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Standard Guide for Characterization and Testing of Substrate Materials for Tissue-Engineered Medical Products
1.1 This guide addresses material characteristics of raw or virgin materials in a non-fabricated form that will ultimately undergo additional processing into growth, support, or delivery vehicles for cells or biomolecules. This guide does not apply to packaged, sterilized, and finished tissue-engineered medical products.
1.2 The purpose of the guide is to assist the developer of tissue-engineered medical products to locate relevant existing StandardDetails and test methods and to provide guidance for interim use of materials for which a standard does not exist.
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