【英文标准名称】:Invitrodiagnosticmedicaldevices-Informationsuppliedbythemanufacturer(labelling)-Terms,definitionsandgeneralrequirements
【原文标准名称】:体外诊断医疗器械.制造商提供的信息(标签).术语、定义和一般要求
【标准号】:BSENISO18113-1-2009
【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;定义;诊断(医学);诊断设备;诊断系统;企业;专家;在体外;信息;使用说明书;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);术语;用户信息
【英文主题词】:Apparatusforanalysis;Applications;Dataofthemanufacturer;Definitions;Diagnosis(medical);Diagnosticequipment;Diagnosticsystems;Enterprises;Experts;Invitro;Information;Instructionsforuse;Investigations;In-vitrodiagnostic;Labelling;Laboratorymedicine;Medicalequipment;Medicalsciences;Medicaltechnology;Operationalinstructions;Self-testing;Specification(approval);Terminology;Userinformation
【摘要】:ThispartofISO18113definesconcepts,establishesgeneralprinciplesandspecifiesessentialrequirementsforinformationsuppliedbythemanufacturerofIVDmedicaldevices.ThispartofISO18113doesnotaddresslanguagerequirements,sincethatisthedomainofnationallawsandregulations.ThispartofISO18113doesnotapplytoa)IVDdevicesforperformanceevaluation(e.g.,forinvestigationaluseonly),b)instrumentmarking,c)materialsafetydatasheets.
【中国标准分类号】:C37
【国际标准分类号】:11_100_10
【页数】:60P.;A4
【正文语种】:英语