【英文标准名称】:Biologicalevaluationofmedicaldevices-Part13:Identificationandandquantificationofdegradationproductsfrompolymericmedicaldevices(ISO10993-13:1998);GermanversionENISO10993-13:1998
【原文标准名称】:医疗装置的生物评估.第13部分:聚合化合物医疗装置产生的降解物的鉴别和合格认证
【标准号】:DINENISO10993-13-1999
【标准状态】:作废
【国别】:德国
【发布日期】:1999-04-01
【实施或试行日期】:
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:识别;方法;生物测定;医疗产品;降解;定义;降解能力;评定;规范(验收);试验;高聚物
【英文主题词】:Accelerated;Bioassay;Biologicaltests;Decomposition;Decompositionproducts;Definitions;Degradability;Degradation;Deterioration;Evaluations;Identification;Medicaldevices;Medicalequipment;Medicalproducts;Methods;Polymers;Quantification;Real-time;Screening-method;Specification(approval);Testing;Verification
【摘要】:Thedocumentprovidesguidanceongeneralrequirementsforthedesignoftestsforidentifyingandquantifyingdegradationproductsfromfinishedmedicaldevicesreadyforclinicaluse.Itdescribestwotestmethodstogeneratedegradtionproducts,anaccelerateddegradataiontestasascreeningmethodandareal-timedegradationtest.Formaterialswhichareintendedtopolymerizeinsitu,thesetorcuredpolymerisusedfortesting.Thedatageneratedareusedinthebiologicalevaluationofthepolymer.Itconsidersonlythosedegradationproductsgeneratedbyachemicalalterationofthefinishedpolymericdevice.
【中国标准分类号】:C30
【国际标准分类号】:11_100_20
【页数】:11P;A4
【正文语种】:德语