【英文标准名称】:Nomenclature-Specificationforanomenclaturesystemformedicaldevicesforthepurposeofregulatorydataexchange
【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】:ISO15225-2000
【标准状态】:作废
【国别】:国际
【发布日期】:2000-09
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC210
【标准类型】:()
【标准水平】:()
【中文主题词】:定义;医疗产品;分类系统;系统学;系统;结构;计算机科学;术语;数据通信;命名;情报系统;技术术语;公共卫生;医学科学;技术语言;规范(验收);信息交换;信息交流
【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】:19P.;A4
【正文语种】:英语