标准摘要
[中文适用范围]： ISO 10993 的这一部分提供了模拟环境中测试设计的一般要求，用于识别和量化可供临床使用的成品聚合物医疗器械的降解产物。 ISO 10993的这一部分描述了两种产生降解产物的测试方法，作为筛选方法的加速降解测试和模拟环境中的实时降解测试。 对于打算原位聚合的材料，使用凝固或固化的聚合物进行测试。 生成的数据用于聚合物的生物学评估。 ISO 10993 的这一部分仅考虑不可吸收的聚合物。 类似但适当修改的程序可适用于可再吸收聚合物。 ISO 10993 的这一部分仅考虑由成品聚合物装置的化学变化产生的降解产物。 它不适用于在预期使用过程中由于机械应力、磨损或电磁辐射或生物因素（例如酶、其他蛋白质和细胞活动）引起的设备降解。 [外文原描述]： ISO 10993‑13:2010 provides general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use. ISO 10993‑13:2010 describes two test methods to generate degradation products, an accelerated degradation test as a screening method and a real-time degradation test in a simulated environment. For materials that are intended to polymerize in situ , the set or cured polymer is used for testing. The data generated are used in the biological evaluation of the polymer. ISO 10993‑13:2010 considers only non-resorbable polymers. Similar, but appropriately modified procedures may be applicable for resorbable polymers. ISO 10993‑13:2010 considers only those degradation products generated by a chemical alteration of the finished polymeric device. It is not applicable to degradation of the device induced during its intended use by mechanical stress, wear or electromagnetic radiation or biological factors such as enzymes, other proteins and cellular activity.
英文名称Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices