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  • ASTM F 1635 : 2016

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    Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-12-2016

    Publisher:  American Society for Testing and Materials

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    Abstract - (Show below) - (Hide below)

    This test method covers in vitro degradation of hydrolytically degradable polymers (HDP) intended for use in surgical implants.

    Scope - (Show below) - (Hide below)

    1.1This test method covers in vitro degradation of hydrolytically degradable polymers (HDP) intended for use in surgical implants.

    1.2The requirements of this test method apply to HDPs in various forms:

    1.2.1Virgin polymer resins, or

    1.2.2Any form fabricated from virgin polymer such as a semi-finished component of a finished product, a finished product, which may include packaged and sterilized implants, or a specially fabricated test specimen.

    1.3This test method provides guidance for mechanical loading or fluid flow, or both, when relevant to the device being evaluated. The specifics of loading type, magnitude, and frequency for a given application are beyond the scope of this test method.

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

    1.5This 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 Test Method
    Publisher American Society for Testing and Materials
    Status Current
    Supersedes

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

    ASTM F 3260 : 2018 Standard Test Method for Determining the Flexural Stiffness of Medical Textiles
    ASTM F 561 : 2019 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
    ASTM F 2883 : 2011 Standard Guide for Characterization of Ceramic and Mineral Based Scaffolds used for Tissue-Engineered Medical Products (TEMPs) and as Device for Surgical Implant Applications (Withdrawn 2020)
    ASTM F 2027 : 2016 Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
    ASTM F 2502 : 2017 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
    ASTM F 2150 : 2013 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products
    ASTM F 3225 : 2017 Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs)
    ASTM F 3223 : 2017 Standard Guide for Characterization and Assessment of Tissue Engineered Medical Products (TEMPs) for Knee Meniscus Surgical Repair and/or Reconstruction
    ASTM F 3036 : 2013 Standard Guide for Testing Absorbable Stents
    ASTM F 2224 : 2009 : R2014 Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
    ASTM F 2903 : 2011 Standard Guide for Tissue Engineered Medical Products (TEMPs) for Reinforcement of Tendon and Ligament Surgical Repair (Withdrawn 2020)

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

    ASTM D 2857 : 2016 Standard Practice for Dilute Solution Viscosity of Polymers
    ASTM D 1708 : 1996 Standard Test Method for Tensile Properties of Plastics By Use of Microtensile Specimens
    ASTM D 1708 : 2006 : REV A Standard Test Method for Tensile Properties of Plastics by Use of Microtensile Specimens
    ASTM D 2857 : 1995 : R2001 Standard Practice for Dilute Solution Viscosity of Polymers
    ASTM D 2857 : 1995 Standard Practice for Dilute Solution Viscosity of Polymers
    ASTM D 1708 : 2002 Standard Test Method for Tensile Properties of Plastics By Use of Microtensile Specimens
    ASTM D 1708 : 2006 Standard Test Method for Tensile Properties of Plastics by Use of Microtensile Specimens
    ASTM D 2857 : 1995 : R2007 Standard Practice for Dilute Solution Viscosity of Polymers (Withdrawn 2016)
    ASTM D 2857 : 1970 : R1977 Standard Test Method for Dilute Solution Viscosity Of Polymers
    ASTM D 2857 : 2022 Standard Practice for Dilute Solution Viscosity of Polymers
    ASTM D 1822 : 2013 Standard Test Method for Tensile-Impact Energy to Break Plastics and Electrical Insulating Materials
    ASTM D 1822 : 2006 Standard Test Method for Tensile-Impact Energy to Break Plastics and Electrical Insulating Materials
    ASTM D 638 : 2014 Standard Test Method for Tensile Properties of Plastics
    ASTM D 1822 : 1999 Standard Test Method for Tensile-Impact Energy to Break Plastics and Electrical Insulating Materials
    ASTM D 1822 : 2021 Standard Test Method for Determining the Tensile-Impact Resistance of Plastics
    ASTM D 1708 : 2013 Standard Test Method for Tensile Properties of Plastics by Use of Microtensile Specimens
    ASTM D 1708 : 2010 Standard Test Method for Tensile Properties of Plastics by Use of Microtensile Specimens
    ASTM D 1708 : 2002 : REV A Standard Test Method for Tensile Properties of Plastics By Use of Microtensile Specimens
    ASTM D 1708 : 2018 Standard Test Method for Tensile Properties of Plastics by Use of Microtensile Specimens
    ASTM D 638 : 2022 Standard Test Method for Tensile Properties of Plastics
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