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【英文标准名称】:Biologicalevaluationofmedicaldevices-Evaluationandtesting
【原文标准名称】:医疗设备的生物评估.评估和测试
【标准号】:BSENISO10993-1-2009-06
【标准状态】:作废
【国别】:英国
【发布日期】:2009-07-31
【实施或试行日期】:2009-07-31
【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】:
【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;Selection;Surgicalequipment;Testing;Use
【摘要】:ThispartofISO10993describesa)thegeneralprinciplesgoverningthebiologicalevaluationofmedicaldevices;b)thecategorizationofdevicesbasedonthenatureanddurationoftheircontactwiththebody;c)theselectionofappropriatetests.ThispartofISO10993doesnotcovertestingofmaterialsanddevicesthatdonotcomeintodirectorindirectcontactwiththepatient'sbody,nordoesitcoverbiologicalhazardsarisingfromanymechanicalfailure.
【中国标准分类号】:
【国际标准分类号】:11_100_20
【页数】:26P.;A4
【正文语种】:英语