Standard Guide for Characterization and Testing of Substrate Materials for Tissue-Engineered Medical Products
|Publication Date:||10 May 2000|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
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 standards and test methods and to provide guidance for interim use of materials for which a standard does not exist.