ISO 10993-9:2019 医疗器械的生物学评价 第9部分：潜在降解产物的定性和定量框架

标准编号：ISO 10993-9:2019

中文名称：医疗器械的生物学评价 第9部分：潜在降解产物的定性和定量框架

英文名称：Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products

发布日期：2019-11

标准范围

本文件提供了通过体外降解研究的设计和性能，系统评估医疗器械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ISO 10993系列中描述的生物学评估。本文件适用于设计用于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） 评估纯机械过程中发生的降解；具体产品标准（如适用）中描述了此类降解产品的生产方法；注:纯机械降解主要导致颗粒物。虽然这不在本文件的范围内，但此类降解产物可引发生物反应，并可按照ISO 10993的其他部分进行生物评估。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设备或部件。

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.

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