# Food and Drug Administration Modernization Act of 1997; Modifications to the List of Recognized Standards, Recognition List Number: 011 > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A04-22183 ## Record - **Collection:** Federal Register - **Document type:** Notice - **Published:** October 4, 2004 - **Citation:** 69 FR 59240 ## Text 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: standards@cdrh.fda.gov . 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 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 No. Standard Change Replacement Item No. A. Anesthesia 1 ASTM F920-93 (1999), Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use With Humans Withdrawn and replaced with newer version 50 2 ASTM F1100-90 (1997), Standard Specification for Ventilators Intended for Use in Critical Care Withdrawn and replaced with newer version 51 5 ASTM F1463-93 (1999), Standard Specification for Alarm Signals in Medical Equipment Used in Anesthesia and Respiratory Care Withdrawn and replaced with newer version 52 6 ASTM F1464-93 (1999), Standard Specification for Oxygen Concentrators for Domiciliary Use Withdrawn and replaced with newer version 53 8 PVHO-1-2002, Safety Standard for Pressure Vessels for Human Occupancy Withdrawn and replaced with newer version 54 23 ASTM F1054-01, Standard Specification for Conical Fittings Withdrawn and replaced with newer version 55 24 ASTM F1456-01, Standard Specification for Minimum Performance and Safety Requirements for Capnometers Withdrawn and replaced with newer version 59 25 ASTM F1462-93, Specification for Oxygen Analyzers Withdrawn 34 ASTM PS127: 2000, Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications Withdrawn 40 CGA V-7.1: 1997 (reaffirmed 2003), Standard Method for Determining Cylinder Valve Outlet Connections for Medical Gases Withdrawn and replaced with newer version 56 45 ASTM 1101-90 (2003) e1, Standard Specification for Ventilators Intended for Use During Anesthesia Withdrawn and replaced with newer version 57 B. Cardiovascular/Neurology 1 ANSI/AAMI EC12: 2000, Disposable Electrocardiogram (ECG) Electrodes Withdrawn and replaced with newer version 52 4 AAMI SP10: 1992, Electronic or Automated Sphygmomanometers Change in processes affected and contact person 44 ANSI/AAMI BP22: 1994 (R2001), Blood Pressure Transducers Change in processes affected and contact person C. Dental/Ear, Nose, and Throat 22 ASTM/F1377-92, Standard Specification for Cobalt-Chromium-Molybdenum Powder for Coating of Orthopaedic Implants Transfer to materials 42 ANSI/ADA Specification No. 3: 1994, Dental Impression Compound Withdrawn 43 ANSI/ADA Specification No. 5: 1997, Dental Casting Alloys Change date of standard 44 ANSI/ADA Specification No. 11: 1997, Agar Impression Material Withdrawn and replaced with newer version 110 45 ANSI/ADA Specification No. 13: 1999, Dental Cold-Curing Repair Resin Withdrawn and replaced with newer version 111 48 ANSI/ADA Specification No. 16: 1999, Dental Impression Paste Zinc Oxide-Eugenol Materials Withdrawn and replaced with newer version 112 51 ANSI/ADA Specification No. 20: 1995, Dental Duplicating Material Withdrawn and replaced with newer version 113 55 ANSI/ADA Specification No. 48: 1989, Ultraviolet Activator and Disclosing Lights Withdrawn and replaced with newer version 114 67 ISO 6871-1: 1994, Dental Base Metal Casting Alloys—Part 1: Cobalt-Based Alloys—Technical Corrigendum 1: 1998 Title correction 80 ISO 9917-1: 2003, Dental Water Based Cements—Part 1: Powder/Liquid Acid-Base Cements—first edition Withdrawn and replaced with newer version 115 81 ISO 10139-1: 1999, Dentistry—Resilient Lining Materials for Removable Dentures—Part 1: Short-Term Materials Withdrawn and replaced with newer version 116 90 ANSI/ASA S3.39: 1987 (R2002), Specification for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance) Change date of standard 103 ANSI/ADA Specification No. 12: 2002, Denture Base Polymers Withdrawn and replaced with newer version 117 105 ANSI/ADA Specification No. 75: 1997 (R2003), Resilient Lining Materials for Removable Dentures—Part 1: Short-Term Materials Title correction 106 ANSI/ADA Specification No. 82: 2003, Dental Reversible/Irreversible Hydrocolloid Impression Material System Withdrawn and replaced with newer version 119 108 ISO 10139-2: 1999, Dentistry—Soft Lining Materials for Removable Dentures—Part 2: Materials for Long-Term Use Withdrawn and replaced with newer version 120 D. General 10 AAMI/ISO 14971-1, Medical Devices—Risk Management—Part 1: Application of Risk Analysis Withdrawn 21 CEN EN 1441: 1997, Medical Devices—Risk Management Withdrawn E. In Vitro Diagnostic 23 NCCLS H1-A5, Tubes and Additives for Venous Blood Specimen Collection; Approved Standard Withdrawn and replaced with newer version 102 69 NCCLS H3-A5, Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard Withdrawn and replaced with newer version 103 24 NCCLS H7-A3, Procedure for Determining Packed Cell Volume by the Microhematocrit Method; Approved Standard—third edition Withdrawn and replaced with newer version 104 33 NCCLS H30-A2, Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline—second edition Withdrawn and replaced with newer version 105 57 NCCLS M2-A8, Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard—eighth edition Withdrawn and replaced with newer version 106 75 NCCLS M11-A6, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically, Approved Standard—sixth edition Withdrawn and replaced with newer version 107 56 NCCLS M7-A6, Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard—sixth edition Withdrawn and replaced with newer version 108 F. Materials 5 ASTM F138-03, Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673) Withdrawn and replaced with newer version 76 6 ASTM F139-03, Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673) Withdrawn and replaced with newer version 77 7 ASTM F560-04, Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400) Withdrawn and replaced with newer version 78 13 ASTM F648-00e1, Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants Change date of standard 16 ASTM F746-87 (1999), Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials Change in processes affected 19 ASTM F961-03, Standard Specification for Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants (UNS R30035) Withdrawn and replaced with newer version 79 21 ASTM F1088-04, Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation Withdrawn and replaced with newer version 80 33 ASTM F1609-03, Standard Specification for Calcium Phosphate for Coatings for Implantable Materials Withdrawn and replaced with newer version 81 34 ASTM F1659-95, Standard Test Method for Bending and Shear Fatigue Testing of Calcium Phosphate Coatings on Solid Metallic Substrates Change in processes affected 35 ASTM F1713-03, Standard Specification for Wrought Titanium-13 Niobium-13 Zirconium Alloy for Surgical Implant Applications Withdrawn and replaced with newer version 82 40 ASTM F2063-00, Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants Change in extent of recognition, contact person, and processes affected 42 ASTM F2119-01, Standard Test Method for Evaluation of MR Image Artifacts From Passive Implants Change in processes affected 48 ASTM F899-02, Standard Specification for Stainless Steel for Surgical Instruments Change in processes affected 70 ASTM F2052-02, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment Withdrawn 72 ASTM F2213-04, Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment Change in processes affected Ortho #91 ASTM F561-97 (2003), Practice for Retrieval and Analysis of Implanted Medical Devices and Associated Tissues Transferred to materials 73 Ortho #93 ASTM 601-03, Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants Transferred to materials 94 Ortho #107 ASTM F1147-99, Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coating Transferred to materials 84 Ortho/PM #113 Dental # 22 ASTM F1377-98a, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075) Transferred to materials 74 Ortho #124 ASTM F86-01, Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants Transferred to materials 93 Ortho #131 ASTM F1044-99, Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings Transferred to materials 83 Ortho #152 ASTM F1160-00e1, Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings Transferred to materials 75 Ortho #160 ASTM F629-02, Standard Practice for Radiography of Cast Metallic Surgical Implants Transferred to materials 95 G. OB-GYN/Gastroenterology 16 AAMI/ANSI ID54: 1996 (R)2001, Enteral Feeding Set Adapters and Connectors Withdrawn and replaced with newer version 31 H. Orthopaedic 58 ASTM F1781-03, Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants Withdrawn and replaced with newer version 168 91 ASTM F561-97, Practice for Retrieval and Analysis of Implanted Medical Devices and Associated Tissues Transferred to materials 73 93 ASTM F601-98, Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants Transferred to materials 94 107 ASTM F1147-99, Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coatings Transferred to materials 84 111 ASTM F1814-97a (2003), Standard Guide for Evaluating Modular Hip and Knee Joint Components Withdrawn and replaced with newer version 171 113 ASTM F1377-98a, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075) Transferred to materials 74 114 ASTM F1798-97 (2003), Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants Withdrawn and replaced with newer version 172 115 ASTM F1800-97 (2003), Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements Withdrawn and replaced with newer version 173 120 ASTM F382-99 (2003), Standard Specification and Test Method for Metallic Bone Plates Withdrawn and replaced with newer version 174 124 ASTM F86-01, Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants Transferred to materials 93 131 ASTM F1044-99, Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings Transferred to materials 83 140 ASTM F1582-98 (2003), Standard Terminology Relating to Spinal Implants Withdrawn and replaced with newer version 175 145 ASTM F565-00 (2003), Standard Practice for Care and Handling of Orthopedic Implants and Instruments Withdrawn and replaced with newer version 176 152 ASTM F1160-00e1, Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings Transferred to materials 75 160 ASTM F629-02, Standard Practice for Radiography of Cast Metallic Surgical Implants Transferred to materials 95 161 ASTM F1264-03, Standard Specification and Test Methods for Intramedullary Fixation Devices Withdrawn and replaced with newer version 177 165 ISO 7206-4: 2002, Implants for Surgery—Partial and Total Hip Joint Prostheses—Part 4: Determination of Endurance Properties of Stemmed Femoral Components Withdrawn I. Physical Medicine 1 ANSI/RESNA WC/volume—1998, Section 1: Determination of Static Stability Withdrawn and replaced with newer version 31 2 ANSI/RESNA WC/volume 2—1998, Section 2: Determination of Dynamic Stability of Electric Wheelchairs Withdrawn and replaced with newer version 32 3 ANSI/RESNA WC/volume 2—1998, Section 3: Test Methods and Requirements for the Effectiveness of Brakes Withdrawn and replaced with newer version 33 4 ANSI/RESNA WC/volume 2—1998, Section 4: Determination of Energy Consumption of Electric Wheelchairs and Scooters—Theoretical Range Withdrawn and replaced with newer version 34 5 ANSI/RESNA WC/volume 1—1998, Section 5: Determination of Overall Dimensions, Mass, and Turning Space Withdrawn and replaced with newer version 35 6 ANSI/RESNA WC/volume 2—1998, Section 6: Determination of Maximum Speed, Acceleration, and Retardation of Electric Wheelchairs Withdrawn and replaced with newer version 36 7 ANSI/RESNA WC/volume 1—1998, Section 7: Method of Measurement of Seating and Wheel Dimensions Withdrawn and replaced with newer version 37 8 ANSI/RESNA WC/volume 1—1998, Section 8: Requirements and Test Methods for Static, Impact, and Fatigue Strengths Withdrawn and replaced with newer version 38 9 ANSI/RESNA WC/volume 2—1998, Section 9: Climatic Tests for Electric Wheelchairs Withdrawn and replaced with newer version 39 10 ANSI/RESNA WC/volume 2—1998, Section 10: Determination of Obstacle-Climbing Ability of Electric Wheelchairs Withdrawn and replaced with newer version 40 11 ANSI/RESNA WC/volume 1—1998, Section 11: Test Dummies Withdrawn and replaced with newer version 41 12 ANSI/RESNA WC/volume 1—1998, Section 13: Determination of Coefficient of Friction of Test Surfaces Withdrawn and replaced with newer version 42 13 ANSI/RESNA WC/volume 2—1998, Section 14: Power and Control Systems for Electric Wheelchairs—Requirements and Test Methods Withdrawn and replaced with newer version 43 14 ANSI/RESNA WC/volume 1—1998, Section 15: Requirements for Information Disclosure, Documentation, and Labeling Withdrawn and replaced with newer version 44 15 ANSI/RESNA WC/volume 1—1998, Section 16: Resistance to Ignition of Upholstered Parts—Requirements and Test Methods Withdrawn and replaced with newer version 45 18 ISO 7176-3: 2003, Wheelchairs—Part 3: Determination of Effectiveness of Brakes Withdrawn and replaced with newer version 50 J. Radiology 39 IEC 60601-2-17, Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of Remote-Controlled Automatically-Drive Gamma-Ray Afterloading Equipment (1989) Amendment No. 1 to IEC 601-2-17 (1996) Withdrawn 71 NEMA UD 2-2004, Revision 3: Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Withdrawn and replaced with newer version 105 72 NEMA UD 3-2004, Revision 2: Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Withdrawn and replaced with newer version 100 78 NEMA PS 3, Set: Digital Imaging and Communications in Medicine (DICOM) Set Withdrawn and replaced with newer version 119 86 IEC 60601-2-33 (2002-05), Medical Electrical Equipment—Part 2-33: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis Withdrawn and replaced with newer version 104 88 IEC 60601-2-17 (2004-01), Medical Electrical Equipment—Part 2-17: Particular Requirements for the Safety of Automatically-Controlled Brachytherapy Afterloading Equipment Withdrawn and replaced with newer version 118 94 IEC 60731 Amendment 1 (2002-06), Medical Electrical Equipment—Dosimeters With Ionization Chambers as Used in Radiotherapy Withdrawn and replaced with newer version 98 K. Sterility 16 ANSI/AAMI ST35: 2003, Safe Handling and Biological Decontamination of Reusable Medical Devices in Health Care Facilities and in Nonclinical Settings Withdrawn and replaced with newer version 117 17 ANSI/AAMI ST44: 1992, BIER/EO Gas Vessels Withdrawn 18 ANSI/AAMI ST45: 1992, BIER/Steam Vessels Withdrawn 20 ANSI/AAMI ST50: 2004, Dry Heat (Heated Air) Sterilizers Withdrawn and replaced with newer version 118 21 ANSI/AAMI ST55: 2003, Table-Top Steam Sterilizers Withdrawn and replaced with newer version 119 48 ANSI/AAMI ST40: 1992/(R)1998, Table-Top Dry Heat (Heated Air) Sterilizers and Sterility Assurance in Dental and Medical Facilities Change in relevant guidance and contact person 50 ANSI/AAMI ST42: 1998, Steam Sterilization and Sterility Assurance Using Table-Top Sterilizers in Office-Based, Ambulatory-Care Medical, Surgical, and Dental Facilities Contact person 52 ANSI/AAMI ST59: 1999, Sterilization of Health Care Products—Biological Indicators—Part 1: General Requirements Change in relevant guidance 53 ANSI/AAMI ST66: 1999, Sterilization of Health Care Products—Chemical Indicators—Part 2: Class 2 Indicators for Air Removal Test Sheets and Packs Contact person 56 ASTM D3078: 2002, Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission Withdrawn and replaced with newer version 120 57 ASTM D4169: 2004, Standard Practice for Performance Testing of Shipping Containers and Systems Withdrawn and replaced with newer version 121 58 ASTM F88: 2000, Standard Test Method for Seal Strength of Flexible Barrier Materials Withdrawn and replaced with newer version 122 63 ASTM F1886: 1998 (2004), Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection Reaffirmation 64 ASTM F1929: 1998 (2004), Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration Reaffirmation 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 Contact person 74 ANSI/AAMI ST60: 1996, Sterilization of Health Care Products—Chemical Indicators—Part 1: General Requirements Contact person 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 Change in title, relevant guidance, and contact person 91 ASTM F2096: 2004, Standard Test Method for Detecting Gross Leaks in Porous Medical Packaging by Internal Pressurization (Bubble Test) Withdrawn and replaced with newer version 123 103 AAMI/ANSI/ISO 11607: 2000, Packaging for Terminally Sterilized Medical Devices Change in relevant guidance 105 ANSI/AAMI ST46: 2002, Steam Sterilization and Sterility Assurance in Health Care Facilities Contact person 106 USP 27: 2004, Biological Indicator for Dry Heat Sterilization, Paper Carrier Withdrawn and replaced with newer version 124 107 USP 27: 2004, Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier Withdrawn and replaced with newer version 125 108 USP 27: 2004, Biological Indicator for Steam Sterilization, Paper Carrier Withdrawn and replaced with newer version 126 109 USP 27: 2004, <61> Microbial Limits Test Withdrawn and replaced with newer version 127 110 USP 27: 2004, <71> Microbiological Tests, Sterility Tests Withdrawn and replaced with newer version 128 111 USP 27: 2004, <85> Biological Tests and Assays, Bacterial Endotoxin Test (LAL) Withdrawn and replaced with newer version 129 112 USP 27: 2004, <151> Pyrogen Test (USP Rabbit Test) Withdrawn and replaced with newer version 130 113 USP 27: 2004, <1211> Sterilization and Sterility Assurance of Compendial Articles Withdrawn and replaced with newer version 131 114 USP 27: 2004, <161> Transfusion and Infusion Assemblies and Similar Medical Devices Withdrawn and replaced with newer version 132 115 USP 27: 2004, Biological Indicator for Steam Sterilization—Self-Contained Withdrawn and replaced with newer version 133 116 ANSI/AAMI ST72: 2002, Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing Change in relevant guidance 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. Item No. Title of Standard Reference No. and Date A. Anesthesia 58 Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications ASTM G175-03 B. Dental/ENT 121 Dentistry—Dental Units—Part 2: Water and Air Supply ISO 7494-2: 2003 C. General Hospital/General Plastic Surgery 112 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilitates ANSI/AAMI PB70: 2003 113 Standard Specification for Performance of Materials Used in Medical Face Masks ASTM F2100-04 D. Materials 85 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants ASTM F1854-01 86 Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Coatings ASTM F1926-03 87 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the TaberT Abraser ASTM F1978-00e1 88 Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings ASTM F2024-00 89 Standard Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant Applications ASTM F1873-98 90 Standard Test Method for Strength Properties of Tissue Adhesives in Lap Shear by Tension Loading ASTM F2255-03 91 Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading ASTM F2256-03 92 Standard Test Method for Strength Properties of Tissue Adhesives in Tension ASTM F2258-03 96 Standard Test Method for In Vitro Degradation Testing of Poly (L-lactic Acid) Resin and Fabricated Form for Surgical Implants ASTM 1635-95 (2000) 97 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices ASTM F2129-04 98 Standard Specification for Acrylic Bone Cement ASTM F451-99ae1 99 Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis ASTM F2004-03 100 Standard Terminology for Nickel-Titanium Shape Memory Alloys ASTM F2005-00 101 Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials ASTM F2118-03 102 Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery ASTM F2082-03 E. OB-GYN/Gastroenterology 30 Water Treatment Equipment for Hemodialysis Applications ANSI/AAMI RD62: 2001 F. Ophthalmic 33 Contact Lens Care Products—Vocabulary, Performance Specifications, and Test Methodology ANSI Z80.18 G. Orthopaedic 178 Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components Without Torsion ASTM F1440-92 (2002) 179 Standard Specification for Femoral Prostheses—Metallic Implants ASTM F2068-03 H. Physical Medicine 46 Determination of Performance of Stand-Up Type Wheelchairs ANSI/RESNA WC/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 101 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems—General Requirements ANSI/ESNA RP-27.1.96 102 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems—Measurement Techniques ANSI/ESNA RP-27.2.00 103 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems—Risk Group Classification and Labeling ANSI/ESNA RP-27.3.96 106 Optics and Optical Instruments—Lasers and Laser-Related Equipment—Lifetime of Lasers ISO 17526: 2003 107 Lasers and Laser-Related Equipment—Test Methods for Laser Beam Parameters—Beam Widths, Divergence Angle, and Beam Propagation Factor ISO 11146: 1999 108 Lasers and Laser-Related Equipment—Determination of Laser-Induced Damage Threshold of Optical Surfaces—Part 1: 1-on-1 Test ISO 11254-1: 2000 109 Lasers and Laser-Related Equipment—Determination of Laser-Induced Damage Threshold of Optical Surfaces—Part 2: S-on-1 Test ISO 11254-2: 2001 110 Optics and Optical Instruments—Lasers and Laser-Related Equipment—Test Method for Absorptance of Optical Laser Components (revision of ISO 11551: 1997) ISO 11551: 2003 111 Optics and Optical Instruments—Lasers and Laser-Related Equipment—Test Methods for Laser Beam Power, Energy, and Temporal Characteristics (revision of ISO 11554: 1998) ISO 11554: 2003 112 Lasers and Laser-Related Equipment—Test Methods for Laser Beam Parameters—Beam Positional Stability (revision of ISO 11670: 1999) ISO 11670: 2003 113 Lasers and Laser-Related Equipment—Test Methods for Laser Beam Parameters—Polarization (revision of ISO 12005: 1999) ISO 12005: 2003 114 Optics and Optical Instruments—Lasers and Laser-Related Equipment—Test Methods for Laser Beam Power (Energy) Density Distribution ISO 13694: 2000 115 Optics and Photonics—Lasers and Laser-Related Equipment—Test Methods for the Spectral Characteristics of Lasers ISO 13695: 2004 116 Optics and Optical Instruments—Test Methods for Radiation Scattered by Optical Components ISO 13696: 2002 117 Lasers and Laser-Related Equipment—Test Methods for Determination of the Shape of a Laser Beam Wavefront—Part 1: Terminology and Fundamental Aspects ISO 15367-1: 2003 120 Particular Requirements for the Safety of X-Ray Equipment for Computed Tomography IEC 60601-2-44 (ed. 2.1) J. Sterility 134 Resistometers Used for Characterizing the Performance of Biological and Chemical Indicators ANSI/AAMI ST44: 2002 135 Sterilization of Health Care Products—Requirements for the Development, Validation, and Routine Control of an Industrial Sterilization Process for Medical Devices—Dry Heat ANSI/AAMI ST63: 2002 136 Sterilization of Health Care Products—Requirements for Products Labeled “Sterile” ANSI/AAMI ST67: 2003 137 Sterilization of Health Care Products—Vocabulary ANSI/AAMI/ISO TIR 11139: 2002 138 Aseptic Processing of Health Care Products—Part 2: Filtration ISO 13408-2: 2003 139 Cleanrooms and Associated Controlled Environments—Part 1: Classification of Air Cleanliness ISO 14644-1: 1999 140 Cleanrooms and Associated Controlled Environments—Part 2: Specifications for Testing and Monitoring to Prove Continued Compliance With ISO 14644-1 ISO 14644-2: 2000 141 Cleanrooms and Associated Controlled Environments—Part 4: Design, Construction, and Start-Up ISO 14644-4: 2001 142 Cleanrooms and Associated Controlled Environments—Biocontamination Control—Part 1: General Principles and Methods ISO 14698-1: 2003 143 Cleanrooms and Associated Controlled Environments—Biocontamination Control—Part 2: Evaluation and Interpretation of Biocontamination Data ISO 14698-2: 2003 K. Tissue Engineering 5 Standard Guide for Characterization and Testing of Hyaluronan as Starting Material Intended for Use in Biomedical and Tissue Engineered Medical Product Applications ASTM F2347-2003 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 --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A04-22183. Public record. Not legal advice.