General requirements of tissue-engineered medical products
General requirements of tissue-engineered medical products
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What is ISO/TS 21560 about?
ISO/TS 21560 is an international standard that specifies general requirements for tissue-engineered medical products (TEMPs), which are used in regenerative medicine. About safety, ISO/TS 21560 outlines requirements for materials, manufacture, quality control, and unintentional biological effects elicited by TEMPs. Note 1: ISO/TS 21560 does not address the requirements for clinical trials and efficacy. Note 2: ISO/TS 21560 is not applicable to tissue-engineered products used for diagnosis, ex-vivo testing or extracorporeal treatments of patients. Note 3: The combi...
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