ASTM WK26326

    Work Item: ASTM WK26326 - New Guide for Characterization and Assessment of Heart Valve Tissue Engineered Medical Products

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    Developed by Subcommittee: F04.44 | Committee F04 | Contact Staff Manager



    1. Scope

    This guide is intended as a resource for individuals and organizations involved in the development, production, delivery, and regulation of tissue engineered medical products (TEMPs) intended for use in the surgical repair, replacement, and/or reconstruction of heart valves.

    A standard guide is needed for the characterization and assessment of tissue-engineered medical products (TEMPs) that will be used by government agencies such as the FDA, companies who develop these products, and companies who develop test equipment for the characterization of these TEMPS. There is currently no standard for tissue-engineered heart valves.


    Keywords

    valve leaflets, calcification, valvular cells, endothelial cells

    The title and scope are in draft form and are under development within this ASTM Committee.

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    Work Item Status

    Date Initiated:
    11-12-2009

    Technical Contact:
    Chrysanthi Williams

    Status:
    Draft Under Development