标准摘要
[中文适用范围]： 本文件提供了通过体外降解研究的设计和执行来系统评估医疗器械的潜在降解和观察到的降解的一般原则。 从这些研究中获得的信息可用于本文件中描述的生物学评估，适用于设计用于在体内降解的材料以及不打算降解的材料。 本文件不适用于： a) 纯机械过程发生的降解评估；如果有的话，具体产品标准中描述了此类降解产物的生产方法；注：纯粹的机械降解主要导致颗粒物。 尽管这被排除在本文件的范围之外，但此类降解产物可以引起生物反应，并且可以按照 ISO 10993 的其他部分所述进行生物评估。 b) 非降解产物的可浸出成分； c) 不直接或间接接触患者身体的医疗器械或部件。 [外文原描述]： This document provides general principles for the systematic evaluation of the potential and observed degradation of medical devices through the design and performance of in vitro degradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series. This document is applicable to both materials designed to degrade in the body as well as materials that are not intended to degrade. This document is not applicable to: a) the evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of this type of degradation product are described in specific product standards, where available; NOTE Purely mechanical degradation causes mostly particulate matter. Although this is excluded from the scope of this document, such degradation products can evoke a biological response and can undergo biological evaluation as described in other parts of ISO 10993. b) leachable components which are not degradation products; c) medical devices or components that do not contact the patient's body directly or indirectly.
英文名称Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products