BS EN ISO 10993-13-2009 医疗器械的生物学评价.第13部分:高分子医用器材降解产物的识别和定量
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【英文标准名称】:Biologicalevaluationofmedicaldevices.Identificationandquantificationofdegradationproductsfrompolymericmedicaldevices
【原文标准名称】:医疗器械的生物学评价.第13部分:高分子医用器材降解产物的识别和定量
【标准号】:BSENISO10993-13-2009
【标准状态】:作废
【国别】:英国
【发布日期】:2009-06-30
【实施或试行日期】:2009-06-30
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【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;评估;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;Acceleratedtesting;Bioassay;Biologicalanalysisandtesting;Biologicaltests;Biology;Chemicalanalysisandtesting;Decomposition;Decompositionproducts;Decompositionreactions;Definitions;Degradability;Degradation;Deterioration;Evaluations;Identification;Identificationmethods;Medicaldevices;Medicalequipment;Medicalproducts;Methods;Polymers;Quantification;Quantitativeanalysis;Real-time;Screening-method;Specification(approval);Testing;Testingconditions;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】:22P.;A4
【正文语种】:英语
【原文标准名称】:医疗器械的生物学评价.第13部分:高分子医用器材降解产物的识别和定量
【标准号】:BSENISO10993-13-2009
【标准状态】:作废
【国别】:英国
【发布日期】:2009-06-30
【实施或试行日期】:2009-06-30
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【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;评估;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;Acceleratedtesting;Bioassay;Biologicalanalysisandtesting;Biologicaltests;Biology;Chemicalanalysisandtesting;Decomposition;Decompositionproducts;Decompositionreactions;Definitions;Degradability;Degradation;Deterioration;Evaluations;Identification;Identificationmethods;Medicaldevices;Medicalequipment;Medicalproducts;Methods;Polymers;Quantification;Quantitativeanalysis;Real-time;Screening-method;Specification(approval);Testing;Testingconditions;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】:22P.;A4
【正文语种】:英语
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