标准编号：ISO 10993-16:2010
中文名称：医疗器械的生物学评价 第16部分：降解产物和可溶出物的毒代动力学研究设计
英文名称：Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
发布日期：2010-02
标准范围
This part of ISO 10993 gives principles on how toxicokinetic studies relevant to medical devices should bedesigned and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in thebiological evaluation of medical devices.
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