1.1 Consistent functionality of scaffolds used in TEMPs can be predictable by monitoring relevant characteristics related to physical and biological properties. This guide may be used in selection of suitable test methods of dried ionically gelled alginate foam scaffolds that may be a component of a medical device or considered a medical device itself. 1.2 This guide provides information relevant for the physical testing of alginate foam scaffolds such as mechanical properties, hydration properties, pore structure and scaffold degradation. In addition, issues related to biological properties such as elemental impurities, bacterial bioburden, bacterial endotoxins, sterility, and biocompatibility are outlined. 1.3 This guide is intended to be used in conjunction with appropriate characterization and evaluation of any raw or starting materials utilized for fabrication of the alginate foam, such as described in Guide F2027 and F2064. 1.4 This guide addresses alginate foam scaffolds with and 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 Solely SI units are used in this standard. 1.6 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 limitations prior to use.
KeywordsAlginate, sodium alginate, foam, scaffold, tissue-engineered medical product, biocompatibility, implantation
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top
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