BS EN ISO 10993-4-2009 医疗器械的生物评估.与血液相互作用的试验选择

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【英文标准名称】:Biologicalevaluationofmedicaldevices-Selectionoftestsforinteractionswithblood
【原文标准名称】:医疗器械的生物评估.与血液相互作用的试验选择
【标准号】:BSENISO10993-4-2009
【标准状态】:现行
【国别】:英国
【发布日期】:2010-02-28
【实施或试行日期】:2010-02-28
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:生物测定;生物危害;生物试验;血液;分类;定义;牙科设备;牙科器械;牙科学;评估;指南;血液学;在体外;相互作用;材料;医疗器械;医疗设备;医疗产品;医学科学;危险;规范(验收);外科设备;外科植入物;试验
【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】:ThispartofISO10993providesgeneralrequirementsforevaluatingtheinteractionsofmedicaldeviceswithblood.Itdescribesa)aclassificationofmedicalanddentaldevicesthatareintendedforuseincontactwithblood,basedontheintendeduseanddurationofcontactasdefinedinISO10993-1,b)thefundamentalprinciplesgoverningtheevaluationoftheinteractionofdeviceswithblood,c)therationaleforstructuredselectionoftestsaccordingtospecificcategories,togetherwiththeprinciplesandscientificbasisofthesetests.Detailedrequirementsfortestingcannotbespecifiedbecauseofthelimitationsinknowledgeandprecisionoftestsforinteractionsofdeviceswithblood.Further,thispartofISO10993describesbiologicalevaluationingeneraltermsandmaynotnecessarilyprovidesufficientguidancefortestmethodsforaspecificdevice.Theselectionanddesignoftestmethodsshouldtakeintoconsiderationdevicedesign,materials,clinicalutility,usageenvironmentandriskbenefit.Thislevelofspecificitycanonlybecoveredinverticalstandards.
【中国标准分类号】:C37
【国际标准分类号】:11_100_20
【页数】:46P.;A4
【正文语种】:英语