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【英文标准名称】:Biologicalevaluationofmedicaldevices-Frameworkforidentificationandquantificationofpotentialdegradationproducts
【原文标准名称】:医疗器械的生物学评估.潜在降解产物的鉴别和定量框架
【标准号】:BSENISO10993-9-2009
【标准状态】:现行
【国别】:英国
【发布日期】:2010-06-30
【实施或试行日期】:2010-06-30
【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】:生物测定;生化制品;生物降解力;生物学;分解产物;定义;降解;变坏;测定;评估;鉴别;医疗器械;医疗产品;医疗技术学;量化
【英文主题词】:Bioassay;Biochemicals;Biodegradability;Biology;Decompositionproducts;Definitions;Degradation;Deterioration;Determination;Evaluations;Identification;Medicaldevices;Medicalproducts;Medicaltechnology;Quantification
【摘要】:ThispartofISO10993providesgeneralprinciplesforthesystematicevaluationofthepotentialandobservedbiodegradationofmedicaldevicesandforthedesignandperformanceofbiodegradationstudies.InformationobtainedfromthesestudiescanbeusedinthebiologicalevaluationdescribedintheISO10993series.ThispartofISO10993considersbothnon-resorbableandresorbablematerials.ThispartofISO10993isnotapplicableto:a)evaluationofdegradationwhichoccursbypurelymechanicalprocesses;methodologiesfortheproductionofthistypeofdegradationproductaredescribedinspecificproductstandards,whereavailable;b)leachablecomponentswhicharenotdegradationproducts;c)medicaldevicesorcomponentsthatdonotcontactthepatient'sbodydirectlyorindirectly.NOTE2ThispartofISO10993canbeappliedtothedegradationofmaterialsusedinanykindofproductthatfallswithinthedefinitionof“medicaldevice”inISO10993-1,evenifsuchproductsaresubjecttodifferentregulationsfromthoseapplyingtomedicaldevices,e.g.thescaffoldinatissueengineeredmedicalproduct,oracarriermatrixtodeliverdrugsorbiologics.
【中国标准分类号】:C30
【国际标准分类号】:11_100_20
【页数】:20P.;A4
【正文语种】:英语