作者:标准资料网 时间:2024-05-27 07:07:39   浏览:8494   来源:标准资料网

【英文标准名称】:Biologicalevaluationofmedicaldevices-Part9:Frameworkforidentificationandquantificationofpotentialdegradationproducts(ISO10993-9:1999);GermanversionENISO10993-9:2009
【原文标准名称】:医疗器械的生物学评定.第9部分:潜在降解产物的识别与量化框架(ISO10993-9-1999);德文版本ENISO10993-9-2009
【标准号】:DINENISO10993-9-2009
【标准状态】:作废
【国别】:德国
【发布日期】:2009-08
【实施或试行日期】:2009-08-01
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:生物测定;生物化学制品;生物降解能力;生物学;分解产物;定义;降解;变坏;测定;评定;识别;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.ThispartofISO10993isnotapplicableto:a)viable-tissueengineeredproducts;b)methodologiesforthegenerationofdegradationproductsbymechanicalprocesses.Methodologiesfortheproductionofthistypeofdegradationproductaredescribedinspecificproductstandards,whereavailable;c)leachablecomponentswhicharenotdegradationproducts.Whereproductstandardsprovideapplicableproduct-specificmethodologiesfortheidentificationandquantificationofdegradationproducts,thosestandardsshallbeconsideredasalternatives.
【中国标准分类号】:C30
【国际标准分类号】:11_100_20
【页数】:19P.;A4
【正文语种】:德语