ISO 10993-13:2010 医疗设备的生物评估 第13部分：聚合医疗设备的降解产品的识别和量化

标准编号：ISO 10993-13:2010

中文名称：医疗设备的生物评估 第13部分：聚合医疗设备的降解产品的识别和量化

英文名称：Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices

发布日期：2010-06

标准范围

This part of ISO 10993 provides general requirements for the design of tests in a simulated environment foridentifying and quantifying degradation products from finished polymeric medical devices ready for clinical use.This part of ISO 10993 describes two test methods to generate degradation products, an accelerateddegradation test as a screening method and a real-time degradation test in a simulated environment. Formaterials that are intended to polymerize in situ, the set or cured polymer is used for testing. The datagenerated are used in the biological evaluation of the polymer. This part of ISO 10993 considers only nonresorbablepolymers. Similar but appropriately modified procedures may be applicable for resorbablepolymers.This part of ISO 10993 considers only those degradation products generated by a chemical alteration of thefinished polymeric device. It is not applicable to degradation of the device induced during its intended use bymechanical stress, wear or electromagnetic radiation or biological factors such as enzymes, other proteinsand cellular activity.

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