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BS EN ISO 10993-16:2017
Biological evaluation of medical devices. Toxicokinetic study design for degradation products and leachables (British Standard)
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.
British Standards Institution [bsi]
