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【英文标准名称】:Biologicalevaluationofmedicaldevices-Part13:Identificationandquantificationofdegradationproductsfrompolymericmedicaldevices(ISO10993-13:1998);GermanversionENISO10993-13:2009
【原文标准名称】:医疗装置的生物学评定.第13部分:聚合物医疗设备产生的降解物的识别和量化(ISO10993-13-1998);德文版本ENISO10993-13-2009
【标准号】:DINENISO10993-13-2009
【标准状态】:作废
【国别】:德国
【发布日期】:2009-08
【实施或试行日期】:2009-08-01
【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】:加速的;生物测定;生物试验;分解;分解产物;定义;降解能力;降解;变坏;评定;识别;医疗器械;医疗设备;医疗产品;方法;高聚物;量化;实时的;筛选法;规范(验收);试验;验证
【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】:ThispartofISO10993providesguidanceongeneralrequirementsforthedesignoftestsforidentifyingandquantifyingdegradationproductsfromfinishedpolymericmedicaldevicesreadyforclinicaluse.ThispartofISO10993describestwotestmethodstogeneratedegradationproducts,anaccelerateddegradationtestasascreeningmethodandareal-timedegradationtest.Formaterialswhichareintendedtopolymerizeinsitu,thesetorcuredpolymerisusedfortesting.Thedatageneratedareusedinthebiologicalevaluationofthepolymer.ThispartofISO10993considersonlythosedegradationproductsgeneratedbyachemicalalterationofthefinishedpolymericdevice.Itisnotapplicabletodegradationofthedeviceinducedduringitsintendedusebymechanicalstress,wearorelectromagneticradiation.ThebiologicalactivityofthedebrisandsolubledegradationproductsisnotaddressedinthispartofISO10993,butshouldbeevaluatedaccordingtotheprinciplesofISO10993-1andISO14538.Becauseofthewiderangeofpolymericmaterialsusedinmedicaldevices,nospecificanalyticaltechniquesareidentifiedorgivenpreference.NospecificrequirementsforacceptablelevelsofdegradationproductsareprovidedinthispartofISO10993.
【中国标准分类号】:C30
【国际标准分类号】:11_100_20
【页数】:21P.;A4
【正文语种】:德语