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  • ASTM F 1538 : 2003

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation

    Available format(s):  Hardcopy, PDF

    Superseded date:  11-11-2014

    Language(s):  English

    Published date:  10-04-2003

    Publisher:  American Society for Testing and Materials

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    Abstract - (Show below) - (Hide below)

    CONTAINED IN VOL. 13.01, 2017 Defines the material requirements and characterization techniques for glass and glass-ceramic biomaterials intended for use as bulk porous or powdered surgical implants, or as coatings on surgical devices, but not including drug delivery systems.

    Scope - (Show below) - (Hide below)

    1.1 This specification covers the material requirements and characterization techniques for glass and glass-ceramic biomaterials intended for use as bulk porous or powdered surgical implants, or as coatings on surgical devices, but not including drug delivery systems.

    1.2 The biological response to glass and glass-ceramic biomaterials in bone and soft tissue has been demonstrated in clinical use (1-12)2 and laboratory studies (13-17).

    1.3 This specification excludes synthetic hydroxylapatite, hydroxylapatite coatings, aluminum oxide ceramics, alpha- and beta-tricalcium phosphate, and whitlockite.

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

    Committee F 04
    Document Type Standard
    Product Note Reconfirmed 2003
    Publisher American Society for Testing and Materials
    Status Superseded
    Superseded By
    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 E 228 : 2017 : REDLINE Standard Test Method for Linear Thermal Expansion of Solid Materials With a Push-Rod Dilatometer
    CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
    ASTM C 693 : 1993 TEST METHOD FOR DENSITY OF GLASS BY BUOYANCY
    ASTM C 158 : 2002 Standard Test Methods for Strength of Glass by Flexure (Determination of Modulus of Rupture)
    ASTM F 748 : 2016 : REDLINE Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
    ASTM C 169 : 2016 : REDLINE Standard Test Methods for Chemical Analysis of Soda-Lime and Borosilicate Glass
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