1. Scope
This guide is intended as a resource for individuals and organizations involved in the development, production, delivery, and regulation of tissue engineered medical products (TEMPs) intended for use in the surgical repair, replacement, and/or reconstruction of heart valves.
A standard guide is needed for the characterization and assessment of tissue-engineered medical products (TEMPs) that will be used by government agencies such as the FDA, companies who develop these products, and companies who develop test equipment for the characterization of these TEMPS. There is currently no standard for tissue-engineered heart valves.
Keywords
valve leaflets, calcification, valvular cells, endothelial cells
The title and scope are in draft form and are under development within this ASTM Committee.
Citing ASTM Standards
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