【英文标准名称】:Invitrodiagnosticmedicaldevices-Informationsuppliedbythemanufacturer(labelling)-Invitrodiagnosticinstrumentsforself-testing
【原文标准名称】:体外诊断医疗器械.制造商提供的信息(标签).自试验用体外诊断仪器
【标准号】:BSENISO18113-5-2009
【标准状态】:作废
【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】:分析装置;应用;制造日期;诊断;诊断设备;诊断系统;企业;在体外;信息;使用说明书;仪器;调查;体外诊断;加标签;实验室医学;医疗设备;医学科学;医疗技术学;操作说明书;自试验;规范(验收);用户信息
【英文主题词】:Apparatusforanalysis;Applications;Dataofthemanufacturer;Diagnosis;Diagnosticequipment;Diagnosticsystems;Enterprises;Invitro;Information;Instructionsforuse;Instruments;Investigations;In-vitrodiagnostic;Labelling;Laboratorymedicine;Medicalequipment;Medicalsciences;Medicaltechnology;Operationalinstructions;Self-testing;Specification(approval);Userinformation
【摘要】:ThispartofISO18113specifiesrequirementsforinformationsuppliedbythemanufacturerofIVDinstrumentsforself-testing.ThispartofISO18113alsoappliestoapparatusandequipmentintendedtobeusedwithIVDinstrumentsforself-testing.ThispartofISO18113canalsobeappliedtoaccessories.ThispartofISO18113doesnotapplytoa)instructionsforinstrumentservicingorrepair,b)IVDreagents,includingcalibratorsandcontrolmaterialsforuseincontrolofthereagent,c)IVDinstrumentsforprofessionaluse.
【中国标准分类号】:C38
【国际标准分类号】:11_100_10
【页数】:20P.;A4
【正文语种】:英语