[Federal Register Volume 69, Number 191 (Monday, October 4, 2004)] [Notices] [Pages 59240-59250] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 04-22183] ----------------------------------------------------------------------- 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: 011 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: 011'' (Recognition List Number: 011), 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 on a 3.5'' diskette of ``Modifications to the List of Recognized Standards, Recognition List Number: 011'' to the Division of Small Manufacturers 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: [email protected]. This document may also be accessed on FDA's Internet site at http://www.fda.gov/cdrh/fedregin.html. 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: 011 modifications and other standards related information. FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices and Radiological Health (HFZ-84), Food and [[Page 59241]] Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 301-594- 4766, ext.156. 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 will implement its standard recognition program and provided the initial list of FDA recognized consensus standards. In Federal Register notices published on 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), and June 18, 2004 (69 FR 34176), FDA modified its initial list of FDA recognized consensus standards. These notices described 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 Recognition List Number: 011 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: 011'' to identify these current modifications. In table 1 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 1. ------------------------------------------------------------------------ Old Item Replacement No. Standard Change Item No. ------------------------------------------------------------------------ A. Anesthesia ------------------------------------------------------------------------ 1 ASTM F920-93 (1999), Standard Withdrawn 50 Specification for Minimum and Performance and Safety replaced Requirements for Resuscitators with newer Intended for Use With Humans version ------------------------------------------------------------------------ 2 ASTM F1100-90 (1997), Standard Withdrawn 51 Specification for Ventilators and Intended for Use in Critical replaced Care with newer version ------------------------------------------------------------------------ 5 ASTM F1463-93 (1999), Standard Withdrawn 52 Specification for Alarm Signals and in Medical Equipment Used in replaced Anesthesia and Respiratory Care with newer version ------------------------------------------------------------------------ 6 ASTM F1464-93 (1999), Standard Withdrawn 53 Specification for Oxygen and Concentrators for Domiciliary replaced Use with newer version ------------------------------------------------------------------------ 8 PVHO-1-2002, Safety Standard for Withdrawn 54 Pressure Vessels for Human and Occupancy replaced with newer version ------------------------------------------------------------------------ 23 ASTM F1054-01, Standard Withdrawn 55 Specification for Conical and Fittings replaced with newer version ------------------------------------------------------------------------ 24 ASTM F1456-01, Standard Withdrawn 59 Specification for Minimum and Performance and Safety replaced Requirements for Capnometers with newer version ------------------------------------------------------------------------ 25 ASTM F1462-93, Specification for Withdrawn .............. Oxygen Analyzers ------------------------------------------------------------------------ 34 ASTM PS127: 2000, Standard Test Withdrawn .............. Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications ------------------------------------------------------------------------ 40 CGA V-7.1: 1997 (reaffirmed Withdrawn 56 2003), Standard Method for and Determining Cylinder Valve replaced Outlet Connections for Medical with newer Gases version ------------------------------------------------------------------------ 45 ASTM 1101-90 (2003) e1, Standard Withdrawn 57 Specification for Ventilators and Intended for Use During replaced Anesthesia with newer version ������������������������������������������������������������������������ B. Cardiovascular/Neurology ------------------------------------------------------------------------ [[Page 59242]] 1 ANSI/AAMI EC12: 2000, Disposable Withdrawn 52 Electrocardiogram (ECG) and Electrodes replaced with newer version ------------------------------------------------------------------------ 4 AAMI SP10: 1992, Electronic or Change in .............. Automated Sphygmomanometers processes affected and contact person ------------------------------------------------------------------------ 44 ANSI/AAMI BP22: 1994 (R2001), Change in .............. Blood Pressure Transducers processes affected and contact person ������������������������������������������������������������������������ C. Dental/Ear, Nose, and Throat ------------------------------------------------------------------------ 22 ASTM/F1377-92, Standard Transfer to .............. Specification for Cobalt- materials Chromium-Molybdenum Powder for Coating of Orthopaedic Implants ------------------------------------------------------------------------ 42 ANSI/ADA Specification No. 3: Withdrawn .............. 1994, Dental Impression Compound ------------------------------------------------------------------------ 43 ANSI/ADA Specification No. 5: Change date .............. 1997, Dental Casting Alloys of standard ------------------------------------------------------------------------ 44 ANSI/ADA Specification No. 11: Withdrawn 110 1997, Agar Impression Material and replaced with newer version ------------------------------------------------------------------------ 45 ANSI/ADA Specification No. 13: Withdrawn 111 1999, Dental Cold-Curing Repair and Resin replaced with newer version ------------------------------------------------------------------------ 48 ANSI/ADA Specification No. 16: Withdrawn 112 1999, Dental Impression Paste and Zinc Oxide-Eugenol Materials replaced with newer version ------------------------------------------------------------------------ 51 ANSI/ADA Specification No. 20: Withdrawn 113 1995, Dental Duplicating and Material replaced with newer version ------------------------------------------------------------------------ 55 ANSI/ADA Specification No. 48: Withdrawn 114 1989, Ultraviolet Activator and and Disclosing Lights replaced with newer version ------------------------------------------------------------------------ 67 ISO 6871-1: 1994, Dental Base Title .............. Metal Casting Alloys--Part 1: correction Cobalt-Based Alloys--Technical Corrigendum 1: 1998 ------------------------------------------------------------------------ 80 ISO 9917-1: 2003, Dental Water Withdrawn 115 Based Cements--Part 1: Powder/ and Liquid Acid-Base Cements--first replaced edition with newer version ------------------------------------------------------------------------ 81 ISO 10139-1: 1999, Dentistry-- Withdrawn 116 Resilient Lining Materials for and Removable Dentures--Part 1: replaced Short-Term Materials with newer version ------------------------------------------------------------------------ 90 ANSI/ASA S3.39: 1987 (R2002), Change date .............. Specification for Instruments to of Measure Aural Acoustic Impedance standard and Admittance (Aural Acoustic Immittance) ------------------------------------------------------------------------ 103 ANSI/ADA Specification No. 12: Withdrawn 117 2002, Denture Base Polymers and replaced with newer version ------------------------------------------------------------------------ 105 ANSI/ADA Specification No. 75: Title .............. 1997 (R2003), Resilient Lining correction Materials for Removable Dentures--Part 1: Short-Term Materials ------------------------------------------------------------------------ 106 ANSI/ADA Specification No. 82: Withdrawn 119 2003, Dental Reversible/ and Irreversible Hydrocolloid replaced Impression Material System with newer version ------------------------------------------------------------------------ 108 ISO 10139-2: 1999, Dentistry-- Withdrawn 120 Soft Lining Materials for and Removable Dentures--Part 2: replaced Materials for Long-Term Use with newer version ������������������������������������������������������������������������ D. General ------------------------------------------------------------------------ 10 AAMI/ISO 14971-1, Medical Withdrawn .............. Devices--Risk Management--Part 1: Application of Risk Analysis ------------------------------------------------------------------------ 21 CEN EN 1441: 1997, Medical Withdrawn .............. Devices--Risk Management ������������������������������������������������������������������������ E. In Vitro Diagnostic ------------------------------------------------------------------------ 23 NCCLS H1-A5, Tubes and Additives Withdrawn 102 for Venous Blood Specimen and Collection; Approved Standard replaced with newer version ------------------------------------------------------------------------ [[Page 59243]] 69 NCCLS H3-A5, Procedures for the Withdrawn 103 Collection of Diagnostic Blood and Specimens by Venipuncture; replaced Approved Standard with newer version ------------------------------------------------------------------------ 24 NCCLS H7-A3, Procedure for Withdrawn 104 Determining Packed Cell Volume and by the Microhematocrit Method; replaced Approved Standard--third edition with newer version ------------------------------------------------------------------------ 33 NCCLS H30-A2, Procedure for the Withdrawn 105 Determination of Fibrinogen in and Plasma; Approved Guideline-- replaced second edition with newer version ------------------------------------------------------------------------ 57 NCCLS M2-A8, Performance Withdrawn 106 Standards for Antimicrobial Disk and Susceptibility Tests; Approved replaced Standard--eighth edition with newer version ------------------------------------------------------------------------ 75 NCCLS M11-A6, Methods for Withdrawn 107 Dilution Antimicrobial and Susceptibility Tests for replaced Bacteria That Grow Aerobically, with newer Approved Standard--sixth edition version ------------------------------------------------------------------------ 56 NCCLS M7-A6, Methods for Withdrawn 108 Antimicrobial Susceptibility and Testing of Anaerobic Bacteria; replaced Approved Standard--sixth edition with newer version ������������������������������������������������������������������������ F. Materials ------------------------------------------------------------------------ 5 ASTM F138-03, Standard Withdrawn 76 Specification for Wrought 18 and Chromium-14 Nickel-2.5 replaced Molybdenum Stainless Steel Bar with newer and Wire for Surgical Implants version (UNS S31673) ------------------------------------------------------------------------ 6 ASTM F139-03, Standard Withdrawn 77 Specification for Wrought 18 and Chromium-14 Nickel-2.5 replaced Molybdenum Stainless Steel Sheet with newer and Strip for Surgical Implants version (UNS S31673) ------------------------------------------------------------------------ 7 ASTM F560-04, Standard Withdrawn 78 Specification for Unalloyed and Tantalum for Surgical Implant replaced Applications (UNS R05200, UNS with newer R05400) version ------------------------------------------------------------------------ 13 ASTM F648-00e1, Standard Change date .............. Specification for Ultra-High- of Molecular-Weight Polyethylene standard Powder and Fabricated Form for Surgical Implants ------------------------------------------------------------------------ 16 ASTM F746-87 (1999), Standard Change in .............. Test Method for Pitting or processes Crevice Corrosion of Metallic affected Surgical Implant Materials ------------------------------------------------------------------------ 19 ASTM F961-03, Standard Withdrawn 79 Specification for Cobalt-35 and Nickel-20 Chromium-10 Molybdenum replaced Alloy Forgings for Surgical with newer Implants (UNS R30035) version ------------------------------------------------------------------------ 21 ASTM F1088-04, Standard Withdrawn 80 Specification for Beta- and Tricalcium Phosphate for replaced Surgical Implantation with newer version ------------------------------------------------------------------------ 33 ASTM F1609-03, Standard Withdrawn 81 Specification for Calcium and Phosphate for Coatings for replaced Implantable Materials with newer version ------------------------------------------------------------------------ 34 ASTM F1659-95, Standard Test Change in .............. Method for Bending and Shear processes Fatigue Testing of Calcium affected Phosphate Coatings on Solid Metallic Substrates ------------------------------------------------------------------------ 35 ASTM F1713-03, Standard Withdrawn 82 Specification for Wrought and Titanium-13 Niobium-13 Zirconium replaced Alloy for Surgical Implant with newer Applications version ------------------------------------------------------------------------ 40 ASTM F2063-00, Standard Change in .............. Specification for Wrought Nickel- extent of Titanium Shape Memory Alloys for recognitio Medical Devices and Surgical n, contact Implants person, and processes affected ------------------------------------------------------------------------ 42 ASTM F2119-01, Standard Test Change in .............. Method for Evaluation of MR processes Image Artifacts From Passive affected Implants ------------------------------------------------------------------------ 48 ASTM F899-02, Standard Change in .............. Specification for Stainless processes Steel for Surgical Instruments affected ------------------------------------------------------------------------ 70 ASTM F2052-02, Standard Test Withdrawn .............. Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment ------------------------------------------------------------------------ 72 ASTM F2213-04, Standard Test Change in .............. Method for Measurement of processes Magnetically Induced Torque on affected Medical Devices in the Magnetic Resonance Environment ------------------------------------------------------------------------ Ortho ASTM F561-97 (2003), Practice for Transferred 73Microbial Withdrawn 127 Limits Test and replaced with newer version ------------------------------------------------------------------------ 110 USP 27: 2004, <71> Withdrawn 128 Microbiological Tests, Sterility and Tests replaced with newer version ------------------------------------------------------------------------ 111 USP 27: 2004, <85> Biological Withdrawn 129 Tests and Assays, Bacterial and Endotoxin Test (LAL) replaced with newer version ------------------------------------------------------------------------ 112 USP 27: 2004, <151> Pyrogen Test Withdrawn 130 (USP Rabbit Test) and replaced with newer version ------------------------------------------------------------------------ 113 USP 27: 2004, <1211> Withdrawn 131 Sterilization and Sterility and Assurance of Compendial Articles replaced with newer version ------------------------------------------------------------------------ 114 USP 27: 2004, <161> Transfusion Withdrawn 132 and Infusion Assemblies and and Similar Medical Devices replaced with newer version ------------------------------------------------------------------------ 115 USP 27: 2004, Biological Withdrawn 133 Indicator for Steam and Sterilization--Self-Contained replaced with newer version ------------------------------------------------------------------------ 116 ANSI/AAMI ST72: 2002, Bacterial Change in .............. Endotoxins--Test Methodologies, relevant Routine Monitoring, and guidance Alternatives to Batch Testing ------------------------------------------------------------------------ III. Listing of New Entries The listing of new entries and consensus standards added as modifications to the list of recognized standards, under Recognition List Number: 011, follows: Table 2. ------------------------------------------------------------------------ Reference No. Item No. Title of Standard and Date ------------------------------------------------------------------------ A. Anesthesia ------------------------------------------------------------------------ 58 Standard Test Method for Evaluating the ASTM G175-03 Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications ������������������������������������������������������������������������ B. Dental/ENT ------------------------------------------------------------------------ 121 Dentistry--Dental Units--Part 2: Water ISO 7494-2: and Air Supply 2003 ������������������������������������������������������������������������ C. General Hospital/General Plastic Surgery ------------------------------------------------------------------------ 112 Liquid Barrier Performance and ANSI/AAMI PB70: Classification of Protective Apparel and 2003 Drapes Intended for Use in Health Care Facilitates ------------------------------------------------------------------------ 113 Standard Specification for Performance of ASTM F2100-04 Materials Used in Medical Face Masks ������������������������������������������������������������������������ D. Materials ------------------------------------------------------------------------ [[Page 59248]] 85 Standard Test Method for Stereological ASTM F1854-01 Evaluation of Porous Coatings on Medical Implants ------------------------------------------------------------------------ 86 Standard Test Method for Evaluation of ASTM F1926-03 the Environmental Stability of Calcium Phosphate Coatings ------------------------------------------------------------------------ 87 Standard Test Method for Measuring ASTM F1978-00e1 Abrasion Resistance of Metallic Thermal Spray Coatings by Using the TaberT Abraser ------------------------------------------------------------------------ 88 Standard Practice for X-Ray Diffraction ASTM F2024-00 Determination of Phase Content of Plasma- Sprayed Hydroxyapatite Coatings ------------------------------------------------------------------------ 89 Standard Specification for High-Purity ASTM F1873-98 Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant Applications ------------------------------------------------------------------------ 90 Standard Test Method for Strength ASTM F2255-03 Properties of Tissue Adhesives in Lap Shear by Tension Loading ------------------------------------------------------------------------ 91 Standard Test Method for Strength ASTM F2256-03 Properties of Tissue Adhesives in T-Peel by Tension Loading ------------------------------------------------------------------------ 92 Standard Test Method for Strength ASTM F2258-03 Properties of Tissue Adhesives in Tension ------------------------------------------------------------------------ 96 Standard Test Method for In Vitro ASTM 1635-95 Degradation Testing of Poly (L-lactic (2000) Acid) Resin and Fabricated Form for Surgical Implants ------------------------------------------------------------------------ 97 Standard Test Method for Conducting ASTM F2129-04 Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices ------------------------------------------------------------------------ 98 Standard Specification for Acrylic Bone ASTM F451-99ae1 Cement ------------------------------------------------------------------------ 99 Standard Test Method for Transformation ASTM F2004-03 Temperature of Nickel-Titanium Alloys by Thermal Analysis ------------------------------------------------------------------------ 100 Standard Terminology for Nickel-Titanium ASTM F2005-00 Shape Memory Alloys ------------------------------------------------------------------------ 101 Test Method for Constant Amplitude of ASTM F2118-03 Force Controlled Fatigue Testing of Acrylic Bone Cement Materials ------------------------------------------------------------------------ 102 Standard Test Method for Determination of ASTM F2082-03 Transformation Temperature of Nickel- Titanium Shape Memory Alloys by Bend and Free Recovery ������������������������������������������������������������������������ E. OB-GYN/Gastroenterology ------------------------------------------------------------------------ 30 Water Treatment Equipment for ANSI/AAMI RD62: Hemodialysis Applications 2001 ������������������������������������������������������������������������ F. Ophthalmic ------------------------------------------------------------------------ 33 Contact Lens Care Products--Vocabulary, ANSI Z80.18 Performance Specifications, and Test Methodology ������������������������������������������������������������������������ G. Orthopaedic ------------------------------------------------------------------------ 178 Standard Practice for Cyclic Fatigue ASTM F1440-92 Testing of Metallic Stemmed Hip (2002) Arthroplasty Femoral Components Without Torsion ------------------------------------------------------------------------ 179 Standard Specification for Femoral ASTM F2068-03 Prostheses--Metallic Implants ������������������������������������������������������������������������ H. Physical Medicine ------------------------------------------------------------------------ 46 Determination of Performance of Stand-Up ANSI/RESNA WC/ Type Wheelchairs volume 1-- 1998, section 20 ------------------------------------------------------------------------ 47 Set Up Procedures ANSI/RESNA WC/ volume 1-- 1998, section 22 ------------------------------------------------------------------------ 48 Maximum Overall Dimensions ANSI/RESNA WC/ volume 1-- 1998, section 93 ------------------------------------------------------------------------ 49 Nomenclature, Terms, and Definitions ANSI/RESNA WC/ volume 1-- 1998, section 0 ������������������������������������������������������������������������ I. Radiology ------------------------------------------------------------------------ [[Page 59249]] 101 Recommended Practice for Photobiological ANSI/ESNA RP- Safety for Lamps and Lamp Systems-- 27.1.96 General Requirements ------------------------------------------------------------------------ 102 Recommended Practice for Photobiological ANSI/ESNA RP- Safety for Lamps and Lamp Systems-- 27.2.00 Measurement Techniques ------------------------------------------------------------------------ 103 Recommended Practice for Photobiological ANSI/ESNA RP- Safety for Lamps and Lamp Systems--Risk 27.3.96 Group Classification and Labeling ------------------------------------------------------------------------ 106 Optics and Optical Instruments--Lasers ISO 17526: 2003 and Laser-Related Equipment--Lifetime of Lasers ------------------------------------------------------------------------ 107 Lasers and Laser-Related Equipment--Test ISO 11146: 1999 Methods for Laser Beam Parameters--Beam Widths, Divergence Angle, and Beam Propagation Factor ------------------------------------------------------------------------ 108 Lasers and Laser-Related Equipment-- ISO 11254-1: Determination of Laser-Induced Damage 2000 Threshold of Optical Surfaces--Part 1: 1- on-1 Test ------------------------------------------------------------------------ 109 Lasers and Laser-Related Equipment-- ISO 11254-2: Determination of Laser-Induced Damage 2001 Threshold of Optical Surfaces--Part 2: S- on-1 Test ------------------------------------------------------------------------ 110 Optics and Optical Instruments--Lasers ISO 11551: 2003 and Laser-Related Equipment--Test Method for Absorptance of Optical Laser Components (revision of ISO 11551: 1997) ------------------------------------------------------------------------ 111 Optics and Optical Instruments--Lasers ISO 11554: 2003 and Laser-Related Equipment--Test Methods for Laser Beam Power, Energy, and Temporal Characteristics (revision of ISO 11554: 1998) ------------------------------------------------------------------------ 112 Lasers and Laser-Related Equipment--Test ISO 11670: 2003 Methods for Laser Beam Parameters--Beam Positional Stability (revision of ISO 11670: 1999) ------------------------------------------------------------------------ 113 Lasers and Laser-Related Equipment--Test ISO 12005: 2003 Methods for Laser Beam Parameters-- Polarization (revision of ISO 12005: 1999) ------------------------------------------------------------------------ 114 Optics and Optical Instruments--Lasers ISO 13694: 2000 and Laser-Related Equipment--Test Methods for Laser Beam Power (Energy) Density Distribution ------------------------------------------------------------------------ 115 Optics and Photonics--Lasers and Laser- ISO 13695: 2004 Related Equipment--Test Methods for the Spectral Characteristics of Lasers ------------------------------------------------------------------------ 116 Optics and Optical Instruments--Test ISO 13696: 2002 Methods for Radiation Scattered by Optical Components ------------------------------------------------------------------------ 117 Lasers and Laser-Related Equipment--Test ISO 15367-1: Methods for Determination of the Shape 2003 of a Laser Beam Wavefront--Part 1: Terminology and Fundamental Aspects ------------------------------------------------------------------------ 120 Particular Requirements for the Safety of IEC 60601-2-44 X-Ray Equipment for Computed Tomography (ed. 2.1) ������������������������������������������������������������������������ J. Sterility ------------------------------------------------------------------------ 134 Resistometers Used for Characterizing the ANSI/AAMI ST44: Performance of Biological and Chemical 2002 Indicators ------------------------------------------------------------------------ 135 Sterilization of Health Care Products-- ANSI/AAMI ST63: Requirements for the Development, 2002 Validation, and Routine Control of an Industrial Sterilization Process for Medical Devices--Dry Heat ------------------------------------------------------------------------ 136 Sterilization of Health Care Products-- ANSI/AAMI ST67: Requirements for Products Labeled 2003 ``Sterile'' ------------------------------------------------------------------------ 137 Sterilization of Health Care Products-- ANSI/AAMI/ISO Vocabulary TIR 11139: 2002 ------------------------------------------------------------------------ 138 Aseptic Processing of Health Care ISO 13408-2: Products--Part 2: Filtration 2003 ------------------------------------------------------------------------ 139 Cleanrooms and Associated Controlled ISO 14644-1: Environments--Part 1: Classification of 1999 Air Cleanliness ------------------------------------------------------------------------ 140 Cleanrooms and Associated Controlled ISO 14644-2: Environments--Part 2: Specifications for 2000 Testing and Monitoring to Prove Continued Compliance With ISO 14644-1 ------------------------------------------------------------------------ 141 Cleanrooms and Associated Controlled ISO 14644-4: Environments--Part 4: Design, 2001 Construction, and Start-Up ------------------------------------------------------------------------ 142 Cleanrooms and Associated Controlled ISO 14698-1: Environments--Biocontamination Control-- 2003 Part 1: General Principles and Methods ------------------------------------------------------------------------ 143 Cleanrooms and Associated Controlled ISO 14698-2: Environments--Biocontamination Control-- 2003 Part 2: Evaluation and Interpretation of Biocontamination Data ������������������������������������������������������������������������ [[Page 59250]] K. Tissue Engineering ------------------------------------------------------------------------ 5 Standard Guide for Characterization and ASTM F2347-2003 Testing of Hyaluronan as Starting Material Intended for Use in Biomedical and Tissue Engineered Medical Product Applications ------------------------------------------------------------------------ IV. List of Recognized Standards FDA maintains the agency's current list of FDA recognized consensus standards in a searchable database that may be accessed directly at FDA's Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA will incorporate the modifications and minor revisions described in this document into the database and, upon publication in the Federal Register, this recognition of consensus standards will be effective. FDA will announce additional modifications and minor revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often, if necessary. V. Recommendation of Standards for Recognition by FDA Any person may recommend consensus standards as candidates for recognition under the new provision of section 514 of the act by submitting such recommendations, with reasons for the recommendation, to the contact person (see FOR FURTHER INFORMATION CONTACT). To be properly considered, such recommendations should contain, at a minimum, the following information: (1) Title of the standard, (2) any reference number and date, (3) name and address of the national or international standards development organization, (4) a proposed list of devices for which a declaration of conformity to this standard should routinely apply, and (5) a brief identification of the testing or performance or other characteristics of the device(s) that would be addressed by a declaration of conformity. VI. Electronic Access In order to receive ``Guidance on the Recognition and Use of Consensus Standards'' via your fax machine, call the Center for Devices and Radiological Health (CDRH) Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt press 1 to order a document. Enter the document number 321 followed by the pound sign. Follow the remaining voice prompts to complete your request. You may also obtain a copy of ``Guidance on the Recognition and Use of Consensus Standards'' by using the Internet. CDRH maintains a site on the Internet for easy access to information including text, graphics, and files that you may download to a personal computer with access to the Internet. Updated on a regular basis, the CDRH home page includes the guidance as well as the current list of recognized standards and other standards related documents. After publication in the Federal Register, this document announcing ``Modifications to the List of Recognized Standards, Recognition List Number: 011,'' will be available on the CDRH home page. You may access the CDRH home page at http://www.fda.gov/cdrh. You may access ``Guidance on the Recognition and Use of Consensus Standards,'' and the searchable database for FDA recognized consensus standards, through the hyperlink at http://www.fda.gov/cdrh/stdsprog.html. This Federal Register document on modifications in FDA's recognition of consensus standards is available at http://www.fda.gov/cdrh/fedregin.html. VII. Submission of Comments and Effective Date Interested persons may submit to the contact person (see FOR FURTHER INFORMATION CONTACT) written or electronic comments regarding this document. Two copies of any mailed comments are to be submitted, except that individuals may submit one paper copy. Comments are to be identified 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: 011. These modifications to the list or recognized standards are effective upon publication of this document in the Federal Register. Dated: September 21, 2004. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. 04-22183 Filed 10-1-04; 8:45 am] BILLING CODE 4160-01-S