STP1452

    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

    Development and Validation of a Detection Method for a Broad Range of Human Papillomavirus Types

    Bronchoscopic Lung Volume Reduction — A Novel Tissue Engineering Treatment for Advanced Emphysema

    NIST and Standards for Tissue Engineered Medical Products

    Mechanical Evaluation of Allograft Bone

    Method to Determine Germicidal In activation in Allograft Processing

    Towards In-Situ Monitoring of Cell Growth in Tissue Engineering Scaffolds: High Resolution Optical Techniques

    Cartilage Mechanical Properties after Injury

    Age Related Differences in Chondrocyte Viability and Biosynthetic Response to Mechanical Injury

    A Comparative Study of Biomarkers of Oxidative DNA Damage Used to Detect Free Radical Damage in Tissue-Engineered Skin

    Endpoint Verification of Bone Demineralization for Tissue Engineering Applications

    Comparative Study of Bone Cell Culture Methods for Tissue Engineering Applications

    A New Method for Real-Time and In-Situ Characterization of the Mechanical and Material Properties of Biological Tissue Constructs

    Alginate and Chitosan Standards for Tissue Engineered Medical Products

    Biomolecules in Tissue Engineered Medical Products (TEMPs): A Case Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)

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

    Microbiological Safety and Adventitious Agents Standards for TEMPS

    Standards Used in Meeting Requirements for a Model Pre-Market Approval (PMA) of a Neural Guidance Conduit

    Storage and Transport Issues for Tissue Engineered Medical Products

    The European Situation on Standards for Tissue Engineering Products

    A European View on Risk Management Strategies for Tissue Engineered Medical Products (TEMPs)

    Molecular Biomarkers Used to Detect Cellular/Genetic Damage in Tissue-Engineered Skin

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

    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.

    0-8031-3471-1
    978-0-8031-3471-3
    STP1452-EB