DIN EN ISO 10993-4-2009 医疗设备的生物评估.第4部分:与血液相互作用试验选择(ISO10993-4:2002,含修改件1:2006),DINENISO10993-4:2009-10的英文版本
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【英文标准名称】:Biologicalevaluationofmedicaldevices-Part4:Selectionoftestsforinteractionswithblood(ISO10993-4:2002,includingAmd1:2006);EnglishversionofDINENISO10993-4:2009-10
【原文标准名称】:医疗设备的生物评估.第4部分:与血液相互作用试验选择(ISO10993-4:2002,含修改件1:2006),DINENISO10993-4:2009-10的英文版本
【标准号】:DINENISO10993-4-2009
【标准状态】:现行
【国别】:德国
【发布日期】:2009-10
【实施或试行日期】:2009-10-01
【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】:
【英文主题词】:Bioassay;Biologicalanalysisandtesting;Biologicalhazards;Biologicaltests;Blood;Classification;Definitions;Dentalequipment;Dentalinstruments;Dentistry;Evaluations;Guidelines;Haematology;Implants(surgical);Invitro;Interaction;Materials;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Risk;Specification(approval);Surgicalequipment;Surgicalimplants;Testing
【摘要】:ThispartofISO10993providesgeneralrequirementsforevaluatingtheinteractionsofmedicaldeviceswithblood.Itdescribesa)aclassificationofmedicalanddentaldevicesthatareintendedforuseincontactwithblood,basedontheintendeduseanddurationofcontactasdefinedinISO10993-1,b)thefundamentalprinciplesgoverningtheevaluationoftheinteractionofdeviceswithblood,c)therationaleforstructuredselectionoftestsaccordingtospecificcategories,togetherwiththeprinciplesandscientificbasisofthesetests.Detailedrequirementsfortestingcannotbespecifiedbecauseoflimitationsintheknowledgeandprecisionoftestsforinteractionsofdeviceswithblood.ThispartofISO10993describesbiologicalevaluationingeneraltermsandmaynotnecessarilyprovidesufficientguidancefortestmethodsforaspecificdevice.
【中国标准分类号】:C30
【国际标准分类号】:11_100_20
【页数】:44P.;A4
【正文语种】:英语
【原文标准名称】:医疗设备的生物评估.第4部分:与血液相互作用试验选择(ISO10993-4:2002,含修改件1:2006),DINENISO10993-4:2009-10的英文版本
【标准号】:DINENISO10993-4-2009
【标准状态】:现行
【国别】:德国
【发布日期】:2009-10
【实施或试行日期】:2009-10-01
【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】:
【英文主题词】:Bioassay;Biologicalanalysisandtesting;Biologicalhazards;Biologicaltests;Blood;Classification;Definitions;Dentalequipment;Dentalinstruments;Dentistry;Evaluations;Guidelines;Haematology;Implants(surgical);Invitro;Interaction;Materials;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Risk;Specification(approval);Surgicalequipment;Surgicalimplants;Testing
【摘要】:ThispartofISO10993providesgeneralrequirementsforevaluatingtheinteractionsofmedicaldeviceswithblood.Itdescribesa)aclassificationofmedicalanddentaldevicesthatareintendedforuseincontactwithblood,basedontheintendeduseanddurationofcontactasdefinedinISO10993-1,b)thefundamentalprinciplesgoverningtheevaluationoftheinteractionofdeviceswithblood,c)therationaleforstructuredselectionoftestsaccordingtospecificcategories,togetherwiththeprinciplesandscientificbasisofthesetests.Detailedrequirementsfortestingcannotbespecifiedbecauseoflimitationsintheknowledgeandprecisionoftestsforinteractionsofdeviceswithblood.ThispartofISO10993describesbiologicalevaluationingeneraltermsandmaynotnecessarilyprovidesufficientguidancefortestmethodsforaspecificdevice.
【中国标准分类号】:C30
【国际标准分类号】:11_100_20
【页数】:44P.;A4
【正文语种】:英语
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