Photonics--Lasers and Laser-   replaced with
           Related equipment--Test        newer version
           Methods for Laser Beam
           Power, Energy and Temporal
           Characteristics
------------------------------------------------------------------------
K. Software
------------------------------------------------------------------------
1         ISO/IEC 12207:1995             Withdrawn       ...............
           Information Technology--
           Software Life Cycle
           Processes
------------------------------------------------------------------------
3         IEEE/EIA 12207.0-1996          Withdrawn       ...............
           Industry Implementation of
           International Standard ISO/
           IEC 12207:1995(ISO/IEC
           12207) Standard for
           Information Technology--
           Software Life Cycle
           Processes
------------------------------------------------------------------------
5         IEEE 1074-1997 Standard for    Withdrawn       ...............
           Developing a Software
           Project Life Cycle Process
------------------------------------------------------------------------
6         IEEE 1012-2004 Standard for    Withdrawn       ...............
           Software Verification and
           Validation
------------------------------------------------------------------------
7         AAMI / ANSI SW68:2001 Medical  Withdrawn       ...............
           Device Software--Software
           Life Cycle Processes
------------------------------------------------------------------------
L. Sterility
------------------------------------------------------------------------
67        ASTM F1140-2005, Standard      Withdrawn and               196
           Test Methods for Internal      replaced with
           Pressurization Failure         newer version
           Resistance of Unrestrained
           Packages for Medical
           Applications
------------------------------------------------------------------------
68        ASTM F1585:2000, Standard      Withdrawn       ...............
           Guide for Integrity Testing
           of Porous Barrier Medical
           Packages
------------------------------------------------------------------------
69        ASTM F1608:2004, Standard      Withdrawn and               197
           Test Method for Microbial      replaced with
           Ranking of Porous Packaging    newer version
           Materials (Exposure Chamber
           Method
------------------------------------------------------------------------
89        ASTM F2054-05, Standard Test   Withdrawn and               198
           Method for Burst Testing of    replaced with
           Flexible Package Seals Using   newer version
           Internal Air Pressurization
           Within Restraining Plates
------------------------------------------------------------------------
121       ASTM D4169-05, Standard        Withdrawn and               199
           Practice for Performance       replaced with
           Testing of Shipping            newer version
           Containers and Systems
------------------------------------------------------------------------
122       ASTM F88-2006, Standard Test   Withdrawn and               200
           Method for Seal Strength of    replaced with
           Flexible Barrier Materials     newer version
------------------------------------------------------------------------

[[Page 28509]]

 
M. Tissue Engineering
------------------------------------------------------------------------
1         ASTM F2064-00(2006): Standard  Withdrawn and                 8
           Guide for Characterization     replaced with
           and Testing of Alginates as    newer version
           Starting Materials Intended
           for use in Biomedical and
           Tissue-Engineered Medical
           Products Application
------------------------------------------------------------------------

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. & Date
----------------------------------------------------------------------------------------------------------------
A. Anesthesia
----------------------------------------------------------------------------------------------------------------
71                       Lung Ventilators for Medical use--Particular                           ISO 10651-5:2006
                          Requirements for Basic Safety and Essential
                          Performance--Part 5: Gas-powered Emergency
                          Resuscitators
----------------------------------------------------------------------------------------------------------------
B. Cardiovascular/Neurology
----------------------------------------------------------------------------------------------------------------
59                       Implants for surgery--Cardiac Pacemakers--Part                          ISO 5841-3:2000
                          3: Low-profile Connectors (IS-1) for
                          Implantable Pacemakers
----------------------------------------------------------------------------------------------------------------
C. Dental/ENT
----------------------------------------------------------------------------------------------------------------
140                      Dental Base Metal Casting Alloys--Part 2: Nickel-            ISO 6871-2:1994/Amd 1:2005
                          based Alloys
----------------------------------------------------------------------------------------------------------------
141                      Dental Base Metal Casting Alloys--Part 1: Cobalt-                       ISO 6871-1:1994
                          based Alloys
----------------------------------------------------------------------------------------------------------------
142                      Dental Base Metal Casting Alloys--Part 1: Cobalt-            ISO 6871-1:1994/Amd 1:2005
                          based Alloys
----------------------------------------------------------------------------------------------------------------
D. General
----------------------------------------------------------------------------------------------------------------
36                       Technical Information Report: Medical Devices--            ANSI/AAMI/ISO TIR 16142:2006
                          Guidance on the Selection of Standards in
                          Support of Recognized Essential Principles of
                          Safety and Performance of Medical Devices,
                          Second Edition
----------------------------------------------------------------------------------------------------------------
E. General Hospital/General Plastic Surgery
----------------------------------------------------------------------------------------------------------------
170                      Sterile hypodermic syringes for single use--Part    ISO 7886-1:1993/ Corrigendum 1:1995
                          1: Syringes for Manual Use
----------------------------------------------------------------------------------------------------------------
171                      Sterile, Single-use Intravascular Catheters-       ISO 10555-3:1996/ Corrigendum 1:2002
                          Part 3: Central Venous Catheters
----------------------------------------------------------------------------------------------------------------
173                      Infusion Equipment for Medical Use--Part 2:         ISO 8536-2:2001/ Corrigendum 1:2003
                          Closures for Infusion Bottles
----------------------------------------------------------------------------------------------------------------
174                      Pen-injectors for Medical Use--Part 4:                                 ISO 11608-4:2006
                          Requirements and Test Methods for Electronic
                          and Electromechanical Pen-injectors
----------------------------------------------------------------------------------------------------------------
176                      Standard Guide for Assessment of Medical Gloves                           ASTM D7103-06
----------------------------------------------------------------------------------------------------------------
179                      Needle-free Injectors for Medical Use--                                  ISO 21649:2006
                          Requirements and Test Methods
----------------------------------------------------------------------------------------------------------------
180                      Standard Specification for Surgical Gowns                                 ASTM F2407-06
                          Intended for Use in Healthcare Facilities
----------------------------------------------------------------------------------------------------------------
182                      Medical Electrical Equipment-- Part 2-38:          IEC 60601-2-38 1996/Amendment 1:1999
                          Particular Requirements for the Safety of
                          Electrically Operated Hospital Beds
----------------------------------------------------------------------------------------------------------------
F. In Vitro Diagnostic
----------------------------------------------------------------------------------------------------------------
128                      Evaluation of Matrix Effects; Approved                                CLSI EP14-A2 2005
                          Guideline--Second Edition
----------------------------------------------------------------------------------------------------------------
129                      Quality Control of Microbiological Transport                            CLSI M40-A 2003
                          Systems
----------------------------------------------------------------------------------------------------------------
G. Materials
----------------------------------------------------------------------------------------------------------------
135                      Standard Test Method for Burst Strength of                                ASTM F2392-04
                          Surgical Sealants
----------------------------------------------------------------------------------------------------------------
136                      Standard Test Method for Wound Closure Strength                           ASTM F2458-05
                          of Tissue Adhesives and Sealants
----------------------------------------------------------------------------------------------------------------

[[Page 28510]]

 
H. OB-GYN/Gastroenterology
----------------------------------------------------------------------------------------------------------------
42                       Medical electrical equipment--Part 2: Particular      IEC 60601-2-18 (1996) Amendment 1
                          Requirements for the Safety of Endoscopic                                         2000
                          Equipment
----------------------------------------------------------------------------------------------------------------
43                       Rubber Condoms--Guidance on the Use of ISO 4074                          ISO 16038:2005
                          in the Quality Management of Natural Rubber
                          Latex Condoms
----------------------------------------------------------------------------------------------------------------
I. Ophthalmic
----------------------------------------------------------------------------------------------------------------
43                       Ophthalmic Implants--Intraocular lenses--Part 8:                       ISO 11979-8:2006
                          Fundamental Requirements
----------------------------------------------------------------------------------------------------------------
J. Radiology
----------------------------------

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