BS EN ISO 10993-13-2010 医疗器械的生物学评价.聚合物医疗器械降解产物的鉴定与定量

标准号：BS EN ISO 10993-13-2010
中文标准名称：医疗器械的生物学评价.聚合物医疗器械降解产物的鉴定与定量
英文标准名称：Biological evaluation of medical devices. Part 13: Identification and quantification of degradation products from polymeric medical devices
标准类型：C37
发布日期：2010/10/31 12:00:00
实施日期：2010/10/31 12:00:00
中国标准分类号：C37
国际标准分类号：11.100.20
适用范围：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.NOTE An informative text discussing environmental stress cracking (ESC) of polymers is included as a potential aidto the design of degradation studies (see Annex B).The biological activity of the debris and soluble degradation products is not addressed in this part ofISO 10993, but should be evaluated according to the principles of ISO 10993-1, ISO 10993-16 andISO 10993-17.Because of the wide range of polymeric materials used in medical devices, no specific analytical techniquesare identified or given preference. No specific requirements for acceptable levels of degradation products areprovided in this part of ISO 10993.