ISO 10993？13:2010提供了模拟环境中试验设计的一般要求，用于识别和量化成品聚合物医疗器械的降解产物，以供临床使用。 ISO 10993？13:2010描述了生成降解产物的两种试验方法，一种是作为筛选方法的加速降解试验，另一种是模拟环境中的实时降解试验。对于打算在原位聚合的材料，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？13:2010仅考虑不可吸收聚合物。类似但经过适当修改的程序可能适用于可吸收聚合物。 ISO 10993？13:2010仅考虑由成品聚合物装置的化学变化产生的降解产物。 本标准不适用于设备在预期使用期间因机械应力、磨损或电磁辐射或生物因素（如酶、其他蛋白质和细胞活性）导致的降解。

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.