DIN EN ISO 10993-9-1999 医疗器械的生物学评价.第9部分:潜在降解产物的定性与定量总则
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【英文标准名称】:Biologicalevaluationofmedicaldevices-Part9:Frameworkforidentificationandquantificationofpotentialdegradationproducts(ISO10993-9:1999);GermanversionENISO10993-9:1999
【原文标准名称】:医疗器械的生物学评价.第9部分:潜在降解产物的定性与定量总则
【标准号】:DINENISO10993-9-1999
【标准状态】:作废
【国别】:德国
【发布日期】:1999-10
【实施或试行日期】:
【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】:变坏;医疗技术学;分解产物;生物学;测定;生物化学制品;医疗产品;识别;生物测定;评定;评定;降解
【英文主题词】:Bioassay;Biochemicals;Biodegradability;Biology;Decompositionproducts;Definitions;Degradation;Deterioration;Determination;Evaluations;Identification;Medicaldevices;Medicalproducts;Medicaltechnology;Quantification
【摘要】:Thedocumentprovidesgeneralprinciplesforthesystematicevaluationofthepotentialandobservedbiodegradationofmedicaldevicesandforthedesignandperformanceofbiodegradationstudies.Thedocumentisnotapplicableto:a)viable-tissueengineeredproducts;b)methodologiesforthegenerationofdegradationproductsbymechanicalprocesses.Methodologiesfortheproductionofthistypeofdegradationproductaredescribedinspecificproductstandards,whereavailable;c)leachablecomponentswhicharenotdegradationproducts.Whereproductstandardsprovideapplicableproduct-specificmethodologiesfortheidentificationandquantificationofdegradationproducts,thosestandardsshallbeconsideredasalternatives.
【中国标准分类号】:C30;C33
【国际标准分类号】:11_100_20
【页数】:8P;A4
【正文语种】:德语
【原文标准名称】:医疗器械的生物学评价.第9部分:潜在降解产物的定性与定量总则
【标准号】:DINENISO10993-9-1999
【标准状态】:作废
【国别】:德国
【发布日期】:1999-10
【实施或试行日期】:
【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】:变坏;医疗技术学;分解产物;生物学;测定;生物化学制品;医疗产品;识别;生物测定;评定;评定;降解
【英文主题词】:Bioassay;Biochemicals;Biodegradability;Biology;Decompositionproducts;Definitions;Degradation;Deterioration;Determination;Evaluations;Identification;Medicaldevices;Medicalproducts;Medicaltechnology;Quantification
【摘要】:Thedocumentprovidesgeneralprinciplesforthesystematicevaluationofthepotentialandobservedbiodegradationofmedicaldevicesandforthedesignandperformanceofbiodegradationstudies.Thedocumentisnotapplicableto:a)viable-tissueengineeredproducts;b)methodologiesforthegenerationofdegradationproductsbymechanicalprocesses.Methodologiesfortheproductionofthistypeofdegradationproductaredescribedinspecificproductstandards,whereavailable;c)leachablecomponentswhicharenotdegradationproducts.Whereproductstandardsprovideapplicableproduct-specificmethodologiesfortheidentificationandquantificationofdegradationproducts,thosestandardsshallbeconsideredasalternatives.
【中国标准分类号】:C30;C33
【国际标准分类号】:11_100_20
【页数】:8P;A4
【正文语种】:德语
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