标准摘要
[中文适用范围]： 本文件提供了设计和执行与医疗器械相关的毒代动力学研究的原则。 附录 A 描述了将毒代动力学研究纳入医疗器械生物学评价的考虑因素。 [外文原描述]： 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.
英文名称Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables