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【英文标准名称】:Nomenclature-Specificationforanomenclaturesystemformedicaldevicesforthepurposeofregulatorydataexchange(ISO15225:2000+Amd1:2004);GermanversionENISO15225:2000+A1:2004+A2:2005
【原文标准名称】:命名.用于管理资料交流的医疗器械命名系统规范
【标准号】:DINENISO15225-2005
【标准状态】:作废
【国别】:德国
【发布日期】:2005-09
【实施或试行日期】:
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:信息交流;信息交换;分类系统;定义;规范(验收);医学科学;公共卫生;术语;术语;技术语言;数据交换;类别;数据通信;计算机科学;情报系统;医疗产品;技术术语;结构;系统;实验室条件下诊断
【英文主题词】:Categories;Classificationsystems;Computersciences;Datacommunication;Dataexchange;Definitions;Informationexchange;Informationinterchange;Informationsystems;In-vitrodiagnostic;Medicaldevices;Medicalproducts;Medicalsciences;Nomenclature;Principle;Products;Publichealth;Specification(approval);Structure;Systematics;Systems;Technicallanguages;Technicalterm;Templates;Terminology;Terms;Vocabulary
【摘要】:ThisEuropeanStandardspecifiesrequirementsandguidancefortheconstructionofanomenclatureformedicaldevicesinordertofacilitateco-operationandexchangeofregulatorydataonaninternationallevelbetweeninterestedpartiessuchas:RegulatoryAuthorities,Manufacturers,Suppliers,HealthCareProviders,andEndUsers.NOTE1:ThisEuropeanStandardincludesguidelinesforaminimumdalasetanditsstructure.Theseguidelinesareprovidedforsystemdesignerssettingupdatabasesutilizingthenomenclaturesystemdescribedherein.TherequirementscontainedinthisstandardareapplicabletothedevelopmentandmaintenanceofaEuropeannomenclatureformedicaldeviceidentification.NOTE2:ThisEuropeanStandardwillnotincludethenomenclatureitself.Thenomenclaturewillbesuppliedasaseparatedocument.NOTE3:ItisintendedtocomplementthespecificrequirementsoftheECDirectivesonmedicaldevicesinthecontextofspecifyingmeansbywhichcommonidentificationcanbeachievedbetweenbodiesrequiredtoexchangedatainconformitywiththerequirementsoftheDirectives.
【中国标准分类号】:C30
【国际标准分类号】:01_040_11;01_040_35;11_040_01;35_240_80
【页数】:28P.;A4
【正文语种】:德语