DIN EN ISO 10993-1-2010 医疗器械的生物学评价.第1部分:在风险管理系统内的评价与试验
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【英文标准名称】:Biologicalevaluationofmedicaldevices-Part1:Evaluationandtestingwithinariskmanagementsystem(ISO10993-1:2009);GermanversionENISO10993-1:2009
【原文标准名称】:医疗器械的生物学评价.第1部分:在风险管理系统内的评价与试验
【标准号】:DINENISO10993-1-2010
【标准状态】:现行
【国别】:德国
【发布日期】:2010-04
【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】:生物测定;生物适应性;生物的;生物分析和试验;生物危害;生物试验;类别;分类;兼容性;定义;评定;精密机械;适用性;人体;外科植入物;医疗器械;医疗设备;医疗产品;医学科学;医疗技术学;原则;风险管理;选择;外科设备;试验;使用
【英文主题词】:Bioassay;Biocompatibility;Biological;Biologicalanalysisandtesting;Biologicalhazards;Biologicaltests;Categories;Classification;Compatibility;Definitions;Evaluations;Finemechanics;Fitnessforpurpose;Humanbody;Implants(surgical);Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Principles;Riskmanagement;Selection;Surgicalequipment;Testing;Use
【摘要】:TheroleofthispartofISO10993istoserveasaframeworkinwhichtoplanabiologicalevaluationwhich,asscientificknowledgeadvancesourunderstandingofthebasicmechanismsoftissueresponses,minimizesthenumberandexposureoftestanimalsbygivingpreferencetochemicalconstituenttestingandinvitromodels,insituationswherethesemethodsyieldequallyrelevantinformationtothatobtainedfrominvivomodels.Itisnotintendedthatthisinternationalstandardwillprovidearigidsetoftestmethods,includingpass/failcriteria,asthismightresultineitheranunnecessaryconstraintonthedevelopmentanduseofnovelmedicaldevices,orafalsesenseofsecurityinthegeneraluseofmedicaldevices.Whereaparticularapplicationwarrantsit,expertsintheproductorintheareaofapplicationconcernedcanchoosetoestablishspecifictestsandcriteria,describedinaproduct-specificverticalstandard.ThispartofISO10993isintendedforusebyprofessionals,appropriatelyqualifiedbytrainingandexperience,whoareabletointerpretitsrequirementsandjudgetheoutcomesoftheevaluationforeachmedicaldevice,takingintoconsiderationallthefactorsrelevanttothedevice,itsintendeduseandthecurrentknowledgeofthemedicaldeviceprovidedbyreviewofthescientificliteratureandpreviousclinicalexperience.
【中国标准分类号】:C30
【国际标准分类号】:11_100_20
【页数】:35P.;A4
【正文语种】:德语
【原文标准名称】:医疗器械的生物学评价.第1部分:在风险管理系统内的评价与试验
【标准号】:DINENISO10993-1-2010
【标准状态】:现行
【国别】:德国
【发布日期】:2010-04
【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】:生物测定;生物适应性;生物的;生物分析和试验;生物危害;生物试验;类别;分类;兼容性;定义;评定;精密机械;适用性;人体;外科植入物;医疗器械;医疗设备;医疗产品;医学科学;医疗技术学;原则;风险管理;选择;外科设备;试验;使用
【英文主题词】:Bioassay;Biocompatibility;Biological;Biologicalanalysisandtesting;Biologicalhazards;Biologicaltests;Categories;Classification;Compatibility;Definitions;Evaluations;Finemechanics;Fitnessforpurpose;Humanbody;Implants(surgical);Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Principles;Riskmanagement;Selection;Surgicalequipment;Testing;Use
【摘要】:TheroleofthispartofISO10993istoserveasaframeworkinwhichtoplanabiologicalevaluationwhich,asscientificknowledgeadvancesourunderstandingofthebasicmechanismsoftissueresponses,minimizesthenumberandexposureoftestanimalsbygivingpreferencetochemicalconstituenttestingandinvitromodels,insituationswherethesemethodsyieldequallyrelevantinformationtothatobtainedfrominvivomodels.Itisnotintendedthatthisinternationalstandardwillprovidearigidsetoftestmethods,includingpass/failcriteria,asthismightresultineitheranunnecessaryconstraintonthedevelopmentanduseofnovelmedicaldevices,orafalsesenseofsecurityinthegeneraluseofmedicaldevices.Whereaparticularapplicationwarrantsit,expertsintheproductorintheareaofapplicationconcernedcanchoosetoestablishspecifictestsandcriteria,describedinaproduct-specificverticalstandard.ThispartofISO10993isintendedforusebyprofessionals,appropriatelyqualifiedbytrainingandexperience,whoareabletointerpretitsrequirementsandjudgetheoutcomesoftheevaluationforeachmedicaldevice,takingintoconsiderationallthefactorsrelevanttothedevice,itsintendeduseandthecurrentknowledgeofthemedicaldeviceprovidedbyreviewofthescientificliteratureandpreviousclinicalexperience.
【中国标准分类号】:C30
【国际标准分类号】:11_100_20
【页数】:35P.;A4
【正文语种】:德语
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