BS EN ISO 13488-2001 质量体系.医疗设备.ISO9002应用的专门要求

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【英文标准名称】:Qualitysystems-Medicaldevices-ParticularrequirementsfortheapplicationofENISO9002
【原文标准名称】:质量体系.医疗设备.ISO9002应用的专门要求
【标准号】:BSENISO13488-2001
【标准状态】:作废
【国别】:英国
【发布日期】:2001-03-15
【实施或试行日期】:2001-03-15
【发布单位】:英国标准学会(BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:质量检查;质量保证;医疗器械;质量控制;质量保证体系;医疗设备
【英文主题词】:
【摘要】:ThisInternationalStandardspecifies,inconjunctionwithISO9002,thequalitysystemrequirementsfortheproductionand,whenrelevant,installationandservicingofmedicaldevices.ThisInternationalStandard,inconjunctionwithISO9002,isapplicablewhenthereisaneedtoassessamedicaldevicesupplier'squalitysystem.Aspartofanassessmentbyathirdpartyforthepurposeofregulatoryrequirements,thesuppliermayberequiredtoprovideaccesstoconfidentialdatainordertodemonstratecompliancewiththisInternationalStandard.Thesuppliermayberequiredtoexhibitthesedatabutisnotobligedtoprovidecopiesforretention.NOTE—InthisInternationalStandardtheterm"ifappropriate"isusedseveraltimes.Whenarequirementisqualifiedbythisphrase,itisdeemedtobe"appropriate"unlessthesuppliercandocumentajustificationotherwise.Arequirementisconsidered"appropriate"ifitsnon-implementationcouldresultin—theproductnotmeetingitsspecifiedrequirements,and/or—thesupplierbeingunabletocarryoutcorrectiveaction.
【中国标准分类号】:C30
【国际标准分类号】:11_040_01;03_120_10
【页数】:20P;A4
【正文语种】:英语