BS EN ISO 15197-2003 体外诊断试验系统.糖尿病症管理中自测用血糖监测系统的要求

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【英文标准名称】:Invitrodiagnostictestsystems-Requirementsforblood-glucosemonitoringsystemsforself-testinginmanagingdiabetesmellitus
【原文标准名称】:体外诊断试验系统.糖尿病症管理中自测用血糖监测系统的要求
【标准号】:BSENISO15197-2003
【标准状态】:现行
【国别】:英国
【发布日期】:2003-05-27
【实施或试行日期】:2003-05-27
【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】:血细胞计数;检验;定义(术语);糖尿病;诊断;诊断(医学);效率;评定;葡萄糖;人用的药物;在体外;使用说明书;实验室条件下诊断;实验室医学;作标记;测量仪器;测量系统;医疗器材;医学科学;医疗技术学;多语种的;性能;产品信息;产品文件;可靠度;安全性;自测;规范(验收);试验
【英文主题词】:Bloodcounts;Checks;Definitions;Diabetes;Diagnosis;Diagnosis(medical);Efficiency;Evaluations;Glucose;Humanmedicine;Invitro;Instructionsforuse;In-vitrodiagnostic;Laboratorymedicine;Marking;Measuringinstruments;Measuringsystems;Medicalequipment;Medicalsciences;Medicaltechnology;Multilingual;Performance;Productinformation;Productsdocumentation;Reliability;Safety;Self-testing;Specification(approval);Testing
【摘要】:ThisInternationalStandardspecifiesrequirementsforinvitroglucosemonitoringsystemsthatmeasureglucoseconcentrationsincapillarybloodsamplesandproceduresfortheverificationandthevalidationofperformancebytheintendedusers.Thesesystemsareintendedforself-testingbylaypersonsformanagementofdiabetesmellitus.ThisInternationalStandardisapplicabletomanufacturersofsuchsystemsandthoseotherorganizations(e.g.regulatoryauthoritiesandconformityassessmentbodies)havingtheresponsibilityforassessingtheperformanceofthesesystems.ThisInternationalStandarddoesnot?provideacomprehensiveevaluationofallpossiblefactorsthatcouldaffecttheperformanceofthesesystems,?pertaintoglucoseconcentrationmeasurementforthepurposeofdiagnosingdiabetesmellitus,?addressthemedicalaspectsofdiabetesmellitusmanagement,or?applytomeasurementprocedureswithresultsonanordinalscale(e.g.visual,semiquantitativetestmethods).
【中国标准分类号】:C38
【国际标准分类号】:11_040_55
【页数】:46P.;A4
【正文语种】:英语