BS EN ISO 15225-2000 命名.管理材料交换用医疗器械命名系统规范

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【英文标准名称】:Nomenclature-Specificationforanomenclaturesystemformedicaldevicesforthepurposeofregulatorydataexchange
【原文标准名称】:命名.管理材料交换用医疗器械命名系统规范
【标准号】:BSENISO15225-2000
【标准状态】:作废
【国别】:英国
【发布日期】:2000-04-15
【实施或试行日期】:2000-04-15
【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】:数据集;主题词表;数据表示;医用电气设备;数据传送;数据库;数据组织;医疗设备;数据结构;医疗器械;分类系统;信息交流;数据处理;数据处理;术语
【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:ThisEuropeanStandardincludesguidelinesforaminimumdatasetanditsstructure.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】:30P;A4
【正文语种】:英语