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【英文标准名称】:Informationsuppliedbythemanufacturerofmedicaldevices
【原文标准名称】:医疗装置厂商提供的信息
【标准号】:BSEN1041-2008
【标准状态】:现行
【国别】:英国
【发布日期】:2008-08-31
【实施或试行日期】:2008-08-31
【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】:附件;制造日期;定义;绷扎材料;企业;外科植入物;信息;使用说明书;作标记;医疗设备;医疗器械;医疗产品;医学科学;医疗技术学;产品信息;产品;保障;规范(验收);手术敷料;术语
【英文主题词】:Accessories;Dataofthemanufacturer;Definition;Definitions;Dressingmaterials;Enterprises;Implants(surgical);Information;Instructionsforuse;Marking;Medicalequipment;Medicalinstruments;Medicalproducts;Medicalsciences;Medicaltechnology;Productinformation;Products;Provision;Specification(approval);Surgicaldressings;Terminology
【摘要】:ThisstandardspecifiesrequirementsforinformationtobesuppliedbyamanufacturerformedicaldevicesregulatedbyCouncilDirective90/385/EECrelatingtoactiveimplantablemedicaldevicesandCouncilDirective93/42/EECconcerningmedicaldevices.Itdoesnotspecifythelanguagetobeusedforsuchinformation,nordoesitspecifythemeansbywhichtheinformationistobesupplied.ItisalsointendedtocomplementthespecificrequirementsofthecitedEUDirectivesonmedicaldevicesbyprovidingguidanceonmeansbywhichcertainrequirementscanbemet.Ifamanufacturerfollowsthesemeans,theywillprovideapresumptionofconformitywiththerelevantEssentialRequirementsregardinginformationtobesupplied.Thisstandarddoesnotcoverrequirementsforprovisionofinformationforinvitrodiagnosticmedicaldevices,whicharecoveredbyotherlabellingstandards(seeBibliography).NOTEWhennationaltranspositionsoftheDirectivesspecifythemeansbywhichinformationshallbesupplied,thisstandarddoesnotprovidederogationfromtheserequirementsforthatcountry.
【中国标准分类号】:C04
【国际标准分类号】:01_110;11_040_01;11_120_01
【页数】:28P.;A4
【正文语种】:英语