# Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 013 > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A05-22267 ## Record - **Collection:** Federal Register - **Document type:** Notice - **Published:** November 8, 2005 - **Citation:** 70 FR 67713 ## 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: 013 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: 013” (Recognition List Number: 013), 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: 013” to the Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to assist that office in processing your requests, or FAX your request to 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: 013 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, 12720 Twinbrook Pkwy., MD 20857, 301-827-0021. 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. 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), June 18, 2004 (69 FR 34176), and October 4, 2004 (69 FR 59240), FDA modified its initial list of FDA recognized consensus standards. 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: 013 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: 013” 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 52 ASTM F1463-93 (1999), Standard Specification for Alarm Signals in Medical Equipment Used in Anesthesia and Respiratory Care Withdrawn B. Biocompatibility 1 ASTM E1262-88 (2003), Standard Guide for Performance of the Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay Withdrawn and replaced with newer version 83 2 ASTM E1263-97 (2003), Standard Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow Erythrocytes Withdrawn and replaced with newer version 84 3 ASTM E1280-97 (2003), Standard Guide for Performing the Mouse Lymphoma Assay for Mammalian Cell Mutagenicity Withdrawn and replaced with newer version 85 19 AAMI/ANSI/ISO10993-10: 2002(E), Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Sensitization Withdrawn and replaced with newer version 86 20 AAMI/ANSI/ISO10993-10: 2002(E), Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Sensitization—Maximization Sensitization Test Withdrawn and replaced with newer version 87 21 AAMI/ANSI/ISO10993-11:1993, Biological Evaluation of Medical Devices—Part 11: Tests for Systemic Toxicity Extent of Recognition and Relevant Guidance 28 AAMI/ANSI/ISO10993-12:2002(E), Biological Evaluation of Medical Devices—Part 12: Sample Preparation and Reference Materials Withdrawn and replaced with newer version 88 34 ASTM F749-98 (2002)e2, Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit Withdrawn and replaced with newer version 89 37 ASTM E1397-91 (2003), Standard Practice for the In Vitro Rat Hepatocyte DNA Repair Assay Withdrawn and replaced with newer version 90 38 ASTM E1398-91 (2003), Standard Practice for the In Vivo Rat Hepatocyte DNA Repair Assay Withdrawn and replaced with newer version 91 39 ASTM F748-04, Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices Withdrawn and replaced with newer version 92 40 ASTM F763-04, Standard Practice for Short-Term Screening of Implant Materials Withdrawn and replaced with newer version 93 41 ASTM F981-04, Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone Withdrawn and replaced with newer version 94 42 ASTM F1984-99 (2003), Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials Withdrawn and replaced with newer version 95 43 ASTM F1903-98 (2003), Standard Practice for Testing for Biological Responses to Particles In Vitro Withdrawn and replaced with newer version 96 45 ASTM F1983-99 (2003), Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications Withdrawn and replaced with newer version 97 51 AAMI/ANSI/ISO10993-1: 2003(E), Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing Withdrawn and replaced with newer version 98 52 ASTM F1904-98e1 (2003), Standard Practice for Testing for Biological Responses to Particles In Vivo Withdrawn and replaced with newer version 99 53 ASTM E1372-95 (2003), Standard Test Method for Conducting a 90-Day Oral Toxicity Study in Rats Withdrawn and replaced with newer version 100 70 ASTM F750-87 (2002)e1, Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse Relevant guidance 74 USP 28-NF21Biological Tests <87>, Biological Reactivity Test, In Vitro—Direct Contact Test Withdrawn and replaced with newer version 101 75 USP 28-NF21Biological Tests <87>, Biological Reactivity Test, In Vitro—Elution Test Withdrawn and replaced with newer version 102 76 USP 28-NF21Biological Tests <88>, Biological Reactivity Test, In Vivo Procedure—Preparation of Sample Withdrawn and replaced with newer version 103 77 USP 28-NF21Biological Tests <88>, Biological Reactivity Test, In Vitro, Classification of Plastics—Intracutaneous Test Withdrawn and replaced with newer version 104 78 USP 28-NF21Biological Tests <88>, Biological Reactivity Test, In Vitro, Classification of Plastics—Systemic Injection Test Withdrawn and replaced with newer version 105 79 ASTM F619-03, Standard Practice for Extraction of Medical Plastics Withdrawn and replaced with newer version 106 80 ASTM F1877 (2003)e1, Standard Practice for Characterization of Particles Withdrawn and replaced with newer version 107 81 ASTM F1905 (2003)e1, Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity Withdrawn and replaced with newer version 108 B. Cardiovascular/Neurology 4 ANSI/AAMI SP10:2002—Manual, Electronic, or Automated Sphygmomanometers Withdrawn and replaced with newer version 53 5 ANSI/AAMI/ISO 7198:1998/2001(R) 2004, Cardiovascular Implants—Tubular vascular prostheses Withdrawn and replaced with newer version 54 14 ASTM F1830:05, Recommended Practice for Selection of Blood for In Vitro Hemolytic Evaluation of Blood Pumps Withdrawn and replaced with newer version 55 15 ASTM F1841:05, Recommended Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps Withdrawn and replaced with newer version 56 48 ASTM F2129:04, Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices Withdrawn and replaced with newer version 57 C. Dental/Ear, Nose, and Throat 29 IEC 60601-2-18:2000 Amendment 1, Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of Endoscopic Equipment Withdrawn and replaced with newer version 122 40 ANSI/ASA S3.6-2004, Specification for Audiometers Withdrawn and replaced with newer version 123 41 ANSI/ASA S3.22:2003, Specification of Hearing Aid Characteristics Withdrawn and replaced with newer version 124 61 ISO 1562:2004, Dentistry—Casting gold alloys Withdrawn and replaced with newer version 125 82 ISO 10477:2004, Dentistry—Polymer-based crown and bridge materials Withdrawn and replaced with newer version 126 D. General 16 ASTM D903:1993, Test Methods for Peel or Stripping Strength of Adhesive Bonds Contact person 28 IEC 60601-1-2, (Second Edition), Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests Extent of recognition 30 AAMI/IEC 60601-1-2, Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral standard: Electromagnetic Compatibility—Requirements and Tests (Edition 2:2001) Title and extent of recognition 2 IEC 60601-1, Medical Electrical Equipment—Part 1: General Requirements for Safety Withdrawn 4 IEC 60601-1, Medical Electrical Equipment—Part 1: General Requirements for Safety, 1988; Amendment 1, l991-11, Amendment 2, 1995-03 Contact person, devices affected and extent of recognition E. General Hospital/General Plastic Surgery 18 ISO 8537:1991 Sterile Single-Use Syringes, With or Without Needle, for Insulin Contact person 38 ASTM F1671-03: 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 130 48 ASTM D6499-03 Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and its Products Withdrawn and replaced with newer version 131 31 Ophthalmic 89 Radiology ISO 11810-1:2005: Lasers and Laser-Related Equipment—Test Method and Classification for the Laser-Resistance of Surgical Drapes and/or Patient-Protective Covers—Part 1: Primary Ignition and Penetration Transferred from Ophthalmic and Radiology 132 97 USP 28: 2005 Nonabsorbable Surgical Suture Withdrawn and replaced with newer version 133 98 USP 28<11>: 2005 Sterile Sodium Chloride for Irrigation Withdrawn and replaced with newer version 134 99 USP 28: 2005 Absorbable Surgical Suture Withdrawn and replaced with newer version 135 100 USP 28<881>: 2005 Tensile Strength Withdrawn and replaced with newer version 136 101 USP 28<861>: 2005 Sutures—Diameter Withdrawn and replaced with newer version 137 102 USP 28<871>: 2005 Sutures Needle Attachment Withdrawn and replaced with newer version 138 103 USP 28<11>: 2005 Sterile Water for Irrigation Withdrawn and replaced with newer version 139 104 USP 28<11>: 2005 Heparin Lock Flush Solution Withdrawn and replaced with newer version 140 105 USP 28<11>: 2005 Sodium Chloride Injection Withdrawn and replaced with newer version 141 11 ISO 594-1:1986 Conical Fittings With a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment—Part 1: General Requirements Title and contact person 13 ISO 595-1:1986 Reusable All-Glass or Metal-and-Glass Syringes for Medical Use—Part 1: Dimensions Title and contact person 14 ISO 595-2:1987 Reusable All-Glass or Metal-and-Glass Syringes for Medical Use—Part 2: Design, Performance Requirements and Tests Title and contact person 15 ISO 7864:1993 Sterile Hypodermic Needles for Single Use Contact person 16 ISO 7886-1:1993 Sterile Hypodermic Syringes for Single Use—Part 1: Syringes for Manual Use Title and contact person 62 ISO 8536-6:1995 Infusion Equipment for Medical Use—Part 6: Freeze Drying Closures for Infusion Bottles Title and contact person 63 ISO 8536-7-1999: Infusion Equipment for Medical Use—Part 7: Caps Made of Aluminum-Plastics Combinations for Infusion Bottles Contact Person 64 ISO 8536-3-1999: Infusion Equipment for Medical Use—Part 3: Aluminum Caps for Infusion Bottles Title and contact person 66 ISO 8536-1-2000: Infusion equipment for medical use—Part 1: Infusion glass bottles Title and Contact Person 68 ISO 7886-2-1996: Sterile Hypodermic Syringes for Single Use—Part 2: Syringes for Use With Power-Driven Syringe Pumps Title and contact person ; 69 ISO 9626-1991: Stainless Steel Needle Tubing for the Manufacture of Medical Devices Title and contact person 70 ASTM E825-98 (2003) Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature Contact person 111 IEC 60601-2-38 Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of Electrically Operated Hospital Beds Contact person 119 AAMI BF7: (R2002) Blood Transfusion Micro-Filters Contact person 120 ASTM F1054-01: Standard Specification for Conical Fittings Contact person 121 ISO 8536-2-2001: Infusion Equipment for Medical Use—Part 2: Closures for Infusion Bottles Contact person 122 ISO 8536-5-2004: Infusion Equipment for Medical Use—Part 5: Burette Infusion Sets for Single Use, Gravity Feed Title and contact person 126 ISO 8536-4-2004: Infusion Equipment for Medical Use—Part 4: Infusion Sets for Single Use, Gravity Feed Contact person 127 ISO 1135-4-2004: Transfusion Equipment for Medical Use—Part 4: Transfusion Sets for Single Use Contact person 129 ISO 594-2:1998 Conical Fittings With a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment—Part 2: Lock Fittings Contact person F. In Vitro Diagnostic 65 CLSI EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline—Second Edition Withdrawn and replaced with new version 110 54 CLSI D12-A2, Immunoprecipitin Analyses: Procedures for Evaluating the Performance of Materials—Second Edition; Approved Guideline Product codes G. Materials 9 ASTM F563-00: Standard Specification for Wrought Cobalt-20 Nickel-20 Chromium-3.5 Molybdenum-3.5 Tungsten-5 Iron Alloy for Surgical Implant Applications (UNS R30563) Withdrawn 13 ASTM F648-04: Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants Withdrawn and replaced with newer version 106 16 ASTM F746-04: Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials Withdrawn and replaced with newer version 107 25 ASTM F1295-05: Standard Specification for Wrought Titanium-6 Aluminum-7 Niobium Alloy for Surgical Implant Applications (UNS R56700) Withdrawn and replaced with newer version 108 34 ASTM F1659-95: Standard Test Method for Bending and Shear Fatigue Testing of Calcium Phosphate Coatings on Solid Metallic Substrates Withdrawn 72 ASTM F2213-04: Standard Test Method for Measurement of Magnetically Induced Torque on Passive Implants in the Magnetic Resonance Environment Title 73 ASTM F561-05, Practice for Retrieval and Analysis of Implanted Medical Devices, and Associated Tissues Withdrawn and replaced with newer version 109 74 ASTM F1377-04: Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075) Withdrawn and replaced with newer version 110 75 ASTM F1160-05: Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings Withdrawn and replaced with newer version 111 80 ASTM F1088-04a: Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation Title 83 ASTM F1044-05: Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings Withdrawn and replaced with newer version 112 84 ASTM F1147-05: Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coatings Withdrawn and replaced with newer version 113 90 ASTM F2255-05: Standard Test Method for Strength Properties of Tissue Adhesives in Lap Shear by Tension Loading Withdrawn and replaced with newer version 114 91 ASTM F2256-05: Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading Withdrawn and replaced with newer version 115 92 ASTM F2258-05: Standard Test Method for Strength Properties of Tissue Adhesives in Tension Withdrawn and replaced with newer version 116 93 ASTM F86-04: Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants Withdrawn and replaced with newer version 117 H. OB-GYN/Gastroenterology 1 AAMI RD5:1992: Hemodialysis systems Withdrawn 17 ASTM D3492-03: Standard Specification for Rubber Contraceptives (Male Condoms) Withdrawn and replaced with newer version 32 24 ASTM F623-99e1: Standard Performance Specification for Foley Catheter Withdrawn and replaced with newer version 33 26 ISO 4074:2002/Cor.1:2003(E): Natural Latex Rubber Condoms—Requirements and Test Methods, Technical Corrigendum 1 Withdrawn and replaced with newer version 34 27 ASTM D6324-99a (Reapproved 2004): Standard Test Methods for Male Condoms Made From Synthetic Materials Withdrawn and replaced with newer version 35 I. Ophthalmic 31 ISO 11810:2002, Optics and Optical Instruments—Lasers and Laser-Related Equipment—Test Method for the Laser-Resistance of Surgical Drapes and/or Patient-Protective Covers Withdrawn newer version recognized under General Hospital/ General Plastic Surgery J. Orthopedic 126 ASTM F366-04: Standard Specification for Fixation Pins and Wires Withdrawn and replaced with newer version 180 159 ASTM F1717-04: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model Withdrawn and replaced with newer version 181 173 ASTM F1800-04: Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements Withdrawn and replaced with newer version 182 K. Radiology 1 ANSI PH 2.43-1982: Method for Sensitometry/Medical X-Ray Screen-Film Contact person 2 ANSI IT 1.48-1997 Photography (Films)—Medical Hard Copy Imaging Film-Dimensions and Specifications Title and contact person 5 ANSI PH 2.50-1983: Method/Sensitometry Direct Exposure Medical/Dental Contact person 6 IEC 60806 (R1984) Determination of the Maximum Symmetrical Radiation Field From a Rotating Anode X-ray Tube for Medical Diagnosis Title and contact person 8 IEC 60336 (R1993) Medical Electrical Equipment—X-ray Tube Assemblies for Medical Diagnosis—Characteristics of Focal Spots Title 23 NEMA XR 10-1986 (R2003) Measurement of the Maximum Symmetrical Radiation Field from a Rotating Anode X-Ray Tube Used for Medical Diagnosis Reaffirmation 34 IEC 60601-2-7-1998 Medical Electrical Equipment—Part 2-7: Particular Requirements for the Safety of High-Voltage Generators of Diagnostic X-ray Generators Tile and contact person 37 IEC 60601-2-11-2004 Amendment 1—Medical electrical equipment—Part 2-11: Particular requirements for the Safety of Gamma Beam Therapy Equipment Withdrawn and Replaced With Newer Version 133 52 UL 544 (1998): Standard for Medical and Dental Equipment—Ed. 4.0 Contact person 56 IEC 61674-1997 Medical Electrical Equipment—Dosimeters With Ionization Chambers and/or Semi-Conductor Detectors as Used in X-ray Diagnostic Imaging Withdrawn 57 IEC 60731-1997 Medical Electrical Equipment—Dosimeters With Ionization Chambers as Used in Radiotherapy Title and devices affected 61 UL 122 (1999): Standard for Photographic Equipment—Ed. 4.0 Contact person 62 UL 187 (1998): Standard for X-Ray Equipment—Ed. 7.0 Contact person 79 NEMA XR 7-1995 (R2000) High-Voltage X-Ray Cable Assemblies and Receptacles Title and contact person 80 NEMA XR 9-1984 (R1994, R2000) Power Supply Guidelines for X-Ray Machines Contact person 81 NEMA XR 13-1990 (R1995, R2000) Mechanical Safety Standard for Power Driven Motions of Electromedical Equipment Contact person 82 NEMA XR 14-1990 (R1995, R2000) Recommended Practices for Load Bearing Mechanical Assemblies Used in Diagnostic Imaging Contact Person 89 ISO 11810:2002 Optics and Optical Instruments—Lasers and Laser-Related Equipment—Test Method for the Laser-Resistance of Surgical Drapes and/or Patient-Protective Covers Withdrawn Newer version recognized under General Hospital/General Plastic Surgery 107 ISO 11146-1:2005 Lasers and Laser-Related Equipment—Test Methods for Laser Beam Widths, Divergence Angles and Beam Propagation Ratios—Part 1: Stigmatic and Simple Astigmatic Beams Withdrawn and replaced with newer version 134 119 NEMA PS 3.1—3.18 Digital Imaging and Communications in Medicine (DICOM) Set Title 126 IEC 60601-2-28-1993 Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of X-ray Source Assemblies and X-ray Tube Assemblies for Medical Diagnosis—Ed. 1.0 Title and contact person 127 IEC 60601-2-32-1994 Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of Associated Equipment of X-ray Equipment—Ed. 1.0 Title and contact person 129 NEMA NU 1-2001 (Errata 2004): Performance Measurements of Scintillation Cameras Title 131 IEC 61217-2002 Radiotherapy Equipment—Coordinates Movements and Scales Consolidated Ed. 1.1 Title 132 IEC 60731-2002 Amendment 1—Medical Electrical Equipment—Dosimeters With Ionization Chambers as Used in Radiotherapy Title and devices affected L. Sterility 48 ANSI/AAMI ST40:2004, Table-Top Dry Heat (Heated Air) Sterilization and Sterility Assurance in Dental and Medical Facilities, 2ed Withdrawn and replaced with newer version 152 52 ANSI/AAMI ST59:1999, Sterilization of Health Care Products—Biological Indicators Part 1: General Title, relevant guidance, and contact person 70 ANSI/AAMI/ISO 14161:2000, Sterilization of Health Care Products—Biological Indicators—Guidance for the Selection, Use, and Interpretation of Results, 2ed. Contact Person 71 ANSI/AAMI ST8:2001, Hospital Steam Sterilizers Contact Person 77 ANSI/AAMI ST24:1999, Automatic, General Purpose Ethylene Oxide Sterilizers and Ethylene Oxide Sterilant Sources Intended for Use in Health Care Facilities, 3ed. Title and contact person 116 ANSI/AAMI ST72:2002, Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing Relevant guidance 117 ANSI/AAMI ST35:2003, Safe Handling and Biological Decontamination of Medical Devices in Health Care Facilities and in Nonclinical Settings Relevant guidance and contact person 119 ANSI/AAMI ST55:2003, Table-Top Steam Sterilizers, 2ed. Correct title and contact person 124 USP 28:2005, Biological Indicator for Dry Heat Sterilization, Paper Carrier Withdrawn and replaced with newer version 153 125 USP 28:2005, Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier Withdrawn and replaced with newer version 154 126 USP 28:2005, Biological Indicator for Steam Sterilization, Paper Carrier Withdrawn and replaced with newer version 155 127 USP28:2005, <61> Microbial Limits Test Withdrawn and replaced with newer version 156 128 USP 28:2005, <71>, Microbiological Tests, Sterility Tests Withdrawn and replaced with newer version 157 129 USP28:2005, <85>, Biological Tests and Assays, Bacterial Endotoxin Test (LAL) Withdrawn and replaced with newer version 158 130 USP28:2005 <151>, Pyrogen Test (USP Rabbit Test) Withdrawn and replaced with newer version 159 131 USP28:2005 <1211>, Sterilization and Sterility Assurance of Compendial Articles Withdrawn and replaced with newer version 160 132 USP28:2005 <161>, Transfusion and Infusion Assemblies and Similar Medical Devices Withdrawn and replaced with newer version 161 133 USP 28:2005, Biological Indicator for Steam Sterilization—Self-Contained Withdrawn and replaced with newer version 162 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: 013, follows: Item No. Title of Standard Reference No. and Date A. Anesthesia 65 Medical Electrical Equipment—Particular Requirements for the Basic Safety and Essential Performance of Respiratory Gas Monitors ISO 21647:2005 66 Medical Electrical Equipment—Particular Requirements for the Basic Safety and Essential Performance of Pulse Oximeter Equipment for Medical Use ISO 9919:2005 B. Dental/Ear, Nose, Throat 127 Root Canal Files, Type H (Hedstrom) ANSI/ADA Specification No. 58:2004 128 Dentistry—Elastomeric Impression Materials ISO/4823:2000 Technical Corrigendum 1:2004 129 Dentistry—Elastomeric Impression Materials ANSI/ADA Specification No. 19:2000 Technical Corrigendum 1:2004 C. General 34 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)) IEC 60601-1-2:2004 35 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/IEC 60601-1-2:2001 D. General Hospital/General Plastic Surgery 142 Medical Electrical Equipment—Part 2: Particular Requirements for Safety of Baby Incubators ANSI/AAMI II36:2004 143 Medical Electrical Equipment—Part 2: Particular Requirements for Safety of Transport Incubators ANSI/AAMI II51:2004 E. In Vitro Diagnostic 109 Laboratory Automation: Data Content for Specimen Identification; Approved Standard CLSI AUTO7-A:2004 111 Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays; Approved Guideline—Fourth Edition CLSI H21-A4:2003 112 Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline CLSI H49-A:2004 113 Assessing the Quality of Immunoassay Systems: Radioimmunoassays, and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guideline CLSI I/LA23-A:2004 114 Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems CLSI LIS01-A:2003 115 Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard—Second Edition CLSI LIS02-A2:2004 116 Standard Guide for Selection of a Clinical Laboratory Information Management System CLSI LIS03-A:2003 117 Standard Guide for Documentation of Clinical Laboratory Computer Systems CLSI LIS04-A:2003 118 Standard Specification for Transferring Clinical Observations Between Independent Computer Systems CLSI LIS05-A:2003 119 Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems CLSI LIS06-A:2003 120 Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory CLSI LIS07-A:2003 121 Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems CLSI LIS08-A:2003 122 Standard Guide for Coordination of Clinical Laboratory Services Within the Electronic Health Record Environment and Networked Architectures CLSI LIS09-A:2003 123 Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine CLSI MM9-A:2004 F. Materials 118 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment ASTM F2503-05 G. OB-GYN/Gastroenterology 36 Mechanical contraceptives—Reusable Natural and Silicone Rubber Contraceptive Diaphragms—Requirements and Tests ISO 8009:2004(E) H. Radiology 135 Medical electrical equipment—Part 2-5: Particular Requirements for the Safety of Ultrasonic Physiotherapy Equipment Ed. 2.0 IEC 60601-2-5:2000 I. Sterility 163 Sterilization of Medical Devices—Microbiological methods—Part 3: Guidance on Evaluation and Interpretation of Bioburden Data ANSI/AAMI/ISO 11737-3:2004 164 Sterilization of Medical Devices—Information To Be Provided by the Manufacturer for the Processing of Resterilizable Medical Devices ANSI/AAMI ST81:2004 165 Cleanrooms and Associated Controlled Environments—Part 5: Operations ISO 14644-5:2004 166 Cleanrooms and Associated Controlled Environments—Part 7: Separative Devices (Clean Air Hoods, Gloveboxes, Isolators and Mini-Environments) ISO 14644-7:2004 J. Tissue Engineering 6 Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue Engineered Medical Products ASTM F2450-04 7 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels ASTM F2315-03 IV. List of Recognized Standards FDA maintains the agency's current list of FDA recognized consensus standards in a searchable database that may be accessed directly at FDA's Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm . FDA will incorporate the modifications and minor revisions described in this notice into the database and, upon publication in the Federal Register , this recognition of consensus standards will be effective. FDA will announce additional modifications and minor revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often, if necessary. V. Recommendation of Standards for Recognition by FDA Any person may recommend consensus standards as candidates for recognition under the new provision of section 514 of the act by submitting such recommendations, with reasons for the recommendation, to the contact person (see FOR FURTHER INFORMATION CONTACT ). To be properly considered such recommendations should contain, at a minimum, the following information: (1) Title of the standard, (2) any reference number and date, (3) name and address of the national or international standards development organization, (4) a proposed list of devices for which a declaration of conformity to this standard should routinely apply, and (5) a brief identification of the testing or performance or other characteristics of the device(s) that would be addressed by a declaration of conformity. VI. Electronic Access In order to receive “Guidance on the Recognition and Use of Consensus Standards” on 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 notice announcing “Modifications to the List of Recognized Standards, Recognition List Number: 013” 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. 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 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: 013. These modifications to the list or recognized standards are effective upon publication of this notice in the Federal Register . Dated: October 10, 2005. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. 05-22267 Filed 11-7-05; 8:45 am] BILLING CODE 4160-01-S --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A05-22267. Public record. Not legal advice.