DS DS/EN ISO 10993-16
DS DSEN SO 10993-16 2010-MAR-29 Bologcal evaluaton of medcal devces - Part 16 Toxcoknetc study desgn for degradaton products and leachables
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This part of ISO 10993 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.