Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products

1.1 This guide is a resource of currently available test methods for the characterization of biomaterial scaffolds used to develop and manufacture tissue-engineered medical products (TEMPs).

1.2 The test methods contained herein guide characterization of the bulk physical, chemical, mechanical, and surface properties of a scaffold construct. Such properties may be important for the success of a TEMP, especially if they affect cell retention, activity and organization, the delivery of bioactive agents, or the biocompatibility and bioactivity within the final product.

1.3 This guide may be used as guidance in the selection of appropriate test methods for the generation of a raw material or original equipment manufacture (OEM) specification. This guide also may be used to characterize the scaffold component of a finished medical product.

1.4 This guide addresses natural, synthetic, or combination scaffold materials with or without bioactive agents or biological activity. This guide does not address the characterization or release profiles of any biomolecules, cells, drugs, or bioactive agents that are used in combination with the scaffold.

1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory requirements prior to use.