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  • ASTM F 1925 : 1999 : R2005

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 Virgin Poly(L-Lactic Acid) Resin for Surgical Implants

    Available format(s):  Hardcopy, PDF

    Superseded date:  11-11-2014

    Language(s):  English

    Published date:  01-03-2005

    Publisher:  American Society for Testing and Materials

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    1.1 This specification covers virgin poly(L-lactic acid) resin (or abbreviated as PLLA resin) intended for use in surgical implants. This specification does not cover stereoisomeric composition based on various D, L, DL copolymer ratios.

    1.2 This specification addresses material characteristics of virgin poly(L-lactic acid) resin and does not apply to packaged and sterilized finished implants fabricated from this material.

    1.3 As with any material, some characteristics may be altered by processing techniques (such as molding, extrusion, machining, assembly, sterilization, etc.) required for the production of a specific part or device. Therefore, properties of fabricated forms of this resin should be evaluated using those test methods which are appropriate to assure safety and efficacy.

    1.4 The values stated in SI units are to be regarded as the standard.

    1.5 The following precautionary statement pertains only to the test method portion, Section 6, of this specification: 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.

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    Committee F 04
    Document Type Standard
    Product Note Reconfirmed 2005
    Publisher American Society for Testing and Materials
    Status Superseded
    Superseded By
    Supersedes

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

    ASTM F 2313 : 2018 Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide
    ASTM F 2579 : 2018 Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
    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 2902 : 2016 : EDT 1 Standard Guide for Assessment of Absorbable Polymeric Implants
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