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ISO 10993-16
M00000245
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ISO 10993-16 3rd Edition, May 1, 2017 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
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Description / Abstract: This document provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices