1.1 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 vascular grafts. 1.2 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 to determine the applicability of regulatory limitations prior to use.
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 vascular grafts.
Keywordsvascular prosthesis; tissue-engineered vascular graft; tissue-engineered vascular construct; vascular scaffold; vascular biomaterial
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top
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