ISO 10993-16:2017 Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables

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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.
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Status: Active ChangeNumber: 3 InternationalClassificationCodeOfStandards: 11.100.20 TechnicalCommittee: ISO/TC 194 ActivatedDate: 05.09.2022 PagesCount: 13 Language: en

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