Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products
IDT ISO 10993-9:2009
全国医疗器械生物学评价标准化技术委员会(SAC/TC 248)
GB/T 16886的本部分为系统评价医疗器械潜在的和已观察到的生物降解以及生物降解研究的设计与实施提供了基本原则。
GB/T 16886的本部分不适用于：
a)〓对单纯由机械过程而引起降解的评价；生成这类降解产物的方法学可视情况在具体产品标准中规定；
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