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
【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】:ISO15197-2003
【标准状态】:现行
【国别】:国际
【发布日期】:2003-05
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC212
【标准类型】:()
【标准水平】:()
【中文主题词】:实验室医学;葡萄糖;作标记;测量仪器;诊断;诊断(医学);性能;人用的药物;血细胞计数;使用说明;医疗设备;实验室条件下诊断;规范(验收);医疗技术学;产品文件;自测;医学科学;糖尿病;定义;在实验室条件下;试验;测量系统;效率;产品信息
【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_100_30
【页数】:33P;A4
【正文语种】:英语