BS EN ISO 10993-13:2010提供了在模拟环境中进行试验设计的一般要求 识别和量化成品聚合物医疗器械的降解产物，以备临床使用。BS EN ISO 10993-13:2010描述了产生降解产物的两种试验方法，一种是加速试验 降解试验作为一种筛选方法，并在模拟环境中进行实时降解试验。对于 用于原位聚合的材料，凝固或固化的聚合物用于测试。数据 生成的聚合物用于聚合物的生物评价。ISO 10993的这一部分仅考虑不可回收性 聚合物。类似但经过适当修改的程序可能适用于可再吸收材料 聚合物。BS EN ISO 10993-13:2010仅考虑由化学物质变化产生的降解产物 成品聚合物装置。本标准不适用于设备在预期使用过程中因以下原因导致的退化: 机械应力、磨损或电磁辐射或生物因素，如酶、其他蛋白质 和细胞活动。注:一篇讨论聚合物环境应力开裂（ESC）的信息性文本作为一种潜在的辅助手段 降解研究的设计（见附录B）。本部分未涉及碎屑和可溶性降解产物的生物活性 ISO 10993，但应根据ISO 10993-1、ISO 10993-16和 ISO 10993-17。由于医疗器械中使用的聚合物材料种类繁多，因此没有专门的分析技术 被识别或给予优先权。未对降解产物的可接受水平提出具体要求 在BS EN ISO 10993中提供- 13:2010交叉引用:ISO 3696ISO 10993-1ISO 10993-9ISO 10993-12ISO 10993-17ISO 13781ISO 1497193/42/EEC90/385/EECAll购买本文件时提供的当前修订包括在购买本文件中。

BS EN 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.BS EN 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. This part of ISO 10993 considers only nonresorbable polymers. Similar but appropriately modified procedures may be applicable for resorbable polymers.BS EN 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.NOTE An informative text discussing environmental stress cracking (ESC) of polymers is included as a potential aid to the design of degradation studies (see Annex B).The biological activity of the debris and soluble degradation products is not addressed in this part of ISO 10993, but should be evaluated according to the principles of ISO 10993-1, ISO 10993-16 and ISO 10993-17.Because of the wide range of polymeric materials used in medical devices, no specific analytical techniques are identified or given preference. No specific requirements for acceptable levels of degradation products are provided in BS EN ISO 10993-13:2010Cross References:ISO 3696ISO 10993-1ISO 10993-9ISO 10993-12ISO 10993-17ISO 13781ISO 1497193/42/EEC90/385/EECAll current amendments available at time of purchase are included with the purchase of this document.