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【英文标准名称】:Biologicalevaluationofmedicaldevices-Part4:Selectionoftestsforinteractionswithblood(ISO10993-4:2002+Amd.1:2006);GermanversionENISO10993-4:2002+A1:2006
【原文标准名称】:医用装置的生物学评估.第4部分:与血液相互作用试验的选择
【标准号】:DINENISO10993-4-2007
【标准状态】:作废
【国别】:德国
【发布日期】:2007-06
【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;生物试验;血液;分类;定义;牙科设备;牙科仪器;牙科;指南;血液学;外科植入物;在生物体外;相互作用;材料;医用设备;医用产品;医学科学;外科设备;测试
【英文主题词】:Bioassay;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】:ThispartofISO10993providesgeneralrequirementsforevaluatingtheinteractionsofmedicadeviceswithblood.Itdescribesa)aclasscificationofmedicalanddentaldevicesthatareintendedforuseincontactwithblood,basedontheintendeduseanddurationofcontactasdefinedinISO10993-1,b)thefundamentalprinciplesgoverningtheevalutaionoftheinteractionofdeviceswithblood,c)therationaleforstructuredselecturedselectionoftestsaccordingtospecificcategories,togetherwiththeprinciplesandscientificbasisofthesetests.Detailedrequirementsfortestingcannotbespecifiedbecauseofthelimitationsinknowledgeandprecisionoftestsforinteractionsofdeviceswithblood.Futher,thispartofISO10993describesbiologicalevaluationingeneraltermsandmaynotnectssarilyprovidesufficientguidancefortestmethodsforaspecificdevice.Theselectionanddesignoftestmethodsshouldtakeintoconsiderationdevicedesign,materials,clinicalutility,usageenvironmentandriskbenefit.Thislevesofspecificitycanonlybecoveredinverticalstandards.
【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】:德语