標(biāo)準(zhǔn)號：BS EN ISO 10993-13-2010
中文標(biāo)準(zhǔn)名稱：醫(yī)療器械的生物學(xué)評價(jià).聚合物醫(yī)療器械降解產(chǎn)物的鑒定與定量
英文標(biāo)準(zhǔn)名稱：Biological evaluation of medical devices. Part 13: Identification and quantification of degradation products from polymeric medical devices
標(biāo)準(zhǔn)類型：C37
發(fā)布日期：2010/10/31 12:00:00
實(shí)施日期：2010/10/31 12:00:00
中國標(biāo)準(zhǔn)分類號：C37
國際標(biāo)準(zhǔn)分類號：11.100.20
適用范圍：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.