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  • ASTM F 2026 : 2017

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    Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  15-11-2017

    Publisher:  American Society for Testing and Materials

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    Scope - (Show below) - (Hide below)

    1.1This specification covers polyetheretherketone (PEEK) polymer in virgin forms as supplied by a vendor (pellets, powder, fabricated forms, and so forth). It provides requirements and associated test methods for these thermoplastics when they are to be used in the manufacture of intracorporeal devices such as surgical implants or components of surgical or dental devices.

    1.2The properties included in this specification are those applicable for PEEK polymers only. Indicated properties are for fabricated forms. Materials or forms containing colorants, fillers, processing aids, or other additives, as well as polymer blends which contain PEEK, or reclaimed materials, are not covered by this specification.

    1.3This specification is designed to recommend physical, chemical, and biological test methods to establish a reasonable level of confidence concerning the performance of virgin PEEK polymers for use in medical implant devices.

    1.4The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

    1.5When evaluating material in accordance with this specification, hazardous materials, operations, and equipment may be involved. 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.

    1.6This 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
    Publisher American Society for Testing and Materials
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    ASTM F 2027 : 2016 Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products

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

    ASTM D 3418 : 2012 : EDT 1 Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
    ASTM D 4000 : 2013 Standard Classification System for Specifying Plastic Materials
    ASTM D 3418 : 1982 : R1988 : EDT 1 Standard Test Method for Transition Temperatures of Polymers By Thermal Analysis
    ASTM D 3418 : 1999 Standard Test Method for Transition Temperatures of Polymers By Differential Scanning Calorimetry
    ASTM D 4000 : 2003 : REV A Standard Classification System for Specifying Plastic Materials
    ASTM D 3418 : 2021 Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
    ASTM D 4000 : 2000 : REV A Standard Classification System for Specifying Plastic Materials
    ASTM D 4000 : 2012 Standard Classification System for Specifying Plastic Materials
    ASTM D 4000 : 2009 Standard Classification System for Specifying Plastic Materials
    ASTM D 4000 : 2011 Standard Classification System for Specifying Plastic Materials
    ASTM D 1505 : 2003 Standard Test Method for Density of Plastics by the Density-Gradient Technique
    ASTM D 4000 : 2004 : EDT 1 Standard Classification System for Specifying Plastic Materials
    ASTM D 3418 : 2012 Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
    ASTM D 3418 : 2003 Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
    ASTM D 3418 : 2015 Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
    ASTM D 4000 : 2009 : REV B Standard Classification System for Specifying Plastic Materials
    ASTM D 4000 : 2000 Standard Classification System for Specifying Plastic Materials
    ASTM D 4000 : 2010 : REV A Standard Classification System for Specifying Plastic Materials
    ASTM D 4000 : 2007 Standard Classification System for Specifying Plastic Materials
    ASTM D 4000 : 2009 : REV A Standard Classification System for Specifying Plastic Materials
    ASTM D 4000 : 2001 Standard Classification System for Specifying Plastic Materials
    ASTM D 4000 : 2008 Standard Classification System for Specifying Plastic Materials
    ASTM D 1505 : 1968 : R1979 Standard Test Method for Density Of Plastics By The Density-Gradient Technique
    ASTM D 3418 : 2008 Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
    ASTM D 4000 : 2001 : REV A : EDT 1 Standard Classification System for Specifying Plastic Materials
    ASTM D 4000 : 2004 Standard Classification System for Specifying Plastic Materials
    ASTM D 1505 : 2010 Standard Test Method for Density of Plastics by the Density-Gradient Technique
    ASTM D 1505 : 2018 Standard Test Method for Density of Plastics by the Density-Gradient Technique
    ASTM D 1505 : 1998 : EDT 1 Standard Test Method for Density of Plastics by the Density-Gradient Technique
    ASTM D 4000 : 2010 Standard Classification System for Specifying Plastic Materials
    ASTM D 4000 : 2003 Standard Classification System for Specifying Plastic Materials
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