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ISO 10993-16:2017 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
standard by International Organization for Standardization, 05/01/2017
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ISO 10993-16:2017 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.