【英文标准名称】:Biologicalevaluationofmedicaldevices-Evaluationandtestingwithinariskmanagementprocess
【原文标准名称】:医疗器械的生物学评估.风险管理过程评估和测试
【标准号】:BSENISO10993-1-2009
【标准状态】:现行
【国别】:英国
【发布日期】:2010-06-30
【实施或试行日期】:2010-06-30
【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;生物适应性;生物的;生物分析和测试;生物危害;生物试验;类别;分类;兼容性;定义;评估;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;选择;外科设备;测试;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;Selection;Surgicalequipment;Testing;Use
【摘要】:ThispartofISO10993describes:-thegeneralprinciplesgoverningthebiologicalevaluationofmedicaldeviceswithinariskmanagementprocess;-thegeneralcategorizationofdevicesbasedonthenatureanddurationoftheircontactwiththebody;-theevaluationofexistingrelevantdatafromallsources;-theidentificationofgapsintheavailabledatasetonthebasisofariskanalysis;-theidentificationofadditionaldatasetsnecessarytoanalysethebiologicalsafetyofthemedicaldevice;-theassessmentofthebiologicalsafetyofthemedicaldevice.ThispartofISO10993doesnotcovertestingofmaterialsanddevicesthatdonotcomeintodirectorindirectcontactwiththepatient'sbody,nordoesitcoverbiologicalhazardsarisingfromanymechanicalfailure.OtherpartsofISO10993coverspecifictests,asindicatedintheForeword.
【中国标准分类号】:C37
【国际标准分类号】:11_100_20
【页数】:32P.;A4
【正文语种】:英语