Tissue Engineered Medical Products (TEMPs)

    Schutte E, Picciolo GL, Kaplan D
    Published: 2004

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    Written by an international group of industry experts, regulators, and academics, this new ASTM publication provides the latest data on tissue engineering and the standards available for manufacturing TEMPs.

    Twenty-three peer-reviewed papers cover:
    • Current Technology
    • Existing Standards
    • Development of New Standards
    • International Standards Used by Regulatory Bodies

    This new publication serves as a valuable resource for regulators, manufacturers, suppliers, developers, academics, patent examiners, and lawyers.

    Table of Contents

    Measurement of Pore Size and Porosity of Tissue Scaffolds
    Grant P., James S., Mikhalovska L., Mikhalovsky S., Tomlins P.

    Development and Validation of a Detection Method for a Broad Range of Human Papillomavirus Types
    Black J., Collins T., Galbraith D., Lovatt A., McManus B., McMutrie D.

    Bronchoscopic Lung Volume Reduction — A Novel Tissue Engineering Treatment for Advanced Emphysema
    Berger R., Hoffman A., Ingenito E., Tsai L.

    NIST and Standards for Tissue Engineered Medical Products
    Karam L., Tesk J.

    Mechanical Evaluation of Allograft Bone
    Bianchi J., Squillace D., Summitt M.

    Method to Determine Germicidal In activation in Allograft Processing
    Bianchi J., Chang J., Mills C., Roberts M., Summitt M.

    Towards In-Situ Monitoring of Cell Growth in Tissue Engineering Scaffolds: High Resolution Optical Techniques
    Cicerone M., Dunkers J., Washburn N.

    Cartilage Mechanical Properties after Injury
    Bergula A., Chen P., Colwell C., D'Lima D., Lotz M., Steklov N.

    Age Related Differences in Chondrocyte Viability and Biosynthetic Response to Mechanical Injury
    Bergula A., Chen P., Colwell C., D'Lima D., Lotz M.

    A Comparative Study of Biomarkers of Oxidative DNA Damage Used to Detect Free Radical Damage in Tissue-Engineered Skin
    Barker P., Birincioglu M., Dizdaroglu M., Jaruga P., O'Connell C., Rodriguez H.

    Endpoint Verification of Bone Demineralization for Tissue Engineering Applications
    Burg K., Jenkins L., Kellam J., Thomas C.

    Comparative Study of Bone Cell Culture Methods for Tissue Engineering Applications
    Burg K., Kellam J., Thomas C.

    A New Method for Real-Time and In-Situ Characterization of the Mechanical and Material Properties of Biological Tissue Constructs
    Gilbert J., Zhang G.

    Alginate and Chitosan Standards for Tissue Engineered Medical Products
    Dessen A., Dornish M.

    Biomolecules in Tissue Engineered Medical Products (TEMPs): A Case Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)
    Denton M., Porter T., Rathore S., Rouse J.

    Development of Standards for the Characterization of Natural Materials Used in Tissue Engineered Medical Products (TEMPs)
    Kaplan D.

    Microbiological Safety and Adventitious Agents Standards for TEMPS
    Sofer G.

    Standards Used in Meeting Requirements for a Model Pre-Market Approval (PMA) of a Neural Guidance Conduit
    Hubel A., Stover L.

    Storage and Transport Issues for Tissue Engineered Medical Products
    Brockbank K., Taylor M., Walsh J.

    The European Situation on Standards for Tissue Engineering Products
    Schutte E.

    A European View on Risk Management Strategies for Tissue Engineered Medical Products (TEMPs)
    Geertsma R., Kallewaard M., Wassenaar C.

    Molecular Biomarkers Used to Detect Cellular/Genetic Damage in Tissue-Engineered Skin
    Atha D., Barker P., Birincioglu M., Jaruga P., Marino M., McAndrew P., O'Connell C., Rodriguez H.

    A Useful Marker for Evaluating the Safety and Efficacy of Tissue Engineered Products
    Tsuchiya T.

    Author Index

    Subject Index

    Committee: F04

    DOI: 10.1520/STP1452-EB

    ISBN-EB: 978-0-8031-5497-1

    ISBN-13: 978-0-8031-3471-3

    ASTM International is a member of CrossRef.