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See Chinese contents: YY/T 1815-2022 YY/T 1815-2022: Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
This document specifies the method that uses threshold of toxicological concern (TTC) to assess the biocompatibility of constituents of a medical device. This document applies to: - Compare with the maximum concentration of identified or unidentified constituents in an extract (see GB/T 16886.18); - Toxicological equivalence studies; - Comparison with the estimated maximum exposure dose for an identified constituent (see GB/T 16886.17).
