BS EN ISO 10993-13-2010 医疗器械的生物学评价.聚合物医疗器械降解产物的鉴定与定量
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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.聚合物医疗器械降解产物的鉴定与定量
【标准号】:BSENISO10993-13-2010
【标准状态】:现行
【国别】:英国
【发布日期】:2010-10-31
【实施或试行日期】:2010-10-31
【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】:生物测定;生物试验;分解;分解产物;定义(术语);降解能力;降解;变坏;评定;识别;医疗器械;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】:Bioassay;Biologicaltests;Decomposition;Decompositionproducts;Definitions;Degradability;Degradation;Deterioration;Evaluations;Identification;Medicaldevices;Medicalproducts;Methods;Polymers;Quantification;Real-time;Screening-method;Specification(approval);Testing;Verification
【摘要】:ThispartofISO10993providesgeneralrequirementsforthedesignoftestsinasimulatedenvironmentforidentifyingandquantifyingdegradationproductsfromfinishedpolymericmedicaldevicesreadyforclinicaluse.ThispartofISO10993describestwotestmethodstogeneratedegradationproducts,anaccelerateddegradationtestasascreeningmethodandareal-timedegradationtestinasimulatedenvironment.Formaterialsthatareintendedtopolymerizeinsitu,thesetorcuredpolymerisusedfortesting.Thedatageneratedareusedinthebiologicalevaluationofthepolymer.ThispartofISO10993considersonlynonresorbablepolymers.Similarbutappropriatelymodifiedproceduresmaybeapplicableforresorbablepolymers.ThispartofISO10993considersonlythosedegradationproductsgeneratedbyachemicalalterationofthefinishedpolymericdevice.Itisnotapplicabletodegradationofthedeviceinducedduringitsintendedusebymechanicalstress,wearorelectromagneticradiationorbiologicalfactorssuchasenzymes,otherproteinsandcellularactivity.NOTEAninformativetextdiscussingenvironmentalstresscracking(ESC)ofpolymersisincludedasapotentialaidtothedesignofdegradationstudies(seeAnnexB).ThebiologicalactivityofthedebrisandsolubledegradationproductsisnotaddressedinthispartofISO10993,butshouldbeevaluatedaccordingtotheprinciplesofISO10993-1,ISO10993-16andISO10993-17.Becauseofthewiderangeofpolymericmaterialsusedinmedicaldevices,nospecificanalyticaltechniquesareidentifiedorgivenpreference.NospecificrequirementsforacceptablelevelsofdegradationproductsareprovidedinthispartofISO10993.
【中国标准分类号】:C37
【国际标准分类号】:11_100_20
【页数】:28P.;A4
【正文语种】:英语
【原文标准名称】:医疗器械的生物学评价.聚合物医疗器械降解产物的鉴定与定量
【标准号】:BSENISO10993-13-2010
【标准状态】:现行
【国别】:英国
【发布日期】:2010-10-31
【实施或试行日期】:2010-10-31
【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】:生物测定;生物试验;分解;分解产物;定义(术语);降解能力;降解;变坏;评定;识别;医疗器械;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】:Bioassay;Biologicaltests;Decomposition;Decompositionproducts;Definitions;Degradability;Degradation;Deterioration;Evaluations;Identification;Medicaldevices;Medicalproducts;Methods;Polymers;Quantification;Real-time;Screening-method;Specification(approval);Testing;Verification
【摘要】:ThispartofISO10993providesgeneralrequirementsforthedesignoftestsinasimulatedenvironmentforidentifyingandquantifyingdegradationproductsfromfinishedpolymericmedicaldevicesreadyforclinicaluse.ThispartofISO10993describestwotestmethodstogeneratedegradationproducts,anaccelerateddegradationtestasascreeningmethodandareal-timedegradationtestinasimulatedenvironment.Formaterialsthatareintendedtopolymerizeinsitu,thesetorcuredpolymerisusedfortesting.Thedatageneratedareusedinthebiologicalevaluationofthepolymer.ThispartofISO10993considersonlynonresorbablepolymers.Similarbutappropriatelymodifiedproceduresmaybeapplicableforresorbablepolymers.ThispartofISO10993considersonlythosedegradationproductsgeneratedbyachemicalalterationofthefinishedpolymericdevice.Itisnotapplicabletodegradationofthedeviceinducedduringitsintendedusebymechanicalstress,wearorelectromagneticradiationorbiologicalfactorssuchasenzymes,otherproteinsandcellularactivity.NOTEAninformativetextdiscussingenvironmentalstresscracking(ESC)ofpolymersisincludedasapotentialaidtothedesignofdegradationstudies(seeAnnexB).ThebiologicalactivityofthedebrisandsolubledegradationproductsisnotaddressedinthispartofISO10993,butshouldbeevaluatedaccordingtotheprinciplesofISO10993-1,ISO10993-16andISO10993-17.Becauseofthewiderangeofpolymericmaterialsusedinmedicaldevices,nospecificanalyticaltechniquesareidentifiedorgivenpreference.NospecificrequirementsforacceptablelevelsofdegradationproductsareprovidedinthispartofISO10993.
【中国标准分类号】:C37
【国际标准分类号】:11_100_20
【页数】:28P.;A4
【正文语种】:英语
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