Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables included-in-kit products or beverages for human

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Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables included-in-kit products or beverages for human1 Scope 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.