• ASTM F 763 : 2004

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    Standard Practice for Short-Term Screening of Implant Materials

    Available format(s):  Hardcopy, PDF

    Superseded date:  11-11-2014

    Language(s):  English

    Published date:  01-05-2004

    Publisher:  American Society for Testing and Materials

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    Abstract - (Show below) - (Hide below)

    CONTAINED IN VOL. 13.01, 2016 Gives guidelines for short-term testing or screening of candidate materials, both porous and dense, as to the effects of the material on animal tissue in which it is implanted.

    Scope - (Show below) - (Hide below)

    1.1 This practice provides guidelines for short-term testing or screening of candidate materials, both porous and dense, as to the effects of the material on animal tissue in which it is implanted. This is a rapid screening prodedure for determining acceptability of candidate materials.

    1.2 This practice, along with other appropriate biological tests (including other appropriate ASTM tests) may be used in the biocompatibility assessment of the candidate materials for use in the fabrication of devices for clinical application.

    1.3 This experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, carcinogenicity, teratogenicity, or mutagenicity of the material since other standards deal with these issues.

    1.4 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F 748 provides guidance for the selection of appropriate methods for testing materials for a specific application.

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

    Committee F 04
    Document Type Standard Practice
    Product Note Reconfirmed 2004
    Publisher American Society for Testing and Materials
    Status Superseded
    Superseded By
    Supersedes

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

    ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation

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

    ASTM F 86 : 2013 : REDLINE Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
    ASTM F 563 : 2000 Standard Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical Implant Applications (UNS R30563) (Withdrawn 2005)
    ASTM F 90 : 2014 : REDLINE Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)
    ASTM F 136 : 2013 : REDLINE Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
    ASTM F 748 : 2016 : REDLINE Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
    ASTM F 562 : 2013 : REDLINE Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
    ASTM F 648 : 2014 : REDLINE Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
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