BS EN ISO 10993-13-1999 医疗器械的生物学评定.聚合物医疗装置降解物的确认与量化

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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定.聚合物医疗装置降解物的确认与量化
【标准号】:BSENISO10993-13-1999
【标准状态】:作废
【国别】:英国
【发布日期】:1999-02-15
【实施或试行日期】:1999-02-15
【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】:定量分析;分解反应;医疗设备;试验条件;生物分析和试验;加速度试验;降解;识别方法;高聚物;生物学;变坏
【英文主题词】:Accelerated;Bioassay;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】:C04
【国际标准分类号】:11_100_20
【页数】:22P;A4
【正文语种】:英语