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[Federal Register: February 25, 1998 (Volume 63, Number 37)] [Notices] [Page 9561-9569] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr25fe98-96] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 98D-0085] FDA Modernization Act of 1997: Guidance for the Recognition and Use of Consensus Standards; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is: (1) Announcing the availability of a guidance entitled ``Guidance on the Recognition and Use of Consensus Standards,'' the purpose of which is to provide guidance to industry and reviewers within the Center for Devices and Radiological Health (CDRH) on the use of recognized consensus standards, including declarations of conformity to the standards, during the evaluation of premarket submissions for medical devices; (2) publishing the initial list of standards that will be recognized for use in the premarket review process; and (3) announcing the agency's policy on updating the list of recognized standards. This guidance will assist manufacturers who elect to declare conformity with consensus standards to meet all or part of medical device review requirements. DATES: This guidance is effective on February 19, 1998; however, written comments concerning this guidance may be submitted at any time. ADDRESSES: Written comments concerning this guidance must be submitted to the first contact person listed below. Comments should be identified with the docket number found in brackets in the heading of this document. Submit written requests for single copies of ``Recognition and Use of Consensus Standards'' to the Division of Small Manufacturers Assistance (DSMA), Center for Devices and Radiological Health (HFZ- 220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to assist that office in processing your request, or fax your request to 301-443-8818. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance. This guidance document may also be accessed via the Internet at FDA's web site ``http://www.fda.gov/cdrh''. FOR FURTHER INFORMATION CONTACT: To comment on this guidance: Melvyn R. Altman, Associate Director for Standards Policy, enter for Devices and Radiological Health (HFZ- 101), [[Page 9562]] Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-4766, ext. 103. To recommend additional standards for recognition: James J. McCue, Director, Standards Program Coordination Staff, enter for Devices and Radiological Health (HFZ-101), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594- 4766, ext. 137. SUPPLEMENTARY INFORMATION: I. Background Many domestic and international consensus standards address relevant aspects of safety and/or effectiveness of medical devices. Many of these consensus standards have been developed with the participation of FDA staff. Section 204 of the Food and Drug Administration Modernization Act of 1997, Pub. L. 105-115, 111 Stat. 2296 (1997) (FDAMA) amends section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d), allowing the agency to recognize consensus standards established by international and national standards development organizations that may be used to satisfy identified portions of device review requirements. This notice announces the availability of a guidance document entitled ``Guidance on the Recognition and Use of Consensus Standards,'' which describes how FDA will implement that part of the FDAMA. The agency has adopted Good Guidance Practices (GGP's), which set forth the agency's policies and procedures for the development, issuance, and use of guidance documents (62 FR 8961, February 27, 1997). Although ``Guidance on the Recognition and Use of Consensus Standards'' is Level 1 guidance under the GGP's, this guidance will become effective upon issuance. Under the GGP's the agency may elect not to solicit public comment prior to implementation when there is a new statutory requirement * * * that requires immediate implementation and guidance is needed to help effect such implementation'' (62 FR 8961 at 8968). However, comments may be submitted at any time by interested parties, and these comments will be considered in any future revisions to the guidance. This guidance document may contain collections of information that require OMB clearance under the Paperwork Reduction Act of 1995. FDA will seek such approval and provide an opportunity for comment, as appropriate. II. Use of Recognized Standards A person required to submit a premarket application (i.e., Premarket Notification (510(k)), Investigational Device Exemptions application (IDE), Premarket Approval application (PMA), Humanitarian Device Exemption application (HDE), or Product Development Protocol (PDP)) must provide information as required by the statute and regulations to allow FDA to make an appropriate decision regarding the clearance or approval of the submission. This guidance document describes how FDA will recognize consensus standards and use conformance with recognized standards to satisfy review requirements. It does not affect FDA's ability to obtain any information authorized by the statute or regulations. Use of consensus standards in this manner is authorized by section 514 of the act, as amended by FDAMA. FDA believes that conformance with applicable recognized consensus standards can provide a reasonable assurance of safety and/or effectiveness for many devices. Therefore, information submitted on conformance with such standards will have a direct bearing on determinations of safety and effectiveness made during the review of IDE's, HDE's, PMA's, and PDP's. In case of 510(k)s, information on conformance with recognized consensus standards may help establish the substantial equivalence of a new device to a legally marketed predicate device. This information can serve as a surrogate for comparative information to show that the new device is as safe and effective as the predicate in the areas covered by the standards. Moreover, if a premarket submission contains a declaration of conformity to recognized consensus standards, this will, in most cases, eliminate the need to review actual test data for those aspects of the device addressed by the standards. The content of a declaration of conformity is described in the guidance document and is consistent with the ISO/IEC Guide 22. Conformance with recognized consensus standards in and of itself, however, may not always be a sufficient basis for regulatory decisions. For example, a specific device may raise a safety or effectiveness issue not addressed by any standard, or a specific FDA regulation may require additional information beyond that which conformity to the recognized consensus standards provides. Under such circumstances, conformity with recognized standards will not satisfy all requirements for marketing, or investigating, the product in the United States. The guidance document, ``Guidance on the Recognition and Use of Consensus Standards'', represents the agency's current thinking on the use of recognized consensus standards for medical devices. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. III. List of Recognized Standards The initial list of consensus standards to be recognized for use in premarket review is presented at the end of this document. This list is also maintained on the FDA web site ``http://www.fda.gov/cdrh''. Also posted on the web site are supplemental data sheets for each recognized standard. These data sheets list the address(es) where the standard can be obtained, information on any limitations to the application of the standard in medical device review, and a list of devices for which declarations of conformity with the recognized standard will be routinely accepted by agency reviewers. In addition to these documents, the web site contains answers to frequently asked questions regarding the use of recognized standards. IV. Recommendation of Standards for Recognition by FDA Modifications to the list of recognized consensus standards related to medical devices will be announced in the Federal Register at least once a year, or more often if necessary. FDA intends that the next revision to the list of recognized standards will include standards to be recognized by the Center for Biologics Evaluation and Research as well as by CDRH. Any person may recommend consensus standards as candidates for recognition under new paragraphof section 514 of the act, by submitting such recommendations, with justification, to the address identified at the beginning of this document. 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 nationally or internationally recognized standards development organization, (4) a proposed list of devices for which a declaration of conformity should routinely apply, and (5) a brief identification of the testing or performance or other characteristics of [[Page 9563]] the device(s) that would be addressed by a declaration of conformity. Opportunity to Recommend Standards for CDRH Recognition V. Electronic Access In order to receive the guidance document ``Recognition and Use of Consensus Standards,'' via your fax machine, call the CDRH Facts-On- Demand (FOD) system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. At the first voice prompt press 1 to access DSMA Facts, at the second voice prompt press 2, and then enter the document number 321, followed by the pound sign (#). Then follow the remaining voice prompts to complete your request. Persons interested in obtaining a copy of the guidance may also do so by using the World Wide Web (WWW). CDRH maintains an entry on the WWW for easy access to information including text, graphics, and files that may be downloaded to a personal computer with access to the Web. Updated on a regular basis, the CDRH Home Page includes the guidance Document ``Guidance on the Recognition and Use of Consensus Standards'', as well as the list of recognized standards and details on their application and information on obtaining copies. The CDRH home page may be accessed at ``http:// www.fda.gov/cdrh''. A text-only version of the CDRH Web site is also available from a computer or VT-100 compatible terminal by dialing 800-222-0185 (terminal settings are 8/1/N). Once the modem answers, press Enter several times and then select menu choice 1: FDA Bulletin Board Service. From there follow instructions for logging in, and at the BBS TOPICS PAGE, arrow down to the FDA home page (do not select the first CDRH entry). Then select Medical Devices and Radiological Health. From there select Center for Devices and Radiological Health for general information, or arrow down for specific topics. VI. Comments Interested persons may, at any time, submit to the contact person listed above written comments regarding the guidance. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments will be considered in determining whether to amend the current guidance. ---------------------------------------------------------------------------------------------------------------- Name of standards Title of standard Reference number and date development organization ---------------------------------------------------------------------------------------------------------------- Generally Applicable Standards ---------------------------------------------------------------------------------------------------------------- 1................. Biological Evaluation of ANSI/AAMI/ISO 10993-1 Association for the Medical Devices--Part 1: Advancement of Medical Guidance on Selection of Instrumentation. Tests--First Edition. 2................. Medical Electrical IEC 60601-1 International Equipment--Part 1: Electrotechnical General Requirements for Commission (IEC). Safety.\1\. 3................. Biological Evaluation of ISO 10993-1 International Medical Devices--Part 1: Organization for Guidance on Selection of Standardization (ISO). Tests--First Edition (Corrigendum 1-1992)(CEN EN 30993-1:1994). ---------------------------------------------------------------------------------------------------------------- In Vitro Devices ---------------------------------------------------------------------------------------------------------------- 1................. How to Define, Determine C28-A (1995) National Committee for and Utilize Reference Clinical Laboratory Intervals in the Standards (NCCLS). Clinical Laboratory; Approved Guideline. 2................. Method Comparison and EP9-A (1995) NCCLS. Bias Estimation Using Patient Samples; Approved Guideline. 3................. Assessment of the GP-10-A (1995) NCCLS. Clinical Accuracy of Laboratory Tests Using Receiver Operating Characteristic (ROC) Plots; Approved Guideline. 4................. Labeling of Home-Use In GP14-A (1996) NCCLS. Vitro Testing Products; Approved Guideline. 5................. Procedures for the H18-A (1990) NCCLS. Handling and Processing of Blood Specimens; Approved Guidelines. 6................. Specifications for ILA18-A (1994) NCCLS. Immunological Testing for Infectious Diseases; Approved Guideline. 7................. Assessing the Quality of LAI-A2 (1994) NCCLS. Radioimmunassay Systems-- Second Edition; Approved. 8................. Performance Standards for M2-A6 (1997) NCCLS. Antimicrobial Disk Susceptibility Tests-- Sixth Edition; Approved Standard. 9................. Methods for Antimicrobial M11-A3 (1993) NCCLS. Susceptibility Testing of Anaerobic Bacteria-- Third Edition; Approved Standard. 10................ Development of In Vitro M23A NCCLS. Susceptibility Testing Criteria and Quality Control Parameters. 11................ Molecular Diagnostic MM3-(1995) NCCLS. Methods for Infectious Diseases; Approved Guideline. ---------------------------------------------------------------------------------------------------------------- OB-GYN/Gastroenterology ---------------------------------------------------------------------------------------------------------------- 1................. Hemodialysis Systems..... ANSI/AAMI RD5-1992 Association for the Advancement of Medical Instrumentation (AAMI). 2................. Standard Performance ASTM-D3492-96 American Society for Specifications for Testing and Materials Rubber Contraceptives (ASTM). (Male Condom). 3................. Standard Performance ASTM F623-89 ASTM. Specifications for Foley Catheters. ---------------------------------------------------------------------------------------------------------------- [[Page 9564]] Ophthalmic ---------------------------------------------------------------------------------------------------------------- 1................. Optics and Optical ISO 9338:1996 International Instruments--Contact Organization for Lenses--Determination of Standardization (ISO). the Diameters. 2................. Optics and Optical ISO 9339-1:1996 ISO. Intruments--Contact Lenses--Determination of the Thickness--Part 1: Rigid Contact Lenses. 3................. Optics and Optical ISO 9340:1996 ISO. Intruments--Contact Lenses--Determination of Strains for Rigid Contact Lenses. 4................. Optics and Optical ISO 9341:1996 ISO. Intruments--Contact Lenses--Determination of Inclusions and Surface Imperfections for Rigid Contact Lens. 5................. Optics and Optical ISO 9363-1:1994 ISO. Intruments--Contact Lenses--Determination of Cytotoxicity of Contact Lens Material--Part 1: Agar Overlay Test and Growth Inhibition Test. 6................. Optics and Optical ISO 9394:1994 ISO. Intruments--Contact Lenses--Determination of Biological Compatibility of Contact Lens Material--Testing of the Contact Lens System by Ocular Study with Rabbit Eyes. 7................. Optics and Optical ISO 9913-1:1996 ISO. Intruments--Contact Lenses--Determination of Oxygen Permeability and Transmissibility with the FATT Method. 8................. Optics and Optical ISO 10338:1996 ISO. Intruments--Contact Lenses--Determination of Curvature. 9................. Optics and Optical ISO 10339:1997 ISO. Intruments--Contact Lenses--Determination of Water Content of Hydrogel Lenses. 10................ Optics and Optical ISO 10340:1995 ISO. Intruments--Contact Lenses--Method for Determining the Extractable Substances. 11................ Optics and Optical ISO 10344:1996 ISO. Intruments--Contact Lenses--Saline Solution for Contact Lens Testing. 12................ Optics and Optical ISO 11980:1997 ISO. Intruments--Contact Lenses and Contact Lens Care Products-- Guidance for Clinical Investigations. ---------------------------------------------------------------------------------------------------------------- Orthopaedics ---------------------------------------------------------------------------------------------------------------- 1................. Standard Specifications ASTM F67-95 American Society for for Unalloyed Titanium Testing and Materials for Surgical Implant (ASTM) Applications. 2................. Standard Specifications ASTM F75-92 ASTM. for Cast Cobalt-Chromium- Molybdenum Alloy for Surgical Implant Applications. 3................. Standard Practice for ASTM F86-91 ASTM. Surface Preparation and Marking of Metallic Surgical Implants. 4................. Standard Specification ASTM F90-96 ASTM. for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Aplications (UNS R30605). 5................. Standard Specification ASTM F136-96 ASTM. for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy (R56401) for Surgical Implant Applications. 6................. Standard Specification ASTM F138-92 ASTM. for Stainless Steel Bar and Wire for Surgical Implants (Special Quality). 7................. Standard Specification ASTM F-139-96 ASTM. for Wrought-18 Chromium- 14 Nickel-2.5 Molybdenum Stainless Sheet and Strip for Surgical Implants (UNS S31673). 8................. Standard Specification ASTM F366-82(r1993) ASTM. for Fixation Pins and Wires. 9................. Standard Specification ASTM F560-92 ASTM. for Unalloyed Tantalum for Surgical Implant Applications. 10................ Standard Practice for ASTM F561-87 ASTM. Analysis of Retrieved Metallic Orthopaedic Implants. 11................ Wrought Cobalt-35 Nickel- ASTM F562-95 ASTM. 20 Chromium-10 Molybdenum Alloy for Surgical Implant Applications. 12................ Standard Practice for ASTM F565 ASTM. Care and Handling of Orthopaedic Implants and Instruments. 13................ Standard Practice for ASTM F601-86(1992) ASTM. Fluorescent Penetrant Inspection of Metallic Surgical Implants. [[Page 9565]] 14................ Standard Specification ASTM F603 ASTM. for High-Purity Dense Aluminum Oxide for Surgical Implants. 15................ Standard Specification ASTM F604 ASTM. Classifications for Silicone Elastomers Used in Medical Applications. 16................ Standard Specification ASTM F620 ASTM. for Titanium 6A1-4V E11 Alloy Forgings for Surgical. 17................ Standard Specification ASTM F621 ASTM. for Stainless Steel Forgings for Surgical Implants. 18................ Standard Practice for ASTM F629-86 ASTM. Radiography of Cast Metallic Surgical Implants. 19................ Standard Specification ASTM F648-84 ASTM. for Ultra-High-Molecular- Weight Polyethylene Powder and Fabricated Form for Surgical Implants. 20................ Standard Specification ASTM F688-95 ASTM. for Wrought Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants. 21................ Standard Specification ASTM F745-95 ASTM. for 18 Chromium--12.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications. 22................ Standard Test Method for ASTM F746-87 ASTM. Pitting or Crevice Corrosion of Metallic Surgical Implant Materials. 23................ Standard Specification ASTM F786-82 ASTM. for Metallic Bone Plates. 24................ Standard Specification ASTM F787-82 ASTM. for Metallic Nail-Plate Appliances. 25................ Standard Specification ASTM F799-96 ASTM. for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537). 26................ Standard Test Method for ASTM F897-84 (r1993) ASTM. Measuring Fretting Corrosion of Osteosynthesis Plates and Screws. 27................ Standard Specification ASTM F899-95 ASTM. for Stainless Steel Billet, Bar, and Wire for Surgical Instruments. 28................ Standard Specification ASTM F961-96 ASTM. for Cobalt-Nickel- Chromium-Molybdenum Alloy Forgings for Surgical Implant Applications. 29................ Standard Practice for ASTM F983-86 ASTM. Permanent Marking of Orthopaedic Implant Components. 30................ Standard Test Method for ASTM F1044-95 ASTM. Shear Testing of Porous Metal Coatings. 31................ Standard Specification ASTM F1088-87(R1992) ASTM. for Beta-Tricalcium Phosphate for Surgical Implantation. 32................ Standard Test Method for ASTM F1089-87 ASTM. Corrosion of Surgical Instruments. 33................ Standard Specification ASTM F1091-91 (R1996) ASTM. for Wrought Cobalt-20 Chromium-15 Tungsten-20 Nickel Alloy Surgical Fixation Wire UNS R30605. 34................ Standard Specification ASTM F1108-97 ASTM. for Titanium-6 Aluminum- 4 Vanadium Alloy Castings for Surgical Implants (UNS R56406). 35................ Standard Test Method for ASTM F1147-95 ASTM. Tension Testing of Porous Metal Coatings. 36................ Standard Test Method for ASTM F1160-91 ASTM. Constant Stree Amplitude Fatigue Testing of Porous Metal-Coated Metallic Materials. 37................ Standard Specification... ASTM F1185-88(1993) ASTM. 38................ Standard Guide for ASTM F1264-96a ASTM. Mechanical Performance Considerations for Intrameduallary Fixation Devices. 39................ Standard Specification ASTM F1295-97 ASTM. for Wrought Titanium-6 Aluminum-7 Niobium Alloy for Surgical Implant Applications. 40................ Standard Specification ASTM F1314-95 ASTM. for Wrought Nitrogen Strengthened-22 Chromium- 12.5 Nickel-5 Manganese- 2.5 Molybdemum Stainless Steel Bar and Wire for Surgical Implants. 41................ Standard Specification ASTM F1341-92 ASTM. for Unalloyed Titanium Wire for Surgical Implant Applications. 42................ Standard Specification ASTM F1350-96 ASTM. for Wrought 18 Chromium- 14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673). 43................ Standard Specification ASTM F1377-92 ASTM. for Cobalt-Chromium- Molybdenum Powder for Coating of Orthopaedic Implants. 44................ Standard Specification ASTM F1472-93 ASTM. for Wrought T1-6A1-4V Alloy for Surgical Implant Applications. [[Page 9566]] 45................ Standard Test Methods for ASTM F1501-95 ASTM. Tension Testing of Calcium Phosphate Coatings. 46................ Standard Specification ASTM F1537-94 ASTM. For Wrought Cobalt-28- Chromium-6-Molybdenum Alloy for Surgical Implants. 47................ Standard Classification ASTM F1541-94 ASTM. of External Skeletal Fixators. 48................ Standard Specification ASTM F1580-95 ASTM. for Titanium and Titanium-6% Aluminum-4% Vanadium Alloy Powders for Coatings of Surgical Implants. 49................ Standard Terminology ASTM F1582-95 ASTM. Relating to Spinal Implants. 50................ Standard Specification ASTM F1586-95 ASTM. for Wrought Nitrogen Strengthened-21 Chromium- 10 Nickel-3 Manganese- 2.5 Molybdenum Stainless Steel Bar for Surgical Implants. 51................ Standard Specification ASTM F1609-95 ASTM. for Calcium Phosphate Coatings for Implantable Materials. 52................ Standard Practice for ASTM F1612-95 ASTM. Cydic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components With Torsion. 53................ Standard Test Method for ASTM F1658-95 ASTM. Shear Testing of Calcium Phosphate Coatings. 54................ Standard Test Method for ASTM F1659-95 ASTM. Bending and Shear Fatigue Testing of Calcium Phosphate Coatings on Solid Metallic Substrates. 55................ Standard Specification ASTM F1672-95 ASTM. for Resurfacing Patellar Prosthesis. 56................ Standard Specification ASTM F1713-96 ASTM. for Wrought Titanium-13 Niobium-13 Zirconium Alloy for Surgical Implant Applications. 57................ Standard Test Methods for ASTM F1717-96 ASTM. Static and Fatigue for Spinal Implant Constructs in a Corpectomy Model. 58................ Standard Specification ASTM F1781-97 ASTM. for Elastomeric Flexible Hinge Finger Total Joint Implants. 59................ Standard Test Methods for ASTM F1798 ASTM. Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis. 60................ Cyclic Fatigue Testing of ASTM F1800 ASTM. Metal Tibial Tray Components of TKR. 61................ Standard Recommended ASTM F1801 ASTM. Practice for Corrosion Fatigue Testing of Metallic Implant Materials. 62................ Implants for Surgery-- ISO 5832-1 (1997) ISO. Metallic Materials--Part 1: Wrought Stainless Steel. 63................ Implants for Surgery-- ISO5832-2-93 ISO. Metallic Materials--Part 2: Unalloyed Titanium. 64................ Implants for Surgery-- ISO 5832-3 (1996) ISO. Metallic--Part 3: Wrought Titanium 6- Aluminum 4-Vanadium Alloy Third Edition (CAN/ CSA-Z310.8-M91). 65................ Implants for Surgery-- ISO 5832-4-96 ISO. Metallic Materials--Part 4: Cobalt-Chromium- Molybdenum Casting Alloy. 66................ Implants for Surgery-- ISO 5832-5-93 ISO. Metal Materials--Part 5: Wrought Cobalt-Chromium- Tungsten-Nickel Alloy. 67................ Implants for Surgery-- ISO 5832-6 ISO. Metallic Materials--Part 6: Wrought Cobalt-Nickel- Chromium-Molybdenum Alloy. 68................ Implants for Surgery-- ISO 5832-9 (1992) ISO. Metallic Materials--Part 9: Wrought High Nitrogen Stainless Steel First Edition. 69................ Implants for Surgery-- ISO 5832-10:1996 ISO. Metallic Materials--Part 10: Wrought Titanium 5- Aluminum 2.5-Iron. 70................ Implants for Surgery-- ISO 5832-11 (1994) ISO. Metallic Materials--Part 11: Wrought Titanium 6- Aluminum 7-Niobium Alloy First Edition; CABN/CSA- Z310.7:M91. 71................ Implants for Surgery-- ISO 5832-12-96 ISO. Metalic Materials--Part 12: Wrought Cobalt- Chromium-Molybdenum Alloy. 72................ Implants for Surgery-- ISO 5834-2:1985 ISO. Ultra-High Molecular Weight Polyethylene-- Part 2: Moulded Forms. 73................ Implants for Surgery-- ISO 5838-1:1995 ISO. Skeletal Pins and Wires-- Part 1: Material and Mechanical Requirements. [[Page 9567]] 74................ Implants for Surgery-- ISO 5838-2:1991 ISO. Skeletal Pins and Wires-- Part 2: Steinmann Skeletal Pins-- Dimensions. 75................ Implants for Surgery-- ISO 5838-3:1993 ISO. Skeletal Pins and Wires-- Part 3: Kirschner Skeletal Wires. 76................ Implants for Surgery-- ISO 6474-94 ISO. Ceramic Materials Based on High Purity Alumina. 77................ Surgical Instruments-- ISO 7153-1:1991 ISO. Metallic Materials--Part 1: Stainless Steel. 78................ Implants for Surgery-- ISO 7206-4:1989 ISO. Partial and Total Hip Joint Prosthesis--Part 4: Determination of Endurance Properties of Stemmed Femoral Components with Application of Torsion. 79................ Implants for Surgery-- ISO 7206-8:1995 ISO. Partial and Total Hip Joint Prosthesis--Part 8: Endurance Performance of Stemmed Femoral Components with Application of Torsion. 80................ Implants for Surgery-- ISO 8828 ISO. Guidance on Care and Handling of Orthopaedic Implants. 81................ Implants for Surgery--Non ISO 9583:1993 ISO. Destructive Testing-- Liguid Penetrant Inspection of Metallic Surgical Implants. 82................ Implants for Surgery--Non ISO 9584:1993 ISO. Destructive Testing-- Radiological Examination of Cast Metallic Surgical Implants. 83................ Surgical and Dental Hand ISO 13402 ISO. Instruments--Determinati on of Resistance Against Autoclaving, Corrosion and Thermal Exposure. 84................ Implants for Surgery-- ISO 13782: 1996 ISO. Metallic Materials-- Unalloyed Tantalum for Surgical Implant Applications. 85................ Non-Active Surgical ISO 14630:1997 ISO Implants--General Requirements. ---------------------------------------------------------------------------------------------------------------- Physical Medicine ---------------------------------------------------------------------------------------------------------------- 1................. Determination of Static ANSI/RESNA WC/01-1990 Rehabilitation Stability. Engineering and Assistive Technology Society of North American (RESNA). 2................. Determination of Dynamic ANSI/RESNA WC/02-1991 RESNA. Stability of Electric Wheelchairs. 3................. Determination of the ANSI/RESNA WC/03-1990 RESNA. Effectiveness of Brakes. 4................. Determination of Energy ANSI/RESNA WC/04-1990 RESNA. Consumption of Electric Wheelchairs. 5................. Determination of Overall ANSI/RESNA WC/05-1990 RESNA. Dimensions, Mass and Turning Space-- Wheelchair. 6................. Determination of Maximum ANSI/RESNA WC/06-1991 RESNA. Speed, Acceleration, and Retardation of Electric Wheelchairs. 7................. Wheelchairs--Determinatio ANSI/RESNA WC/07-1991 RESNA. n of Seating and Wheel Dimensions. 8................. Wheelchairs--Static, ANSI/RESNA WC/08-1991 RESNA. Impact and Fatigue Strength Tests. 9................. Climatic Tests for ANSI/RESNA WC/09-1991 RESNA. Electric Wheelchairs. 10................ Determination of the ANSI/RESNA WC/10-1990 RESNA. Obstacle-Climbing Ability of Electric Wheelchairs. 11................ Wheelchairs--Test Dummies ANSI/RESNA WC/11-1991 RESNA. 12................ Coefficient of Friction ANSI/RESNA WC/13-1991 RESNA. of Test Surfaces. 13................ Wheelchairs--Testing of ANSI/RESNA WC/14-1991 RESNA. Power and Control Systems for Electric Wheelchairs. 14................ Wheelchairs--Requirements ANSI/RESNA WC/15-1991 RESNA. for Information Disclosure, Documentation and Labelling. 15................ Wheelchairs--Determinatio ANSI/RESNA WC/16-1991 RESNA. n of Flammability. 16................ Wheelchairs--Part 1: ISO 7176-1:1986 ISO. Determination of Static Stability. 17................ Wheelchairs--Part 2: ISO 7176-2:1990 ISO. Determination of Dynamic Stability of Electric Wheelchairs. 18................ Wheelchairs--Part 3: ISO 7176-3:1988 ISO. Determination of Efficiency of Brakes. 19................ Wheelchairs--Part 4: ISO 7176-4:1997 ISO. Energy Consumption of Electric Wheelchairs and Scooters for Determination of Theoretical Distance Range. 20................ Wheelchairs--Part 5: ISO 7176-5:1986 ISO. Determination of Overall Dimensions, Mass and Turning Space. [[Page 9568]] 21................ Wheelchairs--Part 6: ISO 7176-6:1988 ISO. Determination of Maximum Speed, Acceleration and Retardation of Electric Wheelchairs. 22................ Wheelchairs--Part 9: ISO 7176-9:1988 ISO. Climatic Tests for Electric Wheelchairs. 23................ Wheelchairs--Part 10: ISO 7176-10:1988 ISO. Determination of Obstacle-Climbing Ability of Electric Wheelchairs. 24................ Wheelchairs--Part 11: ISO 7176-11:1992 ISO. Test Dummies. 25................ Wheelchairs--Part 13: ISO 7176-13:1989 ISO. Determination of Coefficient of Friction of Test Surfaces. 26................ Wheelchairs--Part 14: ISO 7176-14:1997 ISO. Power and Control Systems for Electric Wheelchairs--Requirement s and Test Methods. 27................ Wheelchairs--Part 15: ISO 7176-15:1996 ISO. Requirements for Information Disclosure, Documentation and Labeling. 28................ Wheelchairs--Part 16: ISO 7176-16:1997 ISO. Resistance to Ignition of Upholstered Parts-- Requirements and Test Methods. ---------------------------------------------------------------------------------------------------------------- Radiology ---------------------------------------------------------------------------------------------------------------- 1................. Medical X-Ray Screen-Film- ANSI PH2.43-1982 American National Processing Systems, Standards Institute Method for the (ANSI). Sensitometry. 2................. Photography (films)-- ANSI/NAPM IT1.49-1995 National Association of Medical Hard Copy Photographic Imaging Films-- Manufacturers, (NAPM). Dimensions and Specifications. 3................. Photography (Films)-- ANSI/NAPM IT1.49-1995 NAPM. Medical Radiographic Cassettes/Screens/Films-- Dimensions. 4................. Medical Ultrasound Safety AIUM-1994 American Institute of Ultrasound in Medicine (AIUM). 5................. Photography-Direct-- ANSI/NAPM IT2.48-1993 NAPM. Exposing Medical and Dental Radiographic Film/ Process Systems-- Determination of ISO Speed and ISO Average Gradient. 6................. Determination of the IEC 806(R1984) IEC. Maximum Symmetrical Radiation Field from a Rotating Anode X-Ray Tube for Medical Diagnosis. 7................. Information Technology- ISO/IEC 10918-1:1994 ISO or IEC. Digital Compression and Coding of Continuous- Tone Still Images: Requirements and Guidelines. 8................. X-Ray Tube Assemblies for IEC60336(R1993) IEC. Medical Diagnosis Characteristics of Focal Spots. 9................. Performance Measurements NEMA NU1-1994 NEMA. of Scintillation Cameras. 10................ Determination of Signal NEMA MS1-1988(R1994) NEMA. to Noise Ratio (SNR) in Magnetic Resonance Images. 11................ Determination of Two- NEMA MS2-1989 NEMA. Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images. 12................ Determination of Image NEMA MS3-1989 NEMA. Uniformity in Diagnostic Magnetic Resonance Images. 13................ Acoustic Noise NEMA MS4-1989 NEMA. Measurement Procedure for Diagnostic Magnetic Resonance Imaging Devices. 14................ Determination of Slice NEMA MS5-1991 NEMA. Thickness in Diagnostic Magnetic Resonance Imaging. 15................ Characterization of NEMA MS6-1991 NEMA. Special Purpose Coils for Diagnostic Magnetic Resonance Images. 16................ Measurement Procedure for NEMA MS7-1993 NEMA. Time-Varying Gradiant Fields (dB/dt) for Magnetic Resonance Imaging Systems. 17................ Characterization of the NEMA MS8-1993 NEMA. Specific Absoption Rate for Magnetic Resonance Imaging Systems. 18................ Performance Measurements NEMA NU2-1994 NEMA. of Positron Emission Tomographs. 19................ DICOM set--Digital NEMA PS3 (Set) NEMA. Imaging and Communications in Medicine--Set Includes PS3.1 through PS3.13. 20................ Acoustic Output NEMA UD2-1992 NEMA. Measurement Standard for Diagnostic Ultrasound Equipment. 21................ Standard for Real-Time NEMA UD3-1992 NEMA. Display of Thermal and Mechanical Acoustic Output. 22................ Measurement of Dimensions NEMA XR5-1992 NEMA. and Properties of Focal Spots of Diagnostic X- Ray Tubes. [[Page 9569]] 23................ Measurement of the NEMA XR10-1986 (R1992) NEMA. Maximum Symmetrical Radiation Field from a Rotating Anode X-Ray Tube Used for Medical Diagnosis. 24................ Test Standard for NEM XR11-1993 NEMA. Determination of the Limiting Spatial Resolution of X-Ray Image Intensifier Systems. 25................ Test Standard for the NEMA XR15-1991 NEMA. Determination of the Visible Entrance Field Size of an X-Ray Image Intensifier System. 26................ Test Standard for the NEMA XR16-1991 NEMA. Determination of the System Contrast Ratio and the System Veiling Glare Index of an X-Ray Image Intensifier System. 27................ Test Standard for the NEMA XR17-1993 NEMA. Measurement for the Image Signal Uniformity of an X-Ray Image Intensifier System. 28................ Test Standard for the NEMA XR18-1993 NEMA. Determination of the Radial Image Distortion of an X-Ray Image Intensifier System. 29................ Electrical Thermal and NEMA XR19-1993 NEMA. Loading Characteristics of X-Ray Tubes Used for Medical Diagnosis. 30................ Standard for Safety: UL-122 Underwriters Laboratory Photographic Equipment. (UL). 31................ Standard for Safety: X- UL-187 UL. Ray Equipment. 32................ Standard for Safety: UL-544 UL. Medical and Dental Equipment--Third Edition. ---------------------------------------------------------------------------------------------------------------- \1\ The recognition of this standard for all devices was proposed for comment January 13, 1998 (63 FR 1974), and is not yet final. This listing applies only to radiological imaging devices. Dated: February 13, 1998. D. B. Burlington, Director, Center for Devices and Radiological Health. [FR Doc. 98-4843 Filed 2-20-98; 3:59 pm] BILLING CODE 4160-01-P
Updated 3/12/1998
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