BS EN ISO 10993-9-2009-05 医疗器械的生物学评价.潜在降解产物的识别和定量框架

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【英文标准名称】:Frameworkforidentificationandquantificationofpotentialdegradationproducts
【原文标准名称】:医疗器械的生物学评价.潜在降解产物的识别和定量框架
【标准号】:BSENISO10993-9-2009-05
【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】:
【英文主题词】:Bioassay;Biochemicals;Biodegradability;Biology;Decompositionproducts;Definitions;Degradation;Deterioration;Determination;Evaluations;Identification;Medicaldevices;Medicalproducts;Medicaltechnology;Quantification
【摘要】:ThispartofISO10993providesgeneralprinciplesforthesystematicevaluationofthepotentialandobservedbiodegradationofmedicaldevicesandforthedesignandperformanceofbiodegradationstudies.ThispartofISO10993isnotapplicableto:a)viable-tissueengineeredproducts;b)methodologiesforthegenerationofdegradationproductsbymechanicalprocesses.Methodologiesfortheproductionofthistypeofdegradationproductaredescribedinspecificproductstandards,whereavailable;c)leachablecomponentswhicharenotdegradationproducts.Whereproductstandardsprovideapplicableproduct-specificmethodologiesfortheidentificationandquantificationofdegradationproducts,thosestandardsshallbeconsideredasalternatives.
【中国标准分类号】:
【国际标准分类号】:11_100_20
【页数】:18P.;A4
【正文语种】:英语