• ASTM F 2565 : 2013

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications

    Available format(s):  Hardcopy, PDF

    Superseded date:  26-05-2021

    Language(s):  English

    Published date:  28-08-2013

    Publisher:  American Society for Testing and Materials

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    Scope - (Show below) - (Hide below)

    1.1This guide covers extensively crosslinked ultra-high molecular weight polyethylene (UHMWPE) materials (fabricated forms) that are produced starting with virgin resin powders and consolidated forms meeting all the requirements of Test Method F648.

    1.2This guide does not cover fabricated forms of ultra-high molecular weight polyethylene which have received only gas plasma, ethylene oxide, or less than 40 kGy ionizing radiation treatments, that is, materials treated only by historical sterilization methods.

    1.3This guide pertains only to UHMWPE materials extensively crosslinked by gamma and electron beam sources of ionizing radiation.

    1.4The specific relationships between these mechanical properties and the in vivo performance of a fabricated form have not been determined. While trends are apparent, specific property-polymer structure and polymer-design relationships are not well understood. These mechanical tests are frequently used to evaluate the reproducibility of a fabrication procedure and are applicable for comparative studies of different materials.

    1.5The following precautionary caveat pertains only to the test method portion, Section 5, of this guide. 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.

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

    Committee F 04
    Document Type Guide
    Publisher American Society for Testing and Materials
    Status Superseded
    Superseded By
    Supersedes

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

    ASTM F 2091 : 2015 Standard Specification for Acetabular Prostheses (Withdrawn 2023)
    ASTM F 2665 : 2021 Standard Specification for Total Ankle Replacement Prosthesis

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

    ASTM F 2381 : 2010 Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy
    ASTM E 647 : 1995 Standard Test Method for Measurement of Fatigue Crack Growth Rates
    ASTM D 2765 : 2011 Standard Test Methods for Determination of Gel Content and Swell Ratio of Crosslinked Ethylene Plastics
    ASTM F 2003 : 2002 Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
    ASTM F 2102 : 2001 : EDT 1 Standard Guide for Evaluating the Extent of Oxidation in Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants
    ASTM F 2381 : 2019 Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy
    ASTM D 2765 : 2001 : R2006 Standard Test Methods for Determination of Gel Content and Swell Ratio of Crosslinked Ethylene Plastics
    ASTM F 2625 : 2007 Standard Test Method for Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry
    ASTM F 2003 : 2002 : R2015 Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
    ASTM F 2003 : 2002 : R2008 Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
    ASTM F 2214 : 2002 Standard Test Method forIn Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)
    ASTM F 2102 : 2006 : EDT 1 Standard Guide for Evaluating the Extent of Oxidation in Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants
    ASTM D 2765 : 2001 Standard Test Methods for Determination of Gel Content and Swell Ratio of Crosslinked Ethylene Plastics
    ASTM F 2625 : 2010 Standard Test Method for Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry
    ASTM D 1898 : 1968 : R1989 Standard Practice for Sampling of Plastics (Withdrawn 1998)
    ASTM F 2759 : 2019 Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
    ASTM F 648 : 2014 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
    ASTM F 2102 : 2017 Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants
    ASTM F 2759 : 2011 Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
    ASTM F 763 : 1999 Standard Practice for Short-Term Screening of Implant Materials
    ASTM F 2183 : 2002 : R2008 Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants (Withdrawn 2017)
    ASTM F 2759 : 2009 Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
    ASTM F 648 : 2021 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
    ASTM F 2381 : 2004 Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy
    ASTM F 2183 : 2002 Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants
    ASTM D 2765 : 2016 Standard Test Methods for Determination of Gel Content and Swell Ratio of Crosslinked Ethylene Plastics
    ASTM F 2214 : 2002 : R2008 Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)
    ASTM D 2765 : 1995 Standard Test Methods for Determination of Gel Content and Swell Ratio of Crosslinked Ethylene Plastics
    ASTM F 2102 : 2013 Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants
    ASTM F 2214 : 2016 Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)
    ASTM F 2102 : 2001 Standard Guide for Evaluating the Extent of Oxidation in Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants
    ASTM F 2003 : 2000 Standard Guide for Accelerated Aging of Ultra-High Molecular Weight Polyethylene
    ASTM F 2625 : 2010 : R2016 Standard Test Method for Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry
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