ASTM F997 - 10

    Standard Specification for Polycarbonate Resin for Medical Applications

    Active Standard ASTM F997 | Developed by Subcommittee: F04.11

    Book of Standards Volume: 13.01


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    Abstract

    This specification covers the general, physical property, and biocompatibility requirements, and the associated test methods for establishing a reasonable level of confidence concerning the performance of unfilled thermoplastic polycarbonate resin for use in the manufacture of medical devices or the components thereof.

    This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.

    1. Scope

    1.1 This specification covers polycarbonate resin and provides requirements and associated test methods for this thermoplastic when it is to be used in the manufacture of medical devices or components of medical devices.

    1.2 As with any material, some characteristics may be altered by the processing techniques (such as molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this resin should be evaluated using those test methods that are appropriate to assure safety and efficacy.

    1.3 The properties included in this specification are those applicable for polycarbonate only. The biocompatibility of plastic compounds made up of polycarbonate resin containing colorants, fillers, processing aids, or other additives, as well as polymer blends which contain polycarbonate, should not be assumed. The biocompatibility of these modified polycarbonates must be established by testing the final (end-use) compositions using the appropriate methods of evaluation. In addition, the biocompatibility of the material depends to a large degree on the nature of the end-use application. It is, therefore, necessary to specify a set of biocompatibility test methods for each new and distinct application.

    1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.


    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ISO Standard

    ISO10993 Biological Evaluation of Medical Devices Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.

    Code of Federal Regulations

    Title21 CFR Subpart 177.1580 Available from Standardization Documents Order Desk, Bldg. 4 Section D, 700 Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS.

    ASTM Standards

    D256 Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics

    D570 Test Method for Water Absorption of Plastics

    D638 Test Method for Tensile Properties of Plastics

    D648 Test Method for Deflection Temperature of Plastics Under Flexural Load in the Edgewise Position

    D790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials

    D792 Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement

    D883 Terminology Relating to Plastics

    D955 Test Method of Measuring Shrinkage from Mold Dimensions of Thermoplastics

    D1003 Test Method for Haze and Luminous Transmittance of Transparent Plastics

    D1238 Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer

    D1600 Terminology for Abbreviated Terms Relating to Plastics

    D1898 Practice for Sampling of Plastics

    D3892 Practice for Packaging/Packing of Plastics

    D3935 Specification for Polycarbonate (PC) Unfilled and Reinforced Material

    F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices

    Underwriters Laboratories Document

    ULStandard94 Tests and Flammability of Plastic Materials for Parts in Devices and Appliances Available from Underwriters Laboratories (UL), 333 Pfingsten Rd., Northbrook, IL 60062-2096, http://www.ul.com.


    ICS Code

    ICS Number Code 11.120.01 (Pharmaceutics in general); 83.080.20 (Thermoplastic materials); 11.100.99 (Other standards related to laboratory medicine)

    UNSPSC Code

    UNSPSC Code 13111012(Polycarbonate resin)


    DOI: 10.1520/F0997-10

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