DIN EN ISO 10993-14-2009 医疗器械的生物学评定.第14部分:陶瓷降解产品的识别与量化(ISO10993-14-2001);德文版本ENISO10993-14-2009
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【英文标准名称】:Biologicalevaluationofmedicaldevices-Part14:Identificationandquantificationofdegradationproductsfromceramics(ISO10993-14:2001);EnglishversionofDINEN10993-14:2009-08
【原文标准名称】:医疗器械的生物学评定.第14部分:陶瓷降解产品的识别与量化(ISO10993-14-2001);德文版本ENISO10993-14-2009
【标准号】:DINENISO10993-14-2009
【标准状态】:现行
【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;生物试验;陶瓷;分解;分解产物;定义;降解能力;降解;变坏;评定;识别;医疗器械;医疗设备;医疗产品;量化;测试
【英文主题词】:Bioassay;Biologicaltests;Ceramics;Decomposition;Decompositionproducts;Definitions;Degradability;Degradation;Deterioration;Evaluations;Identification;Medicaldevices;Medicalequipment;Medicalproducts;Quantification;Testing
【摘要】:ThispartofISO10993specifiestwomethodsofobtainingsolutionsofdegradationproductsfromceramics(includingglasses)forthepurposesofquantification.Italsogivesguidanceontheanalysisofthesesolutionsinordertoidentifythedegradationproducts.BecauseofthegeneralizednatureofthispartofISO10993,productspecificstandards,whenavailable,thataddressdegradationproductformationundermorerelevantconditionsofuse,shouldbeconsideredfirst.ThispartofISO10993considersonlythosedegradationproductsgeneratedbyachemicaldissociationofceramicsduringinvitrotesting.Nodegradationinducedbymechanicalstressorexternalenergyiscovered.ItisnotedthatwhileISO6872andISO9693coverchemicaldegradationtests,theydonotaddresstheanalysisofdegradationproducts.Becauseoftherangeofceramicsusedinmedicaldevicesandthedifferentrequirementsforaccuracyandprecisionoftheresults,nospecificanalyticaltechniquesareidentified.Further,thispartofISO10993providesnospecificrequirementsforacceptablelevelsofdegradationproducts.Althoughthesematerialsareintendedforbiomedicalapplications,thebiologicalactivityofthesedegradationproductsisnotaddressedinthispartofISO10993.
【中国标准分类号】:C30
【国际标准分类号】:11_100_20
【页数】:21P.;A4
【正文语种】:英语
【原文标准名称】:医疗器械的生物学评定.第14部分:陶瓷降解产品的识别与量化(ISO10993-14-2001);德文版本ENISO10993-14-2009
【标准号】:DINENISO10993-14-2009
【标准状态】:现行
【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;生物试验;陶瓷;分解;分解产物;定义;降解能力;降解;变坏;评定;识别;医疗器械;医疗设备;医疗产品;量化;测试
【英文主题词】:Bioassay;Biologicaltests;Ceramics;Decomposition;Decompositionproducts;Definitions;Degradability;Degradation;Deterioration;Evaluations;Identification;Medicaldevices;Medicalequipment;Medicalproducts;Quantification;Testing
【摘要】:ThispartofISO10993specifiestwomethodsofobtainingsolutionsofdegradationproductsfromceramics(includingglasses)forthepurposesofquantification.Italsogivesguidanceontheanalysisofthesesolutionsinordertoidentifythedegradationproducts.BecauseofthegeneralizednatureofthispartofISO10993,productspecificstandards,whenavailable,thataddressdegradationproductformationundermorerelevantconditionsofuse,shouldbeconsideredfirst.ThispartofISO10993considersonlythosedegradationproductsgeneratedbyachemicaldissociationofceramicsduringinvitrotesting.Nodegradationinducedbymechanicalstressorexternalenergyiscovered.ItisnotedthatwhileISO6872andISO9693coverchemicaldegradationtests,theydonotaddresstheanalysisofdegradationproducts.Becauseoftherangeofceramicsusedinmedicaldevicesandthedifferentrequirementsforaccuracyandprecisionoftheresults,nospecificanalyticaltechniquesareidentified.Further,thispartofISO10993providesnospecificrequirementsforacceptablelevelsofdegradationproducts.Althoughthesematerialsareintendedforbiomedicalapplications,thebiologicalactivityofthesedegradationproductsisnotaddressedinthispartofISO10993.
【中国标准分类号】:C30
【国际标准分类号】:11_100_20
【页数】:21P.;A4
【正文语种】:英语
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