[Federal Register: September 9, 2008 (Volume 73, Number 175)] [Notices] [Page 52358-52385] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr09se08-89] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2004-N-0451] (formerly FDA-2004-N-0226) Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 020 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: 020'' (Recognition List Number: 020), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. DATES: Effective September 9, 2008. Submit written or electronic comments concerning this document at any time. ADDRESSES: Submit written requests for single copies of ``Modifications to the List of Recognized Standards, Recognition List Number: 020'' to the Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health (CDRH) (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to assist that office in processing your requests, or fax your request to 240-276-3151. Submit written comments concerning this document, or recommendations for additional standards for recognition, to the contact person (see FOR FURTHER INFORMATION CONTACT). Submit electronic comments to standards@cdrh.fda.gov. This document may also be accessed on FDA's Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/cdrhnew.cfm. See section VI of this document for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 020 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, 7520 Standish Pl., Rockville, MD 20855, 240-276-8714. 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 document described how FDA would implement its standard recognition program and provided the initial list of recognized standards. Modifications to the initial list of recognized standards, as published in [[Page 52359]] the Federal Register, are identified in table 1 of this document. Table 1.--Previous Publications of Standard Recognition Lists October 16, 1998 October 4, 2004 (63 FR 55617) (69 FR 59240) July 12, 1999 May 27, 2005 (64 FR 37546) (70 FR 30756) November 15, 2000 November 8, 2005 (65 FR 69022) (70 FR 67713) May 7, 2001 March 31, 2006 (66 FR 23032) (71 FR 16313) January 14, 2002 June 23, 2006 (67 FR 1774) (71 FR 36121) October 2, 2002 November 3, 2006 (67 FR 61893) (71 FR 64718) April 28, 2003 May 21, 2007 (68 FR 22391) (72 FR 28500) March 8, 2004 September 12, 2007 (69 FR 10712) (72 FR 52142) June 18, 2004 December 19, 2007 (69 FR 34176) (72 FR 71924) ------------------------------------------------------------------------ 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: 020 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. In addition to these changes, FDA has also established a new internal numbering system that assigns unique identification recognition numbers. FDA believes this new numbering system will facilitate the use of FDA Form 3654, ``Standards Data Report for 510(k)s,'' which was implemented in November 2007. 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: 020'' to identify these current modifications. In table 2 of this document, FDA describes the following modifications: (1) The withdrawal of standards and their replacement by others, (2) the correction of errors made by FDA in listing previously recognized standards, and (3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards. In section III of this document, FDA lists modifications the agency is making that involve the initial addition of standards not previously recognized by FDA. Table 2.--Modifications to the List of Recognized Standards ------------------------------------------------------------------------ Old Replacement Recognition Recognition Standard Change No. No. ------------------------------------------------------------------------ A. Anesthesia ------------------------------------------------------------------------ 1-11 ............ IEC 60601-3-1:1996-08 Withdrawn Medical Electrical Equipment Part 3-1: Essential Performance Requirements for Transcutaneous Oxygen and Carbon Dioxide Partial Pressure Monitoring Equipment ------------------------------------------------------------------------ 1-46 ............ ISO 5367:2000 Breathing Relevant Tubes Intended for Use guidance and With Anaesthetic Extent of Apparatus and Ventilators recognition ------------------------------------------------------------------------ 1-51 ............ ASTM F1101-90(1997) Withdrawn Standard Specification for Ventilators Intended for Use During Anesthesia ------------------------------------------------------------------------ 1-62 ............ ISO 5356-1:2004 Relevant Anaesthetic and guidance Respiratory Equipment-- Conical Connectors: Part 1: Cones and Sockets ------------------------------------------------------------------------ 1-66 ............ ISO 9919:2005: Medical Relevant Electrical Equipment-- guidance Particular Requirements for the Basic Safety and Essential Performance of Pulse Oximeter Equipment for Medical Use ------------------------------------------------------------------------ 1-68 ............ CGA V-5:2005 Diameter- Relevant Index Safety System guidance (Noninterchangeable Low Pressure Connections for Medical Gas Applications) ------------------------------------------------------------------------ 1-72 ............ ISO 10651-5:2006 Lung Relevant Ventilators for Medical guidance, Code Use--Particular of Federal Requirements for Basic Regulations Safety and Essential (CFR) Citation Performance--Part 5: Gas- and Product powered Emergency Codes Resuscitators ------------------------------------------------------------------------ 1-73 ............ ISO 10651-4:2002 Lung Relevant Ventilators--Part 4: guidance Particular Requirements for Operator Powered Resuscitators ------------------------------------------------------------------------ B. Biocompatibility ------------------------------------------------------------------------ 2-21 2-118 ANSI/AAMI/ISO 10993-11: Withdrawn and 2006 Biological replaced with Evaluation of Medical newer version Devices--Part 11: Tests for System Toxicity ------------------------------------------------------------------------ 2-56 2-119 ASTM F813-07 Standard Withdrawn and Practice for Direct replaced with Contact Cell Culture newer version Evaluation of Materials for Medical Devices ------------------------------------------------------------------------ [[Page 52360]] 2-63 2-120 ANSI/AAMI/ISO 10993-6: Withdrawn and 2007 Biological replaced with Evaluation of Medical newer version Devices--Part 6: Tests for Local Effects After Implantation ------------------------------------------------------------------------ 2-66 2-121 ASTM F2148-07e1 Standard Withdrawn and Practice for Evaluation replaced with of Delayed Contact newer version Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA) ------------------------------------------------------------------------ 2-68 2-122 ASTM F719-81 (2007) e1 Withdrawn and Standard Practice for replaced with Testing Biomaterials in newer version Rabbits for Primary Skin Irritation ------------------------------------------------------------------------ 2-69 2-123 ASTM F720-81 (2007) e1 Withdrawn and Standard Practice for replaced with Testing Guinea Pigs for newer version Contact Allergens: Guinea Pig Maximization Test ------------------------------------------------------------------------ 2-70 2-124 ASTM F750-87 (2007) e1 Withdrawn and Standard Practice for replaced with Evaluating Material newer version Extracts by Systemic Injection in the Mouse ------------------------------------------------------------------------ 2-89 2-125 ASTM F749-98 (2007) e1 Withdrawn and Standard Practice for replaced with Evaluating Material newer version Extracts by Intracutaneous Injection in the Rabbit ------------------------------------------------------------------------ 2-92 2-126 ASTM F748-06 Standard Withdrawn and Practice for Selecting replaced with Generic Biological Test newer version Methods for Materials and Devices ------------------------------------------------------------------------ 2-95 ............ ASTM F1984-99(2003) Relevant Standard Practice for guidance Testing for Whole Complement Activation in Serum by Solid Materials ------------------------------------------------------------------------ 2-109 2-128 USP 31-NF26 Biological Withdrawn and Test <87> 2008 Biological replaced with Reactivity Test, In newer version Vitro--Direct Contact Test ------------------------------------------------------------------------ 2-110 2-129 USP 31-NF26 Biological Withdrawn and Test <88> 2008 Biological replaced with Reactivity Test, In newer version Vitro--Elution Test ------------------------------------------------------------------------ 2-111 2-130 USP 31-NF26 Biological Withdrawn and Test <88> 2008 Biological replaced with Reactivity Test, In newer version Vitro, Procedure-- Preparation of Sample ------------------------------------------------------------------------ 2-112 2-131 USP 31-NF26 Biological Withdrawn and Test <88> 2008 Biological replaced with Reactivity Test, In newer version Vitro, Classification of Plastics--Intracutaneous Test ------------------------------------------------------------------------ 2-113 2-132 USP 31-NF26Biological Test Withdrawn and <88> 2008 Biological replaced with Reactivity Test, In Vivo-- newer version Classification of Plastics--Systemic Injection Test ------------------------------------------------------------------------ C. Cardiovascular/Neurology ------------------------------------------------------------------------ 3-2 ............ ANSI/AAMI EC53:1995/ Reaffirmation (R)2001--ECG Cables and Leadwires ------------------------------------------------------------------------ 3-3 ............ ANSI/AAMI NS28:1988/ Reaffirmation (R)2006--Intracranial Pressure Monitoring Devices ------------------------------------------------------------------------ 3-16 3-60 IEC 60601-2-10: Amendment Withdrawn and 1: 2001-09, Medical replaced with Electrical Equipment-- newer version Part 2-10: Particular Requirements for the Safety of Nerve and Muscle Stimulators ------------------------------------------------------------------------ 3-18 3-61 IEC 60601-2-27: 2005-08, Withdrawn and Second Edition, Medical replaced with Electrical Equipment-- newer version Part 2-27: Particular Requirements for the Safety, Including Essential Performance, of Electrocardiographic Monitoring Equipment ------------------------------------------------------------------------ 3-20 3-62 IEC 60601-2-31: 2008-03, Withdrawn and Edition 2.0, Medical replaced with Electrical Equipment-- newer version Part 2-31: Particular Requirements for the Basic Safety and Essential Performance of External Cardiac Pacemakers with Internal Power Source ------------------------------------------------------------------------ 3-25 3-63 ISO 11318:2002, Second Withdrawn and Edition, Cardiac replaced with Defibrillators--Connector newer version Assembly DF-1 for Implantable Defibrillators--Dimension s and Test Requirements ------------------------------------------------------------------------ [[Page 52361]] 3-40 ............ ANSI/AAMI SP9:1994, Non- Withdrawn automated Sphygmomanometers ------------------------------------------------------------------------ 3-41 ............ ANSI/AAMI EC11:1991/ Reaffirmation (R)2007--Diagnostic Electrocardiographic Devices ------------------------------------------------------------------------ 3-42 ............ ANSI/AAMI EC13:2002/ Reaffirmation (R)2007--Cardiac Monitors, Heart Rate Meters, and Alarms ------------------------------------------------------------------------ 3-43 3-65 ANSI/AAMI EC38:2007-- Withdrawn and Medical Electrical replaced with Equipment--Part 2-47: newer version Particular Requirements for the Safety, Including Essential Performance, of Ambulatory Electrocardiographic Systems ------------------------------------------------------------------------ 3-44 ............ ANSI/AAMI BP22:1994/ Reaffirmation (R)2006, Blood Pressure Transducers ------------------------------------------------------------------------ 3-45 ............ ANSI/AAMI EC57:1998/ Reaffirmation (R)2003, Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms ------------------------------------------------------------------------ 3-47 3-66 ASTM F2081-06, Standard Withdrawn and Guide for replaced with Characterization and newer version Presentation of the Dimensional Attributes of Vascular Stents ------------------------------------------------------------------------ 3-52 ............ ANSI/AAMI EC12:2000/ Reaffirmation (R)2005, Disposable ECG Electrodes ------------------------------------------------------------------------ 3-57 3-67 ASTM F2129-06, Standard Withdrawn and Test Method for replaced with Conducting Cyclic newer version Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices ------------------------------------------------------------------------ D. Dental/Ear, Nose, and Throat ------------------------------------------------------------------------ 4-43 ............ ANSI/ADA Specification No. Type of 5-Dental Casting standard, and Alloys:1997 Relevant guidance ------------------------------------------------------------------------ 4-50 ............ ANSI/ADA Specification No. Title and 18-Alginate Impression Relevant Materials:1992 guidance ------------------------------------------------------------------------ 4-52 4-147 ANSI/ADA Specification No. Withdrawn and 27-Resin-Based Filling replaced with Materials: 2005 newer year ------------------------------------------------------------------------ 4-62 ............ ISO 1563:1990 Dental Relevant Alginate Impression guidance and Material Extent of recognition ------------------------------------------------------------------------ 4-63 ............ ISO 1564:1995 Dental Relevant Aqueous Impression guidance Materials Based on Agar ------------------------------------------------------------------------ 4-65 4-151 ISO 3336:1993, Dentistry-- Withdrawn and Synthetic Polymer Teeth replaced with newer version ------------------------------------------------------------------------ 4-66 ............ ISO 4049:1988, Dentistry-- Withdrawn--newer Resin-Based Filling version Materials previously recognized ------------------------------------------------------------------------ 4-67 ............ ISO 6871-1:1994, Dental Withdrawn--newer Base Metal Casting Alloys version Part 1: Cobalt-based previously Alloys--TECHNICAL recognized CORRIGENDUM 1:1998 ------------------------------------------------------------------------ 4-68 ............ ISO 6871-2:1994, Dental Withdrawn--newer Base Metal Casting Alloys version Part 2: Nickel-Based previously Alloys recognized ------------------------------------------------------------------------ 4-69 ............ ISO 6872:1995/Amendment Date of standard 1:1997 Dental Ceramic and Extent of recognition ------------------------------------------------------------------------ 4-73 ............ ISO 7405:1997 Dentistry-- Extent of Preclinical Evaluation of recognition and Biocompatibility of Contact person Medical Devices Used in Dentistry--Test Methods for Dental Materials ------------------------------------------------------------------------ 4-75 ............ ISO 7785-1:1997 Dental Relevant Handpieces--Part 1: High- guidance and Speed Air Turbine Extent of Handpieces recognition ------------------------------------------------------------------------ [[Page 52362]] 4-76 ............ ISO 7785-2:1995 Dental Relevant Handpieces--Part 2: guidance and Straight and Geared Angle Extent of Handpieces recognition ------------------------------------------------------------------------ 4-78 ............ ISO 9168:1991 Dental Relevant Handpieces--Hose guidance and Connectors Extent of recognition ------------------------------------------------------------------------ 4-83 ............ ISO 11498:1997 Dental Relevant Handpieces--Dental Low- guidance and Voltage Electrical Motors Extent of recognition ------------------------------------------------------------------------ 4-84 ............ ISO 13294:1997 Dental Relevant Handpieces--Dental Air- guidance and Motors Extent of recognition ------------------------------------------------------------------------ 4-88 4-148 ANSI/ADA Specification No. Withdrawn and 78-Endodontic Obturating replaced with Cones: 2005 newer version ------------------------------------------------------------------------ 4-89 ............ ANSI/ADA Specification No. Reaffirmation 53-Polymer-Based Crowns and Relevant and Bridge Resins: 1999 guidance (Reaffirmed 2005) ------------------------------------------------------------------------ 4-90 ............ ANSI/ASA S3.39:1987 Reaffirmation (R2007), Specifications and Type of for Instruments to standard Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance) ------------------------------------------------------------------------ 4-91 ............ ANSI/ADA Specification No. Relevant 80-Dental Materials-- guidance Determination of Color Stability: 2001 ------------------------------------------------------------------------ 4-92 ............ ANSI/ADA Specification No. Reaffirmation 88-Dental Brazing Alloys: and Relevant 2000 (Reaffirmed 2006) guidance ------------------------------------------------------------------------ 4-93 4-159 IEEE ANSI C63.19:2007 Withdrawn and Methods of Measurement of replaced with Compatibility Between newer version Wireless Communications Devices and Hearing Aids ------------------------------------------------------------------------ 4-94 ............ ANSI/ADA Specification No. Reaffirmation, 14--Dental Base Metal Date of Casting Alloys: 1982 standard, Type (Reaffirmed 1998) of standard, Offices, Relevant guidance ------------------------------------------------------------------------ 4-95 ............ ANSI/ADA Specification Withdrawn--newer No.17:1999, Dental Base version Temporary Relining Resin previously recognized ------------------------------------------------------------------------ 4-96 ............ ANSI/ADA Specification No. Reaffirmation 30--Dental Zinc Oxide-- and Relevant Eugenol and Zinc Oxide-- guidance Non-Eugenol Cements: 2000 (Reaffirmed 2005) ------------------------------------------------------------------------ 4-97 ............ ANSI/ADA Specification No. Reaffirmation, 57--Endodontic Sealing Offices and Material: 2000 Type of (Reaffirmed 2006) standard ------------------------------------------------------------------------ 4-98 ............ ANSI/ADA Specification No. Withdrawn--newer 96:2000, Dental-Water- version Based Cements previously recognized ------------------------------------------------------------------------ 4-99 ............ ISO 4049: 2000 Dentistry-- Relevant Polymer-based Filling, guidance, Type Restorative and Luting of standard and Materials Extent of recognition ------------------------------------------------------------------------ 4-100 4-133 ISO 6876:2001, Dental Root Withdrawn Canal Sealing Materials (duplicate) ------------------------------------------------------------------------ 4-101 ............ ISO 8891:1998, Dental Withdrawn--newer Casting Alloys With Noble version Metal Content of At Least previously 25% but Less Than 75% recognized ------------------------------------------------------------------------ 4-102 4-152 ISO 9693:1999, Metal- Withdrawn and Ceramic Dental replaced with Restorative Systems newer version ------------------------------------------------------------------------ 4-104 4-149 ANSI/ADA Specification No. Withdrawn and 39--Pit and Fissure replaced with Sealants: 2006 newer version ------------------------------------------------------------------------ 4-105 ............ ANSI/ADA Specification No. Type of standard 75--Resilient Lining and Relevant Materials for Removable guidance Dentures--Part 1: Short- Term Materials: 1997 (Reaffirmed 2003) ------------------------------------------------------------------------ 4-107 ............ ISO 9917-2:1998 Dental Devices Water-Based Cements--Part affected, Type 2: Light-Activated of standard, Cements Relevant guidance and Extent of recognition ------------------------------------------------------------------------ [[Page 52363]] 4-109 ............ ISO 13716:1999 Dentistry-- Type of Reversible-Irreversible standard, Hydrocolloid Impression Relevant Material Systems guidance, Extent of recognition and Code of Federal Regulations (CFR) citation ------------------------------------------------------------------------ 4-110 ............ ANSI/ADA Specification No. Type of standard 11--Agar Impression and Relevant Materials: 1997 guidance ------------------------------------------------------------------------ 4-111 ............ ANSI/ADA Specification No. Reaffirmation, 13--Denture Cold-Curing Date of Repair Resins: 1981 standard, Type (Reaffirmed 2006) of standard and Relevant guidance ------------------------------------------------------------------------ 4-112 ............ ANSI/ADA Specification No. Reaffirmation, 16--Dental Impression Date of Paste--Zinc Oxide-Eugenol standard, Type Type: 1961 (Reaffirmed of standard and 1999) Relevant guidance ------------------------------------------------------------------------ 4-113 ............ ANSI/ADA Specification No. Reaffirmation, 20--Dental Duplicating Date of Material: 1972 standard, Type (Reaffirmed 1995) of standard and Relevant guidance ------------------------------------------------------------------------ 4-115 4-153 ISO 9917-1:2007 Dentistry-- Withdrawn and Water-Based Cements--Part replaced with a 1: Powder/Liquid Acid- newer year Base Cements ------------------------------------------------------------------------ 4-117 ............ ANSI/ADA Specification No. Type of standard 12--Denture Base Polymers: 2002 ------------------------------------------------------------------------ 4-119 ............ ANSI/ADA Specification No. Reaffirmation, 82--Dental Reversible/ Date of Irreversible Hydrocolloid standard, Type Impression Material of standard and Systems: 1998 (Reaffirmed Relevant 2003) guidance ------------------------------------------------------------------------ 4-120 ............ ISO 10139-2:1999 Type of Dentistry--Soft Lining standard, Materials for Removable Relevant Dentures--Part 2: guidance and Materials for Long-Term Extent of Use recognition ------------------------------------------------------------------------ 4-121 ............ ISO 7494-2:2003 Dentistry-- Type of standard Dental Units--Part 2: and Extent of Water and Air Supply recognition ------------------------------------------------------------------------ 4-125 ............ ISO 1562:2004, Dentistry-- Withdrawn--newer Casting Gold Alloys version previously recognized ------------------------------------------------------------------------ 4-126 ............ ISO 10477:2004 Dentistry-- Extent of Polymer-Based Crown and recognition and Bridge Materials Relevant guidance ------------------------------------------------------------------------ 4-127 ............ ANSI/ADA Specification No. Type of standard 58--Root Canal Files, and Extent of Type H (Hedstrom): 2004 recognition ------------------------------------------------------------------------ 4-128 ............ ISO 4823:2000,, Dentistry-- Withdrawn Elastomeric Impression Materials and Technical Corrigendum 1:2004 ------------------------------------------------------------------------ 4-129 4-150 ANSI/ADA Specification No. Withdrawn and 19--Dental Elastomeric replaced with Impression Material: 2004 newer version ------------------------------------------------------------------------ 4-130 ............ ANSI/ADA Specification No. Reaffirmation, 17--Denture Base Processes Temporary Relining impacted, Resins: 1983 (Reaffirmed Extent of 2006) recognition, CFR citations and Relevant guidance ------------------------------------------------------------------------ 4-131 ............ ISO 3107: 2004 Dentistry-- Processes Zinc Oxide/Eugenol and impacted and Zinc Oxide/Non-eugenol Relevant Cements Technical guidance Corrigendum 1:2006-Third Edition ------------------------------------------------------------------------ 4-132 ............ ISO 6874:2005 Dentistry-- Extent of Polymer-Based Pit and recognition and Fissure Sealants Relevant guidance ------------------------------------------------------------------------ 4-133 ............ ISO 6876:2001 Dental Root Processes Canal Sealing Materials impacted and Extent of recognition ------------------------------------------------------------------------ 4-134 ............ ISO 7494-1:2004 Dentistry-- Extent of Dental Units--Part 1: recognition General Requirements and Test Methods ------------------------------------------------------------------------ 4-135 ............ ISO 10139-1:2005 Relevant Dentistry--Soft Lining guidance and Materials for Removable Extent of Dentures--Part 1: recognition Materials for Short-term Use ------------------------------------------------------------------------ [[Page 52364]] 4-136 ............ ASTM F2504-05 Standard Relevant Practice for Describing guidance System Output of Implantable Middle Ear Hearing Devices ------------------------------------------------------------------------ 4-137 ............ ISO 6877:2006 Dentistry-- Extent of Root-Canal Obturating recognition Points ------------------------------------------------------------------------ 4-139 ............ ANSI/ADA Specification No. Relevant 48--Visible Light Curing guidance Units: 2004 ------------------------------------------------------------------------ 4-140 ............ ISO 6871-2:1994/Amd Withdrawn--newer 1:2005, Dental Base Metal version Casting Alloys--Part 2: previously Nickel-Based Alloys recognized ------------------------------------------------------------------------ 4-141 ............ ISO 6871-1:1994, Dental Withdrawn--newer Base Metal Casting version Alloys--Part 1: Cobalt- previously Based Alloys recognized ------------------------------------------------------------------------ 4-142 ............ ISO 6871-1:1994/Amd Withdrawn--newer 1:2005, Dental Base Metal version Casting Alloys--Part 1: previously Cobalt-Based Alloys recognized ------------------------------------------------------------------------ 4-143 ............ ANSI/ADA Specification Reaffirmation, No.96, Dental-Water-Based Type of Cements standard and Relevant guidance ------------------------------------------------------------------------ 4-145 ............ ISO 22803:2004 Dentistry-- Relevant Membrane Materials for guidance and Guided Tissue Devices Regeneration in Oral and affected Maxillofacial Surgery-- Contents of a Technical File ------------------------------------------------------------------------ 4-146 ............ ISO 22674:2006 Dentistry-- Devices affected Metallic Materials for and Processes Fixed and Removable impacted Restorations and Appliances ------------------------------------------------------------------------ E. General ------------------------------------------------------------------------ 5-7 12-185 IEC 60601-1-3(1994-07) Transferred Medical Electrical Equipment--Part 1: General Requirements for Safety; General Requirements for Radiation Protection in Diagnostic X-Ray Equipment ------------------------------------------------------------------------ 5-8 5-41 IEC 60601-1-4:2000 Medical Withdrawn and Electrical Equipment-- replaced with Part 1-4: General newer version Requirements for Safety-- Collateral Standard: Programmable Electrical Medical Systems, Edition 1.1 ------------------------------------------------------------------------ 5-16 5-42 ASTM D903-98(2004) Withdrawn and Standard Test Methods for replaced with Peel or Stripping newer version Strength of Adhesive Bonds ------------------------------------------------------------------------ 5-19 ............ ASTM E876/1995 Standard Withdrawn Practice for Use of Statistics in the Evaluation of Spectrometric Data ------------------------------------------------------------------------ 5-25 5-43 ANSI/ESD S20.20-2007 Withdrawn and Standard for the replaced with Development of an newer version Electrostatic Discharge Control Program for Protection of Electrical and Electronic Parts, Assemblies and Equipment (Excluding Electrically Initiated Explosive Devices) ------------------------------------------------------------------------ 5-28 ............ IEC 60601-1-2, (Second Extent of Edition, 2001) Medical recognition Electrical Equipment-- Part 1-2: General Requirements for Safety-- Collateral Standard: Electromagnetic Compatibility--Requiremen ts and Tests ------------------------------------------------------------------------ 5-30 ............ AAMI/ANSI/IEC 60601-1-2 Type of standard Medical Electrical and Extent of Equipment--Part 1-2: recognition General Requirements for Safety--Collateral Standard: Electromagnetic Compatibility--Requiremen ts and Tests (AAMI/ANSI/ IEC 60601-1-2:2001 is the U.S. version of IEC 60601- 1-2:2001 with identical requirements for electromagnetic compatibility (EMC) of medical electrical equipment.) ------------------------------------------------------------------------ 5-33 5-44 IEC 60601-1-8:2006 Medical Withdrawn and Electrical Equipment-- replaced with Part 1-8: General newer version Requirements for Basic Safety and Essential Performance--Collateral Standard: General Requirements, Tests and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems, Second Edition ------------------------------------------------------------------------ [[Page 52365]] 5-34 ............ IEC 60601-1-2 Medical Extent of Electrical Equipment-- recognition Part 1-2: General Requirements for Safety-- Collateral Standard: Electromagnetic Compatibility--Requiremen ts and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)) ------------------------------------------------------------------------ 5-35 ............ AAMI/ANSI/IEC 60601-1-2 Type of standard Medical Electrical and Extent of Equipment--Part 1-2: recognition General Requirements for Safety--Collateral standard: Electromagnetic Compatibility--Requiremen ts and Tests (Edition 2:2001 with Amendment 1:2004) (AAMI/ANSI/IEC 60601-1-2:2001 with Amendment 1:2004 is the U.S. version of IEC 60601- 1-2:2001 with Amendment 1:2004, with identical requirements for electromagnetic compatibility (EMC) of medical electrical equipment) ------------------------------------------------------------------------ 5-36 ............ ANSI/AAMI/ISO TIR CFR Citations, 16142:2006: Technical Product codes Information Report: and Relevant Medical Devices--Guidance guidance on the Selection of Standards in Support of Recognized Essential Principles of Safety and Performance of Medical Devices, Second Edition ------------------------------------------------------------------------ F. General Hospital/General Plastic Surgery ------------------------------------------------------------------------ 6-16 ............ ISO 7886-1:1993 Sterile Withdrawn Hypodermic Syringes for Single Use--Part 1: Syringes for Manual Use ------------------------------------------------------------------------ 6-117 ............ ASTM F2172-02: Standard Relevant Specification for Blood/ guidance Intravenous Fluid/ Irrigation Fluid Warmers ------------------------------------------------------------------------ 6-118 ............ ASTM F2196-02 Standard Relevant Specification for guidance, Circulating Liquid and Contact person Forced Air Patient Temperature Management Devices ------------------------------------------------------------------------ 6-131 6-203 ASTM D6499-07 Standard Withdrawn and Test Method for the replaced with Immunological Measurement newer version of Antigenic Protein in Natural Rubber and Its Products ------------------------------------------------------------------------ 6-160 6-204 ISO 8537:2007 Sterile Withdrawn and Single-Use Syringes, With replaced with or Without Needle, for newer version Insulin ------------------------------------------------------------------------ 6-166 6-215 ASTM F2132-01(2008) Withdrawn and Standard Specification replaced with for Puncture Resistance newer version of Materials Used in Containers for Discarded Medical Needles and Other Sharps ------------------------------------------------------------------------ 6-167 ............ ASTM D6319-00a(2005) Relevant Standard Specification guidance for Nitrile Examination Gloves for Medical Application ------------------------------------------------------------------------ 6-188 6-205 USP 31:2008 Nonabsorbable Withdrawn and Surgical Suture replaced with newer version ------------------------------------------------------------------------ 6-189 6-206 USP 31<11>2008 Sterile Withdrawn and Sodium Chloride for replaced with Irrigation newer version ------------------------------------------------------------------------ 6-190 6-207 USP 31:2008 Absorbable Withdrawn and Surgical Suture replaced with newer version ------------------------------------------------------------------------ 6-191 6-208 USP 31<881>:2008 Tensile Withdrawn and Strength replaced with newer version ------------------------------------------------------------------------ 6-192 6-209 USP 31<861>:2008 Sutures-- Withdrawn and Diameter replaced with newer version ------------------------------------------------------------------------ 6-193 6-210 USP 31<871>:2008 Sutures Withdrawn and Needle Attachment replaced with newer version ------------------------------------------------------------------------ 6-194 6-211 USP 31<11>: 2008 Sterile Withdrawn and Water for Irrigation replaced with newer version ------------------------------------------------------------------------ 6-195 6-212 USP 31<11>: 2008 Heparin Withdrawn and Lock Flush Solution replaced with newer version ------------------------------------------------------------------------ [[Page 52366]] 6-196 6-213 USP 31<11>: 2008 Sodium Withdrawn and Chloride Injection replaced with newer version ------------------------------------------------------------------------ 6-198 ............ ASTM F2100-07 Standard Relevant Specification for guidance Performance of Materials Used in Medical Face Masks ------------------------------------------------------------------------ 6-201 ............ ISO 8536-4:2007 Infusion Relevant Equipment for Medical guidance Use--Part 4: Infusion Sets for Single Use, Gravity Feed ------------------------------------------------------------------------ G. In Vitro Diagnostic ------------------------------------------------------------------------ 7-6 7-131 CLSI ILA18-A2 Withdrawn and Specifications for replaced with Immunological Testing for newer version Infectious Diseases ------------------------------------------------------------------------ 7-11 7-132 CLSI MM03-A2 Molecular Withdrawn and Diagnostic Methods for replaced with Infectious Diseases newer version ------------------------------------------------------------------------ 7-12 ............ CLSI/NCCLS C12-A Withdrawn Definitions of Quantities and Conventions Related to Blood pH and Gas Analysis; Approved Standard (1994) ------------------------------------------------------------------------ 7-13 ............ CLSI/NCCLS C21-A Withdrawn Performance Characteristics for Devices Measuring PO2 and PCO2 in Blood Samples; Approved Standard (1992) ------------------------------------------------------------------------ 7-15 ............ CLSI/NCCLS C25-A Withdrawn Fractional Oxyhemoglobin, Oxygen Content and Saturation, and Related Quantities in Blood: Terminology, Measurement, and Reporting; Approved Guideline (1997) ------------------------------------------------------------------------ 7-16 ............ CLSI/NCCLS C27-A Blood Gas Withdrawn Preanalytical Considerations: Specimen Collection, Calibration, and Controls; Approved Guideline (1993) ------------------------------------------------------------------------ 7-18 7-133 CLSI C30-A2, Point-of Care Withdrawn and Blood Glucose Testing in replaced with Acute and Chronic Care newer version Facilities ------------------------------------------------------------------------ 7-21 ............ CLSI C42-A, Erythrocyte Contact person Protoporphyrin Testing; Approved Guideline (1996) ------------------------------------------------------------------------ 7-22 7-134 CLSI GP20-A2 Fine-Needle Withdrawn and Aspiration Biopsy (FNAB) replaced with Techniques newer versions ------------------------------------------------------------------------ 7-25 ............ NCCLS H8-A2 Detection of Withdrawn Abnormal Hemoglobin Using Cellulose Acetate Electrophoresis--Second Edition; Approved Standard (1994) ------------------------------------------------------------------------ 7-26 ............ NCCLS H9-A Chromatographic Withdrawn (Microcolumn) Determination of Hemoglobin A2; Approved Standard (1989) ------------------------------------------------------------------------ 7-27 ............ NCCLS H10-A2 Solubility Withdrawn Test to Confirm the Presence of Sickling Hemoglobins--Second Edition; Approved Standard (1995) ------------------------------------------------------------------------ 7-29 ............ NCCLS H14-A2 Devices for Withdrawn Collection of Skin Puncture Blood Specimens-- Second Edition; Approved Guideline (1990) ------------------------------------------------------------------------ 7-34 7-135 CLSI H44-A2 Methods for Withdrawn and Reticulocyte Counting replaced with (Flow Cytometry and newer version Supravital Dyes) ------------------------------------------------------------------------ 7-35 ............ CLSI H47-A One-Stage Contact person Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline (1996) ------------------------------------------------------------------------ 7-36 7-136 CLSI ILA02-A2 Quality Withdrawn and Assurance of Laboratory replaced with Tests for Autoantibodies newer version to Nuclear Antigens ------------------------------------------------------------------------ 7-37 ............ CLSI ILA06-A Detection and Contact person Quantitation of Rubella IgG Antibody ------------------------------------------------------------------------ [[Page 52367]] 7-38 ............ CLSI/NCCLS I/LA10-A Withdrawn Choriogonadotropin Testing: Nomenclature, Reference Preparations, Assay Performance, and Clinical Application; Approved Guideline (1996) ------------------------------------------------------------------------ 7-39 ............ CLSI/NCCLS I/LA17-A Withdrawn Assessing the Quality of Systems for Alpha- Fetoprotein (AFP) Assays Used in Prenatal Screening and Diagnosis of Neural Tube Defects; Approved Guideline (1997) ------------------------------------------------------------------------ 7-40 ............ NCCLS I/LA18-A Withdrawn Specifications for Immunological Testing for Infectious Diseases; Approved Guideline (1994) ------------------------------------------------------------------------ 7-41 ............ CLSI ILA19-A Primary Contact person Reference Preparations Used to Standardize Calibration of Immunochemical Assays for Serum Prostate Specific Antigen (PSA); Approved Guideline (1997) ------------------------------------------------------------------------ 7-42 ............ CLSI ILA20-A Evaluation Contact person Methods and Analytical Performance Characteristics of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies of Defined Allergen Specificities; Approved Guideline (1997) ------------------------------------------------------------------------ 7-43 7-137 CLSI LA04-A5 Blood Withdrawn and Collection on Filter replaced with Paper for Newborn newer version Screening Programs ------------------------------------------------------------------------ 7-46 7-138 CLSI M27-A2, Reference Withdrawn and Method for Broth Dilution replaced with Antifungal Susceptibility newer version Testing of Yeasts ------------------------------------------------------------------------ 7-49 ............ CLSI H26-A Performance Contact person Goals for the Internal Quality Control of Multichannel Hematology Analyzers; Approved Standard ------------------------------------------------------------------------ 7-50 ............ NCCLS D11-A2 Glossary and Withdrawn Guidance for Immunodiagnostic Procedures, Reagents, and Reference Materials-- Second Edition, Approved Guideline ------------------------------------------------------------------------ 7-51 7-139 CLSI GP27-A2 Using Withdrawn and Proficiency Testing to replaced with Improve the Clinical newer version Laboratory ------------------------------------------------------------------------ 7-52 ............ CLSI / NCCLS NRSCL 8-A Withdrawn Terminology and Definitions for use in NCCLS Documents; Approved Standard ------------------------------------------------------------------------ 7-53 7-140 CLSI GP22-A2 Continuous Withdrawn and Quality Improvement replaced with newer version ------------------------------------------------------------------------ 7-55 7-141 CLSI H18-A3 Procedures for Withdrawn and the Handling and replaced with Processing of Blood newer version Specimens ------------------------------------------------------------------------ 7-58 7-142 CLSI H11-A4 Procedures for Withdrawn and the Collection of replaced with Arterial Blood Specimens newer version ------------------------------------------------------------------------ 7-59 13-9 CLSI / NCCLS AUTO2-A Transferred Laboratory Automation: Bar Codes for Specimen Container Identification; Approved Standard ------------------------------------------------------------------------ 7-60 13-10 NCCLS AUTO1-A Laboratory Transferred Automation: Specimen Container/Specimen Carrier; Approved Standard ------------------------------------------------------------------------ 7-61 13-11 NCCLS AUTO3-A Laboratory Transferred Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard ------------------------------------------------------------------------ 7-62 13-12 NCCLS AUTO4-A Laboratory Transferred Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard ------------------------------------------------------------------------ 7-63 13-13 NCCLS AUTO5-A Laboratory Transferred Automation: Electromechanical Interfaces; Approved Standard ------------------------------------------------------------------------ 7-64 13-14 NCCLS POCT1-A Point-of- Transferred Care Connectivity; Approved Standard ------------------------------------------------------------------------ [[Page 52368]] 7-67 7-143 CLSI EP14-A2 Evaluation of Withdrawn and Matrix Effects replaced with newer version ------------------------------------------------------------------------ 7-68 13-15 NCCLS GP19-A2 Laboratory Transferred Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline--Second Edition ------------------------------------------------------------------------ 7-70 7-144 CLSI H4-A5 Procedures and Withdrawn and Devices for the replaced with Collection of Diagnostic newer version Blood Specimens by Skin Puncture ------------------------------------------------------------------------ 7-72 7-145 CLSI H42-A2 Enumeration of Withdrawn and Immunologically Defined replaced with Cell Populations by Flow newer version Cytometry ------------------------------------------------------------------------ 7-74 7-146 NCCLS M6-A2 Protocols for Withdrawn and Evaluating Dehydrated replaced with Mueller-Hinton Agar newer version ------------------------------------------------------------------------ 7-77 7-147 CLSI M22-A3 Quality Withdrawn and Control for Commercially replaced with Prepared Microbiological newer version Culture Media ------------------------------------------------------------------------ 7-79 7-148 CLSI M28-A2 Procedures for Withdrawn and the Recovery and replaced with Identification of newer version Parasites From the Intestinal Tract ------------------------------------------------------------------------ 7-80 ............ CLSI MM01-A2 Molecular Withdrawn Diagnostic Methods for Genetic Diseases ------------------------------------------------------------------------ 7-83 ............ NCCLS C46-A Blood Gas and Withdrawn pH Analysis and Related Measurements; Approved Guideline ------------------------------------------------------------------------ 7-85 7-149 CLSI C24-A3 Statistical Withdrawn and Quality Control for replaced with Quantitative Measurement newer version Procedures ------------------------------------------------------------------------ 7-90 7-150 CLSI H43-A2 Clinical Flow Withdrawn and Cytometric Analysis of replaced with Neoplastic Hematolymphoid newer version Cells ------------------------------------------------------------------------ 7-93 ............ NCCLS EP10-A2, Preliminary Withdrawn Evaluation of Quantitative Clinical Laboratory Methods; Approved Guideline ------------------------------------------------------------------------ 7-94 7-152 CLSI EP12-A2 User Protocol Withdrawn and for Evaluation of replaced with Qualitative Test newer version Performance ------------------------------------------------------------------------ 7-95 7-153 CLSI EP15-A2 User Withdrawn and Verification of replaced with Performance for Precision newer version and Trueness ------------------------------------------------------------------------ 7-98 7-154 CLSI MM02-A2 Immunoglobin Withdrawn and and T-Cell Receptor Gene replaced with Rearrangement Assays newer version ------------------------------------------------------------------------ 7-99 ............ CLSI MM5-A Nucleic Acid Contact person Amplification Assays for Molecular Hematopathology ------------------------------------------------------------------------ 7-103 7-155 CLSI H03-A6 Procedures for Withdrawn and the Collection of replaced with Diagnostic Blood newer version Specimens by Venipunture ------------------------------------------------------------------------ 7-106 7-156 CLSI M02-A9 Performance Withdrawn and Standards for replaced with Antimicrobial Disk newer version Susceptibility Tests ------------------------------------------------------------------------ 7-107 7-157 CLSI M11-A7 Methods for Withdrawn and Antimicrobial replaced with Susceptibility Testing of newer version Anaerobic Bacteria ------------------------------------------------------------------------ 7-108 7-158 CLSI M7-A7 Methods for Withdrawn and Antimicrobial replaced with Susceptibility Tests of newer version Anaerobic Bacteria ------------------------------------------------------------------------ 7-109 ............ CLSI AUTO7-A Laboratory Withdrawn Automation: Data Content for Specimen Identification; Approved Standard ------------------------------------------------------------------------ 7-111 7-159 CLSI H21-A5 Collection, Withdrawn and Transport, and Processing replaced with of Blood Specimens for newer version Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays ------------------------------------------------------------------------ [[Page 52369]] 7-114 13-16 CLSI LIS01-A Standard Transferred Specification for Low- Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems ------------------------------------------------------------------------ 7-115 13-17 CLSI LIS02-A2 Standard Transferred Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard-Second Edition ------------------------------------------------------------------------ 7-116 13-18 CLSI LIS03-A Standard Transferred Guide for Selection of a Clinical Laboratory Information Management System ------------------------------------------------------------------------ 7-117 13-19 CLSI LIS04-A Standard Transferred Guide for Documentation of Clinical Laboratory Computer Systems ------------------------------------------------------------------------ 7-118 13-20 CLSI LIS05-A, Standard Transferred Specification for Transferring Clinical Observations Between Independent Computer Systems ------------------------------------------------------------------------ 7-119 13-21 CLSI LIS06-A Standard Transferred Practice for Reporting Reliability of Clinical Laboratory Information Systems ------------------------------------------------------------------------ 7-120 13-22 CLSI LIS07-A Standard Transferred Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory ------------------------------------------------------------------------ 7-121 13-23 CLSI LIS08-A Standard Transferred Guide for Functional Requirements of Clinical Laboratory Information Management Systems ------------------------------------------------------------------------ 7-122 13-24 CLSI LIS09-A Standard Transferred Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architectures ------------------------------------------------------------------------ 7-125 ............ CLSI/NCCLS M28-A2 Volume Withdrawn 25, No. 16 Procedures for the Recovery and Identification of Parasites From the Intestinal Tract; Approved Guideline ------------------------------------------------------------------------ H. Materials ------------------------------------------------------------------------ 8-32 ............ ASTM F1586-02: Standard Contact person Specification for Wrought Nitrogen Strengthened 21 Chromium-10 Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675) ------------------------------------------------------------------------ 8-44 ............ ASTM F0136-02a: Standard Contact person Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) ------------------------------------------------------------------------ 8-46 8-154 ASTM F0621-08: Standard Withdrawn and Specification for replaced with Stainless Steel Forgings newer year for Surgical Implants version ------------------------------------------------------------------------ 8-50 ............ ASTM F1091-02: Standard Contact person Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R30605) ------------------------------------------------------------------------ 8-52 ............ ASTM F1350-02: Standard Contact person Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673) ------------------------------------------------------------------------ 8-53 ............ ASTM F1472-02a: Standard Contact person Specification for Wrought Titanium -6Aluminum - 4Vanadium Alloy for Surgical Implant Applications (UNS R56400) ------------------------------------------------------------------------ 8-54 8-155 ASTM F1580-07 Standard Withdrawn and Specification for replaced with Titanium and Titanium-6 newer year Aluminum-4 Vanadium Alloy version Powders for Coatings of Surgical Implants ------------------------------------------------------------------------ 8-57 ............ ISO 5832-2:1999, Implants Contact person for Surgery--Metallic Materials--Part 2: Unalloyed Titanium ------------------------------------------------------------------------ 8-58 ............ ISO 5832-3:1996, Implants Contact person for Surgery--Metallic Materials--Part 3: Wrought Titanium 6- Aluminium 4-Vanadium Alloy ------------------------------------------------------------------------ [[Page 52370]] 8-59 ............ ISO 5832-4:1996, Implants Contact person for Surgery--Metallic Materials--Part 4: Cobalt- Chromium-Molybdenum Casting Alloy ------------------------------------------------------------------------ 8-61 ............ ISO 5832-6:1997, Implants Contact person for Surgery--Metallic Materials--Part 6: Wrought Cobalt-Nickel- Chromium-Molybdenum Alloy ------------------------------------------------------------------------ 8-63 ............ ISO 5832-11:1994, Implants Contact person for Surgery--Metallic Materials--Part 11: Wrought Titanium 6- Aluminium 7-Niobium Alloy ------------------------------------------------------------------------ 8-76 ............ ASTM F138-03: Standard Contact person Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673) ------------------------------------------------------------------------ 8-77 8-156 ASTM F0139-08, Standard Withdrawn and Specification for Wrought replaced with 18 Chromium-14 Nickel-2.5 newer year Molybdenum Stainless version Steel Sheet and Strip for Surgical Implants (UNS S31673) ------------------------------------------------------------------------ 8-79 ............ ASTM F0961-03, Standard Contact person Specification for Cobalt- 35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants [UNS R30035] ------------------------------------------------------------------------ 8-81 ............ ASTM F1609-03 Standard Contact person Specification for Calcium Phosphate Coatings for Implantable Materials ------------------------------------------------------------------------ 11-81 8-157 ISO 9583:1993 Implants for Transferred Surgery--Non-Destructive Testing--Liquid Penetrant Inspection of Metallic Surgical Implants ------------------------------------------------------------------------ 8-82 8-158 ASTM F1713-08 Standard Withdrawn and Specification for Wrought replaced with Titanium-13 Niobium-13 newer year Zirconium Alloy for version Surgical Implant Applications (UNS R58130) ------------------------------------------------------------------------ 11-82 8-159 ISO 9584:1993 Implants for Transferred Surgery--Non-Destructive Testing--Radiographic Examination of Cast Metallic Surgical Implants ------------------------------------------------------------------------ 8-86 ............ ASTM F1926-03 Standard Relevant Test Method for guidance Evaluation of the Environmental Stability of Calcium Phosphate Coatings ------------------------------------------------------------------------ 8-88 ............ ASTM F2024-00 Standard Relevant Practice for X-Ray guidance Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings ------------------------------------------------------------------------ 8-98 8-162 ASTM F451-99a(2007)e1 Withdrawn and Standard Specification replaced with for Acrylic Bone Cement newer year version ------------------------------------------------------------------------ 8-104 ............ ASTM F1108-04 Standard Contact person Specification for Titanium-6Aluminum-4Vanad ium Alloy Castings for Surgical Implants (UNS R56406) ------------------------------------------------------------------------ 8-108 ............ ASTM F1295-05 Standard Contact person Specification for Wrought Titanium-6 Aluminum-7 Niobium Alloy for Surgical Implant Applications (UNS R56700) ------------------------------------------------------------------------ 8-110 ............ ASTM F1377-04 Standard Contact person Specification for Cobalt- 28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075) ------------------------------------------------------------------------ 8-112 ............ ASTM F1044-05 Standard Relevant Test Method for Shear guidance Testing of Calcium Phosphate Coatings and Metallic Coatings ------------------------------------------------------------------------ 8-113 ............ ASTM F1147-05 Standard Relevant Test Method for Tension guidance Testing of Calcium Phosphate and Metal Coatings ------------------------------------------------------------------------ 8-119 ............ ASTM F688-05 Standard Contact person Specification for Wrought Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035) ------------------------------------------------------------------------ [[Page 52371]] 8-120 8-160 ASTM F0560-07 Standard Withdrawn and Specification for replaced with Unalloyed Tantalum for newer year Surgical Implant version Applications (UNS R05200, UNS R05400) ------------------------------------------------------------------------ 8-123 ............ ISO 5832-5:2005 Implants Contact person for Surgery--Metallic Materials--Part 5: Wrought Cobalt-Chromium- Tungsten-Nickel Alloy ------------------------------------------------------------------------ 8-127 ............ ISO 5834-2:2006 Implants Relevant for Surgery--Ultra-high- guidance molecular-weight polyethylene--Part 2: Moulded Forms ------------------------------------------------------------------------ 8-129 ............ ASTM F67-06 Standard Contact person Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700) ------------------------------------------------------------------------ 8-130 ............ ASTM F620-06 Standard Contact person Specification for Alpha Plus Beta Titanium Alloy Forgings for Surgical Implants ------------------------------------------------------------------------ 8-131 ............ ASTM F799-06 Standard Contact person Specification for Cobalt- 28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539) ------------------------------------------------------------------------ 8-132 ............ ASTM F1088-04ae1 Standard Contact person Specification for Beta- Tricalcium Phosphate for Surgical Implantation ------------------------------------------------------------------------ 8-137 ............ ASTM F0075-07 Standard Contact person Specification for Cobalt- 28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075) ------------------------------------------------------------------------ 8-138 ............ ASTM F0745-07 Standard Contact person Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications ------------------------------------------------------------------------ 8-139 ............ ASTM F1314-07 Standard Contact person Specification for Wrought Nitrogen Strengthened 22 Chromium - 13 Nickel - 5 Manganese - 2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910) ------------------------------------------------------------------------ 8-142 ............ ASTM F1978-00(2007)e2 Relevant Standard Test Method for guidance Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser ------------------------------------------------------------------------ 8-144 ............ ASTM F0754-00 Standard Contact person Specification for Implantable Polytetrafluoroethylene (PTFE) Polymer Fabricated in Sheet, Tube and Rod Shapes ------------------------------------------------------------------------ 8-145 ............ ASTM F0090-07 Standard Contact person Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605) ------------------------------------------------------------------------ 8-147 ............ ASTM F0562-07 Standard Contact person Specification for Wrought 35Cobalt-35Nickel-20Chrom ium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035) ------------------------------------------------------------------------ 8-149 ............ ISO 5832-1:2007 Implants Contact person for Surgery--Metallic Materials--Part 1: Wrought Stainless Steel ------------------------------------------------------------------------ 8-150 ............ ISO 5832-9:2007 Implants Contact person for Surgery--Metallic Materials--Part 9: Wrought High Nitrogen Stainless Steel ------------------------------------------------------------------------ 8-151 ............ ISO 5832-12:2007 Implants Contact person for Surgery--Metallic Materials--Part 12: Wrought Cobalt-Chromium- Molybdenum Alloy ------------------------------------------------------------------------ 8-152 ............ ASTM F1537-07 Standard Contact person Specification for Wrought Cobalt-28Chromium-6Molybd enum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) ------------------------------------------------------------------------ I. OB-GYN/Gastroenterology ------------------------------------------------------------------------ [[Page 52372]] 9-4 ............ IEC 60601-2-16 (1998) Relevant Medical Electrical guidance and Equipment--Part 2-16: Contact person Particular Requirements for the Safety of Haemodialysis, Haemodiafiltration and Haemofiltration Equipment ------------------------------------------------------------------------ 9-6 ............ IEC 60601-2-36 (1997) Title, Relevant Medical Electrical guidance, CFR Equipment--Part 2-36: Citation, and Particular Requirements Product Codes for the Safety of Equipment for Extracorporeally Induced Lithotripsy ------------------------------------------------------------------------ 9-7 ............ IEC 61846 (1998) Relevant Ultrasonics--Pressure guidance, CFR Pulse Lithotripters-- Citation, and Characteristics of Fields Product Codes ------------------------------------------------------------------------ 9-21 ............ ISO 8600-4:1997 Optics and Relevant Optical Instruments-- guidance Medical Endoscopes and Certain Accessories--Part 4: Determination of Maximum Width of Insertion Portion ------------------------------------------------------------------------ 9-23 ............ ASTM F1518-00 Standard Relevant Practice for Cleaning and guidance, CDRH Disinfection of Flexible Office and Fiberoptic and Video Division Endoscopes Used in the associated with Examination of the Hollow recognized Viscera standard ------------------------------------------------------------------------ 9-25 ............ AAMI / ANSI HF18:2001 Withdrawn Electrosurgical Devices ------------------------------------------------------------------------ 9-28 9-47 ANSI/AAMI RD16:2007 Withdrawn and Cardiovascular Implants replaced with and Artificial Organs-- newer version Hemodialyzers, Hemodiafilters, Hemofilters, and Hemoconcentrators ------------------------------------------------------------------------ 9-29 9-48 AAMI / ANSI RD17 :2007 Withdrawn and Cardiovascular Implants replaced with and artificial organs-- newer version Extracorporeal Blood Circuit for Hemodialyzers, Hemodiafilters, and Hemofilters ------------------------------------------------------------------------ 9-32 ............ ASTM D3492-03 Standard Relevant Specification for Rubber guidance Contraceptives (Male Condoms) ------------------------------------------------------------------------ 9-34 ............ ISO 4074:2002/ Relevant Cor.1:2003(E) Natural guidance Latex Rubber Condoms-- Requirements and Test Methods, Technical Corrigendum 1 ------------------------------------------------------------------------ 9-37 ............ ISO 8600-1:2005 Optics and Relevant Photonics--Medical guidance Endoscopes and Endotherapy Devices--Part 1: General Requirements ISO 8600-1:2005 ------------------------------------------------------------------------ 9-38 ............ ISO 8600-3:1997 Amendment Relevant 1 2003, Optics and guidance Optical Instruments-- Medical Endoscopes and Endoscopic Accessories Part 3: Determination of Field of View and Direction of View of Endoscopes with Optics ------------------------------------------------------------------------ 9-39 ............ ISO 8600-5:2005 Optics and Relevant Photonics--Medical guidance Endoscopes and Endotherapy Devices--Part 5: Determination of Optical Resolution of Rigid Endoscopes with Optics ------------------------------------------------------------------------ 9-40 ............ ISO 8600-6:2005 Optics and Relevant Photonics--Medical guidance Endoscopes and Endotherapy Devices--Part 6: Vocabulary ------------------------------------------------------------------------ 9-41 ............ ASTM D6324-05 Standard Relevant Test Methods for Male guidance Condoms Made from Synthetic Materials ------------------------------------------------------------------------ 9-42 ............ IEC 60601-2-18 (1996) Relevant Amendment 1 2000 Medical guidance electrical equipment-- Part 2: Particular Requirements for the Safety of Endoscopic Equipment ------------------------------------------------------------------------ 9-43 ............ ISO 16038:2005 Rubber Relevant Condoms--Guidance on the guidance Use of ISO 4074 in the Quality Management of Natural Rubber Latex Condoms ------------------------------------------------------------------------ J. Ophthalmic ------------------------------------------------------------------------ 10-21 ............ ISO 11979-2:1999 Withdrawn Ophthalmic Implants-- Intraocular Lenses--Part 2: Optical Properties and Test Methods ------------------------------------------------------------------------ [[Page 52373]] 10-23 ............ ISO 11981:1999 Ophthalmic Withdrawn Optics--Contact Lenses and Contact Lens Care Products--Determination of Physical Compatibility of Contact Lens Care Products With Contact Lenses ------------------------------------------------------------------------ 10-42 ............ ISO 11979-2:1999/ Extent of Corrigendum1:2003 recognition and Ophthalmic Implants-- Process Intraocular Lenses--Part impacted 2: Optical Properties and Test Methods ------------------------------------------------------------------------ 10-44 ............ ISO 11981:1999/ Relevant Corrigendum1:2005 guidance and Ophthalmic Optics-- Process Contact Lenses and impacted Contact Lens Car Products--Determination of Physical Compatibility of Contact Lens Care Products with Contact Lenses ------------------------------------------------------------------------ K. Orthopedic ------------------------------------------------------------------------ 11-73 ............ ISO 5838-1:1995 Implants Type of standard for Surgery--Skeletal and Contact Pins and Wires--Part 1: person Material and Mechanical Requirements ------------------------------------------------------------------------ 11-74 ............ ISO 5838-2:1991 Implants Type of standard for Surgery--Skeletal and Contact Pins and Wires--Part 2: person Steinmann Skeletal Pins-- Dimensions ------------------------------------------------------------------------ 11-75 ............ ISO 5838-3:1993 Implants Type of standard for Surgery--Skeletal and Contact Pins and Wires--Part 3: person Kirschner Skeletal Wires ------------------------------------------------------------------------ 11-79 ............ ISO 7206-8:1995 Implants Type of for Surgery--Partial and standard, CFR Total Hip Joint Citation, Prostheses--Part 8: Product codes Endurance Performance of and Relevant Stemmed Femoral guidance Components with Application of Torsion ------------------------------------------------------------------------ 11-80 ............ ISO 8828:1988 Implants for Contact person Surgery--Guidance on Care Processes and Handling of Impacted Orthopaedic Implants ------------------------------------------------------------------------ 11-81 8-157 ISO 9583:1993 Implants for Transferred Surgery--Non-Destructive Testing--Liquid Penetrant Inspection of Metallic Surgical Implants ------------------------------------------------------------------------ 11-82 8-159 ISO 9584:1993 Implants for Transferred Surgery--Non-Destructive Testing--Radiographic Examination of Cast Metallic Surgical Implants ------------------------------------------------------------------------ 11-155 ............ ISO 7207-2:1998 Implants Type of standard for Surgery--Components and Relevant for Partial and Total guidance Knee Joint Prostheses-- Part 2: Articulating Surfaces Made of Metal, Ceramic and Plastics Materials ------------------------------------------------------------------------ 11-164 11-203 ASTM F1541-02(2007) Withdrawn and Standard Specification replaced with and Test Methods for newer version External Skeletal Fixation Devices ------------------------------------------------------------------------ 11-166 11-204 ASTM F0897-02(2007) Withdrawn and Standard Test Method for replaced with Measuring Fretting newer version Corrosion of Osteosynthesis Plates and Screws ------------------------------------------------------------------------ 11-168 ............ ASTM F1781-03 Standard Type of standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants ------------------------------------------------------------------------ 11-171 ............ ASTM F1814-97a(2003) Type of standard Standard Guide for and Relevant Evaluating Modular Hip guidance and Knee Joint Components ------------------------------------------------------------------------ 11-172 ............ ASTM F1798-97(2003) Type of standard Standard Guide for and Relevant Evaluating the Static and guidance Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants ------------------------------------------------------------------------ 11-175 ............ ASTM F1582-98(2003) Type of Standard Terminology standard, CFR Relating to Spinal Citation, Implants Product codes and Relevant guidance ------------------------------------------------------------------------ 11-177 11-205 ASTM F1264-03(2007) Withdrawn and Standard Specification replaced with and Test Methods for newer version Intramedullary Fixation Devices ------------------------------------------------------------------------ [[Page 52374]] 11-178 ............ ASTM F1440-92(2002) Processes Standard Practice for impacted, Type Cyclic Fatigue Testing of of standard, Metallic Stemmed Hip CFR Citation, Arthroplasty Femoral Product codes Components Without and Relevant Torsion guidance ------------------------------------------------------------------------ 11-179 ............ ASTM F2068-03 Standard Processes Specification for Femoral impacted, Type Prostheses--Metallic of standard, Implants CFR Citation, Product codes and Relevant guidance ------------------------------------------------------------------------ 11-180 ............ ASTM F0366-04 Standard Type of standard Specification for and Contact Fixation Pins and Wires person ------------------------------------------------------------------------ 11-181 ............ ASTM F1717-04 Standard Type of standard Test Methods for Spinal and Relevant Implant Constructs in a guidance Vertebrectomy Model ------------------------------------------------------------------------ 11-182 11-206 ASTM F1800-07 Standard Withdrawn and Test Method for Cyclic replaced with Fatigue Testing of Metal newer version Tibial Tray Components of Total Knee Joint Replacements ------------------------------------------------------------------------ 11-183 ............ ASTM F1875-98(2004) Type of Standard Practice for standard, CFR Fretting Corrosion Citations, Testing of Modular Product codes Implant Interfaces: Hip and Relevant Femoral Head-Bore and guidance Cone Taper Interface ------------------------------------------------------------------------ 11-184 ............ ISO 8827:1988 Implants for Type of standard surgery--Staples with and Contact Parallel Legs for person Orthopaedic Use--General Requirements ------------------------------------------------------------------------ 11-185 ............ ASTM F2267-04 Standard CFR Citations, Test Method for Measuring Product codes Load Induced Subsidence and Relevant of an Intervertebral Body guidance Fusion Device Under Static Axial Compression ------------------------------------------------------------------------ 11-186 ............ ASTM F2077-03 Test Methods Type of for Intervertebral Body standard, CFR Fusion Devices Citations, Product codes and Relevant guidance ------------------------------------------------------------------------ 11-187 11-207 ASTM F2193-02(2007) Withdrawn and Standard Specifications replaced with and Test Methods for newer version Components Used in the Surgical Fixation of the Spinal Skeletal System ------------------------------------------------------------------------ 11-188 ............ ISO 14243-1:2002 Implants Type of for Surgery--Wear of standard, CFR Total Knee-Joint Citations and Prostheses--Part 1: Product codes Loading and Displacement Parameters for Wear- Testing Machines With Load Control and Corresponding Environmental Conditions for Test ------------------------------------------------------------------------ 11-189 ............ ISO 14243-2:2000 Implants Type of for Surgery--Wear of standard, Total Knee-Joint Extent of Prostheses--Part 2: recognition, Methods of Measurement CFR Citations and Product codes ------------------------------------------------------------------------ 11-190 ............ ISO 14243-3:2004 Implants Type of for Surgery--Wear of standard, CFR Total Knee-Joint Citations and Prostheses--Part 3: Product codes Loading and Displacement Parameters for Wear- Testing Machines With Displacement Control and Corresponding Environmental Conditions for Test ------------------------------------------------------------------------ 11-191 ............ ISO 14879-1:2000 Implants Type of standard for Surgery--Total Knee- Joint Prostheses--Part 1: Determination of Endurance Properties of Knee Tibial Trays ------------------------------------------------------------------------ 11-192 ............ ASTM F1223-05 Standard Type of standard Test Method for CFR Citations Determination of Total and Product Knee Replacement codes Constraint ------------------------------------------------------------------------ 11-194 11-208 ISO 14630:2008 Non-Active Withdrawn and Surgical Implants-- replaced with General Requirements--3d newer version Edition ------------------------------------------------------------------------ 11-195 ............ ASTM F1612-95(2005) Type of Standard Practice for standard, CFR Cyclic Fatigue Testing of Citations, Metallic Stemmed Hip Product codes Arthroplasty Femoral and Relevant Components with Torsion guidance ------------------------------------------------------------------------ 11-196 ............ ASTM F1672-95(2005) Type of standard Standard Specification and Relevant for Resurfacing Patellar guidance Prosthesis ------------------------------------------------------------------------ [[Page 52375]] 11-197 ............ ASTM F0983-86(2005) Contact person Standard Practice for and Processes Permanent Marking of impacted Orthopaedic Implant Components ------------------------------------------------------------------------ 11-198 ............ ASTM F0382-99(2003)e1 Type of standard Standard Specification and Contact and Test Method for person Metallic Bone Plates ------------------------------------------------------------------------ 11-199 ............ ASTM F0565-04 Standard Contact person Practice for Care and and Processes Handling of Orthopedic impacted Implants and Instruments ------------------------------------------------------------------------ 11-200 11-209 ASTM F2083-07 Standard Withdrawn and Specification for Total replaced with Knee Prosthesis newer version ------------------------------------------------------------------------ 11-201 ............ ASTM F0564-02(2006) Contact person Standard Specification and Test Methods for Metallic Bone Staples ------------------------------------------------------------------------ 11-202 11-210 ASTM F0543-07 Standard Withdrawn and Specification and Test replaced with Methods for Metallic newer version Medical Bone Screws ------------------------------------------------------------------------ L. Physical Medicine ------------------------------------------------------------------------ 16-19 ............ ISO 7176-4:1997 Contact person Wheelchairs--Part 4: and Type of Energy Consumption of standard Electric Wheelchairs and Scooters for Determination of Theoretical Distance Range ------------------------------------------------------------------------ 16-20 ............ ISO 7176-5:1986 Contact person Wheelchairs--Part 5: and Type of Determination of Overall standard Dimensions, Mass and Turning Space ------------------------------------------------------------------------ 16-23 ............ ISO 7176-10:1988 Contact person Wheelchairs--Part 10: and Type of Determination of Obstacle- standard Climbing Ability of Electric Wheelchairs ------------------------------------------------------------------------ 16-24 ............ ISO 7176-11:1992 Contact person Wheelchairs--Part 11: and Type of Test Dummies standard ------------------------------------------------------------------------ 16-25 ............ ISO 7176-13:1989 Contact person Wheelchairs--Part 13: and Type of Determination of standard Coefficient of Friction of Test Surfaces ------------------------------------------------------------------------ 16-26 ............ ISO 7176-14:1997 Contact person Wheelchairs--Part 14: and Type of Power and Control Systems standard for Electric Wheelchairs-- Requirements and Test Methods ------------------------------------------------------------------------ 16-27 ............ ISO 7176-15:1996 Contact person Wheelchairs--Part 15: and Type of Requirements for standard Information Disclosure, Documentation and Labeling ------------------------------------------------------------------------ 16-28 ............ ISO 7176-16: 1997 Contact person Wheelchairs--Part 16: and Type of Resistance to Ignition of standard Upholstered Parts-- Requirements and Test Methods ------------------------------------------------------------------------ 16-29 ............ ISO 7176-6:2001 Contact person Wheelchairs--Part 6: and Type of Determination of Maximum standard Speed, Acceleration and Deceleration of Electric Wheelchairs ------------------------------------------------------------------------ 16-30 ............ ISO 7176-9:2001 Contact person Wheelchairs--Part 9: and Type of Climatic Tests for standard Electric Wheelchairs ------------------------------------------------------------------------ 16-31 ............ ANSI/RESNA WC/Volume 1- Contact person 1998 Section 1: and Type of Determination of Static standard Stability ------------------------------------------------------------------------ 16-32 ............ ANSI/RESNA WC/Volume 2- Contact person 1998 Section 2: and Type of Determination of Dynamic standard Stability of Electric Wheelchairs ------------------------------------------------------------------------ 16-33 ............ ANSI/RESNA WC/Volume 2- Contact person 1998 Section 3: Test and Type of Methods and Requirements standard for the Effectiveness of Brakes ------------------------------------------------------------------------ 16-34 ............ ANSI/RESNA WC/Volume 2- Contact person 1998 Section 4: and Type of Determination of Energy standard Consumption of Electric Wheelchairs ------------------------------------------------------------------------ 16-35 ............ ANSI/RESNA WC/Volume 1- Contact person 1998 Section 5: and Type of Determination of Overall standard Dimensions, Mass, and Turning Space--Wheelchair ------------------------------------------------------------------------ [[Page 52376]] 16-36 ............ ANSI/RESNA WC/Volume 2- Contact person 1998 Section 6: and Type of Determination of Maximum standard Speed, Acceleration, and Retardation of Electric Wheelchairs ------------------------------------------------------------------------ 16-37 ............ ANSI/RESNA WC/Volume 1- Contact person 1998 Section 7: and Type of Wheelchairs - standard Determination of Seating and Wheel Dimensions ------------------------------------------------------------------------ 16-38 ............ ANSI/RESNA WC/Volume 1- Contact person 1998 Section 8: and Type of Wheelchairs--Static, standard Impact and Fatigue Strength Tests ------------------------------------------------------------------------ 16-39 ............ ANSI/RESNA WC/Volume 2 - Contact person 1998 Section 9: Climatic and Type of Tests for Electric standard Wheelchairs ------------------------------------------------------------------------ 16-40 ............ ANSI/RESNA WC/Volume 2 - Contact person 1998 Section 10: and Type of Determination of the standard Obstacle-Climbing Ability of Electric Wheelchairs ------------------------------------------------------------------------ 16-41 ............ ANSI/RESNA WC/Volume 1 - Contact person 1998 Section 11: and Type of Wheelchairs--Test Dummies standard ------------------------------------------------------------------------ 16-42 ............ ANSI/RESNA WC/Volume 1 - Contact person 1998 Section 13: and Type of Determination of standard Coefficient of Friction of Test Surfaces ------------------------------------------------------------------------ 16-43 ............ ANSI/RESNA WC/Volume 2 - Contact person 1998 Section 14: and Type of Wheelchairs--Testing of standard Power and Control Systems for Electric Wheelchairs ------------------------------------------------------------------------ 16-44 ............ ANSI/RESNA WC/Volume 1 - Contact person 1998 Section 15: and Type of Wheelchairs--Requirements standard for Information Disclosures, Documentation and Labeling ------------------------------------------------------------------------ 16-45 ............ ANSI/RESNA WC/Volume 1 - Title change, 1998 Section 16: Contact person Wheelchairs--Determinatio and Type of n of Flammability standard ------------------------------------------------------------------------ 16-46 ............ ANSI/RESNA WC/Volume 1 - Contact person 1998 Section 20: and Type of Wheelchairs--Determinatio standard n of the Performance of Stand-Up Wheelchairs ------------------------------------------------------------------------ 16-47 ............ ANSI/RESNA WC/Volume 1 - Contact person 1998 Section 22: and Type of Wheelchairs--Set Up standard Procedures ------------------------------------------------------------------------ 16-48 ............ ANSI/RESNA WC/Volume 1 - Contact person 1998 Section 93: Maximum and Type of Overall Dimensions standard ------------------------------------------------------------------------ 16-49 ............ ANSI/RESNA WC/Volume 1 - Contact person 1998 Section 0: and Type of Nomenclature, Terms, and standard Definitions ------------------------------------------------------------------------ 16-50 ............ ISO 7176-3:2003 Contact person Wheelchairs--Part 3: and Type of Determination of standard Effectiveness of Brakes ------------------------------------------------------------------------ 16-158 ............ ISO 7176-1:1999 Contact person Wheelchairs--Part 1: and Type of Determination of Static standard Stability ------------------------------------------------------------------------ 16-159 ............ ISO 7176-2:2001 Contact person Wheelchairs--Part 2: and Type of Determination of Dynamic standard Stability of Electric Wheelchairs ------------------------------------------------------------------------ M. Radiology ------------------------------------------------------------------------ 12-17 ............ NEMA MS 8-1993 (2000), Relevant Characterization of the guidance and Specific Absorption Rate Contact person for Magnetic Resonance Imaging Systems ------------------------------------------------------------------------ 12-61 12-177 UL 122 (2007): Standard Withdrawn and for Photographic replaced with Equipment--Ed. 5.0 newer version ------------------------------------------------------------------------ 12-64 12-178 IEC 60601-2-45 Ed. 2.0, Withdrawn and (2006) Medical Electrical replaced with Equipment--Part 2-45: newer version Particular Requirements for the Safety of Mammographic X-ray Equipment and Mammographic Stereotactic Devices ------------------------------------------------------------------------ [[Page 52377]] 12-69 ............ NEMA MS 6-1991 (R2000) Relevant Characterization of guidance, Special Purpose Coils for Contact person Diagnostic Magnetic and CFR Resonance Images Citations ------------------------------------------------------------------------ 12-95 ............ NEMA MS 2-2003 Relevant Determination of Two- guidance and Dimensional Geometric Contact person Distortion in Diagnostic Magnetic Resonance Images ------------------------------------------------------------------------ 12-96 ............ NEMA MS 3-2003 Relevant Determination of Image guidance and Uniformity in Diagnostic Contact person Magnetic Resonance Images ------------------------------------------------------------------------ 12-97 ............ NEMA MS-1-2001 Relevant Determination of Signal- guidance, to-Noise Ratio (SNR) in Contact person Diagnostic Magnetic and CFR Resonance Imaging Citations ------------------------------------------------------------------------ 12-103 12-179 ANSI / IESNA RP-27.3-2007 Withdrawn and Recommended Practice for replaced with Photobiological Safety newer version for Lamps--Risk Group Classification and Labeling ------------------------------------------------------------------------ 12-120 ............ IEC 60601-2-44 (2002-11): Relevant Medical Electrical guidance and Equipment--Part 2-44: CFR Citations Particular Requirements for the Safety of X-ray Equipment for Computed Tomography--Ed. 2.1 ------------------------------------------------------------------------ 12-123 12-180 IEC 61689:2007 Withdrawn and Ultrasonics--Physiotherap replaced with y Systems--Field newer version Specifications and Methods of Measurement in the Frequency Range 0,5 MHz to 5 MHz Ed. 2.0 ------------------------------------------------------------------------ 12-125 ............ NEMA MS 5-2003 Relevant Determination of Slice guidance and Thickness in Diagnostic Contact person Magnetic Resonance Imaging ------------------------------------------------------------------------ 12-129 12-181 NU 1-2007 Performance Withdrawn and Measurements of Gamma replaced with Cameras newer version ------------------------------------------------------------------------ 12-131 12-184 IEC 61217 2002 Withdrawn and Consolidated Ed. 1.1, replaced with 2007 Amendment 2 Ed. 1.0 newer version Radiotherapy Equipment-- Coordinates, Movements, and Scales ------------------------------------------------------------------------ 12-150 ............ IEC / ISO 10918-1:1994 Relevant Technical Corrigendum guidance, 1:2005 Information Contact person, Technology--Digital CFR Citations, Compression and Coding of Product code, Continuous-Tone Still and Devices Images--Part 1: affected Requirements ------------------------------------------------------------------------ 12-151 ............ NEMA MS 4 (2006) Acoustic Relevant Noise Measurement guidance, Procedure for Diagnosing Contact person Magnetic Resonance and CFR Imaging Devices Citations ------------------------------------------------------------------------ 12-158 ............ NEMA MS 10-2006 Relevant Determination of Local guidance, Specific Absorption Rate Contact person (SAR) in Diagnostic and CFR Magnetic Resonance Citations Imaging ------------------------------------------------------------------------ 12-159 ............ NEMA MS 11-2006 Relevant Determination of Gradient- guidance, Induced Electric Fields Contact person in Diagnostic Magnetic and CFR Resonance Imaging Citations ------------------------------------------------------------------------ 12-160 ............ NEMA MS 12-2006 Relevant Quantification and guidance, Mapping of Geometric Contact person Distortion for Special and CFR Applications Citations ------------------------------------------------------------------------ 12-161 ............ IEC 60601-2-33 (2006), Relevant Medical Electrical guidance and Equipment--Part 2-33: Contact person Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis ------------------------------------------------------------------------ 12-164 12-182 IEC 60601-2-37:2007 Withdrawn and Medical Electrical replaced with Equipment--Part 2-37: newer version Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment ------------------------------------------------------------------------ 12-165 ............ NEMA XR 22-2006 ``Quality Relevant Control Manual'' Template guidance for Manufacturers of Displays and Workstations Labeled for Final Interpretation in Full- Field Digital Mammography ------------------------------------------------------------------------ 12-166 ............ NEMA XR 23-2006 ``Quality Relevant Control Manual'' Template guidance for Manufacturers of Hardcopy Output Devices Labeled for Final Interpretation in Full- Field Digital Mammography ------------------------------------------------------------------------ 12-168 ............ IEC 60825-1 Ed. 2.0 (2007) Contact person Safety of Laser Products-- and Processes Part 1: Equipment impacted Classification, and Requirements ------------------------------------------------------------------------ [[Page 52378]] 12-169 ............ IEC 60601-2-22 Ed. 3.0 Contact person, (2007) Medical Electrical Processes Equipment--Part 2-22: impacted and Particular Requirements Title for Basic Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment ------------------------------------------------------------------------ 12-170 12-183 NEMA PS 3.1 - 3.18 (2008) Withdrawn and Digital Imaging and replaced with Communications in newer versions Medicine (DICOM) Set ------------------------------------------------------------------------ 5-7 12-185 IEC 60601-1-3 2008 Edition Transferred 2.0 Medical Electrical Equipment--Part 1- 3:General Requirements for Basic Safety and Essential Performance-- Collateral Standard: Radiation Protection in Diagnostic X-ray Equipment ------------------------------------------------------------------------ N. Software/Informatics ------------------------------------------------------------------------ 13-4 ............ ANSI/UL 1998, Software in CFR Citations, Programmable Components Product codes, Relevant guidance and Extent of recognition ------------------------------------------------------------------------ 13-5 ............ IEEE 1074:1997, Standard Withdrawn for Developing Software Life Cycle Processes ------------------------------------------------------------------------ 13-8 ............ IEC 62304 Ed. 1.0, Medical CFR Citations, Device Software--Software Product codes, Life Cycle Processes Relevant guidance, and Extent of recognition ------------------------------------------------------------------------ 7-59 13-9 CLSI AUTO2-A2 Laboratory Transferred Automation: Bar Codes for Specimen Container Identification; Approved Standard ------------------------------------------------------------------------ 7-60 13-10 CLSI AUTO1-A Laboratory Transferred Automation: Specimen Container/Specimen Carrier; Approved Standard ------------------------------------------------------------------------ 7-61 13-11 CLSI AUTO3-A Laboratory Transferred Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard ------------------------------------------------------------------------ 7-62 13-12 CLSI AUTO4-A Laboratory Transferred Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard ------------------------------------------------------------------------ 7-63 13-13 CLSI AUTO5-A Laboratory Transferred Automation: Electromechanical Interfaces; Approved Standard ------------------------------------------------------------------------ 7-64 13-14 CLSI POCT1-A2 Point-of- Transferred Care Connectivity; Approved Standard ------------------------------------------------------------------------ 7-68 13-15 CLSI GP19-A2 Laboratory Transferred Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline--Second Edition ------------------------------------------------------------------------ 7-114 13-16 CLSI LIS01-A Standard Transferred Specification for Low- Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems ------------------------------------------------------------------------ 7-115 13-17 CLSI LIS02-A2 Standard Transferred Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard-Second Edition ------------------------------------------------------------------------ 7-116 13-18 CLSI LIS03-A Standard Transferred Guide for Selection of a Clinical Laboratory Information Management System ------------------------------------------------------------------------ 7-117 13-19 CLSI LIS04-A Standard Transferred Guide for Documentation of Clinical Laboratory Computer Systems ------------------------------------------------------------------------ 7-118 13-20 CLSI LIS05-A Standard Transferred Specification for Transferring Clinical Observations Between Independent Computer Systems ------------------------------------------------------------------------ 7-119 13-21 CLSI LIS06-A Standard Transferred Practice for Reporting Reliability of Clinical Laboratory Information Systems ------------------------------------------------------------------------ [[Page 52379]] 7-120 13-22 CLSI LIS07-A Standard Transferred Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory ------------------------------------------------------------------------ 7-121 13-23 CLSI LIS08-A Standard Transferred Guide for Functional Requirements of Clinical Laboratory Information Management Systems ------------------------------------------------------------------------ 7-122 13-24 CLSI LIS09-A Standard Transferred Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architectures ------------------------------------------------------------------------ O. Sterility ------------------------------------------------------------------------ 14-24 ............ AAMI/ANSI/ISO 11134:1993 Withdrawn Sterilization of Health Care Products-- Requirements for Validation and Routine Control-Industrial Moist Heat Sterilization ------------------------------------------------------------------------ 14-53 ............ AAMI/ANSI ST66:1996 Withdrawn Sterilization of Health Care Products--Chemical Indicators--Part 2: Indicators for Air Removal Test Sheets and Packs ------------------------------------------------------------------------ 14-54 ............ AAMI/ANSI/ISO 11737-2:1998 CFR Citations, Sterilization of Medical Product codes Devices--Microbiological and Devices Methods--Part 2: Tests of affected Sterility Performed in the Validation of a Sterilization Process ------------------------------------------------------------------------ 14-55 ............ AAMI/ANSI/ISO 14160:1998 Relevant Sterilization of Single- guidance Use Medical Devices Incorporating Materials of Animal Origin-- Validation and Routine Control of Sterilization by Liquid Chemical Sterilants ------------------------------------------------------------------------ 14-60 ............ ASTM F1327:1998 Standard Withdrawn Terminology Relating to Barrier Materials for Medical Packaging ------------------------------------------------------------------------ 14-63 ............ ASTM F1886: 1998 (2004) CFR Citations Standard Test Method for and Product Determining Integrity of codes Seals for Medical Packaging by Visual Inspection ------------------------------------------------------------------------ 14-64 ............ ASTM F1929:1998 (2004) CFR Citations Standard Test Method for and Product Detecting Seal Leaks in codes Porous Medical Packaging by Dye Penetration ------------------------------------------------------------------------ 14-70 ............ AAMI/ANSI/ISO 14161:2000 CFR Citations, Sterilization of Health Product codes Care Products--Biological and Devices Indicators--Guidance for affected the Selection, Use and Interpretation of Results, 2ed. ------------------------------------------------------------------------ 14-76 ............ AAMI/ANSI/ISO 10993-7:1995 CFR Citations, (R) 2001 Biological Product codes Evaluation of Medical and Contact Devices--Part 7: Ethylene person Oxide Sterilization Residuals ------------------------------------------------------------------------ 14-88 ............ AAMI/ANSI/ISO 14937:2000 CFR Citations Sterilization of Health and Product Care Products--General codes Requirements for Characterization of a Sterilizing Agent and the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices ------------------------------------------------------------------------ 14-90 14-256 ASTM F2095-07 Standard Withdrawn and Test Methods for Pressure replaced with Decay Leak Test for newer version Nonporous Flexible Packages With and Without Restraining Plates ------------------------------------------------------------------------ 14-116 ............ AAMI ST72:2002 Bacterial CFR Citations, endotoxins--Test Product codes, Methodologies, Routine Type of Monitoring, and standard, Alternatives to Batch Guidance and Testing Extent of recognition ------------------------------------------------------------------------ 14-120 ............ ASTM D3078:2002 Standard CFR Citations, Test Method for Product codes Determination of Leaks in and Type of Flexible Packaging by standard Bubble Emission ------------------------------------------------------------------------ 14-123 ............ ASTM F2096-04 Standard CFR Citations, Test Method for Detecting Product codes, Gross Leaks in Medical CDRH Office and Packaging by Internal Division Pressurization (Bubble associated with Test) recognized standard ------------------------------------------------------------------------ [[Page 52380]] 14-135 ............ AAMI/ANSI ST63:2002 CFR Citations, Sterilization of Health Product codes Care Products-- and Type of Requirements for the standard Development, Validation and Routine Control of an Industrial Sterilization Process for Medical Devices--Dry Heat ------------------------------------------------------------------------ 14-136 ............ AAMI/ANSI ST67:2003 CFR Citations, Sterilization of Health Product codes Care Products-- and Guidance Requirements for Products Labeled 'Sterile' 1st Edition ------------------------------------------------------------------------ 14-138 ............ ISO 13408-2:2003 Aseptic CFR Citations, Processing of Health Care Product codes, Products--Part 2: Type of Filtration standard and Guidance ------------------------------------------------------------------------ 14-139 ............ ISO 14644-1:1999 CFR Citations, Cleanrooms and Associated Product codes Controlled Environments-- and Type of Part 1: Classification of standard Air Cleanliness ------------------------------------------------------------------------ 14-140 ............ ISO 14644-2:2000 CFR Citations, Cleanrooms and Associated Product codes Controlled Environments-- and Type of Part 2: Specification for standard Testing and Monitoring to Prove Continued Compliance With ISO 14644- 1 ------------------------------------------------------------------------ 14-141 ............ ISO 14644-4:2001 CFR Citations, Cleanrooms and Associated Product codes Controlled Environments-- and Type of Part 4: Design, standard Construction and Startup ------------------------------------------------------------------------ 14-142 ............ ISO 14698-1:2003 CFR Citations, Cleanrooms and Associated Product codes Controlled Environments-- and Type of Biocontamination Control-- standard Part 1: General Principles and Methods ------------------------------------------------------------------------ 14-143 ............ ISO 14698-2:2003 CFR Citations, Cleanrooms and Associated Product codes Controlled Environments-- and Type of Biocontamination Control-- standard Part 2: Evaluation and Interpretation of Biocontamination Data ------------------------------------------------------------------------ 14-148 ............ ASTM F2250-03 Standard CFR Citations, Practice for Evaluation Product codes of Chemical Resistance of and Type of Printed Inks and Coatings standard on Flexible Packaging Materials ------------------------------------------------------------------------ 14-149 ............ ASTM F2251-03e1 Standard CFR Citations, Test Method for Thickness Product codes Measurement of Flexible and Type of Packaging Material standard ------------------------------------------------------------------------ 14-150 ............ ASTM F2252-03 Standard CFR Citations, Practice for Evaluating Product codes Ink or Coating Adhesion and Type of to Flexible Packaging standard Materials Using Tape ------------------------------------------------------------------------ 14-164 ............ AAMI/ANSI ST81:2004 CFR Citations, Sterilization of Medical Product codes, Devices--Information to and Devices be Provided by the affected Manufacturer for the Processing of Resterilizable Devices ------------------------------------------------------------------------ 14-165 ............ ISO 14644-5:2004 CFR Citations, Cleanrooms and Associated Product codes Controlled Environments-- and Type of Part 5: Operations standard ------------------------------------------------------------------------ 14-166 ............ ISO 14644-7:2004 CFR Citations, Cleanrooms and Associated Product codes Controlled Environments-- and Type of Part 7: Separative standard Devices (Clean Air Hoods, Gloveboxes, Isolators and Mini-Environments) ------------------------------------------------------------------------ 14-168 14-245 ASTM F2338-07 Standard Withdrawn and Test Method for replaced with Nondestructive Detection newer version of Leaks in Packages by Vacuum Decay Method ------------------------------------------------------------------------ 14-169 ............ ASTM F2391-05 Standard CFR Citations, Test Method for Measuring Product codes Package and Seal and Type of Integrity Using Helium as standard Tracer Gas ------------------------------------------------------------------------ 14-170 ............ ASTM F2475-05 Standard CFR Citations, Guide for Product codes Biocompatibility and Type of Evaluation of Medical standard Device Packaging Materials ------------------------------------------------------------------------ 14-191 ............ ISO 13408-4:2005 Aseptic CFR Citations, Processing of Health care Product codes, Products--Part 4: Clean- Type of in-Place Technologies standard and Relevant guidance ------------------------------------------------------------------------ 14-193 ............ AAMI/ANSI/ISO 11607-1:2006 CFR Citations, Packaging for terminally Product codes, Sterilized Medical Devices Devices--Part 1: affected and Requirements for Relevant Materials, Sterile guidance Barrier Systems and Packaging Systems, 3d ed. ------------------------------------------------------------------------ [[Page 52381]] 14-194 ............ AAMI/ANSI/ISO 11607-2:2006 CFR Citations, Packaging for Terminally Product codes, Sterilized Medical Devices Devices--Part 2: affected and Validation Requirements Relevant for Forming, Sealing and guidance Assembly Processes, 1st ed. ------------------------------------------------------------------------ 14-197 ............ ASTM F1608:00(2004) CFR Citations Standard Test Method for and Product Microbial Ranking of codes Porous Packaging Materials (Exposure Chamber Method) ------------------------------------------------------------------------ 14-199 ............ ASTM D4169-05 Standard Related CFR Practice for Performance Citations and Testing of Shipping Product codes Containers and Systems ------------------------------------------------------------------------ 14-202 14-246 USP 31:2008 Biological Withdrawn and Indicator for Dry-Heat replaced with Sterilization, Paper newer version Carrier ------------------------------------------------------------------------ 14-203 14-247 USP 31:2008 Biological Withdrawn and Indicator for Ethylene replaced with Oxide Sterilization, newer version Paper Carrier. ------------------------------------------------------------------------ 14-204 14-248 USP 31:2008 Biological Withdrawn and Indicator for Steam replaced with Sterilization, Paper newer version Carrier ------------------------------------------------------------------------ 14-205 14-249 USP 31:2008 <61> Microbial Withdrawn and Limits Test replaced with newer version ------------------------------------------------------------------------ 14-206 14-250 USP 31:2008 <71> Withdrawn and Microbiological Tests, replaced with Sterility Tests newer version ------------------------------------------------------------------------ 14-207 14-251 USP 31:2008 <85> Withdrawn and Biological Tests and replaced with Assays, Bacterial newer version Endotoxin Test (LAL) ------------------------------------------------------------------------ 14-208 14-252 USP 31:2008 <151> Pyrogen Withdrawn and Test (USP Rabbit Test) replaced with newer version ------------------------------------------------------------------------ 14-209 14-253 USP 31:2008 <161> Withdrawn and Transfusion and Infusion replaced with Assemblies and Similar newer version Medical Devices ------------------------------------------------------------------------ 14-210 14-254 USP 31:2008 Biological Withdrawn and Indicator for Steam replaced with Sterilization--Self newer version Contained ------------------------------------------------------------------------ 14-220 ............ AAMI/ANSI ST79:2006 Type of Standard Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities ------------------------------------------------------------------------ 14-221 ............ AAMI/ANSI/ISO TIR CFR Citations, 11139:2006 Sterilization Product codes, of Health Care Products-- Title, Devices Vocabulary affected, and Type of standard ------------------------------------------------------------------------ 14-222 ............ AAMI/ANSI/ISO 18472:2006 Type of standard Sterilization of Health Care Products--Biological and Chemical Indicators-- Test Equipment ------------------------------------------------------------------------ 14-223 ............ ANSI/AAMI/ISO 11138-1:2006 Type of Sterilization of Health standard, Care Products--Biological Guidance and Indicators--Part 1: Extent of General Requirements recognition ------------------------------------------------------------------------ 14-224 ............ AAMI/ANSI/ISO 11137-1:2006 CFR Citations, Sterilization of Health Product codes, Care Products--Radiation-- and Type of Part 1: Requirements for standard Development, Validation, and Routine Control of a Sterilization Process for Medical Devices ------------------------------------------------------------------------ 14-225 ............ AAMI/ANSI/ISO 11137-2:2006 CFR Citations, Sterilization of Health Product codes Care Products--Radiation-- and Type of Part 2: Establishing the standard Sterilization Dose ------------------------------------------------------------------------ 14-226 ............ AAMI/ANSI/ISO 11137-3:2006 CFR Citations, Sterilization of Health Product codes Care Products--Radiation-- and Type of Part 3: Guidance on standard Dosimetric Aspects ------------------------------------------------------------------------ [[Page 52382]] 14-227 ............ AAMI/ANSI/ISO 11737-1:2006 CFR Citations, Sterilization of Medical Product codes, Devices-Microbiological Devices Methods-Part 1: affected, CDRH Determination of the Office and Population of Division Microorganisms on associated with Products, 2d, ed. recognized standard ------------------------------------------------------------------------ 14-228 ............ ANSI/AAMI/ISO 11135-1:2007 CFR Citations, Sterilization of Health Product codes, Care Products--Ethylene Devices Oxide--Part 1: affected, and Requirements for the Type of Development, Validation, standard and Routine Control of a Sterilization Process for Medical Devices ------------------------------------------------------------------------ 14-229 ............ ASTM F1980-07 Standard CFR Citations Guide for Accelerated and Product Aging of Sterile Barrier codes Systems for Medical Devices ------------------------------------------------------------------------ 14-230 ............ ASTM F2203-02(2007) CFR Citations, Standard Test Method for Product codes Linear Measurement Using and Type of Precision Steel Rule standard ------------------------------------------------------------------------ 14-231 ............ ASTM F2217-02(2007) CFR Citations, Standard Practice for Product codes Coating/Adhesive Weight and Type of Determination standard ------------------------------------------------------------------------ 14-232 ............ ASTM F2227-02(2007) CFR Citations, Standard Test Method for Product codes Non-Destructive Detection and Type of of Leaks in Non-Sealed standard and Empty Medical Packaging Trays by CO2 Tracer Gas Method ------------------------------------------------------------------------ 14-233 ............ ASTM F2228-02(2007) CFR Citations, Standard Test Method for Product codes Non-Destructive Detection and Type of of Leaks in Medical standard Packaging Which Incorporates Porous Barrier Material by CO2 Tracer Gas Method ------------------------------------------------------------------------ 14-234 ............ ASTM F2097-07 Standard CFR Citations, Guide for Design and Product codes Evaluation of Primary and Type of Flexible Packaging for standard Medical Products ------------------------------------------------------------------------ 14-235 ............ ASTM F1140-07 Standard CFR Citations, Test Methods for Internal Product codes Pressurization Failure and Type of Resistance of standard Unrestrained Packages ------------------------------------------------------------------------ 14-236 ............ ASTM F2054-07 Standard CFR Citations, Test Method for Burst Product codes Testing of Flexible and Type of Package Seals Using standard Internal Air Pressurization Within Restraining Plates ------------------------------------------------------------------------ 14-237 ............ ASTM F88-07 Standard Test CFR Citations, Method for Seal Strength Product codes of Flexible Barrier and Type of Materials standard ------------------------------------------------------------------------ 14-239 ............ ISO 13408-3:2006 Aseptic CFR Citations Processing of Health Care and Product Products--Part 3: codes Lyophilization ------------------------------------------------------------------------ 14-240 ............ ISO 13408-5:2006 Aseptic CFR Citations Processing of Health Care and Product Products--Part 5: codes Sterilization-in-Place ------------------------------------------------------------------------ 14-241 ............ ISO 13408-6:2005 Aseptic CFR Citations Processing of Health Care and Product Products--Part 6: codes Isolator Systems ------------------------------------------------------------------------ 14-242 ............ ISO 14644-3:2005 CFR Citations Cleanrooms and Associated and Product Controlled Environments-- codes Part 3: Test Methods ------------------------------------------------------------------------ 14-243 ............ ISO 14644-6:2007 CFR Citations Cleanrooms and Associated and Product Controlled Environments-- codes Part 6: Vocabulary ------------------------------------------------------------------------ 14-244 ............ ISO 14644-8:2006 CFR Citations Cleanrooms and Associated and Product Controlled Environments-- codes Part 8: Classification of Airborne Molecular Contamination ------------------------------------------------------------------------ P. Tissue Engineering ------------------------------------------------------------------------ 15-12 ............ ASTM F2103-01(2007)e1 CFR Citations Standard Guide for and Product Characterization and codes, Relevant Testing of Chitosan Salts guidance, Type as Starting Materials of standard and Intended for Use in CDRH Office and Biomedical and Tissue- Division Engineered Medical associated with Product Applications recognized standard ------------------------------------------------------------------------ [[Page 52383]] 15-5 ............ ASTM F2347-03, Standard CFR Citations Guide for and Product Characterization and codes, Relevant Testing of Hyaluronan as guidance, Type Starting Materials of standard and Intended for Use in CDRH Office and Biomedical and Tissue Division Engineered Medical associated with Product Applications recognized standard ------------------------------------------------------------------------ 15-6 ............ ASTM F2450-04, Standard CFR Citations Guide for Assessing and Product Microstructure of codes, Relevant Polymeric Scaffolds for guidance, Type Use in Tissue Engineered of standard and Medical Products CDRH Office and Division associated with recognized standard ------------------------------------------------------------------------ 15-7 ............ ASTM F2315-03, Standard CFR Citations Guide for Immobilization and Product or Encapsulation of codes, Relevant Living Cells or Tissue in guidance, Type Alginate Gels of standard and CDRH Office and Division associated with recognized standard ------------------------------------------------------------------------ 15-8 ............ ASTM F2064-00(2006), CFR Citations Standard Guide for and Product Characterization and codes, Relevant Testing of Alginates as guidance, Type Starting Materials of standard and Intended for use in CDRH Office and Biomedical and Tissue- Division Engineered Medical associated with Products Application recognized standard ------------------------------------------------------------------------ 15-9 ............ ASTM F2311-06, Standard CFR Citations Guide for Classification and Product of Therapeutic Skin codes, Relevant Substitutes guidance, Type of standard and CDRH Office and Division associated with recognized standard ------------------------------------------------------------------------ 15-10 ............ ASTM F2451-05, Standard CFR Citations Guide for in vivo and Product Assessment of Implantable codes, Relevant Devices Intended to guidance, Type Repair or Regenerate of standard and Articular Cartilage CDRH Office and Division associated with recognized standard ------------------------------------------------------------------------ 15-11 ............ ASTM F2212-02(2007)e1, CFR Citations Standard Guide for and Product Characterization of Type codes, Relevant I Collagen as a Starting guidance, Type Material for Surgical of standard and Implants and Substrates CDRH Office and for Tissue Engineered Division Medical Products associated with recognized standard ------------------------------------------------------------------------ III. Listing of New Entries In table 3 of this document, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 020. Table 3.--New Entries to the List of Recognized Standards ------------------------------------------------------------------------ Recognition Reference No. and No. Title of Standard Date ------------------------------------------------------------------------ A. Biocompatibility ------------------------------------------------------------------------ 2-127 Biological Evaluation of Medical ANSI/AAMI BE Devices--Part 10: Tests for 78:2002/A1:2006 Irritation and Delayed-Type Hypersensitivity--Amendment 1 ------------------------------------------------------------------------ B. Cardiovascular/Neurology ------------------------------------------------------------------------ 3-70 Manual, Electronic or Automated ANSI/AAMI Sphygmomanometers SP10:2002/ A1:2003--Amendmen t 1 to ANSI/AAMI SP10:2002 ------------------------------------------------------------------------ 3-71 Manual, Electronic and Automated ANSI/AAMI Sphygmomanometers SP10:2002/ A2:2006--Amendmen t 2 to ANSI/AAMI SP10:2002 ------------------------------------------------------------------------ C. Dental/ Ear, Nose, and Throat ------------------------------------------------------------------------ 4-151 Dentistry--Artificial Teeth for ISO 22112:2005 Dental Prostheses ------------------------------------------------------------------------ [[Page 52384]] 4-152 Metal-Ceramic Dental Restorative ISO 9693:1999/ Systems Amendment 1:2005 ------------------------------------------------------------------------ 4-154 Dentistry--Elastometric Impression ISO 4823:2000 Materials-Third Edition ------------------------------------------------------------------------ 4-155 Dentistry--Elastomeric Impression ISO 4823:2000 Materials Technical Corrigendum 1- Technical Third Edition Corrigendum 1:2004 ------------------------------------------------------------------------ 4-156 Dentistry--Elastomeric Impression ISO 4823:2000 Materials Amendment 1-Third Edition Amendment 1:2007 ------------------------------------------------------------------------ 4-157 Dentistry--Zinc Oxide/Eugenol and ISO 3107: 2004 Zinc Oxide/Non-eugenol Cements- Third Edition ------------------------------------------------------------------------ 4-158 Dentistry--Soft Lining Materials for ISO 10139-1:2005 Removable Dentures--Part 1: Technical Materials for Short-Term Use Corrigendum Technical Corrigendum 1 1:2006 ------------------------------------------------------------------------ D. General Hospital/ General Plastic Surgery ------------------------------------------------------------------------ 6-214 Standard Test Method for Human ASTM D6355-07 Repeat Insult Patch Testing of Medical Gloves ------------------------------------------------------------------------ E. In Vitro Diagnostic ------------------------------------------------------------------------ 7-160 Abbreviated Identification of CLSI M35-A, Bacteria and Yeast; Approved Guideline ------------------------------------------------------------------------ 7-161 Laboratory Detection and CLSI M48-P Identification of Mycobacteria; Proposed Guideline. ------------------------------------------------------------------------ 7-162 Point-of-Care Monitoring of CLSI H49-A Anticoagulant Therapy; Approved Guideline ------------------------------------------------------------------------ 7-163 Body Fluid Analysis for Cellular CLSI H56-A Composition ------------------------------------------------------------------------ 7-164 Microwave Device Use in the CLSI GP28-A Histology Laboratory; Approved Guideline ------------------------------------------------------------------------ 7-165 Reference Leukocyte (WBC) CLSI H20-A2 Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard-Second Edition ------------------------------------------------------------------------ 7-166 Fine Needle Aspiration Biopsy (FNAB) CLSI GP20-A2 Techniques; Approved Guideline-- Second Edition ------------------------------------------------------------------------ 7-167 Nongynecologic Cytologic Specimens: CLSI GP23-A Collection and Cytopreparatory Techniques; Approved Guideline ------------------------------------------------------------------------ 7-168 Reference Method for Broth Dilution CLSI M38-A Antifungal Susceptibility Testing of Filamentous Fungi; Approved Standard ------------------------------------------------------------------------ F. Materials ------------------------------------------------------------------------ 8-161 Standard Test Method for Tension ASTM F2516-07 Testing of Nickel-Titanium Superelastic Materials ------------------------------------------------------------------------ G. OB-GYN/Gastroenterology ------------------------------------------------------------------------ 9-46 Medical Electrical Equipment--Part 2- ANSI/AAMI 60601-2- 2: Particular Requirements for the 2:2006 Safety of High Frequency Surgical Equipment ------------------------------------------------------------------------ 9-49 Concentrates for Hemodialysis AAMI / ANSI RD61:2006 ------------------------------------------------------------------------ 9-50 Dialysate for Hemodialysis ANSI/AAMI RD52:2004 ------------------------------------------------------------------------ 9-51 Cardiovascular Implants and ISO 8637:2004 Artificial Organs--Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators ------------------------------------------------------------------------ 9-52 Cardiovascular Implants and ISO 8638:2004 Artificial Organs--Extracorporeal Blood Circuit for Haemodialysers, Haemodiafilters and Haemofilters ------------------------------------------------------------------------ 9-53 Standard Practice for Reprocessing ASTM F1992- of Reusable, Heat-Stable Endoscopic 99(2007) Accessory Instruments (EAI) Used with Flexible Endoscopes ------------------------------------------------------------------------ 9-54 Standard Specification for Rubber ASTM D6976-08 Contraceptives--Vaginal Diaphragms ------------------------------------------------------------------------ H. Ophthalmic ------------------------------------------------------------------------ 10-56 Ophthalmics Multifocal Intraocular ANSI Z80.12-2007 Lenses ------------------------------------------------------------------------ [[Page 52385]] 10-57 Phakic Intraocular Lenses ANSI Z80.13-2007 ------------------------------------------------------------------------ I. Physical Medicine ------------------------------------------------------------------------ 16-161 Safety Standard for Platform Lifts ASME A18.1-2005 and Stairway Chairlifts ------------------------------------------------------------------------ J. Sterility ------------------------------------------------------------------------ 14-255 Standard Terminology Relating to ASTM F17-07a Flexible Barrier Packaging ------------------------------------------------------------------------ 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 Persons interested in obtaining a copy of ``Guidance on the Recognition and Use of Consensus Standards'' by using the Internet. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, Federal Register reprints, information on premarket submissions [including lists of approved applications and manufacturers' addresses], small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html. Guidance documents are also available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. This Federal Register document on modifications in FDA's recognition of consensus standards is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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: 020. These modifications to the list or recognized standards are effective upon publication of this notice in the Federal Register. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. Dated: August 27, 2008. Daniel G. Schultz, Director, Center for Devices and Radiological Health. [FR Doc. E8-20939 Filed 9-8-08; 8:45 am] BILLING CODE 4160-01-S