ISO/TR 14969-2004 医疗装置.质量管理系统.ISO13485-2003应用指南
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【英文标准名称】:Medicaldevices-Qualitymangementsystems-GuidanceontheapplicationofISO13485:2003
【原文标准名称】:医疗装置.质量管理系统.ISO13485-2003应用指南
【标准号】:ISO/TR14969-2004
【标准状态】:现行
【国别】:国际
【发布日期】:2004-10
【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】:国际标准;医疗产品;指导手册;定义;说明书;质量保证体系;规范;质量保证;质量要求;质量评定系统;使用;医疗器械;医疗设备
【英文主题词】:Applications;Definitions;Guidebooks;Instructions;Internationalstandards;Medicaldevices;Medicalequipment;Medicalinstruments;Medicalproducts;Qualityassessmentsystems;Qualityassurance;Qualityassurancesystems;Qualityrequirements;Specification
【摘要】:ThisTechnicalReportprovidesguidancefortheapplicationoftherequirementsforqualitymanagementsystemscontainedinISO13485.Itdoesnotaddto,orotherwisechange,therequirementsofISO13485.ThisTechnicalReportdoesnotincluderequirementstobeusedasthebasisofregulatoryinspectionorcertificationassessmentactivities.NOTETheterms“should”,“can”and“might”withinthisTechnicalReportareusedasfollows.“Should”isusedtoindicatethat,amongstseveralpossibilitiestomeetarequirementinISO13485,oneisrecommendedasbeingparticularlysuitable,withoutmentioningorexcludingothers,orthatacertaincourseofactionispreferredbutnotnecessarilyrequired.“Can”and“might”areusedtoindicatepossibilitiesoroptions.Thesetermsdonotindicaterequirements.ThisguidancecanbeusedtobetterunderstandtherequirementsofISO13485andtoillustratesomeofthevarietyofmethodsandapproachesavailableformeetingtherequirementsofISO13485.
【中国标准分类号】:C30
【国际标准分类号】:03_120_10;11_040_01
【页数】:74P;A4
【正文语种】:英语
【原文标准名称】:医疗装置.质量管理系统.ISO13485-2003应用指南
【标准号】:ISO/TR14969-2004
【标准状态】:现行
【国别】:国际
【发布日期】:2004-10
【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】:国际标准;医疗产品;指导手册;定义;说明书;质量保证体系;规范;质量保证;质量要求;质量评定系统;使用;医疗器械;医疗设备
【英文主题词】:Applications;Definitions;Guidebooks;Instructions;Internationalstandards;Medicaldevices;Medicalequipment;Medicalinstruments;Medicalproducts;Qualityassessmentsystems;Qualityassurance;Qualityassurancesystems;Qualityrequirements;Specification
【摘要】:ThisTechnicalReportprovidesguidancefortheapplicationoftherequirementsforqualitymanagementsystemscontainedinISO13485.Itdoesnotaddto,orotherwisechange,therequirementsofISO13485.ThisTechnicalReportdoesnotincluderequirementstobeusedasthebasisofregulatoryinspectionorcertificationassessmentactivities.NOTETheterms“should”,“can”and“might”withinthisTechnicalReportareusedasfollows.“Should”isusedtoindicatethat,amongstseveralpossibilitiestomeetarequirementinISO13485,oneisrecommendedasbeingparticularlysuitable,withoutmentioningorexcludingothers,orthatacertaincourseofactionispreferredbutnotnecessarilyrequired.“Can”and“might”areusedtoindicatepossibilitiesoroptions.Thesetermsdonotindicaterequirements.ThisguidancecanbeusedtobetterunderstandtherequirementsofISO13485andtoillustratesomeofthevarietyofmethodsandapproachesavailableformeetingtherequirementsofISO13485.
【中国标准分类号】:C30
【国际标准分类号】:03_120_10;11_040_01
【页数】:74P;A4
【正文语种】:英语
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