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1、Clause2014Influence20071ScopeNothingsignificantchangefortheindustrial1.1InclusionNEWSpecifyrequirementofEOsterilizationforindustrialandhealthcarefacility.1.2ExclusionNEW1.2.1=20071,DONOTincludeseveralkindsofinactivation1.2.2=20071,DONOTspecifyrequirementfordes
2、ignatingSTERILE1.2.3=20071,DONOTspecifyaqualitymanagementsystem1.2.4=2007.1,DONOTspecifyoccupationalsafety1.2.5=2007.1,DONOTincludeinjectingEOtopackage1.2.6=2007.1,DONOTcoveranalyticalmethodforEOresidualorreaction2NormativeReferenceISO10012,sameISO10993-1DELET
3、EISO10993-7sameISO11138-1:2006sameISO11138-2:2009versionupdateISO11140-1sameISO11737-1sameISO11737-2sameISO13485:2003/Cor1:2009,changeISO14161DELETEISO14937:2000DELETE3TermandDefinitionDewPoint:NEWHealthcarefacility:NEWOverkillapproach:onlytermchangeProcesscha
4、llengedevice:internalPCD/externalPCDProcessingcategory:NEWProducefamily:NEWReusablemedicaldevice:NEWSingleusemedicaldevice:NEWSLR:newmethodtocalculateSterilebarriersystem:NEWSterilizationspecialist:NEWTestforsterility:NEWVirginmaterial:NEW4Qualitymanagementsys
5、tem4.1Documentation4.1.1=20074.1.1,procedurefordevelopment,validation,routinecontrolandproductreleaseshallbespecified.4.1.2=20074.1.2,reviewedandapprovedbydesignatedpersonnel,documentandrecordaccordingtoISO13485Noeffect4.2Managementresponsibility4.2.1=20074.2.
6、1,responsibilityandauthorityshallbespecifiedaccordingtoISO134854.2.2=20074.2.2,organizationwithseparatequalitymanagementsystemAddHCF’sresponsibilityNoeffect4.3Productionrealization4.3.1=20074.3.1,purchasingprocedure4.3.2=20074.3.2,procedureforidentificationand
7、traceability4.3.3=20074.3.3,qualitymanagementsystemforcalibrationNoeffect4.4Measurement,analysisandimprovement=20074.4,procedurefornonconformingproductandforcorrection,correctiveactionandpreventiveaction.Noeffect5Sterilizingagentcharacterization5.1GeneralNEWPu
8、rpose5.2Sterilizingagent=20075.1,composition,storageDescriptionchangewhilethecontentkeepthesame5.3Microbicidaleffectiveness=20075.2,recognizedrangeofEOanddiluents,otherwisemicrobic
