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  • ASTM F 997 : 2018

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    Standard Specification for Polycarbonate Resin for Medical Applications

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-12-2018

    Publisher:  American Society for Testing and Materials

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    Abstract - (Show below) - (Hide below)

    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.

    Scope - (Show below) - (Hide below)

    1.1This 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.

    1.2As 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.

    1.3The 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.

    1.4This 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

    1.5This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

    General Product Information - (Show below) - (Hide below)

    Committee F 04
    Document Type Standard
    Product Note THIS STANDARD ALSO REFERS TO Title 21 CFR Subpart 177.1580
    Publisher American Society for Testing and Materials
    Status Current
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    ASTM D 1600 : 1999 Standard Terminology for Abbreviated Terms Relating to Plastics
    ASTM D 1238 : 2000 Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
    ASTM D 1238 : 2004 : REV C Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
    ASTM D 955 : 2008 : R2014 Standard Test Method of Measuring Shrinkage from Mold Dimensions of Thermoplastics
    ASTM D 3892 : 2015 : R2020 Standard Practice for Packaging/Packing of Plastics
    ASTM D 1238 : 2013 Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
    ASTM D 1003 : 2013 Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics
    ASTM D 1238 : 2010 Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
    ASTM D 3935 : 2015 Standard Classification System and Basis for Specification for Polycarbonate (PC) Unfilled and Reinforced Material
    ASTM D 3892 : 1993 : R2003 Standard Practice for Packaging/Packing of Plastics
    ASTM D 3892 : 2015 Standard Practice for Packaging/Packing of Plastics
    ASTM D 3935 : 1994 Standard Specification for Polycarbonate (PC) Unfilled and Reinforced Material
    ASTM D 3892 : 1993 : R1998 Standard Practice for Packaging/Packing of Plastics
    ASTM D 1600 : 2007 Standard Terminology for Abbreviated Terms Relating to Plastics
    ASTM D 1600 : 2013 Standard Terminology for Abbreviated Terms Relating to Plastics
    ASTM D 1600 : 2014 Standard Terminology for Abbreviated Terms Relating to Plastics
    ASTM D 1003 : 2007 : EDT 1 Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics
    ASTM D 1600 : 2008 Standard Terminology for Abbreviated Terms Relating to Plastics
    ASTM D 1003 : 2011 Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics
    ASTM D 1238 : 2004 Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
    ASTM D 1600 : 2018 Standard Terminology for Abbreviated Terms Relating to Plastics
    ASTM D 3935 : 2021 Standard Classification System and Basis for Specification for Polycarbonate (PC) Unfilled and Reinforced Material
    ASTM D 1003 : 2021 Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics
    ASTM D 955 : 2021 Standard Test Method of Measuring Shrinkage from Mold Dimensions of Thermoplastics
    ASTM D 1003 : 2000 Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics
    ASTM D 3892 : 1993 : R2009 Standard Practice for Packaging/Packing of Plastics
    ASTM D 1238 : 2001 : EDT 1 Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
    ASTM D 1003 : 2011 : EDT 1 Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics
    ASTM D 1238 : 2004 : REV A Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
    ASTM D 3935 : 2002 Standard Specification for Polycarbonate (PC) Unfilled and Reinforced Material
    ASTM D 1003 : 1992 Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics
    ASTM D 1238 : 1985 Standard Test Method for Flow Rates of Thermoplastics by Extrusion Plastometer
    ASTM D 3935 : 2009 Standard Specification for Polycarbonate (PC) Unfilled and Reinforced Material
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