【国外标准】 Standard Guide for Testing and Characterization of Alginate Foam Scaffolds Used in Tissue-Engineered Medical Products (TEMPs)

5.1 This guide is a guideline for the characterizing and testing of alginate foam scaffolds used in tissue-engineered medical products. Alginate foam scaffolds can be used in a number of tissue engineering and regenerative medicine applications such as anti-adhesion, internal wound healing, and guided tissue regeneration. In addition, alginate foam can be used as a matrix for cell-based cell therapies and for the release of bioactive agents.1.1 Consistent functionality of scaffolds used in TEMPs can be made more predictable by monitoring relevant characteristics related to physical and biological properties. This guide may be used in the 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 Guides 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 Only 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.