ISO 10993-13-1998 医疗器械的生物学评价第13部分:聚合物医疗器械降解产物的定性与定量

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【英文标准名称】:Biologicalevaluationofmedicaldevices-Part13:Identificationandquantificationofdegradationproductsfrompolymericmedicaldevices
【原文标准名称】:医疗器械的生物学评价第13部分:聚合物医疗器械降解产物的定性与定量
【标准号】:ISO10993-13-1998
【标准状态】:作废
【国别】:国际
【发布日期】:1998-11
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC194
【标准类型】:()
【标准水平】:()
【中文主题词】:识别;生物测定;定义;试验;医疗设备;高聚物;分解产物;变坏
【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_040_01;11_100_20
【页数】:10P;A4
【正文语种】:英语