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  • ISO 17853:2011

    Current The latest, up-to-date edition.

    Wear of implant materials Polymer and metal wear particles Isolation and characterization

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English, Russian

    Published date:  16-02-2011

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 17853:2011 specifies methods for sampling wear particles generated by joint replacement implants in humans and in joint simulators. It specifies the apparatus, reagents and test methods to isolate and characterize both polymer and metal wear particles from samples of tissues excised from around the joint replacement implant, obtained at revision surgery or post mortem, and from samples of joint simulator test fluids. Some of these procedures could certainly be adapted for isolation and characterization of particles from human biological fluids (e.g. synovial fluid).

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    Development Note Supersedes ISO/DIS 17853. (02/2011)
    Document Type Standard
    Product Note THIS STANDARD ALSO REFERS TO ASTM F 1877-05
    Publisher International Organization for Standardization
    Status Current
    Supersedes

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

    S.R. CWA 17253-2:2018 JOINT IMPLANTS - PART 2: TIERED TOOLKIT APPROACH TO EVALUATE THE BIOLOGICAL IMPACT OF WEAR PARTICLES FROM JOINT REPLACEMENTS AND RELATED DEVICES
    DD ISO/TS 10993-19:2006 Biological evaluation of medical devices Physico-chemical, morphological and topographical characterization of materials
    S.R. CWA 17253-1:2018 JOINT IMPLANTS - PART 1: NOVEL METHODS FOR ISOLATING WEAR PARTICLES FROM JOINT REPLACEMENTS AND RELATED DEVICES
    ANSI/AAMI/ISO TIR10993-19:2006 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 19: PHYSICOCHEMICAL, MORPHOLOGICAL, AND TOPOGRAPHICAL CHARACTERIZATION OF MATERIALS
    ASTM F 3018 : 2017 Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
    ISO/TR 10993-22:2017 Biological evaluation of medical devices — Part 22: Guidance on nanomaterials
    ASTM F 3047M : 2015 Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations
    ISO/TS 10993-19:2006 Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials
    PD ISO/TR 10993-22:2017 Biological evaluation of medical devices Guidance on nanomaterials
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