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【英文标准名称】:Nomenclature-Collectivetermsandcodesforgroupsofmedicaldevices
【原文标准名称】:术语.医疗装置类的综合术语和代码
【标准号】:PDCEN/TR15133-2005
【标准状态】:现行
【国别】:英国
【发布日期】:2005-12-12
【实施或试行日期】:2005-12-12
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:
【摘要】:ThisTechnicalReportlistscollectivetermsandcodesforgroupsofmedicaldeviceshavingcommonfeatures.Thelistingisstructuredsothatthetermscanbeusedforthepurposesrequiredinregulatoryreportingandforcommunicationrelevanttotheapplicationofthemedicaldeviceregulation.ForcertainpurposesintheapplicationoftheMedicalDevicesDirectives,thereisanurgentneedforthedevelopmentofalistofcollectivetermsbasedontheidentifiedprinciplestobeused,forexamples,asfollows:?toillustratethescopeofcertificatesissuedbyNotifiedBodieswhenassessingwhichgroups,familiesortypesofmedicaldevicesarecoveredwithinamanufacturer’squalitysystem,?tobeusedtoidentifytherangeofskillsandgeneraltechnologicalabilitiesforwhichaNotifiedBodyhasbeenapproved,andissoappointedbytherelevantCompetentAuthority,?fortheexchangesofinformationbetweenCompetentAuthoritieswhengeneralinformationonindividualmanufacturerscapabilitiesisnotifiedforinclusionintheEuropeanDatabaseforMedicalDevices(EUDAMED).Forthepurposeofdevelopingsetsofcollectiveterms,Accessoriestomedicaldevicesareintegrateddefactointhecorrespondingmedicaldevicecollectiveterm.
【中国标准分类号】:C04
【国际标准分类号】:01_040_11;11_040_01
【页数】:18P.;A4
【正文语种】:英语