Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 018, 52142-52153 [E7-18021]

Download as PDF 52142 Federal Register / Vol. 72, No. 176 / Wednesday, September 12, 2007 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. jlentini on PROD1PC65 with NOTICES ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public. Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held on October 10 and 11, 2007, from 8 a.m. to 6 p.m. Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and C, 620 Perry Pkwy, Gaithersburg, MD. Contact Person: James Swink, Center for Devices and Radiological Health (HFZ–450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240–276–4179, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512625. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: On October 10, 2007, the committee will discuss; make recommendations; and vote on a premarket approval application, sponsored by Medtronic, Inc., for the Endeavor Zotarolimus-Eluting Coronary Stent System, which is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo lesions of length ≤ 27 millimeters (mm) in native coronary arteries with reference vessel diameters of ≥ 2.5 mm to ≤ 3.5 mm. On October 11, 2007, the committee will discuss and make recommendations regarding clinical trial designs for carotid artery stenting VerDate Aug<31>2005 18:43 Sep 11, 2007 Jkt 211001 in patients not at high risk for adverse events from surgical revascularization. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ohrms/ dockets/ac/acmenu.htm, click on the year 2007 and scroll down to the appropriate advisory committee link. Procedure: On October 10, 2007, from 8 a.m. to 6 p.m., and on October 11, 2007, from 10:15 a.m. to 6 p.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before September 26, 2007. Oral presentations from the public will be scheduled for approximately 30 minutes at the beginning of committee deliberations on each day and for approximately 30 minutes near the end of the deliberations on each day. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before September 18, 2007. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by September 19, 2007. Closed Presentation of Data: On October 11, 2007, from 8 a.m. to 10:15 a.m., the meeting will be closed to permit discussion and review of clinical trial design issues for carotid artery stents intended to reopen stenotic carotid arteries in the neck. Information regarding trial designs and actual experience in conducting ongoing trials is considered trade secret and/or confidential information (5 U.S.C. 552b(c)(4)). Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. PO 00000 Frm 00098 Fmt 4703 Sfmt 4703 FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact AnnMarie Williams, Conference Management Staff, at 240–276–8932, at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/oc/advisory/ default.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: September 5, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7–17983 Filed 9–11–07; 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: 018 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ‘‘Modifications to the List of Recognized Standards, Recognition List Number: 018’’ (Recognition List Number: 018), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. DATES: Submit written or electronic comments concerning this document at any time. See section VII of this document for the effective date of the recognition of standards announced in this document. ADDRESSES: Submit written requests for single copies of ‘‘Modifications to the List of Recognized Standards, Recognition List Number: 018’’ to the Division of Small Manufacturers, E:\FR\FM\12SEN1.SGM 12SEN1 Federal Register / Vol. 72, No. 176 / Wednesday, September 12, 2007 / Notices 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 301–443–8818. Submit written comments concerning this document, or recommendations for additional standards for recognition, to the contact person (see FOR FURTHER INFORMATION CONTACT). Submit electronic comments by e-mail: standards@cdrh.fda.hhs.gov. This document may also be accessed on FDA’s Web site at 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: 018 modifications and other standards related information. FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices and Radiological Health (HFZ–84), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240–276–0533. SUPPLEMENTARY INFORMATION: 9561), FDA announced the availability of a guidance entitled ‘‘Recognition and Use of Consensus Standards.’’ The notice described how FDA would implement its standard recognition program and provided the initial list of recognized standards. Modifications to the initial list of recognized standards, as published in the Federal Register, are identified in table 1 of this document. TABLE 1. Federal Register Cite October 16, 1998 (63 FR 55617) July 12, 1999 (64 FR 37546) November 15, 2000 (65 FR 69022) May 7, 2001 (66 FR 23032) January 14, 2002 (67 FR 1774) October 2, 2002 (67 FR 61893) April 28, 2003 (68 FR 22391) March 8, 2004 (69 FR 10712) June 18, 2004 (69 FR 34176) October 4, 2004 (69 FR 59240) 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 May 27, 2005 (70 FR 30756) November 8, 2005 (70 FR 67713) March 31, 2006 (71 FR 16313) June 23, 2006 (71 FR 36121) November 3, 2006 (71 FR 64718) May 21, 2007 (72 FR 28500) These notices describe the addition, withdrawal, and revision of certain 52143 standards recognized by FDA. The agency maintains ‘‘hypertext markup language’’ (HTML) and ‘‘portable document format’’ (PDF) versions of the list of ‘‘FDA Recognized Consensus Standards.’’ Both versions are publicly accessible at the agency’s Internet site. See section VI of this document for electronic access information. Interested persons should review the supplementary information sheet for the standard to understand fully the extent to which FDA recognizes the standard. II. Modifications to the List of Recognized Standards, Recognition List Number: 018 FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the agency will recognize for use in satisfying premarket reviews and other requirements for devices. FDA will incorporate these modifications in the list of FDA Recognized Consensus Standards in the agency’s searchable database. FDA will use the term ‘‘Recognition List Number: 018’’ to identify these current modifications. In table 2 of this document, FDA describes the following modifications: (1) The withdrawal of standards and their replacement by others; (2) the correction of errors made by FDA in listing previously recognized standards; and (3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards. In section III of this document, FDA lists modifications the agency is making that involve the initial addition of standards not previously recognized by FDA. TABLE 2. Old Item No. Standard Change Replacement Item No. A. Anesthesia ASTM F1161–88, Standard Specification for Minimum Performance and Safety Requirements for Components and Systems of Anesthesia Gas Machines Withdrawn 15 ISO 5361–4:1987, Tracheal Tubes—Part 4: Cole Type Contact person 35 jlentini on PROD1PC65 with NOTICES 3 ISO 5361:1999, Anaesthetic and Respiratory Equipment—Tracheal Tubes and Connectors Contact person 36 ISO 5366–3:2001, Anaesthetic and Respiratory Equipment—Tracheostomy Tubes— Part 3: Pediatric Tracheostomy Tubes Contact person 42 ISO 5360:2006, Anaesthetic Vaporizers—Agent Specific Filling Systems Withdrawn and replaced with newer version VerDate Aug<31>2005 18:43 Sep 11, 2007 Jkt 211001 PO 00000 Frm 00099 Fmt 4703 Sfmt 4703 E:\FR\FM\12SEN1.SGM 12SEN1 74 52144 Federal Register / Vol. 72, No. 176 / Wednesday, September 12, 2007 / Notices TABLE 2.—Continued Old Item No. Standard Change 43 ISO 5362:2006, Anaesthetic Reservoir Bags Withdrawn and replaced with newer version 44 ISO 5366–1:2000, Anaesthetic and Respiratory Equipment—Tracheostomy Tubes— Part 1: Tubes and Connectors for Use in Adults Contact person 46 ISO 5367:2000, Breathing Tubes Intended for Use With Anaesthetic Apparatus and Ventilators Contact person 50 ASTM F920–93(1999): Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use with Humans Withdrawn 55 ASTM F1054–01: Standard Specification for Conical Fittings Withdrawn 61 IEC 60601–2–13(2003–05), Medical Electrical Equipment—Part 2–13: Particular Requirements for the Safety and Essential Performance of Anaesthetic Systems Contact person 62 ISO 5356–1:2004, Anaesthetic and Respiratory Equipment—Conical Connectors: Part 1: Cones and Sockets Contact person B. Biocompatibility AAMI / ANSI / ISO 10993–11:1993, Biological Evaluation of Medical Devices—Part 11: Tests for Systemic Toxicity Contact person 63 AAMI / ANSI / ISO 10993–6:1995/(R) 2001, Biological Evaluation of Medical Devices—Part 6: Test for Local Effects After Implantation Contact person 64 AAMI / ANSI / ISO 10993–5:1999, Biological Evaluation of Medical Devices—Part 5: Tests for In Vitro Cytotoxicity Contact person 68 ASTM F719–81(2002)e1: Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation Contact person 70 ASTM F750–87 (2002)e1: Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse Contact person 71 ASTM F1408–02e1: Standard Practice for Subcutaneous Screening Test for Implant Materials Contact person 83 ASTM E1262–88(2003): Standard Guide for Performance of the Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay Contact person 84 ASTM E1263–97(2003): Standard Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow Erythrocytes Contact person 85 ASTM E1280–97 (2003): Standard Guide for Performing the Mouse Lymphoma Assay for Mammalian Cell Mutagenicity Contact person 87 AAMI / ANSI / ISO 10993–10:2002, Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Sensitization Contact person 88 AAMI / ANSI / ISO 10993–12: 2002(E), Biological Evaluation of Medical Devices— Part 12: Sample Preparation and Reference materials Contact person 89 ASTM F749–98 (2002)e2: Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit Contact person 90 ASTM E1397–91(2003): Standard Practice for the in vitro Rat Hepatocyte DNA Repair Assay Contact person 91 jlentini on PROD1PC65 with NOTICES 21 ASTM E1398–91(2003): Standard Practice for the in vivo Rat Hepatocyte DNA Repair Assay Contact person 92 ASTM F748–04: Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices Contact person 93 ASTM F763–04: Standard Practice for Short-Term Screening of Implant Materials Contact person VerDate Aug<31>2005 18:43 Sep 11, 2007 Jkt 211001 PO 00000 Frm 00100 Fmt 4703 Sfmt 4703 E:\FR\FM\12SEN1.SGM 12SEN1 Replacement Item No. 75 Federal Register / Vol. 72, No. 176 / Wednesday, September 12, 2007 / Notices 52145 TABLE 2.—Continued Old Item No. Standard Change Replacement Item No. 94 ASTM F981–04: Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone Contact person 97 ASTM F1983–99(2003): Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications Contact person 98 AAMI / ANSI / ISO 10993–1:2003(E), Biological evaluation of medical devices—Part 1: Evaluation and Testing Contact person 99 ASTM F1904–98(2003): Standard Practice for Testing the Biological Responses to Particles In Vivo Contact person 100 ASTM E1372–95(2003): Standard Test Method for Conducting a 90–Day Oral Toxicity Study in Rats Contact person 106 ASTM F619–03: Standard Practice for Extraction of Medical Plastics Contact person 109 USP 29–NF21 Biological Tests <87>, Biological Reactivity Test, In Vitro—Direct Contact Test Contact person 110 USP 29–NF21 Biological Tests <87>, Biological Reactivity Test, In Vitro—Elution Test Contact person 111 USP 29–NF21 Biological Tests <88>, Biological Reactivity Tests, In Vivo, Procedure—Preparation of Sample Contact person 112 USP 29–NF21 Biological Tests <88>, Biological Reactivity Test, In Vitro, Classification of Plastics—Intracutaneous Test Contact person 113 USP 29–NF21 Biological Tests <88>, Biological Reactivity Tests, In Vivo, Classification of Plastics—Systemic Injection Test Contact person 114 ASTM F1877–05: Standard Practice for Characterization of Particles Contact person 115 ASTM F895–84(2006): Standard Test Method for Agar Diffusion cell Culture Screening for Cytotoxicity Contact person 116 ASTM F1439–03: Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials Contact person 2 IEC 60601-1, Medical electrical equipment — Part 1: General requirements for safety Withdrawn 11 ISO 2859–1:1999: Sampling Procedures for Inspection By Attributes—Part 1: Sampling Schemes Indexed by Acceptance Quality Limit (AQL)for Lot-by-Lot Inspection Withdrawn and replaced with newer year version 37 14 ANSI/ASQ Z1.4–2003: Sampling Procedures and Tables for Inspection by Attributes Withdrawn and replaced with newer year version 38 22 ISO 2768–1: 1989, General Tolerances—Part 1: Tolerances for Linear and Angular Dimensions Without Individual Tolerance Indications Contact name 23 ISO 2768–2: 1989, General Tolerances—Part 2: Geometrical Tolerances for Features Without Individual Tolerance Indications Contact name 24 IEC 60812, edition 2.0: 2006–01, Analysis Technique for System Reliability—Procedure for Failure Mode and Effects Analysis Withdrawn and replaced with newer year version 39 26 ISO 14971:2007: Medical devices—Application of Risk Management to Medical Devices Withdrawn and replaced with newer year version 40 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 jlentini on PROD1PC65 with NOTICES C. General VerDate Aug<31>2005 18:43 Sep 11, 2007 Jkt 211001 PO 00000 Frm 00101 Fmt 4703 Sfmt 4703 E:\FR\FM\12SEN1.SGM 12SEN1 52146 Federal Register / Vol. 72, No. 176 / Wednesday, September 12, 2007 / Notices TABLE 2.—Continued Old Item No. Standard Change 30 AAMI/ANSI/IEC 60601–1–2, Medical Electrical Equipment—Part 1–2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests. (The AAMI/ANSI/IEC 60601–1–2:2001 is the U.S. version of IEC 60601–1–2:2001 with identical requirements for electromagnetic compatibility (EMC) of medical electrical equipment.) Title change Type of standard Extent of recognition 34 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; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)) Extent of recognition 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. Extent of recognition D. General Hospital/ General Plastic Surgery ISO 8537:1991 Sterile Single-use Syringes, With or Without Needle, for Insulin Withdrawn duplicate 20 ISO 10555–1–1995 Sterile, Single-use Intravascular Catheters—Part 1: General Requirements Withdrawn duplicate 46 IEC 60601–2–2 2006 Medical Electrical Equipment—Part 2–2: Particular Requirements for the Safety of High Frequency Surgical Equipment Withdrawn and replaced with newer version 69 ISO 9626–1991: Stainless Steel Needle Tubing for the Manufacture of Medical Devices Withdrawn duplicate 72 ISO 10555–5 1996–06–15 Sterile, Single-use Intravascular Catheters—Part 5: Over-needle Peripheral Catheters Withdrawn duplicate 96 ASTM F2101–07 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus Aureus Withdrawn and replaced with newer version 199 113 ASTM F2100–07 Standard Specification for Performance of Materials Used in Medical Face Masks Withdrawn and replaced with newer version 198 108 ASTM F754–00 Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Polymer Fabricated in Sheet, Tube and Rod Shapes Transferred to materials 109 ASTM F881–94(2006) Standard Specification for Silicone Elastomer Facial Implants Withdrawn and replaced with newer version 185 128 ASTM F1670–07 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood Withdrawn and replaced with newer version 186 130 ASTM F1671–07 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System Withdrawn and replaced with newer version 187 151 USP 30:2007 Nonabsorbable Surgical Suture Withdrawn and replaced with newer version 188 152 USP 30<11>: 2007 Sterile Sodium Chloride for Irrigation Withdrawn and replaced with newer version 189 153 USP 30:2007 Absorbable Surgical Suture Withdrawn and replaced with newer version 190 154 jlentini on PROD1PC65 with NOTICES 18 USP 30<881>:2007 Tensile Strength Withdrawn and replaced with newer version 191 155 USP 30<861>:2007 Sutures—Diameter Withdrawn and replaced with newer version 192 156 USP 30<871>:2007 Sutures Needle Attachment Withdrawn and replaced with newer version 193 VerDate Aug<31>2005 18:43 Sep 11, 2007 Jkt 211001 PO 00000 Frm 00102 Fmt 4703 Sfmt 4703 E:\FR\FM\12SEN1.SGM 12SEN1 197 Federal Register / Vol. 72, No. 176 / Wednesday, September 12, 2007 / Notices 52147 TABLE 2.—Continued Old Item No. Standard Change Replacement Item No. 157 USP 30<11>: 2007 Sterile Water for Irrigation Withdrawn and replaced with newer version 194 158 USP 30<11>: 2007 Heparin Lock Flush Solution Withdrawn and replaced with newer version 195 159 USP 30<11>: 2007 Sodium Chloride Injection Withdrawn and replaced with newer version 196 181 ASTM F1862–07: 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 184 2 ASTM F75–07: Standard Specification for Cobalt–28 Chromium–6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075) Withdrawn and replaced with newer year version 137 15 ASTM F745–07: Standard Specification for 18 Chromium–12.5 Nickel–2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications Withdrawn and replaced with newer year version 138 26 ASTM F1314–07: 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) Withdrawn and replaced with newer year version 139 37 ASTM F1813–06: Standard Specification for Wrought Titanium—12 Molybdenum—6 Zirconium—2 Iron Alloy for Surgical Implant (UNS R58120) Withdrawn and replaced with newer year version 140 43 ASTM F2146–07: Standard Specification for Wrought Titanium–3Aluminum– 2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320) Withdrawn and replaced with newer year version 141 67 ISO 7153–1:1991/Amd. 1:1999, Surgical Instruments—Metallic Materials—Part 1: Stainless Steel Contact person 87 ASTM F1978–00(2007)e2: Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser Withdrawn and replaced with newer year version 89 ASTM F1873–98: Standard Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant Applications Withdrawn 106 ASTM F648–07: Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants Withdrawn and replaced with newer year version 128 ASTM F2213–06: Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment Title GH/GPS 108 ASTM F754–00: Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Polymer Fabricated in Sheet, Tube, and Rod Shapes Transferred from GH/GPS to Materials E. Materials 142 143 144 F. OB-GYN/Gastroenterology ISO 8600–3:1997 Amendment 1 2003, Optics and Optical Instruments—Medical Endoscopes and Endoscopic Accessories Part 3: Determination of Field of View and Direction of View of Endoscopes with Optics Withdraw duplicate 32 ASTM D3492–03 Standard Specification for Rubber Contraceptives (Male Condoms) Extent of recognition, processes impacted, relevant guidance 33 ASTM F623–99(2006) Standard Performance Specification for Foley Catheter Withdrawn and replaced with newer version 34 jlentini on PROD1PC65 with NOTICES 20 ISO 4074:2002/Cor.1:2003(E) Natural Latex Rubber Condoms—Requirements and Test Methods, Technical Corrigendum 1 Extent of recognition, relevant guidance G. Ophthalmic 1 VerDate Aug<31>2005 ISO 9338:1996 Optics and Optical Instruments—Contact Lenses—Determination of the Diameters 18:43 Sep 11, 2007 Jkt 211001 PO 00000 Frm 00103 Fmt 4703 Sfmt 4703 Withdrawn E:\FR\FM\12SEN1.SGM 12SEN1 44 52148 Federal Register / Vol. 72, No. 176 / Wednesday, September 12, 2007 / Notices TABLE 2.—Continued Old Item No. Standard Change Replacement Item No. 2 ISO 9339–1:1996 Optics and Optical Instruments—Contact Lenses—Determination of the Thickness—Part 1: Rigid Contact Lenses Withdrawn 4 ISO 9341:1996 Optics and Optical Instruments—Contact Lenses—Determination of Inclusions and Surface Imperfections for Rigid Contact Lenses Withdrawn 7 ISO 9913–1:1996 Optics and Optical Instruments—Contact Lenses—Part 1: Determination of Oxygen Permeability and Transmissibility with the FATT Method Withdrawn 8 ISO 10338:1996 Optics and Optical Instruments—Contact Lenses—Determination of Curvature Withdrawn 9 ISO 10339:1997 Ophthalmic Optics—Contact Lenses—Determination of Water Content of Hydrogel Lenses Withdrawn 10 ISO 10340:1995 Optics and Optical Instruments—Contact Lenses—Method for Determining the Extractable Substances Withdrawn 11 ISO 10344:1996 Optics and Optical Instruments—Contact Lenses—Saline Solution for Contact Lens Testing Withdrawn 16 ISO 9913–2:2000 Optics and Optical Instruments—Contact Lenses—Part 2: Determination of Oxygen Permeability and Transmissibility by the Coulometric Method Withdrawn 17 ISO 10939:2007 Ophthalmic Instruments—Slit-lamp Microscopes Withdrawn and replaced with newer version 19 ISO 11539:1999 Ophthalmic Optics—Contact Lenses—Classification of Contact Lenses and Contact Lens Materials Withdrawn 22 ISO 11979–3:2006 Ophthalmic Implants—Intraocular Lenses—Part 3: Mechanical Properties and Test Methods Withdrawn and replaced with newer version 36 25 ISO 12865:2006 Ophthalmic Instruments—Retinoscopes Withdrawn and replaced with newer version 39 27 ISO 11979–7:2006 Ophthalmic Implants—Intraocular Lenses—Part 7: Clinical Investigations Withdrawn and replaced with newer version 41 35 H. Orthopedic/ Physical Medicine 121 ISO 7207–1:1994, Implants for Surgery—Components for Partial and Total Knee Joint Prostheses—Part 1: Classification, Definitions and Designation of Dimensions Withdrawn 57 & 132 IEC 60731 (1997), (2002) Amendment 1, Medical Electrical Equipment—Dosimeters with Ionization Chambers as Used in Radiotherapy Withdrawn and combine 59 IEC 61168:1993, Radiotherapy Simulators—Functional Performance Characteristics Contact person 63 IEC 60601–2–43—Ed. 1.0, Medical Electrical Equipment—Part 2–43: Particular Requirements for the Safety of X-ray Equipment for Interventional Procedures Contact person 91 IEC 60601–2–8 (1997–08), Amendment 1—Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of Therapeutic X-ray Equipment Operating in the Range of 10 kV to 1 MV Withdrawn duplicate 103 ANSI / IESNA RP–27.3–1996, Recommended Practice for Photobiological Safety for Lamps—Risk Group Classification and Labeling Title 130 & 148 IEC 60601–2–37 (2004), (2005) Amendment 2, Medical Electrical Equipment—Part 2–37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment Withdrawn and combine 131 IEC 61217 2002:, Radiotherapy Equipment—Coordinates, Movements, and Scales Consolidated Ed. 1.1 Contact person jlentini on PROD1PC65 with NOTICES I. Radiology VerDate Aug<31>2005 18:43 Sep 11, 2007 Jkt 211001 PO 00000 Frm 00104 Fmt 4703 Sfmt 4703 E:\FR\FM\12SEN1.SGM 12SEN1 162 164 Federal Register / Vol. 72, No. 176 / Wednesday, September 12, 2007 / Notices 52149 TABLE 2.—Continued Old Item No. Standard Change 133 IEC 60601–2–11 (1997), (2004) Amendment 1, Medical Electrical Equipment—Part 2–11: Particular Requirements for the Safety of gamma Beam Therapy Equipment Title 145 IEC 61674 (1997), (2002) Amendment 1, Medical Electrical Equipment—Dosimeters with Ionization Chambers and/or Semi-conductor Detectors as Used in X-ray Diagnostic Imaging Contact person 28 ANSI/AAMI/ISO 11737–1:2006, Sterilization of Medical Devices—Microbiological Methods—Part 1: Determination of a Population of Microorganisms on Products, 2nd ed. Withdrawn and replaced with newer version 47 ANSI/AAMI ST37:1996, Flash Sterilization: Steam Sterilization of Patient Care Items for Immediate Use Withdrawn 49 ANSI/AAMI ST41:1999/(R) 2005, Ethylene Oxide Sterilization in Health Care Facilities: Safety and Effectiveness Reaffirmation 50 ANSI/AAMI ST42:1998, Steam Sterilization and Sterility Assurance Using Table-top Sterilizers in Office-based, Ambulatory-care Medical, Surgical, and Dental Facilities. Withdrawn 52 ANSI/AAMI ST59:1999, Sterilization of Health Care Products—Biological Indicators—Part 1: General Withdrawn 53 ANSI/AAMI ST66:1996, Sterilization of Health Care Products—Chemical Indicators—Part 2: Indicators for Air Removal Test Sheets and Packs Contact person 54 ANSI/AAMI/ISO 11737–2:1998, Sterilization of Medical Devices—Microbiological Methods—Part 2: Tests of Sterility Performed in the Validation of a Sterilization Process Contact person 60 ASTM F1327:1998, Standard Terminology Relating to Barrier Materials for Medical Packaging Contact person 63 ASTM F1886: 1998 (2004), Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection Contact person 64 ASTM F1929:1998 (2004), Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration Contact person 72 ANSI/AAMI ST33:1996, Guidelines for the Selection and Use of Reusable Rigid Sterilization Container Systems for Ethylene Oxide Sterilization and Steam Sterilization in Health Care Facilities Withdrawn 75 ANSI/AAMI/ISO 11137:1994, Sterilization of Health Care Products—Requirements for Validation and Routine Control—Radiation Sterilization and ANSI/AAMI/ISO 11137:1994 (Amendment 1:2002) Withdrawn 77 ANSI/AAMI ST24:1999/(R) 2005, Automatic, General Purpose Ethylene Oxide Sterilizers and Ethylene Oxide Sterilant Sources Intended for use in Health Care Facilities, 3rd ed. Reaffirmation 86 ASTM F1980:2002, Standard Guide for Accelerated Aging of Sterile Medical Device Packages Contact person 88 ANSI/AAMI/ISO 14937:2000, Sterilization of Health Care Products—General Requirements for Characterization of a Sterilizing Agent and the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices Extent of recognition 90 ASTM F2095–01, Standard Test Methods for Pressure Decay Leak Test for Nonporous Flexible Packages With and Without Restraining Plates Contact person 105 ANSI/AAMI ST46:2002, Steam Sterilization and Sterility Assurance in Health Care Facilities Withdrawn 116 ANSI/AAMI ST72:2002, Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing Contact person Replacement Item No. jlentini on PROD1PC65 with NOTICES J. Sterility VerDate Aug<31>2005 18:43 Sep 11, 2007 Jkt 211001 PO 00000 Frm 00105 Fmt 4703 Sfmt 4703 E:\FR\FM\12SEN1.SGM 12SEN1 227 52150 Federal Register / Vol. 72, No. 176 / Wednesday, September 12, 2007 / Notices TABLE 2.—Continued Old Item No. Standard Change Replacement Item No. ANSI/AAMI ST35:2003, Safe Handling and Biological Decontamination of Reusable Medical Devices in Health Care Facilities and in Nonclinical Settings Extent of recognition 120 ASTM D3078:2002, Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission Contact person 123 ASTM F2096–04, Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test) Contact person 134 ANSI/AAMI ST44:2002, Resistometers Used for Characterizing the Performance of Biological and Chemical Indicators Withdrawn 135 ANSI/AAMI ST63:2002, Sterilization of Health Care Products—Requirements for the Development, Validation and Routine Control of an Industrial Sterilization Process for Medical Devices—Dry heat Extent of recognition 136 ANSI/AAMI ST67:2003, Sterilization of Health Care Products—Requirements for Products Labeled ‘sterile’ Contact person 137 ANSI/AAMI/ISO TIR 11139:2006, Sterilization of Health Care Products—Vocabulary Withdrawn and replaced with newer version 144 ASTM F2203–02e1, Standard Test Method for Linear Measurement Using Precision Steel Rule Contact person 145 ASTM F2217–02, Standard Practice for Coating/Adhesive Weight Determination Contact person 146 ASTM F2227–02, Standard Test Method of Leaks in Non-sealed and Empty Medical Packaging Trays by C02 Tracer Gas Method Contact person 147 ASTM F2228–02, Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by C02 Tracer Gas Method Contact person 148 ASTM F2250–03, Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials Contact person 149 ASTM F2251–03e1, Standard Test Method for Thickness Measurement of Flexible Packaging Material Contact person 150 ASTM F2252–03, Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape Contact person 163 ANSI/AAMI/ISO 11737–3:2004, Sterilization of Medical Devices—Microbiological Methods—Part 3: Guidance on Evaluation and Interpretation of Bioburden Data Withdrawn 167 ASTM F2097–05, Standard Guide for Design and Evaluation of Primary Packaging for Medical Products Contact person 168 ASTM F2338–05, Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method Contact person 169 ASTM F2391–05, Standard Test Method for Measuring Package and Seal Integrity Using Helium as Tracer Gas Contact person 170 ASTM F2475–05, Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials Contact person 171 ANSI/AAMI/ISO 15882:2003, Chemical Indicators—Guidance on the Selection, Use, and Interpretation of Results Contact person 172 jlentini on PROD1PC65 with NOTICES 117 AOAC 6.2.01:2006, Official Method 955.14, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution Method Withdrawn and replaced with newer version 211 173 AOAC 6.2.02:2006, Official Method 991.47, Testing Disinfectants Against Salmonella choleraesuis, Hard Surface Carrier Test Method Withdrawn and replaced with newer version 212 174 AOAC 6.2.03:2006, Official Method 991.48, Testing Disinfectants Against Staphylococcus aureus, Hard Surface Carrier Test Method Withdrawn and replaced with newer version 213 VerDate Aug<31>2005 18:43 Sep 11, 2007 Jkt 211001 PO 00000 Frm 00106 Fmt 4703 Sfmt 4703 E:\FR\FM\12SEN1.SGM 12SEN1 221 Federal Register / Vol. 72, No. 176 / Wednesday, September 12, 2007 / Notices 52151 TABLE 2.—Continued Old Item No. Standard Change Replacement Item No. AOAC 6.2.04:2006, Official Method 955.15, Testing Disinfectants Against Staphylococcus aureus, Use-Dilution Method Withdrawn and replaced with newer version 214 176 AOAC 6.2.05:2006, Official Method 991.49, Testing Disinfectants Against Pseudomonas aeruginosa, Hard Surface Carrier Test Method Withdrawn and replaced with newer version 215 177 AOAC 6.2.06:2006, Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use-Dilution Method Withdrawn and replaced with newer version 216 178 AOAC 6.3.02:2006, Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes Withdrawn and replaced with newer version 217 179 AOAC 6.3.05:2006, Official Method 966.04, Sporicidal Activity of Disinfectants, Method I Withdrawn and replaced with newer version 218 180 AOAC 6.3.06:2006, Official Method 965.12, Tuberculocidal Activity of Disinfectants Withdrawn and replaced with newer version 219 181 ANSI/AAMI ST58:2005, Chemical Sterilization and High-Level Disinfection in Health Care Facilities Title, Devices affected and Relevant guidance 182 USP 30:2007, Biological Indicator for Dry-Heat Sterilization, Paper Carrier Withdrawn and replaced with newer version 202 183 USP 30:2007, Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier Withdrawn and replaced with newer version 203 184 USP 30:2007, Biological Indicator for Steam Sterilization, Paper Carrier Withdrawn and replaced with newer version 204 185 USP 30:2007, <61> Microbial Limits Test Withdrawn and replaced with newer version 205 186 USP 30:2007, <71> Microbiological Tests, Sterility Tests Withdrawn and replaced with newer version 206 187 USP 30:2007, <85> Biological Tests and Assays, Bacterial Endotoxin Test (LAL) Withdrawn and replaced with newer version 207 188 USP 30:2007, <151> Pyrogen Test (USP Rabbit Test) Withdrawn and replaced with newer version 208 189 USP 30:2007, <161> Transfusion and Infusion Assemblies and Similar Medical Devices Withdrawn and replaced with newer version 209 190 USP 30:2007, Biological Indicator for Steam Sterilization, Self-Contained Withdrawn and replaced with newer version 210 193 ANSI/AAMI/ISO 11607–1:2006, Packaging for Terminally Sterilized Medical Devices—Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems, 3rd ed. Contact person 194 ANSI/AAMI/ISO 11607–2:2006, Packaging for Terminally Sterilized Medical Devices—Part 2: Validation Requirements for Forming, Sealing and Assembly Processes, 1st ed. Contact person 196 ASTM F1140–2005, Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages for Medical Applications Contact person 197 ASTM F1608:2004, Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) Contact person 198 jlentini on PROD1PC65 with NOTICES 175 ASTM F2054–05, Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates Contact person 199 ASTM D4169–05, Standard Practice for Performance Testing of Shipping Containers and Systems Contact person 200 ASTM F88–2005, Standard Test Method for Seal Strength of Flexible Barrier Materials Contact person VerDate Aug<31>2005 18:43 Sep 11, 2007 Jkt 211001 PO 00000 Frm 00107 Fmt 4703 Sfmt 4703 E:\FR\FM\12SEN1.SGM 12SEN1 52152 Federal Register / Vol. 72, No. 176 / Wednesday, September 12, 2007 / Notices TABLE 2.—Continued Old Item No. Standard Change Replacement Item No. K. Tissue Engineering 3 ASTM F2212–02(2007)e1, Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) III. Listing of New Entries In table 3 of this document, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized Withdrawn and replaced with newer version standards under Recognition List Number: 018. TABLE 3. Item No. Title of Standard Reference No. and Date A. Anesthesia 72 Lung Ventilators for Medical Use—Particular Requirements for Basic Safety and Essential Performance—Part 5: Gas-powered Emergency Resuscitators ISO 10651–5:2006 73 Lung Ventilators—Part 4: Particular Requirements for Operator Powered Resuscitators ISO 10651–4:2002 B. Biocompatibility 117 Biological Evaluation of Medical Devices—Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity ANSI/AAMI/ISO 10993–3: 2003 C. Dental/ ENT 144 Dentistry-Mercury and Alloys for Dental Amalgam ISO 24234: 2004(E) D. OB-GYN/Gastroenterology 45 Standard Test Methods for Enteral Feeding Devices with a Retention Balloon ASTM F2528–06 E. Ophthalmic 42 Ophthalmic Implants—Intraocular lenses—Part 2: Optical Properties and Test Methods ISO 11979–2:1999/ Corrigendum1:2003 43 Ophthalmic Optics—Contact Lenses and Contact Lens Care Products—Determination of Physical Compatibility of Contact Lens Care Products with Contact Lenses ISO 11981:1999/ Corrigendum1:2005 45 Ophthalmic Optics—Contact Lenses—Part 2: Tolerances ISO 18369–2:2006 46 Ophthalmic Optics—Contact Lenses—Part 3: Measurement Methods ISO 18369–3:2006 48 Ophthalmic Implants—Intraocular Lenses—Part 5: Biocompatibility ISO 11979–5:2006 49 Ophthalmic Implants—Intraocular Lenses—Part 9: Multifocal Intraocular Lenses ISO 11979–9:2006 50 Ophthalmic implants—Intraocular lenses—Part 10: Phakic Intraocular Lenses ISO 11979–10:2006 51 Ophthalmic Instruments—Fundamental Requirements and Test Methods Part 2: Light Hazard Protection ISO 15004–2:2007 165 ‘‘Quality Control Manual’’ Template for Manufacturers of Displays and Workstations Labeled for Final Interpretation in Full-field Digital Mammography NEMA XR 22–2006 166 ‘‘Quality Control Manual’’ Template for Manufacturers of Hardcopy Output Devices Labeled for Final Interpretation in Full-field Digital Mammography NEMA XR 23–2006 201 Containment Devices for Reusable Medical Device Sterilization ANSI/AAMI ST77:2006 220 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities ANSI/AAMI ST79:2006 F. Radiology jlentini on PROD1PC65 with NOTICES G. Sterility VerDate Aug<31>2005 18:43 Sep 11, 2007 Jkt 211001 PO 00000 Frm 00108 Fmt 4703 Sfmt 4703 E:\FR\FM\12SEN1.SGM 12SEN1 11 Federal Register / Vol. 72, No. 176 / Wednesday, September 12, 2007 / Notices 52153 TABLE 3.—Continued Item No. Title of Standard Reference No. and Date 222 Sterilization of Health Care Products—Biological and Chemical Indicators—Test Equipment ANSI/AAMI/ISO 18472:2006 223 Sterilization of Health Care Products—Biological Indicators—Part 1: General Requirements ANSI/AAMI/ISO 11138–1:2006 224 Sterilization of Health Care Products—Radiation—Part 1: Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices ANSI/AAMI/ISO 11137–1:2006 225 Sterilization of Health Care Products—Radiation—Part 2: Establishing the Sterilization Dose ANSI/AAMI/ISO 11137–2:2006 226 Sterilization of Health Care Products—Radiation—Part 3: Guidance on Dosimetric Aspects ANSI/AAMI/ISO 11137–3:2006 H. Tissue Engineering 9 Standard Guide for Classification of Therapeutic Skin Substitutes ASTM F2311–06 10 Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage ASTM F2451–05 IV. List of Recognized Standards VI. Electronic Access FDA maintains the agency’s current list of FDA recognized consensus standards in a searchable database that may be accessed directly at FDA’s Web site at 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. You may obtain a copy of ‘‘Guidance on the Recognition and Use of Consensus Standards’’ by using the Internet. The Center for Devices and Radiological Health (CDRH) maintains a site on the Internet for easy access to information including text, graphics, and files that you may download to a personal computer with access to the Internet. Updated on a regular basis, the CDRH home page includes the guidance as well as the current list of recognized standards and other standards related documents. After publication in the Federal Register, this notice announcing ‘‘Modification to the List of Recognized Standards, Recognition List Number: 018’’ will be available on the CDRH home page. You may access the CDRH home page at 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. jlentini on PROD1PC65 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 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. VerDate Aug<31>2005 18:43 Sep 11, 2007 Jkt 211001 VII. Submission of Comments and Effective Date Interested persons may submit to the contact person (see FOR FURTHER INFORMATION CONTACT) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified PO 00000 Frm 00109 Fmt 4703 Sfmt 4703 with the docket number found in brackets in the heading of this document. FDA will consider any comments received in determining whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 018. These modifications to the list or recognized standards are effective upon publication of this notice in the Federal Register. Dated: August 30, 2007. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E7–18021 Filed 9–11–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; Comment Request; The Hispanic Community Health Study (HCHS)/ Study of Latinos (SOL) SUMMARY: Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on July 11, 2007, pages 37789– 37790, and allowed 60-days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may E:\FR\FM\12SEN1.SGM 12SEN1

Agencies

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


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0226]


Food and Drug Administration Modernization Act of 1997: 
Modifications to the List of Recognized Standards, Recognition List 
Number: 018

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a 
publication containing modifications the agency is making to the list 
of standards FDA recognizes for use in premarket reviews (FDA 
recognized consensus standards). This publication, entitled 
``Modifications to the List of Recognized Standards, Recognition List 
Number: 018'' (Recognition List Number: 018), will assist manufacturers 
who elect to declare conformity with consensus standards to meet 
certain requirements for medical devices.

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

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

[[Page 52143]]

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

FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices 
and Radiological Health (HFZ-84), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 240-276-0533.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 204 of the Food and Drug Administration Modernization Act 
of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended 
section 514 allows FDA to recognize consensus standards developed by 
international and national organizations for use in satisfying portions 
of device premarket review submissions or other requirements.
    In a notice published in the Federal Register of February 25, 1998 
(63 FR 9561), FDA announced the availability of a guidance entitled 
``Recognition and Use of Consensus Standards.'' The notice described 
how FDA would implement its standard recognition program and provided 
the initial list of recognized standards.
    Modifications to the initial list of recognized standards, as 
published in the Federal Register, are identified in table 1 of this 
document.

                                Table 1.
------------------------------------------------------------------------
                          Federal Register Cite
-------------------------------------------------------------------------
October 16, 1998 (63 FR 55617)
------------------------------------------------------------------------
July 12, 1999 (64 FR 37546)
------------------------------------------------------------------------
November 15, 2000 (65 FR 69022)
------------------------------------------------------------------------
May 7, 2001 (66 FR 23032)
------------------------------------------------------------------------
January 14, 2002 (67 FR 1774)
------------------------------------------------------------------------
October 2, 2002 (67 FR 61893)
------------------------------------------------------------------------
April 28, 2003 (68 FR 22391)
------------------------------------------------------------------------
March 8, 2004 (69 FR 10712)
------------------------------------------------------------------------
June 18, 2004 (69 FR 34176)
------------------------------------------------------------------------
October 4, 2004 (69 FR 59240)
------------------------------------------------------------------------
May 27, 2005 (70 FR 30756)
------------------------------------------------------------------------
November 8, 2005 (70 FR 67713)
------------------------------------------------------------------------
March 31, 2006 (71 FR 16313)
------------------------------------------------------------------------
June 23, 2006 (71 FR 36121)
------------------------------------------------------------------------
November 3, 2006 (71 FR 64718)
------------------------------------------------------------------------
May 21, 2007 (72 FR 28500)
------------------------------------------------------------------------

    These notices describe the addition, withdrawal, and revision of 
certain standards recognized by FDA. The agency maintains ``hypertext 
markup language'' (HTML) and ``portable document format'' (PDF) 
versions of the list of ``FDA Recognized Consensus Standards.'' Both 
versions are publicly accessible at the agency's Internet site. See 
section VI of this document for electronic access information. 
Interested persons should review the supplementary information sheet 
for the standard to understand fully the extent to which FDA recognizes 
the standard.

II. Modifications to the List of Recognized Standards, Recognition List 
Number: 018

    FDA is announcing the addition, withdrawal, correction, and 
revision of certain consensus standards the agency will recognize for 
use in satisfying premarket reviews and other requirements for devices. 
FDA will incorporate these modifications in the list of FDA Recognized 
Consensus Standards in the agency's searchable database. FDA will use 
the term ``Recognition List Number: 018'' to identify these current 
modifications.
    In table 2 of this document, FDA describes the following 
modifications: (1) The withdrawal of standards and their replacement by 
others; (2) the correction of errors made by FDA in listing previously 
recognized standards; and (3) the changes to the supplementary 
information sheets of recognized standards that describe revisions to 
the applicability of the standards.
    In section III of this document, FDA lists modifications the agency 
is making that involve the initial addition of standards not previously 
recognized by FDA.

                                Table 2.
------------------------------------------------------------------------
  Old
  Item                Standard                   Change      Replacement
  No.                                                         Item No.
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
3        ASTM F1161-88, Standard             Withdrawn      ............
          Specification for Minimum
          Performance and Safety
          Requirements for Components and
          Systems of Anesthesia Gas
          Machines
------------------------------------------------------------------------
15       ISO 5361-4:1987, Tracheal Tubes--   Contact        ............
          Part 4: Cole Type                   person
------------------------------------------------------------------------
35       ISO 5361:1999, Anaesthetic and      Contact        ............
          Respiratory Equipment--Tracheal     person
          Tubes and Connectors
------------------------------------------------------------------------
36       ISO 5366-3:2001, Anaesthetic and    Contact        ............
          Respiratory Equipment--             person
          Tracheostomy Tubes--Part 3:
          Pediatric Tracheostomy Tubes
------------------------------------------------------------------------
42       ISO 5360:2006, Anaesthetic          Withdrawn and            74
          Vaporizers--Agent Specific          replaced
          Filling Systems                     with newer
                                              version
------------------------------------------------------------------------

[[Page 52144]]

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

[[Page 52145]]

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

[[Page 52146]]

 
30       AAMI/ANSI/IEC 60601-1-2, Medical    Title change   ............
          Electrical Equipment--Part 1-2:    Type of
          General Requirements for Safety--   standard
          Collateral Standard:                Extent of
          Electromagnetic Compatibility--     recognition
          Requirements and Tests. (The AAMI/
          ANSI/IEC 60601-1-2:2001 is the
          U.S. version of IEC 60601-1-
          2:2001 with identical
          requirements for electromagnetic
          compatibility (EMC) of medical
          electrical equipment.)
------------------------------------------------------------------------
34       IEC 60601-1-2, Medical Electrical   Extent of      ............
          Equipment--Part 1-2: General        recognition
          Requirements for Safety--
          Collateral Standard:
          Electromagnetic Compatibility--
          Requirements and Tests (Edition
          2:2001 with Amendment 1:2004;
          Edition 2.1 (Edition 2:2001
          consolidated with Amendment
          1:2004))
------------------------------------------------------------------------
35       AAMI/ANSI/IEC 60601-1-2, Medical    Extent of      ............
          Electrical Equipment--Part 1-2:     recognition
          General Requirements for Safety--
          Collateral Standard:
          Electromagnetic Compatibility--
          Requirements and Tests (Edition
          2:2001 with Amendment 1:2004)
          (AAMI/ANSI/IEC 60601-1-2:2001 is
          the U.S. version of IEC 60601-1-
          2:2001, with identical
          requirements for electromagnetic
          compatibility (EMC) of medical
          electrical equipment.)
------------------------------------------------------------------------
D. General Hospital/ General Plastic Surgery
------------------------------------------------------------------------
18       ISO 8537:1991 Sterile Single-use    Withdrawn      ............
          Syringes, With or Without Needle,   duplicate
          for Insulin
------------------------------------------------------------------------
20       ISO 10555-1-1995 Sterile, Single-   Withdrawn      ............
          use Intravascular Catheters--Part   duplicate
          1: General Requirements
------------------------------------------------------------------------
46       IEC 60601-2-2 2006 Medical          Withdrawn and           197
          Electrical Equipment--Part 2-2:     replaced
          Particular Requirements for the     with newer
          Safety of High Frequency Surgical   version
          Equipment
------------------------------------------------------------------------
69       ISO 9626-1991: Stainless Steel      Withdrawn      ............
          Needle Tubing for the Manufacture   duplicate
          of Medical Devices
------------------------------------------------------------------------
72       ISO 10555-5 1996-06-15 Sterile,     Withdrawn      ............
          Single-use Intravascular            duplicate
          Catheters--Part 5: Over-needle
          Peripheral Catheters
------------------------------------------------------------------------
96       ASTM F2101-07 Standard Test Method  Withdrawn and           199
          for Evaluating the Bacterial        replaced
          Filtration Efficiency (BFE) of      with newer
          Medical Face Mask Materials,        version
          Using a Biological Aerosol of
          Staphylococcus Aureus
------------------------------------------------------------------------
113      ASTM F2100-07 Standard              Withdrawn and           198
          Specification for Performance of    replaced
          Materials Used in Medical Face      with newer
          Masks                               version
------------------------------------------------------------------------
108      ASTM F754-00 Standard               Transferred    ............
          Specification for Implantable       to materials
          Polytetrafluoroethylene (PTFE)
          Polymer Fabricated in Sheet, Tube
          and Rod Shapes
------------------------------------------------------------------------
109      ASTM F881-94(2006) Standard         Withdrawn and           185
          Specification for Silicone          replaced
          Elastomer Facial Implants           with newer
                                              version
------------------------------------------------------------------------
128      ASTM F1670-07 Standard Test Method  Withdrawn and           186
          for Resistance of Materials Used    replaced
          in Protective Clothing to           with newer
          Penetration by Synthetic Blood      version
------------------------------------------------------------------------
130      ASTM F1671-07 Standard Test Method  Withdrawn and           187
          for Resistance of Materials Used    replaced
          in Protective Clothing to           with newer
          Penetration by Blood-Borne          version
          Pathogens Using Phi-X174
          Bacteriophage Penetration as a
          Test System
------------------------------------------------------------------------
151      USP 30:2007 Nonabsorbable Surgical  Withdrawn and           188
          Suture                              replaced
                                              with newer
                                              version
------------------------------------------------------------------------
152      USP 30<11>: 2007 Sterile Sodium     Withdrawn and           189
          Chloride for Irrigation             replaced
                                              with newer
                                              version
------------------------------------------------------------------------
153      USP 30:2007 Absorbable Surgical     Withdrawn and           190
          Suture                              replaced
                                              with newer
                                              version
------------------------------------------------------------------------
154      USP 30<881>:2007 Tensile Strength   Withdrawn and           191
                                              replaced
                                              with newer
                                              version
------------------------------------------------------------------------
155      USP 30<861>:2007 Sutures--Diameter  Withdrawn and           192
                                              replaced
                                              with newer
                                              version
------------------------------------------------------------------------
156      USP 30<871>:2007 Sutures Needle     Withdrawn and           193
          Attachment                          replaced
                                              with newer
                                              version
------------------------------------------------------------------------

[[Page 52147]]

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

[[Page 52148]]

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

[[Page 52149]]

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

[[Page 52150]]

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

[[Page 52151]]

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

[[Page 52152]]

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

III. Listing of New Entries

    In table 3 of this document, FDA provides the listing of new 
entries and consensus standards added as modifications to the list of 
recognized standards under Recognition List Number: 018.

                                Table 3.
------------------------------------------------------------------------
                                                      Reference No. and
 Item No.              Title of Standard                     Date
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
72          Lung Ventilators for Medical Use--       ISO 10651-5:2006
             Particular Requirements for Basic
             Safety and Essential Performance--Part
             5: Gas-powered Emergency Resuscitators
------------------------------------------------------------------------
73          Lung Ventilators--Part 4: Particular     ISO 10651-4:2002
             Requirements for Operator Powered
             Resuscitators
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
117         Biological Evaluation of Medical         ANSI/AAMI/ISO 10993-
             Devices--Part 3: Tests for               3: 2003
             Genotoxicity, Carcinogenicity, and
             Reproductive Toxicity
------------------------------------------------------------------------
C. Dental/ ENT
------------------------------------------------------------------------
144         Dentistry-Mercury and Alloys for Dental  ISO 24234: 2004(E)
             Amalgam
------------------------------------------------------------------------
D. OB-GYN/Gastroenterology
------------------------------------------------------------------------
45          Standard Test Methods for Enteral        ASTM F2528-06
             Feeding Devices with a Retention
             Balloon
------------------------------------------------------------------------
E. Ophthalmic
------------------------------------------------------------------------
42          Ophthalmic Implants--Intraocular         ISO 11979-2:1999/
             lenses--Part 2: Optical Properties and   Corrigendum1:2003
             Test Methods
------------------------------------------------------------------------
43          Ophthalmic Optics--Contact Lenses and    ISO 11981:1999/
             Contact Lens Care Products--             Corrigendum1:2005
             Determination of Physical
             Compatibility of Contact Lens Care
             Products with Contact Lenses
------------------------------------------------------------------------
45          Ophthalmic Optics--Contact Lenses--Part  ISO 18369-2:2006
             2: Tolerances
------------------------------------------------------------------------
46          Ophthalmic Optics--Contact Lenses--Part  ISO 18369-3:2006
             3: Measurement Methods
-------------------------------------------------------------------

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