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  • ASTM F 1635 : 2016 : REDLINE

    Current The latest, up-to-date edition.

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

    Available format(s):  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)

    CONTAINED IN VOL. 13.01, 2017 Describes 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 Redline
    Publisher American Society for Testing and Materials
    Status Current

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

    ASTM F 3225 : 2017 Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs)
    PD ISO/TS 17137:2014 Cardiovascular implants and extracorporeal systems. Cardiovascular absorbable implants
    BS ISO 13781:2017 Implants for surgery. Homopolymers, copolymers and blends on poly(lactide). In vitro degradation testing
    ISO/TS 17137:2014 Cardiovascular implants and extracorporeal systems Cardiovascular absorbable implants
    AAMI ISO TIR 17137 : 2014 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIOVASCULAR ABSORBABLE IMPLANTS
    ASTM F 2027 : 2016 : REDLINE Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
    ASTM F 2150 : 2013 : REDLINE Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products
    ASTM F 2502 : 2017 : REDLINE Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
    ASTM F 2224 : 2009 : R2014 Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
    ASTM F 3036 : 2013 Standard Guide for Testing Absorbable Stents
    ISO 13781:2017 Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing
    ASTM F 2903 : 2011 Standard Guide for Tissue Engineered Medical Products (TEMPs) for Reinforcement of Tendon and Ligament Surgical Repair (Withdrawn 2020)
    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)
    15/30296854 DC : 0 BS ISO 13781 - INPLANTS FOR SURGERY - HOMOPOLYMERS, COPOLYMERS AND BLENDS ON POLY(LACTIDE) - IN VITRO DEGRADATION TESTING
    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 3260 : 2018 : REDLINE Standard Test Method for Determining the Flexural Stiffness of Medical Textiles
    ASTM F 2224 : 2009 Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants

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

    ASTM D 2857 : 2016 Standard Practice for Dilute Solution Viscosity of Polymers
    ASTM D 671 : 1993 Standard Test Method for Flexural Fatigue of Plastics by Constant-Amplitude-of-Force (Withdrawn 2002)
    ISO 13781:2017 Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing
    ASTM D 790 : 2017 : REDLINE Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
    ASTM F 748 : 2016 : REDLINE Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
    ASTM D 695 : 2015 : REDLINE Standard Test Method for Compressive Properties of Rigid Plastics
    ASTM D 1822 : 2013 : REDLINE Standard Test Method for Tensile-Impact Energy to Break Plastics and Electrical Insulating Materials
    ASTM D 638 : 2014 : REDLINE Standard Test Method for Tensile Properties of Plastics
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