ISO 10993-16:2017 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

标准编号：ISO 10993-16:2017

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：2017-05

标准范围

This document 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.

标准预览图