Skip to Content

Notice

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 020

Document Details

Information about this document as published in the Federal Register.

Enhanced Content

Relevant information about this document from Regulations.gov provides additional context. This information is not part of the official Federal Register document.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

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://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.

Start Further Info

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.

End Further Info End Preamble Start Supplemental Information

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 Start Printed Page 52359the Federal Register, are identified in table 1 of this document.

Table 1.—Previous Publications of Standard Recognition Lists

October 16, 1998 (63 FR 55617)October 4, 2004 (69 FR 59240)
July 12, 1999 (64 FR 37546)May 27, 2005 (70 FR 30756)
November 15, 2000 (65 FR 69022)November 8, 2005 (70 FR 67713)
May 7, 2001 (66 FR 23032)March 31, 2006 (71 FR 16313)
January 14, 2002 (67 FR 1774)June 23, 2006 (71 FR 36121)
October 2, 2002 (67 FR 61893)November 3, 2006 (71 FR 64718)
April 28, 2003 (68 FR 22391)May 21, 2007 (72 FR 28500)
March 8, 2004 (69 FR 10712)September 12, 2007 (72 FR 52142)
June 18, 2004 (69 FR 34176)December 19, 2007 (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 Recognition No.Replacement Recognition No.StandardChange
A. Anesthesia
1-11IEC 60601-3-1:1996-08 Medical Electrical Equipment Part 3-1: Essential Performance Requirements for Transcutaneous Oxygen and Carbon Dioxide Partial Pressure Monitoring EquipmentWithdrawn
1-46ISO 5367:2000 Breathing Tubes Intended for Use With Anaesthetic Apparatus and VentilatorsRelevant guidance and Extent of recognition
1-51ASTM F1101-90(1997) Standard Specification for Ventilators Intended for Use During AnesthesiaWithdrawn
1-62ISO 5356-1:2004 Anaesthetic and Respiratory Equipment—Conical Connectors: Part 1: Cones and SocketsRelevant guidance
1-66ISO 9919:2005: Medical Electrical Equipment—Particular Requirements for the Basic Safety and Essential Performance of Pulse Oximeter Equipment for Medical UseRelevant guidance
1-68CGA V-5:2005 Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications)Relevant guidance
1-72ISO 10651-5:2006 Lung Ventilators for Medical Use—Particular Requirements for Basic Safety and Essential Performance—Part 5: Gas-powered Emergency ResuscitatorsRelevant guidance, Code of Federal Regulations (CFR) Citation and Product Codes
1-73ISO 10651-4:2002 Lung Ventilators—Part 4: Particular Requirements for Operator Powered ResuscitatorsRelevant guidance
B. Biocompatibility
2-212-118ANSI/AAMI/ISO 10993-11: 2006 Biological Evaluation of Medical Devices—Part 11: Tests for System ToxicityWithdrawn and replaced with newer version
2-562-119ASTM F813-07 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical DevicesWithdrawn and replaced with newer version
Start Printed Page 52360
2-632-120ANSI/AAMI/ISO 10993-6: 2007 Biological Evaluation of Medical Devices—Part 6: Tests for Local Effects After ImplantationWithdrawn and replaced with newer version
2-662-121ASTM F2148-07e1 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)Withdrawn and replaced with newer version
2-682-122ASTM F719-81 (2007) e1 Standard Practice for Testing Biomaterials in Rabbits for Primary Skin IrritationWithdrawn and replaced with newer version
2-692-123ASTM F720-81 (2007) e1 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization TestWithdrawn and replaced with newer version
2-702-124ASTM F750-87 (2007) e1 Standard Practice for Evaluating Material Extracts by Systemic Injection in the MouseWithdrawn and replaced with newer version
2-892-125ASTM F749-98 (2007) e1 Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the RabbitWithdrawn and replaced with newer version
2-922-126ASTM F748-06 Standard Practice for Selecting Generic Biological Test Methods for Materials and DevicesWithdrawn and replaced with newer version
2-95ASTM F1984-99(2003) Standard Practice for Testing for Whole Complement Activation in Serum by Solid MaterialsRelevant guidance
2-1092-128USP 31-NF26 Biological Test <87> 2008 Biological Reactivity Test, In Vitro—Direct Contact TestWithdrawn and replaced with newer version
2-1102-129USP 31-NF26 Biological Test <88> 2008 Biological Reactivity Test, In Vitro—Elution TestWithdrawn and replaced with newer version
2-1112-130USP 31-NF26 Biological Test <88> 2008 Biological Reactivity Test, In Vitro, Procedure—Preparation of SampleWithdrawn and replaced with newer version
2-1122-131USP 31-NF26 Biological Test <88> 2008 Biological Reactivity Test, In Vitro, Classification of Plastics—Intracutaneous TestWithdrawn and replaced with newer version
2-1132-132USP 31-NF26Biological Test <88> 2008 Biological Reactivity Test, In Vivo—Classification of Plastics—Systemic Injection TestWithdrawn and replaced with newer version
C. Cardiovascular/Neurology
3-2ANSI/AAMI EC53:1995/(R)2001—ECG Cables and LeadwiresReaffirmation
3-3ANSI/AAMI NS28:1988/(R)2006—Intracranial Pressure Monitoring DevicesReaffirmation
3-163-60IEC 60601-2-10: Amendment 1: 2001-09, Medical Electrical Equipment—Part 2-10: Particular Requirements for the Safety of Nerve and Muscle StimulatorsWithdrawn and replaced with newer version
3-183-61IEC 60601-2-27: 2005-08, Second Edition, Medical Electrical Equipment—Part 2-27: Particular Requirements for the Safety, Including Essential Performance, of Electrocardiographic Monitoring EquipmentWithdrawn and replaced with newer version
3-203-62IEC 60601-2-31: 2008-03, Edition 2.0, Medical Electrical Equipment—Part 2-31: Particular Requirements for the Basic Safety and Essential Performance of External Cardiac Pacemakers with Internal Power SourceWithdrawn and replaced with newer version
3-253-63ISO 11318:2002, Second Edition, Cardiac Defibrillators—Connector Assembly DF-1 for Implantable Defibrillators—Dimensions and Test RequirementsWithdrawn and replaced with newer version
Start Printed Page 52361
3-40ANSI/AAMI SP9:1994, Non-automated SphygmomanometersWithdrawn
3-41ANSI/AAMI EC11:1991/(R)2007—Diagnostic Electrocardiographic DevicesReaffirmation
3-42ANSI/AAMI EC13:2002/(R)2007—Cardiac Monitors, Heart Rate Meters, and AlarmsReaffirmation
3-433-65ANSI/AAMI EC38:2007—Medical Electrical Equipment—Part 2-47: Particular Requirements for the Safety, Including Essential Performance, of Ambulatory Electrocardiographic SystemsWithdrawn and replaced with newer version
3-44ANSI/AAMI BP22:1994/(R)2006, Blood Pressure TransducersReaffirmation
3-45ANSI/AAMI EC57:1998/(R)2003, Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement AlgorithmsReaffirmation
3-473-66ASTM F2081-06, Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular StentsWithdrawn and replaced with newer version
3-52ANSI/AAMI EC12:2000/(R)2005, Disposable ECG ElectrodesReaffirmation
3-573-67ASTM F2129-06, Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant DevicesWithdrawn and replaced with newer version
D. Dental/Ear, Nose, and Throat
4-43ANSI/ADA Specification No. 5-Dental Casting Alloys:1997Type of standard, and Relevant guidance
4-50ANSI/ADA Specification No. 18-Alginate Impression Materials:1992Title and Relevant guidance
4-524-147ANSI/ADA Specification No. 27-Resin-Based Filling Materials: 2005Withdrawn and replaced with newer year
4-62ISO 1563:1990 Dental Alginate Impression MaterialRelevant guidance and Extent of recognition
4-63ISO 1564:1995 Dental Aqueous Impression Materials Based on AgarRelevant guidance
4-654-151ISO 3336:1993, Dentistry—Synthetic Polymer TeethWithdrawn and replaced with newer version
4-66ISO 4049:1988, Dentistry—Resin-Based Filling MaterialsWithdrawn—newer version previously recognized
4-67ISO 6871-1:1994, Dental Base Metal Casting Alloys Part 1: Cobalt-based Alloys—TECHNICAL CORRIGENDUM 1:1998Withdrawn—newer version previously recognized
4-68ISO 6871-2:1994, Dental Base Metal Casting Alloys Part 2: Nickel-Based AlloysWithdrawn—newer version previously recognized
4-69ISO 6872:1995/Amendment 1:1997 Dental CeramicDate of standard and Extent of recognition
4-73ISO 7405:1997 Dentistry—Preclinical Evaluation of Biocompatibility of Medical Devices Used in Dentistry—Test Methods for Dental MaterialsExtent of recognition and Contact person
4-75ISO 7785-1:1997 Dental Handpieces—Part 1: High-Speed Air Turbine HandpiecesRelevant guidance and Extent of recognition
Start Printed Page 52362
4-76ISO 7785-2:1995 Dental Handpieces—Part 2: Straight and Geared Angle HandpiecesRelevant guidance and Extent of recognition
4-78ISO 9168:1991 Dental Handpieces—Hose ConnectorsRelevant guidance and Extent of recognition
4-83ISO 11498:1997 Dental Handpieces—Dental Low-Voltage Electrical MotorsRelevant guidance and Extent of recognition
4-84ISO 13294:1997 Dental Handpieces—Dental Air-MotorsRelevant guidance and Extent of recognition
4-884-148ANSI/ADA Specification No. 78-Endodontic Obturating Cones: 2005Withdrawn and replaced with newer version
4-89ANSI/ADA Specification No. 53-Polymer-Based Crowns and Bridge Resins: 1999 (Reaffirmed 2005)Reaffirmation and Relevant guidance
4-90ANSI/ASA S3.39:1987 (R2007), Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance)Reaffirmation and Type of standard
4-91ANSI/ADA Specification No. 80-Dental Materials—Determination of Color Stability: 2001Relevant guidance
4-92ANSI/ADA Specification No. 88-Dental Brazing Alloys: 2000 (Reaffirmed 2006)Reaffirmation and Relevant guidance
4-934-159IEEE ANSI C63.19:2007 Methods of Measurement of Compatibility Between Wireless Communications Devices and Hearing AidsWithdrawn and replaced with newer version
4-94ANSI/ADA Specification No. 14—Dental Base Metal Casting Alloys: 1982 (Reaffirmed 1998)Reaffirmation, Date of standard, Type of standard, Offices, Relevant guidance
4-95ANSI/ADA Specification No.17:1999, Dental Base Temporary Relining ResinWithdrawn—newer version previously recognized
4-96ANSI/ADA Specification No. 30—Dental Zinc Oxide—Eugenol and Zinc Oxide—Non-Eugenol Cements: 2000 (Reaffirmed 2005)Reaffirmation and Relevant guidance
4-97ANSI/ADA Specification No. 57—Endodontic Sealing Material: 2000 (Reaffirmed 2006)Reaffirmation, Offices and Type of standard
4-98ANSI/ADA Specification No. 96:2000, Dental-Water-Based CementsWithdrawn—newer version previously recognized
4-99ISO 4049: 2000 Dentistry—Polymer-based Filling, Restorative and Luting MaterialsRelevant guidance, Type of standard and Extent of recognition
4-1004-133ISO 6876:2001, Dental Root Canal Sealing MaterialsWithdrawn (duplicate)
4-101ISO 8891:1998, Dental Casting Alloys With Noble Metal Content of At Least 25% but Less Than 75%Withdrawn—newer version previously recognized
4-1024-152ISO 9693:1999, Metal-Ceramic Dental Restorative SystemsWithdrawn and replaced with newer version
4-1044-149ANSI/ADA Specification No. 39—Pit and Fissure Sealants: 2006Withdrawn and replaced with newer version
4-105ANSI/ADA Specification No. 75—Resilient Lining Materials for Removable Dentures—Part 1: Short-Term Materials: 1997 (Reaffirmed 2003)Type of standard and Relevant guidance
4-107ISO 9917-2:1998 Dental Water-Based Cements—Part 2: Light-Activated CementsDevices affected, Type of standard, Relevant guidance and Extent of recognition
Start Printed Page 52363
4-109ISO 13716:1999 Dentistry—Reversible-Irreversible Hydrocolloid Impression Material SystemsType of standard, Relevant guidance, Extent of recognition and Code of Federal Regulations (CFR) citation
4-110ANSI/ADA Specification No. 11—Agar Impression Materials: 1997Type of standard and Relevant guidance
4-111ANSI/ADA Specification No. 13—Denture Cold-Curing Repair Resins: 1981 (Reaffirmed 2006)Reaffirmation, Date of standard, Type of standard and Relevant guidance
4-112ANSI/ADA Specification No. 16—Dental Impression Paste—Zinc Oxide-Eugenol Type: 1961 (Reaffirmed 1999)Reaffirmation, Date of standard, Type of standard and Relevant guidance
4-113ANSI/ADA Specification No. 20—Dental Duplicating Material: 1972 (Reaffirmed 1995)Reaffirmation, Date of standard, Type of standard and Relevant guidance
4-1154-153ISO 9917-1:2007 Dentistry—Water-Based Cements—Part 1: Powder/Liquid Acid-Base CementsWithdrawn and replaced with a newer year
4-117ANSI/ADA Specification No. 12—Denture Base Polymers: 2002Type of standard
4-119ANSI/ADA Specification No. 82—Dental Reversible/Irreversible Hydrocolloid Impression Material Systems: 1998 (Reaffirmed 2003)Reaffirmation, Date of standard, Type of standard and Relevant guidance
4-120ISO 10139-2:1999 Dentistry—Soft Lining Materials for Removable Dentures—Part 2: Materials for Long-Term UseType of standard, Relevant guidance and Extent of recognition
4-121ISO 7494-2:2003 Dentistry—Dental Units—Part 2: Water and Air SupplyType of standard and Extent of recognition
4-125ISO 1562:2004, Dentistry—Casting Gold AlloysWithdrawn—newer version previously recognized
4-126ISO 10477:2004 Dentistry—Polymer-Based Crown and Bridge MaterialsExtent of recognition and Relevant guidance
4-127ANSI/ADA Specification No. 58—Root Canal Files, Type H (Hedstrom): 2004Type of standard and Extent of recognition
4-128ISO 4823:2000,, Dentistry—Elastomeric Impression Materials and Technical Corrigendum 1:2004Withdrawn
4-1294-150ANSI/ADA Specification No. 19—Dental Elastomeric Impression Material: 2004Withdrawn and replaced with newer version
4-130ANSI/ADA Specification No. 17—Denture Base Temporary Relining Resins: 1983 (Reaffirmed 2006)Reaffirmation, Processes impacted, Extent of recognition, CFR citations and Relevant guidance
4-131ISO 3107: 2004 Dentistry—Zinc Oxide/Eugenol and Zinc Oxide/Non-eugenol Cements Technical Corrigendum 1:2006-Third EditionProcesses impacted and Relevant guidance
4-132ISO 6874:2005 Dentistry—Polymer-Based Pit and Fissure SealantsExtent of recognition and Relevant guidance
4-133ISO 6876:2001 Dental Root Canal Sealing MaterialsProcesses impacted and Extent of recognition
4-134ISO 7494-1:2004 Dentistry—Dental Units—Part 1: General Requirements and Test MethodsExtent of recognition
4-135ISO 10139-1:2005 Dentistry—Soft Lining Materials for Removable Dentures—Part 1: Materials for Short-term UseRelevant guidance and Extent of recognition
Start Printed Page 52364
4-136ASTM F2504-05 Standard Practice for Describing System Output of Implantable Middle Ear Hearing DevicesRelevant guidance
4-137ISO 6877:2006 Dentistry—Root-Canal Obturating PointsExtent of recognition
4-139ANSI/ADA Specification No. 48—Visible Light Curing Units: 2004Relevant guidance
4-140ISO 6871-2:1994/Amd 1:2005, Dental Base Metal Casting Alloys—Part 2: Nickel-Based AlloysWithdrawn—newer version previously recognized
4-141ISO 6871-1:1994, Dental Base Metal Casting Alloys—Part 1: Cobalt-Based AlloysWithdrawn—newer version previously recognized
4-142ISO 6871-1:1994/Amd 1:2005, Dental Base Metal Casting Alloys—Part 1: Cobalt-Based AlloysWithdrawn—newer version previously recognized
4-143ANSI/ADA Specification No.96, Dental-Water-Based CementsReaffirmation, Type of standard and Relevant guidance
4-145ISO 22803:2004 Dentistry—Membrane Materials for Guided Tissue Regeneration in Oral and Maxillofacial Surgery—Contents of a Technical FileRelevant guidance and Devices affected
4-146ISO 22674:2006 Dentistry—Metallic Materials for Fixed and Removable Restorations and AppliancesDevices affected and Processes impacted
E. General
5-712-185IEC 60601-1-3(1994-07) Medical Electrical Equipment—Part 1: General Requirements for Safety; General Requirements for Radiation Protection in Diagnostic X-Ray EquipmentTransferred
5-85-41IEC 60601-1-4:2000 Medical Electrical Equipment—Part 1-4: General Requirements for Safety—Collateral Standard: Programmable Electrical Medical Systems, Edition 1.1Withdrawn and replaced with newer version
5-165-42ASTM D903-98(2004) Standard Test Methods for Peel or Stripping Strength of Adhesive BondsWithdrawn and replaced with newer version
5-19ASTM E876/1995 Standard Practice for Use of Statistics in the Evaluation of Spectrometric DataWithdrawn
5-255-43ANSI/ESD S20.20-2007 Standard for the Development of an Electrostatic Discharge Control Program for Protection of Electrical and Electronic Parts, Assemblies and Equipment (Excluding Electrically Initiated Explosive Devices)Withdrawn and replaced with newer version
5-28IEC 60601-1-2, (Second Edition, 2001) Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and TestsExtent of recognition
5-30AAMI/ANSI/IEC 60601-1-2 Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements 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.)Type of standard and Extent of recognition
5-335-44IEC 60601-1-8:2006 Medical Electrical Equipment—Part 1-8: General 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 EditionWithdrawn and replaced with newer version
Start Printed Page 52365
5-34IEC 60601-1-2 Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004))Extent of recognition
5-35AAMI/ANSI/IEC 60601-1-2 Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral standard: Electromagnetic Compatibility—Requirements and Tests (Edition 2:2001 with Amendment 1:2004) (AAMI/ANSI/IEC 60601-1-2:2001 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)Type of standard and Extent of recognition
5-36ANSI/AAMI/ISO TIR 16142:2006: Technical Information Report: Medical Devices—Guidance on the Selection of Standards in Support of Recognized Essential Principles of Safety and Performance of Medical Devices, Second EditionCFR Citations, Product codes and Relevant guidance
F. General Hospital/General Plastic Surgery
6-16ISO 7886-1:1993 Sterile Hypodermic Syringes for Single Use—Part 1: Syringes for Manual UseWithdrawn
6-117ASTM F2172-02: Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid WarmersRelevant guidance
6-118ASTM F2196-02 Standard Specification for Circulating Liquid and Forced Air Patient Temperature Management DevicesRelevant guidance, Contact person
6-1316-203ASTM D6499-07 Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and Its ProductsWithdrawn and replaced with newer version
6-1606-204ISO 8537:2007 Sterile Single-Use Syringes, With or Without Needle, for InsulinWithdrawn and replaced with newer version
6-1666-215ASTM F2132-01(2008) Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other SharpsWithdrawn and replaced with newer version
6-167ASTM D6319-00a(2005) Standard Specification for Nitrile Examination Gloves for Medical ApplicationRelevant guidance
6-1886-205USP 31:2008 Nonabsorbable Surgical SutureWithdrawn and replaced with newer version
6-1896-206USP 31<11>2008 Sterile Sodium Chloride for IrrigationWithdrawn and replaced with newer version
6-1906-207USP 31:2008 Absorbable Surgical SutureWithdrawn and replaced with newer version
6-1916-208USP 31<881>:2008 Tensile StrengthWithdrawn and replaced with newer version
6-1926-209USP 31<861>:2008 Sutures—DiameterWithdrawn and replaced with newer version
6-1936-210USP 31<871>:2008 Sutures Needle AttachmentWithdrawn and replaced with newer version
6-1946-211USP 31<11>: 2008 Sterile Water for IrrigationWithdrawn and replaced with newer version
6-1956-212USP 31<11>: 2008 Heparin Lock Flush SolutionWithdrawn and replaced with newer version
Start Printed Page 52366
6-1966-213USP 31<11>: 2008 Sodium Chloride InjectionWithdrawn and replaced with newer version
6-198ASTM F2100-07 Standard Specification for Performance of Materials Used in Medical Face MasksRelevant guidance
6-201ISO 8536-4:2007 Infusion Equipment for Medical Use—Part 4: Infusion Sets for Single Use, Gravity FeedRelevant guidance
G. In Vitro Diagnostic
7-67-131CLSI ILA18-A2 Specifications for Immunological Testing for Infectious DiseasesWithdrawn and replaced with newer version
7-117-132CLSI MM03-A2 Molecular Diagnostic Methods for Infectious DiseasesWithdrawn and replaced with newer version
7-12CLSI/NCCLS C12-A Definitions of Quantities and Conventions Related to Blood pH and Gas Analysis; Approved Standard (1994)Withdrawn
7-13CLSI/NCCLS C21-A Performance Characteristics for Devices Measuring PO2 and PCO2 in Blood Samples; Approved Standard (1992)Withdrawn
7-15CLSI/NCCLS C25-A Fractional Oxyhemoglobin, Oxygen Content and Saturation, and Related Quantities in Blood: Terminology, Measurement, and Reporting; Approved Guideline (1997)Withdrawn
7-16CLSI/NCCLS C27-A Blood Gas Preanalytical Considerations: Specimen Collection, Calibration, and Controls; Approved Guideline (1993)Withdrawn
7-187-133CLSI C30-A2, Point-of Care Blood Glucose Testing in Acute and Chronic Care FacilitiesWithdrawn and replaced with newer version
7-21CLSI C42-A, Erythrocyte Protoporphyrin Testing; Approved Guideline (1996)Contact person
7-227-134CLSI GP20-A2 Fine-Needle Aspiration Biopsy (FNAB) TechniquesWithdrawn and replaced with newer versions
7-25NCCLS H8-A2 Detection of Abnormal Hemoglobin Using Cellulose Acetate Electrophoresis—Second Edition; Approved Standard (1994)Withdrawn
7-26NCCLS H9-A Chromatographic (Microcolumn) Determination of Hemoglobin A2; Approved Standard (1989)Withdrawn
7-27NCCLS H10-A2 Solubility Test to Confirm the Presence of Sickling Hemoglobins—Second Edition; Approved Standard (1995)Withdrawn
7-29NCCLS H14-A2 Devices for Collection of Skin Puncture Blood Specimens—Second Edition; Approved Guideline (1990)Withdrawn
7-347-135CLSI H44-A2 Methods for Reticulocyte Counting (Flow Cytometry and Supravital Dyes)Withdrawn and replaced with newer version
7-35CLSI H47-A One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline (1996)Contact person
7-367-136CLSI ILA02-A2 Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear AntigensWithdrawn and replaced with newer version
7-37CLSI ILA06-A Detection and Quantitation of Rubella IgG AntibodyContact person
Start Printed Page 52367
7-38CLSI/NCCLS I/LA10-A Choriogonadotropin Testing: Nomenclature, Reference Preparations, Assay Performance, and Clinical Application; Approved Guideline (1996)Withdrawn
7-39CLSI/NCCLS I/LA17-A Assessing the Quality of Systems for Alpha-Fetoprotein (AFP) Assays Used in Prenatal Screening and Diagnosis of Neural Tube Defects; Approved Guideline (1997)Withdrawn
7-40NCCLS I/LA18-A Specifications for Immunological Testing for Infectious Diseases; Approved Guideline (1994)Withdrawn
7-41CLSI ILA19-A Primary Reference Preparations Used to Standardize Calibration of Immunochemical Assays for Serum Prostate Specific Antigen (PSA); Approved Guideline (1997)Contact person
7-42CLSI ILA20-A Evaluation Methods and Analytical Performance Characteristics of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies of Defined Allergen Specificities; Approved Guideline (1997)Contact person
7-437-137CLSI LA04-A5 Blood Collection on Filter Paper for Newborn Screening ProgramsWithdrawn and replaced with newer version
7-467-138CLSI M27-A2, Reference Method for Broth Dilution Antifungal Susceptibility Testing of YeastsWithdrawn and replaced with newer version
7-49CLSI H26-A Performance Goals for the Internal Quality Control of Multichannel Hematology Analyzers; Approved StandardContact person
7-50NCCLS D11-A2 Glossary and Guidance for Immunodiagnostic Procedures, Reagents, and Reference Materials—Second Edition, Approved GuidelineWithdrawn
7-517-139CLSI GP27-A2 Using Proficiency Testing to Improve the Clinical LaboratoryWithdrawn and replaced with newer version
7-52CLSI / NCCLS NRSCL 8-A Terminology and Definitions for use in NCCLS Documents; Approved StandardWithdrawn
7-537-140CLSI GP22-A2 Continuous Quality ImprovementWithdrawn and replaced with newer version
7-557-141CLSI H18-A3 Procedures for the Handling and Processing of Blood SpecimensWithdrawn and replaced with newer version
7-587-142CLSI H11-A4 Procedures for the Collection of Arterial Blood SpecimensWithdrawn and replaced with newer version
7-5913-9CLSI / NCCLS AUTO2-A Laboratory Automation: Bar Codes for Specimen Container Identification; Approved StandardTransferred
7-6013-10NCCLS AUTO1-A Laboratory Automation: Specimen Container/Specimen Carrier; Approved StandardTransferred
7-6113-11NCCLS AUTO3-A Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved StandardTransferred
7-6213-12NCCLS AUTO4-A Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved StandardTransferred
7-6313-13NCCLS AUTO5-A Laboratory Automation: Electromechanical Interfaces; Approved StandardTransferred
7-6413-14NCCLS POCT1-A Point-of-Care Connectivity; Approved StandardTransferred
Start Printed Page 52368
7-677-143CLSI EP14-A2 Evaluation of Matrix EffectsWithdrawn and replaced with newer version
7-6813-15NCCLS GP19-A2 Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline—Second EditionTransferred
7-707-144CLSI H4-A5 Procedures and Devices for the Collection of Diagnostic Blood Specimens by Skin PunctureWithdrawn and replaced with newer version
7-727-145CLSI H42-A2 Enumeration of Immunologically Defined Cell Populations by Flow CytometryWithdrawn and replaced with newer version
7-747-146NCCLS M6-A2 Protocols for Evaluating Dehydrated Mueller-Hinton AgarWithdrawn and replaced with newer version
7-777-147CLSI M22-A3 Quality Control for Commercially Prepared Microbiological Culture MediaWithdrawn and replaced with newer version
7-797-148CLSI M28-A2 Procedures for the Recovery and Identification of Parasites From the Intestinal TractWithdrawn and replaced with newer version
7-80CLSI MM01-A2 Molecular Diagnostic Methods for Genetic DiseasesWithdrawn
7-83NCCLS C46-A Blood Gas and pH Analysis and Related Measurements; Approved GuidelineWithdrawn
7-857-149CLSI C24-A3 Statistical Quality Control for Quantitative Measurement ProceduresWithdrawn and replaced with newer version
7-907-150CLSI H43-A2 Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid CellsWithdrawn and replaced with newer version
7-93NCCLS EP10-A2, Preliminary Evaluation of Quantitative Clinical Laboratory Methods; Approved GuidelineWithdrawn
7-947-152CLSI EP12-A2 User Protocol for Evaluation of Qualitative Test PerformanceWithdrawn and replaced with newer version
7-957-153CLSI EP15-A2 User Verification of Performance for Precision and TruenessWithdrawn and replaced with newer version
7-987-154CLSI MM02-A2 Immunoglobin and T-Cell Receptor Gene Rearrangement AssaysWithdrawn and replaced with newer version
7-99CLSI MM5-A Nucleic Acid Amplification Assays for Molecular HematopathologyContact person
7-1037-155CLSI H03-A6 Procedures for the Collection of Diagnostic Blood Specimens by VenipuntureWithdrawn and replaced with newer version
7-1067-156CLSI M02-A9 Performance Standards for Antimicrobial Disk Susceptibility TestsWithdrawn and replaced with newer version
7-1077-157CLSI M11-A7 Methods for Antimicrobial Susceptibility Testing of Anaerobic BacteriaWithdrawn and replaced with newer version
7-1087-158CLSI M7-A7 Methods for Antimicrobial Susceptibility Tests of Anaerobic BacteriaWithdrawn and replaced with newer version
7-109CLSI AUTO7-A Laboratory Automation: Data Content for Specimen Identification; Approved StandardWithdrawn
7-1117-159CLSI H21-A5 Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis AssaysWithdrawn and replaced with newer version
Start Printed Page 52369
7-11413-16CLSI LIS01-A Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer SystemsTransferred
7-11513-17CLSI LIS02-A2 Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard-Second EditionTransferred
7-11613-18CLSI LIS03-A Standard Guide for Selection of a Clinical Laboratory Information Management SystemTransferred
7-11713-19CLSI LIS04-A Standard Guide for Documentation of Clinical Laboratory Computer SystemsTransferred
7-11813-20CLSI LIS05-A, Standard Specification for Transferring Clinical Observations Between Independent Computer SystemsTransferred
7-11913-21CLSI LIS06-A Standard Practice for Reporting Reliability of Clinical Laboratory Information SystemsTransferred
7-12013-22CLSI LIS07-A Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical LaboratoryTransferred
7-12113-23CLSI LIS08-A Standard Guide for Functional Requirements of Clinical Laboratory Information Management SystemsTransferred
7-12213-24CLSI LIS09-A Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked ArchitecturesTransferred
7-125CLSI/NCCLS M28-A2 Volume 25, No. 16 Procedures for the Recovery and Identification of Parasites From the Intestinal Tract; Approved GuidelineWithdrawn
H. Materials
8-32ASTM F1586-02: Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-10 Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675)Contact person
8-44ASTM F0136-02a: Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)Contact person
8-468-154ASTM F0621-08: Standard Specification for Stainless Steel Forgings for Surgical ImplantsWithdrawn and replaced with newer year version
8-50ASTM F1091-02: Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R30605)Contact person
8-52ASTM F1350-02: Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)Contact person
8-53ASTM F1472-02a: Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy for Surgical Implant Applications (UNS R56400)Contact person
8-548-155ASTM F1580-07 Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical ImplantsWithdrawn and replaced with newer year version
8-57ISO 5832-2:1999, Implants for Surgery—Metallic Materials—Part 2: Unalloyed TitaniumContact person
8-58ISO 5832-3:1996, Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminium 4-Vanadium AlloyContact person
Start Printed Page 52370
8-59ISO 5832-4:1996, Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting AlloyContact person
8-61ISO 5832-6:1997, Implants for Surgery—Metallic Materials—Part 6: Wrought Cobalt-Nickel-Chromium-Molybdenum AlloyContact person
8-63ISO 5832-11:1994, Implants for Surgery—Metallic Materials—Part 11: Wrought Titanium 6-Aluminium 7-Niobium AlloyContact person
8-76ASTM F138-03: Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)Contact person
8-778-156ASTM F0139-08, Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)Withdrawn and replaced with newer year version
8-79ASTM F0961-03, Standard Specification for Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants [UNS R30035]Contact person
8-81ASTM F1609-03 Standard Specification for Calcium Phosphate Coatings for Implantable MaterialsContact person
11-818-157ISO 9583:1993 Implants for Surgery—Non-Destructive Testing—Liquid Penetrant Inspection of Metallic Surgical ImplantsTransferred
8-828-158ASTM F1713-08 Standard Specification for Wrought Titanium-13 Niobium-13 Zirconium Alloy for Surgical Implant Applications (UNS R58130)Withdrawn and replaced with newer year version
11-828-159ISO 9584:1993 Implants for Surgery—Non-Destructive Testing—Radiographic Examination of Cast Metallic Surgical ImplantsTransferred
8-86ASTM F1926-03 Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate CoatingsRelevant guidance
8-88ASTM F2024-00 Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite CoatingsRelevant guidance
8-988-162ASTM F451-99a(2007)e1 Standard Specification for Acrylic Bone CementWithdrawn and replaced with newer year version
8-104ASTM F1108-04 Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)Contact person
8-108ASTM F1295-05 Standard Specification for Wrought Titanium-6 Aluminum-7 Niobium Alloy for Surgical Implant Applications (UNS R56700)Contact person
8-110ASTM F1377-04 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)Contact person
8-112ASTM F1044-05 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic CoatingsRelevant guidance
8-113ASTM F1147-05 Standard Test Method for Tension Testing of Calcium Phosphate and Metal CoatingsRelevant guidance
8-119ASTM F688-05 Standard Specification for Wrought Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)Contact person
Start Printed Page 52371
8-1208-160ASTM F0560-07 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)Withdrawn and replaced with newer year version
8-123ISO 5832-5:2005 Implants for Surgery—Metallic Materials—Part 5: Wrought Cobalt-Chromium-Tungsten-Nickel AlloyContact person
8-127ISO 5834-2:2006 Implants for Surgery—Ultra-high-molecular-weight polyethylene—Part 2: Moulded FormsRelevant guidance
8-129ASTM F67-06 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)Contact person
8-130ASTM F620-06 Standard Specification for Alpha Plus Beta Titanium Alloy Forgings for Surgical ImplantsContact person
8-131ASTM F799-06 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)Contact person
8-132ASTM F1088-04ae1 Standard Specification for Beta-Tricalcium Phosphate for Surgical ImplantationContact person
8-137ASTM F0075-07 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)Contact person
8-138ASTM F0745-07 Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant ApplicationsContact person
8-139ASTM F1314-07 Standard Specification for Wrought Nitrogen Strengthened 22 Chromium - 13 Nickel - 5 Manganese - 2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)Contact person
8-142ASTM F1978-00(2007)e2 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber AbraserRelevant guidance
8-144ASTM F0754-00 Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Polymer Fabricated in Sheet, Tube and Rod ShapesContact person
8-145ASTM F0090-07 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)Contact person
8-147ASTM F0562-07 Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)Contact person
8-149ISO 5832-1:2007 Implants for Surgery—Metallic Materials—Part 1: Wrought Stainless SteelContact person
8-150ISO 5832-9:2007 Implants for Surgery—Metallic Materials—Part 9: Wrought High Nitrogen Stainless SteelContact person
8-151ISO 5832-12:2007 Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum AlloyContact person
8-152ASTM F1537-07 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)Contact person
I. OB-GYN/Gastroenterology
Start Printed Page 52372
9-4IEC 60601-2-16 (1998) Medical Electrical Equipment—Part 2-16: Particular Requirements for the Safety of Haemodialysis, Haemodiafiltration and Haemofiltration EquipmentRelevant guidance and Contact person
9-6IEC 60601-2-36 (1997) Medical Electrical Equipment—Part 2-36: Particular Requirements for the Safety of Equipment for Extracorporeally Induced LithotripsyTitle, Relevant guidance, CFR Citation, and Product Codes
9-7IEC 61846 (1998) Ultrasonics—Pressure Pulse Lithotripters—Characteristics of FieldsRelevant guidance, CFR Citation, and Product Codes
9-21ISO 8600-4:1997 Optics and Optical Instruments—Medical Endoscopes and Certain Accessories—Part 4: Determination of Maximum Width of Insertion PortionRelevant guidance
9-23ASTM F1518-00 Standard Practice for Cleaning and Disinfection of Flexible Fiberoptic and Video Endoscopes Used in the Examination of the Hollow VisceraRelevant guidance, CDRH Office and Division associated with recognized standard
9-25AAMI / ANSI HF18:2001 Electrosurgical DevicesWithdrawn
9-289-47ANSI/AAMI RD16:2007 Cardiovascular Implants and Artificial Organs—Hemodialyzers, Hemodiafilters, Hemofilters, and HemoconcentratorsWithdrawn and replaced with newer version
9-299-48AAMI / ANSI RD17 :2007 Cardiovascular Implants and artificial organs—Extracorporeal Blood Circuit for Hemodialyzers, Hemodiafilters, and HemofiltersWithdrawn and replaced with newer version
9-32ASTM D3492-03 Standard Specification for Rubber Contraceptives (Male Condoms)Relevant guidance
9-34ISO 4074:2002/Cor.1:2003(E) Natural Latex Rubber Condoms—Requirements and Test Methods, Technical Corrigendum 1Relevant guidance
9-37ISO 8600-1:2005 Optics and Photonics—Medical Endoscopes and Endotherapy Devices—Part 1: General Requirements ISO 8600-1:2005Relevant guidance
9-38ISO 8600-3:1997 Amendment 1 2003, Optics and Optical Instruments—Medical Endoscopes and Endoscopic Accessories Part 3: Determination of Field of View and Direction of View of Endoscopes with OpticsRelevant guidance
9-39ISO 8600-5:2005 Optics and Photonics—Medical Endoscopes and Endotherapy Devices—Part 5: Determination of Optical Resolution of Rigid Endoscopes with OpticsRelevant guidance
9-40ISO 8600-6:2005 Optics and Photonics—Medical Endoscopes and Endotherapy Devices—Part 6: VocabularyRelevant guidance
9-41ASTM D6324-05 Standard Test Methods for Male Condoms Made from Synthetic MaterialsRelevant guidance
9-42IEC 60601-2-18 (1996) Amendment 1 2000 Medical electrical equipment—Part 2: Particular Requirements for the Safety of Endoscopic EquipmentRelevant guidance
9-43ISO 16038:2005 Rubber Condoms—Guidance on the Use of ISO 4074 in the Quality Management of Natural Rubber Latex CondomsRelevant guidance
J. Ophthalmic
10-21ISO 11979-2:1999 Ophthalmic Implants—Intraocular Lenses—Part 2: Optical Properties and Test MethodsWithdrawn
Start Printed Page 52373
10-23ISO 11981:1999 Ophthalmic Optics—Contact Lenses and Contact Lens Care Products—Determination of Physical Compatibility of Contact Lens Care Products With Contact LensesWithdrawn
10-42ISO 11979-2:1999/Corrigendum1:2003 Ophthalmic Implants—Intraocular Lenses—Part 2: Optical Properties and Test MethodsExtent of recognition and Process impacted
10-44ISO 11981:1999/Corrigendum1:2005 Ophthalmic Optics—Contact Lenses and Contact Lens Car Products—Determination of Physical Compatibility of Contact Lens Care Products with Contact LensesRelevant guidance and Process impacted
K. Orthopedic
11-73ISO 5838-1:1995 Implants for Surgery—Skeletal Pins and Wires—Part 1: Material and Mechanical RequirementsType of standard and Contact person
11-74ISO 5838-2:1991 Implants for Surgery—Skeletal Pins and Wires—Part 2: Steinmann Skeletal Pins—DimensionsType of standard and Contact person
11-75ISO 5838-3:1993 Implants for Surgery—Skeletal Pins and Wires—Part 3: Kirschner Skeletal WiresType of standard and Contact person
11-79ISO 7206-8:1995 Implants for Surgery—Partial and Total Hip Joint Prostheses—Part 8: Endurance Performance of Stemmed Femoral Components with Application of TorsionType of standard, CFR Citation, Product codes and Relevant guidance
11-80ISO 8828:1988 Implants for Surgery—Guidance on Care and Handling of Orthopaedic ImplantsContact person Processes Impacted
11-818-157ISO 9583:1993 Implants for Surgery—Non-Destructive Testing—Liquid Penetrant Inspection of Metallic Surgical ImplantsTransferred
11-828-159ISO 9584:1993 Implants for Surgery—Non-Destructive Testing—Radiographic Examination of Cast Metallic Surgical ImplantsTransferred
11-155ISO 7207-2:1998 Implants for Surgery—Components for Partial and Total Knee Joint Prostheses—Part 2: Articulating Surfaces Made of Metal, Ceramic and Plastics MaterialsType of standard and Relevant guidance
11-16411-203ASTM F1541-02(2007) Standard Specification and Test Methods for External Skeletal Fixation DevicesWithdrawn and replaced with newer version
11-16611-204ASTM F0897-02(2007) Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and ScrewsWithdrawn and replaced with newer version
11-168ASTM F1781-03 Standard Specification for Elastomeric Flexible Hinge Finger Total Joint ImplantsType of standard
11-171ASTM F1814-97a(2003) Standard Guide for Evaluating Modular Hip and Knee Joint ComponentsType of standard and Relevant guidance
11-172ASTM F1798-97(2003) Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis ImplantsType of standard and Relevant guidance
11-175ASTM F1582-98(2003) Standard Terminology Relating to Spinal ImplantsType of standard, CFR Citation, Product codes and Relevant guidance
11-17711-205ASTM F1264-03(2007) Standard Specification and Test Methods for Intramedullary Fixation DevicesWithdrawn and replaced with newer version
Start Printed Page 52374
11-178ASTM F1440-92(2002) Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components Without TorsionProcesses impacted, Type of standard, CFR Citation, Product codes and Relevant guidance
11-179ASTM F2068-03 Standard Specification for Femoral Prostheses—Metallic ImplantsProcesses impacted, Type of standard, CFR Citation, Product codes and Relevant guidance
11-180ASTM F0366-04 Standard Specification for Fixation Pins and WiresType of standard and Contact person
11-181ASTM F1717-04 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy ModelType of standard and Relevant guidance
11-18211-206ASTM F1800-07 Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint ReplacementsWithdrawn and replaced with newer version
11-183ASTM F1875-98(2004) Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper InterfaceType of standard, CFR Citations, Product codes and Relevant guidance
11-184ISO 8827:1988 Implants for surgery—Staples with Parallel Legs for Orthopaedic Use—General RequirementsType of standard and Contact person
11-185ASTM F2267-04 Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial CompressionCFR Citations, Product codes and Relevant guidance
11-186ASTM F2077-03 Test Methods for Intervertebral Body Fusion DevicesType of standard, CFR Citations, Product codes and Relevant guidance
11-18711-207ASTM F2193-02(2007) Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal SystemWithdrawn and replaced with newer version
11-188ISO 14243-1:2002 Implants for Surgery—Wear of Total Knee-Joint Prostheses—Part 1: Loading and Displacement Parameters for Wear-Testing Machines With Load Control and Corresponding Environmental Conditions for TestType of standard, CFR Citations and Product codes
11-189ISO 14243-2:2000 Implants for Surgery—Wear of Total Knee-Joint Prostheses—Part 2: Methods of MeasurementType of standard, Extent of recognition, CFR Citations and Product codes
11-190ISO 14243-3:2004 Implants for Surgery—Wear of Total Knee-Joint Prostheses—Part 3: Loading and Displacement Parameters for Wear-Testing Machines With Displacement Control and Corresponding Environmental Conditions for TestType of standard, CFR Citations and Product codes
11-191ISO 14879-1:2000 Implants for Surgery—Total Knee-Joint Prostheses—Part 1: Determination of Endurance Properties of Knee Tibial TraysType of standard
11-192ASTM F1223-05 Standard Test Method for Determination of Total Knee Replacement ConstraintType of standard CFR Citations and Product codes
11-19411-208ISO 14630:2008 Non-Active Surgical Implants—General Requirements—3d EditionWithdrawn and replaced with newer version
11-195ASTM F1612-95(2005) Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components with TorsionType of standard, CFR Citations, Product codes and Relevant guidance
11-196ASTM F1672-95(2005) Standard Specification for Resurfacing Patellar ProsthesisType of standard and Relevant guidance
Start Printed Page 52375
11-197ASTM F0983-86(2005) Standard Practice for Permanent Marking of Orthopaedic Implant ComponentsContact person and Processes impacted
11-198ASTM F0382-99(2003)e1 Standard Specification and Test Method for Metallic Bone PlatesType of standard and Contact person
11-199ASTM F0565-04 Standard Practice for Care and Handling of Orthopedic Implants and InstrumentsContact person and Processes impacted
11-20011-209ASTM F2083-07 Standard Specification for Total Knee ProsthesisWithdrawn and replaced with newer version
11-201ASTM F0564-02(2006) Standard Specification and Test Methods for Metallic Bone StaplesContact person
11-20211-210ASTM F0543-07 Standard Specification and Test Methods for Metallic Medical Bone ScrewsWithdrawn and replaced with newer version
L. Physical Medicine
16-19ISO 7176-4:1997 Wheelchairs—Part 4: Energy Consumption of Electric Wheelchairs and Scooters for Determination of Theoretical Distance RangeContact person and Type of standard
16-20ISO 7176-5:1986 Wheelchairs—Part 5: Determination of Overall Dimensions, Mass and Turning SpaceContact person and Type of standard
16-23ISO 7176-10:1988 Wheelchairs—Part 10: Determination of Obstacle-Climbing Ability of Electric WheelchairsContact person and Type of standard
16-24ISO 7176-11:1992 Wheelchairs—Part 11: Test DummiesContact person and Type of standard
16-25ISO 7176-13:1989 Wheelchairs—Part 13: Determination of Coefficient of Friction of Test SurfacesContact person and Type of standard
16-26ISO 7176-14:1997 Wheelchairs—Part 14: Power and Control Systems for Electric Wheelchairs—Requirements and Test MethodsContact person and Type of standard
16-27ISO 7176-15:1996 Wheelchairs—Part 15: Requirements for Information Disclosure, Documentation and LabelingContact person and Type of standard
16-28ISO 7176-16: 1997 Wheelchairs—Part 16: Resistance to Ignition of Upholstered Parts—Requirements and Test MethodsContact person and Type of standard
16-29ISO 7176-6:2001 Wheelchairs—Part 6: Determination of Maximum Speed, Acceleration and Deceleration of Electric WheelchairsContact person and Type of standard
16-30ISO 7176-9:2001 Wheelchairs—Part 9: Climatic Tests for Electric WheelchairsContact person and Type of standard
16-31ANSI/RESNA WC/Volume 1-1998 Section 1: Determination of Static StabilityContact person and Type of standard
16-32ANSI/RESNA WC/Volume 2-1998 Section 2: Determination of Dynamic Stability of Electric WheelchairsContact person and Type of standard
16-33ANSI/RESNA WC/Volume 2-1998 Section 3: Test Methods and Requirements for the Effectiveness of BrakesContact person and Type of standard
16-34ANSI/RESNA WC/Volume 2-1998 Section 4: Determination of Energy Consumption of Electric WheelchairsContact person and Type of standard
16-35ANSI/RESNA WC/Volume 1-1998 Section 5: Determination of Overall Dimensions, Mass, and Turning Space—WheelchairContact person and Type of standard
Start Printed Page 52376
16-36ANSI/RESNA WC/Volume 2-1998 Section 6: Determination of Maximum Speed, Acceleration, and Retardation of Electric WheelchairsContact person and Type of standard
16-37ANSI/RESNA WC/Volume 1-1998 Section 7: Wheelchairs - Determination of Seating and Wheel DimensionsContact person and Type of standard
16-38ANSI/RESNA WC/Volume 1-1998 Section 8: Wheelchairs—Static, Impact and Fatigue Strength TestsContact person and Type of standard
16-39ANSI/RESNA WC/Volume 2 - 1998 Section 9: Climatic Tests for Electric WheelchairsContact person and Type of standard
16-40ANSI/RESNA WC/Volume 2 - 1998 Section 10: Determination of the Obstacle-Climbing Ability of Electric WheelchairsContact person and Type of standard
16-41ANSI/RESNA WC/Volume 1 - 1998 Section 11: Wheelchairs—Test DummiesContact person and Type of standard
16-42ANSI/RESNA WC/Volume 1 - 1998 Section 13: Determination of Coefficient of Friction of Test SurfacesContact person and Type of standard
16-43ANSI/RESNA WC/Volume 2 - 1998 Section 14: Wheelchairs—Testing of Power and Control Systems for Electric WheelchairsContact person and Type of standard
16-44ANSI/RESNA WC/Volume 1 - 1998 Section 15: Wheelchairs—Requirements for Information Disclosures, Documentation and LabelingContact person and Type of standard
16-45ANSI/RESNA WC/Volume 1 - 1998 Section 16: Wheelchairs—Determination of FlammabilityTitle change, Contact person and Type of standard
16-46ANSI/RESNA WC/Volume 1 - 1998 Section 20: Wheelchairs—Determination of the Performance of Stand-Up WheelchairsContact person and Type of standard
16-47ANSI/RESNA WC/Volume 1 - 1998 Section 22: Wheelchairs—Set Up ProceduresContact person and Type of standard
16-48ANSI/RESNA WC/Volume 1 - 1998 Section 93: Maximum Overall DimensionsContact person and Type of standard
16-49ANSI/RESNA WC/Volume 1 - 1998 Section 0: Nomenclature, Terms, and DefinitionsContact person and Type of standard
16-50ISO 7176-3:2003 Wheelchairs—Part 3: Determination of Effectiveness of BrakesContact person and Type of standard
16-158ISO 7176-1:1999 Wheelchairs—Part 1: Determination of Static StabilityContact person and Type of standard
16-159ISO 7176-2:2001 Wheelchairs—Part 2: Determination of Dynamic Stability of Electric WheelchairsContact person and Type of standard
M. Radiology
12-17NEMA MS 8-1993 (2000), Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging SystemsRelevant guidance and Contact person
12-6112-177UL 122 (2007): Standard for Photographic Equipment—Ed. 5.0Withdrawn and replaced with newer version
12-6412-178IEC 60601-2-45 Ed. 2.0, (2006) Medical Electrical Equipment—Part 2-45: Particular Requirements for the Safety of Mammographic X-ray Equipment and Mammographic Stereotactic DevicesWithdrawn and replaced with newer version
Start Printed Page 52377
12-69NEMA MS 6-1991 (R2000) Characterization of Special Purpose Coils for Diagnostic Magnetic Resonance ImagesRelevant guidance, Contact person and CFR Citations
12-95NEMA MS 2-2003 Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance ImagesRelevant guidance and Contact person
12-96NEMA MS 3-2003 Determination of Image Uniformity in Diagnostic Magnetic Resonance ImagesRelevant guidance and Contact person
12-97NEMA MS-1-2001 Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance ImagingRelevant guidance, Contact person and CFR Citations
12-10312-179ANSI / IESNA RP-27.3-2007 Recommended Practice for Photobiological Safety for Lamps—Risk Group Classification and LabelingWithdrawn and replaced with newer version
12-120IEC 60601-2-44 (2002-11): Medical Electrical Equipment—Part 2-44: Particular Requirements for the Safety of X-ray Equipment for Computed Tomography—Ed. 2.1Relevant guidance and CFR Citations
12-12312-180IEC 61689:2007 Ultrasonics—Physiotherapy Systems—Field Specifications and Methods of Measurement in the Frequency Range 0,5 MHz to 5 MHz Ed. 2.0Withdrawn and replaced with newer version
12-125NEMA MS 5-2003 Determination of Slice Thickness in Diagnostic Magnetic Resonance ImagingRelevant guidance and Contact person
12-12912-181NU 1-2007 Performance Measurements of Gamma CamerasWithdrawn and replaced with newer version
12-13112-184IEC 61217 2002 Consolidated Ed. 1.1, 2007 Amendment 2 Ed. 1.0 Radiotherapy Equipment—Coordinates, Movements, and ScalesWithdrawn and replaced with newer version
12-150IEC / ISO 10918-1:1994 Technical Corrigendum 1:2005 Information Technology—Digital Compression and Coding of Continuous-Tone Still Images—Part 1: RequirementsRelevant guidance, Contact person, CFR Citations, Product code, and Devices affected
12-151NEMA MS 4 (2006) Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging DevicesRelevant guidance, Contact person and CFR Citations
12-158NEMA MS 10-2006 Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance ImagingRelevant guidance, Contact person and CFR Citations
12-159NEMA MS 11-2006 Determination of Gradient-Induced Electric Fields in Diagnostic Magnetic Resonance ImagingRelevant guidance, Contact person and CFR Citations
12-160NEMA MS 12-2006 Quantification and Mapping of Geometric Distortion for Special ApplicationsRelevant guidance, Contact person and CFR Citations
12-161IEC 60601-2-33 (2006), Medical Electrical Equipment—Part 2-33: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical DiagnosisRelevant guidance and Contact person
12-16412-182IEC 60601-2-37:2007 Medical Electrical Equipment—Part 2-37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring EquipmentWithdrawn and replaced with newer version
12-165NEMA XR 22-2006 “Quality Control Manual” Template for Manufacturers of Displays and Workstations Labeled for Final Interpretation in Full-Field Digital MammographyRelevant guidance
12-166NEMA XR 23-2006 “Quality Control Manual” Template for Manufacturers of Hardcopy Output Devices Labeled for Final Interpretation in Full-Field Digital MammographyRelevant guidance
12-168IEC 60825-1 Ed. 2.0 (2007) Safety of Laser Products—Part 1: Equipment Classification, and RequirementsContact person and Processes impacted
Start Printed Page 52378
12-169IEC 60601-2-22 Ed. 3.0 (2007) Medical Electrical Equipment—Part 2-22: Particular Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser EquipmentContact person, Processes impacted and Title
12-17012-183NEMA PS 3.1 - 3.18 (2008) Digital Imaging and Communications in Medicine (DICOM) SetWithdrawn and replaced with newer versions
5-712-185IEC 60601-1-3 2008 Edition 2.0 Medical Electrical Equipment—Part 1-3:General Requirements for Basic Safety and Essential Performance—Collateral Standard: Radiation Protection in Diagnostic X-ray EquipmentTransferred
N. Software/Informatics
13-4ANSI/UL 1998, Software in Programmable ComponentsCFR Citations, Product codes, Relevant guidance and Extent of recognition
13-5IEEE 1074:1997, Standard for Developing Software Life Cycle ProcessesWithdrawn
13-8IEC 62304 Ed. 1.0, Medical Device Software—Software Life Cycle ProcessesCFR Citations, Product codes, Relevant guidance, and Extent of recognition
7-5913-9CLSI AUTO2-A2 Laboratory Automation: Bar Codes for Specimen Container Identification; Approved StandardTransferred
7-6013-10CLSI AUTO1-A Laboratory Automation: Specimen Container/Specimen Carrier; Approved StandardTransferred
7-6113-11CLSI AUTO3-A Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved StandardTransferred
7-6213-12CLSI AUTO4-A Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved StandardTransferred
7-6313-13CLSI AUTO5-A Laboratory Automation: Electromechanical Interfaces; Approved StandardTransferred
7-6413-14CLSI POCT1-A2 Point-of-Care Connectivity; Approved StandardTransferred
7-6813-15CLSI GP19-A2 Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline—Second EditionTransferred
7-11413-16CLSI LIS01-A Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer SystemsTransferred
7-11513-17CLSI LIS02-A2 Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard-Second EditionTransferred
7-11613-18CLSI LIS03-A Standard Guide for Selection of a Clinical Laboratory Information Management SystemTransferred
7-11713-19CLSI LIS04-A Standard Guide for Documentation of Clinical Laboratory Computer SystemsTransferred
7-11813-20CLSI LIS05-A Standard Specification for Transferring Clinical Observations Between Independent Computer SystemsTransferred
7-11913-21CLSI LIS06-A Standard Practice for Reporting Reliability of Clinical Laboratory Information SystemsTransferred
Start Printed Page 52379
7-12013-22CLSI LIS07-A Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical LaboratoryTransferred
7-12113-23CLSI LIS08-A Standard Guide for Functional Requirements of Clinical Laboratory Information Management SystemsTransferred
7-12213-24CLSI LIS09-A Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked ArchitecturesTransferred
O. Sterility
14-24AAMI/ANSI/ISO 11134:1993 Sterilization of Health Care Products—Requirements for Validation and Routine Control-Industrial Moist Heat SterilizationWithdrawn
14-53AAMI/ANSI ST66:1996 Sterilization of Health Care Products—Chemical Indicators—Part 2: Indicators for Air Removal Test Sheets and PacksWithdrawn
14-54AAMI/ANSI/ISO 11737-2:1998 Sterilization of Medical Devices—Microbiological Methods—Part 2: Tests of Sterility Performed in the Validation of a Sterilization ProcessCFR Citations, Product codes and Devices affected
14-55AAMI/ANSI/ISO 14160:1998 Sterilization of Single-Use Medical Devices Incorporating Materials of Animal Origin—Validation and Routine Control of Sterilization by Liquid Chemical SterilantsRelevant guidance
14-60ASTM F1327:1998 Standard Terminology Relating to Barrier Materials for Medical PackagingWithdrawn
14-63ASTM F1886: 1998 (2004) Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual InspectionCFR Citations and Product codes
14-64ASTM F1929:1998 (2004) Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye PenetrationCFR Citations and Product codes
14-70AAMI/ANSI/ISO 14161:2000 Sterilization of Health Care Products—Biological Indicators—Guidance for the Selection, Use and Interpretation of Results, 2ed.CFR Citations, Product codes and Devices affected
14-76AAMI/ANSI/ISO 10993-7:1995 (R) 2001 Biological Evaluation of Medical Devices—Part 7: Ethylene Oxide Sterilization ResidualsCFR Citations, Product codes and Contact person
14-88AAMI/ANSI/ISO 14937:2000 Sterilization of Health Care Products—General Requirements for Characterization of a Sterilizing Agent and the Development, Validation, and Routine Control of a Sterilization Process for Medical DevicesCFR Citations and Product codes
14-9014-256ASTM F2095-07 Standard Test Methods for Pressure Decay Leak Test for Nonporous Flexible Packages With and Without Restraining PlatesWithdrawn and replaced with newer version
14-116AAMI ST72:2002 Bacterial endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch TestingCFR Citations, Product codes, Type of standard, Guidance and Extent of recognition
14-120ASTM D3078:2002 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble EmissionCFR Citations, Product codes and Type of standard
14-123ASTM F2096-04 Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)CFR Citations, Product codes, CDRH Office and Division associated with recognized standard
Start Printed Page 52380
14-135AAMI/ANSI ST63:2002 Sterilization of Health Care Products—Requirements for the Development, Validation and Routine Control of an Industrial Sterilization Process for Medical Devices—Dry HeatCFR Citations, Product codes and Type of standard
14-136AAMI/ANSI ST67:2003 Sterilization of Health Care Products—Requirements for Products Labeled 'Sterile' 1st EditionCFR Citations, Product codes and Guidance
14-138ISO 13408-2:2003 Aseptic Processing of Health Care Products—Part 2: FiltrationCFR Citations, Product codes, Type of standard and Guidance
14-139ISO 14644-1:1999 Cleanrooms and Associated Controlled Environments—Part 1: Classification of Air CleanlinessCFR Citations, Product codes and Type of standard
14-140ISO 14644-2:2000 Cleanrooms and Associated Controlled Environments—Part 2: Specification for Testing and Monitoring to Prove Continued Compliance With ISO 14644-1CFR Citations, Product codes and Type of standard
14-141ISO 14644-4:2001 Cleanrooms and Associated Controlled Environments—Part 4: Design, Construction and StartupCFR Citations, Product codes and Type of standard
14-142ISO 14698-1:2003 Cleanrooms and Associated Controlled Environments—Biocontamination Control—Part 1: General Principles and MethodsCFR Citations, Product codes and Type of standard
14-143ISO 14698-2:2003 Cleanrooms and Associated Controlled Environments—Biocontamination Control—Part 2: Evaluation and Interpretation of Biocontamination DataCFR Citations, Product codes and Type of standard
14-148ASTM F2250-03 Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging MaterialsCFR Citations, Product codes and Type of standard
14-149ASTM F2251-03e1 Standard Test Method for Thickness Measurement of Flexible Packaging MaterialCFR Citations, Product codes and Type of standard
14-150ASTM F2252-03 Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using TapeCFR Citations, Product codes and Type of standard
14-164AAMI/ANSI ST81:2004 Sterilization of Medical Devices—Information to be Provided by the Manufacturer for the Processing of Resterilizable DevicesCFR Citations, Product codes, and Devices affected
14-165ISO 14644-5:2004 Cleanrooms and Associated Controlled Environments—Part 5: OperationsCFR Citations, Product codes and Type of standard
14-166ISO 14644-7:2004 Cleanrooms and Associated Controlled Environments—Part 7: Separative Devices (Clean Air Hoods, Gloveboxes, Isolators and Mini-Environments)CFR Citations, Product codes and Type of standard
14-16814-245ASTM F2338-07 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay MethodWithdrawn and replaced with newer version
14-169ASTM F2391-05 Standard Test Method for Measuring Package and Seal Integrity Using Helium as Tracer GasCFR Citations, Product codes and Type of standard
14-170ASTM F2475-05 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging MaterialsCFR Citations, Product codes and Type of standard
14-191ISO 13408-4:2005 Aseptic Processing of Health care Products—Part 4: Clean-in-Place TechnologiesCFR Citations, Product codes, Type of standard and Relevant guidance
14-193AAMI/ANSI/ISO 11607-1:2006 Packaging for terminally Sterilized Medical Devices—Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems, 3d ed.CFR Citations, Product codes, Devices affected and Relevant guidance
Start Printed Page 52381
14-194AAMI/ANSI/ISO 11607-2:2006 Packaging for Terminally Sterilized Medical Devices—Part 2: Validation Requirements for Forming, Sealing and Assembly Processes, 1st ed.CFR Citations, Product codes, Devices affected and Relevant guidance
14-197ASTM F1608:00(2004) Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)CFR Citations and Product codes
14-199ASTM D4169-05 Standard Practice for Performance Testing of Shipping Containers and SystemsRelated CFR Citations and Product codes
14-20214-246USP 31:2008 Biological Indicator for Dry-Heat Sterilization, Paper CarrierWithdrawn and replaced with newer version
14-20314-247USP 31:2008 Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier.Withdrawn and replaced with newer version
14-20414-248USP 31:2008 Biological Indicator for Steam Sterilization, Paper CarrierWithdrawn and replaced with newer version
14-20514-249USP 31:2008 <61> Microbial Limits TestWithdrawn and replaced with newer version
14-20614-250USP 31:2008 <71> Microbiological Tests, Sterility TestsWithdrawn and replaced with newer version
14-20714-251USP 31:2008 <85> Biological Tests and Assays, Bacterial Endotoxin Test (LAL)Withdrawn and replaced with newer version
14-20814-252USP 31:2008 <151> Pyrogen Test (USP Rabbit Test)Withdrawn and replaced with newer version
14-20914-253USP 31:2008 <161> Transfusion and Infusion Assemblies and Similar Medical DevicesWithdrawn and replaced with newer version
14-21014-254USP 31:2008 Biological Indicator for Steam Sterilization—Self ContainedWithdrawn and replaced with newer version
14-220AAMI/ANSI ST79:2006 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care FacilitiesType of Standard
14-221AAMI/ANSI/ISO TIR 11139:2006 Sterilization of Health Care Products—VocabularyCFR Citations, Product codes, Title, Devices affected, and Type of standard
14-222AAMI/ANSI/ISO 18472:2006 Sterilization of Health Care Products—Biological and Chemical Indicators—Test EquipmentType of standard
14-223ANSI/AAMI/ISO 11138-1:2006 Sterilization of Health Care Products—Biological Indicators—Part 1: General RequirementsType of standard, Guidance and Extent of recognition
14-224AAMI/ANSI/ISO 11137-1:2006 Sterilization of Health Care Products—Radiation—Part 1: Requirements for Development, Validation, and Routine Control of a Sterilization Process for Medical DevicesCFR Citations, Product codes, and Type of standard
14-225AAMI/ANSI/ISO 11137-2:2006 Sterilization of Health Care Products—Radiation—Part 2: Establishing the Sterilization DoseCFR Citations, Product codes and Type of standard
14-226AAMI/ANSI/ISO 11137-3:2006 Sterilization of Health Care Products—Radiation—Part 3: Guidance on Dosimetric AspectsCFR Citations, Product codes and Type of standard
Start Printed Page 52382
14-227AAMI/ANSI/ISO 11737-1:2006 Sterilization of Medical Devices-Microbiological Methods-Part 1: Determination of the Population of Microorganisms on Products, 2d, ed.CFR Citations, Product codes, Devices affected, CDRH Office and Division associated with recognized standard
14-228ANSI/AAMI/ISO 11135-1:2007 Sterilization of Health Care Products—Ethylene Oxide—Part 1: Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical DevicesCFR Citations, Product codes, Devices affected, and Type of standard
14-229ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical DevicesCFR Citations and Product codes
14-230ASTM F2203-02(2007) Standard Test Method for Linear Measurement Using Precision Steel RuleCFR Citations, Product codes and Type of standard
14-231ASTM F2217-02(2007) Standard Practice for Coating/Adhesive Weight DeterminationCFR Citations, Product codes and Type of standard
14-232ASTM F2227-02(2007) Standard Test Method for Non-Destructive Detection of Leaks in Non-Sealed and Empty Medical Packaging Trays by CO2 Tracer Gas MethodCFR Citations, Product codes and Type of standard
14-233ASTM F2228-02(2007) Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by CO2 Tracer Gas MethodCFR Citations, Product codes and Type of standard
14-234ASTM F2097-07 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical ProductsCFR Citations, Product codes and Type of standard
14-235ASTM F1140-07 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained PackagesCFR Citations, Product codes and Type of standard
14-236ASTM F2054-07 Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining PlatesCFR Citations, Product codes and Type of standard
14-237ASTM F88-07 Standard Test Method for Seal Strength of Flexible Barrier MaterialsCFR Citations, Product codes and Type of standard
14-239ISO 13408-3:2006 Aseptic Processing of Health Care Products—Part 3: LyophilizationCFR Citations and Product codes
14-240ISO 13408-5:2006 Aseptic Processing of Health Care Products—Part 5: Sterilization-in-PlaceCFR Citations and Product codes
14-241ISO 13408-6:2005 Aseptic Processing of Health Care Products—Part 6: Isolator SystemsCFR Citations and Product codes
14-242ISO 14644-3:2005 Cleanrooms and Associated Controlled Environments—Part 3: Test MethodsCFR Citations and Product codes
14-243ISO 14644-6:2007 Cleanrooms and Associated Controlled Environments—Part 6: VocabularyCFR Citations and Product codes
14-244ISO 14644-8:2006 Cleanrooms and Associated Controlled Environments—Part 8: Classification of Airborne Molecular ContaminationCFR Citations and Product codes
P. Tissue Engineering
15-12ASTM F2103-01(2007)e1 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product ApplicationsCFR Citations and Product codes, Relevant guidance, Type of standard and CDRH Office and Division associated with recognized standard
Start Printed Page 52383
15-5ASTM F2347-03, Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product ApplicationsCFR Citations and Product codes, Relevant guidance, Type of standard and CDRH Office and Division associated with recognized standard
15-6ASTM F2450-04, Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue Engineered Medical ProductsCFR Citations and Product codes, Relevant guidance, Type of standard and CDRH Office and Division associated with recognized standard
15-7ASTM F2315-03, Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate GelsCFR Citations and Product codes, Relevant guidance, Type of standard and CDRH Office and Division associated with recognized standard
15-8ASTM F2064-00(2006), Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for use in Biomedical and Tissue-Engineered Medical Products ApplicationCFR Citations and Product codes, Relevant guidance, Type of standard and CDRH Office and Division associated with recognized standard
15-9ASTM F2311-06, Standard Guide for Classification of Therapeutic Skin SubstitutesCFR Citations and Product codes, Relevant guidance, Type of standard and CDRH Office and Division associated with recognized standard
15-10ASTM F2451-05, Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular CartilageCFR Citations and Product codes, Relevant guidance, Type of standard and CDRH Office and Division associated with recognized standard
15-11ASTM F2212-02(2007)e1, Standard Guide for Characterization of Type I Collagen as a Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical ProductsCFR Citations and Product codes, Relevant guidance, Type of standard and CDRH Office and Division 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 No.Title of StandardReference No. and Date
A. Biocompatibility
2-127Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Delayed-Type Hypersensitivity—Amendment 1ANSI/AAMI BE 78:2002/A1:2006
B. Cardiovascular/Neurology
3-70Manual, Electronic or Automated SphygmomanometersANSI/AAMI SP10:2002/A1:2003—Amendment 1 to ANSI/AAMI SP10:2002
3-71Manual, Electronic and Automated SphygmomanometersANSI/AAMI SP10:2002/A2:2006—Amendment 2 to ANSI/AAMI SP10:2002
C. Dental/ Ear, Nose, and Throat
4-151Dentistry—Artificial Teeth for Dental ProsthesesISO 22112:2005
Start Printed Page 52384
4-152Metal-Ceramic Dental Restorative SystemsISO 9693:1999/Amendment 1:2005
4-154Dentistry—Elastometric Impression Materials-Third EditionISO 4823:2000
4-155Dentistry—Elastomeric Impression Materials Technical Corrigendum 1-Third EditionISO 4823:2000 Technical Corrigendum 1:2004
4-156Dentistry—Elastomeric Impression Materials Amendment 1-Third EditionISO 4823:2000 Amendment 1:2007
4-157Dentistry—Zinc Oxide/Eugenol and Zinc Oxide/Non-eugenol Cements-Third EditionISO 3107: 2004
4-158Dentistry—Soft Lining Materials for Removable Dentures—Part 1: Materials for Short-Term Use Technical Corrigendum 1ISO 10139-1:2005 Technical Corrigendum 1:2006
D. General Hospital/ General Plastic Surgery
6-214Standard Test Method for Human Repeat Insult Patch Testing of Medical GlovesASTM D6355-07
E. In Vitro Diagnostic
7-160Abbreviated Identification of Bacteria and Yeast; Approved GuidelineCLSI M35-A,
7-161Laboratory Detection and Identification of Mycobacteria; Proposed Guideline.CLSI M48-P
7-162Point-of-Care Monitoring of Anticoagulant Therapy; Approved GuidelineCLSI H49-A
7-163Body Fluid Analysis for Cellular CompositionCLSI H56-A
7-164Microwave Device Use in the Histology Laboratory; Approved GuidelineCLSI GP28-A
7-165Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard-Second EditionCLSI H20-A2
7-166Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline—Second EditionCLSI GP20-A2
7-167Nongynecologic Cytologic Specimens: Collection and Cytopreparatory Techniques; Approved GuidelineCLSI GP23-A
7-168Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi; Approved StandardCLSI M38-A
F. Materials
8-161Standard Test Method for Tension Testing of Nickel-Titanium Superelastic MaterialsASTM F2516-07
G. OB-GYN/Gastroenterology
9-46Medical Electrical Equipment—Part 2-2: Particular Requirements for the Safety of High Frequency Surgical EquipmentANSI/AAMI 60601-2-2:2006
9-49Concentrates for HemodialysisAAMI / ANSI RD61:2006
9-50Dialysate for HemodialysisANSI/AAMI RD52:2004
9-51Cardiovascular Implants and Artificial Organs—Haemodialysers, Haemodiafilters, Haemofilters and HaemoconcentratorsISO 8637:2004
9-52Cardiovascular Implants and Artificial Organs—Extracorporeal Blood Circuit for Haemodialysers, Haemodiafilters and HaemofiltersISO 8638:2004
9-53Standard Practice for Reprocessing of Reusable, Heat-Stable Endoscopic Accessory Instruments (EAI) Used with Flexible EndoscopesASTM F1992-99(2007)
9-54Standard Specification for Rubber Contraceptives—Vaginal DiaphragmsASTM D6976-08
H. Ophthalmic
10-56Ophthalmics Multifocal Intraocular LensesANSI Z80.12-2007
Start Printed Page 52385
10-57Phakic Intraocular LensesANSI Z80.13-2007
I. Physical Medicine
16-161Safety Standard for Platform Lifts and Stairway ChairliftsASME A18.1-2005
J. Sterility
14-255Standard Terminology Relating to Flexible Barrier PackagingASTM F17-07a

IV. List of Recognized Standards

FDA maintains the agency's current list of FDA recognized consensus standards in a searchable database that may be accessed directly at FDA's Internet site at http://www.accessdata.fda.gov/​scripts/​cdrh/​cfdocs/​cfStandards/​search.cfm. FDA will incorporate the modifications and minor revisions described in this notice into the database and, upon publication in the Federal Register, this recognition of consensus standards will be effective. FDA will announce additional modifications and minor revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often, if necessary.

V. Recommendation of Standards for Recognition by FDA

Any person may recommend consensus standards as candidates for recognition under the new provision of section 514 of the act by submitting such recommendations, with reasons for the recommendation, to the contact person (see FOR FURTHER INFORMATION CONTACT). To be properly considered such recommendations should contain, at a minimum, the following information: (1) Title of the standard, (2) any reference number and date, (3) name and address of the national or international standards development organization, (4) a proposed list of devices for which a declaration of conformity to this standard should routinely apply, and (5) a brief identification of the testing or performance or other characteristics of the device(s) that would be addressed by a declaration of conformity.

VI. Electronic Access

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://www.fda.gov/​cdrh. A search capability for all CDRH guidance documents is available at http://www.fda.gov/​cdrh/​guidance.html. Guidance documents are also available at http://www.regulations.gov.

This Federal Register document on modifications in FDA's recognition of consensus standards is available at http://www.fda.gov/​cdrh/​fedregin.html.

VII. Submission of Comments and Effective Date

Interested persons may submit to the contact person (see FOR FURTHER INFORMATION CONTACT) written or electronic comments regarding this document. Two copies of any mailed comments are to be submitted, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. FDA will consider any comments received in determining whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 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://www.regulations.gov.

Start Signature

Dated: August 27, 2008.

Daniel G. Schultz,

Director, Center for Devices and Radiological Health.

End Signature End Supplemental Information

[FR Doc. E8-20939 Filed 9-8-08; 8:45 am]

BILLING CODE 4160-01-S