ISO 11135 两个版本的比较

Clause2014Influence20071ScopeNothingsignificantchangefortheindustrial1.1InclusionNEWSpecifyrequirementofEOsterilizationforindustrialandhealthcarefacility.1.2ExclusionNEW1.2.1=20071,DONOTincludeseveralkindsofinactivation1.2.2=20071,DONOTspecifyrequirementfordesignatingSTERILE1.2.3=20071,DONOTspecifyaqualitymanagementsystem1.2.4=2007.1,DONOTspecifyoccupationalsafety1.2.5=2007.1,DONOTincludeinjectingEOtopackage1.2.6=2007.1,DONOTcoveranalyticalmethodforEOresidualorreaction2NormativeReferenceISO10012,sameISO10993-1DELETEISO10993-7sameISO11138-1:2006sameISO11138-2:2009versionupdateISO11140-1sameISO11737-1sameISO11737-2sameISO13485:2003/Cor1:2009,changeISO14161DELETEISO14937:2000DELETE3TermandDefinitionDewPoint:NEWHealthcarefacility:NEWOverkillapproach:onlytermchangeProcesschallengedevice:internalPCD/externalPCDProcessingcategory:NEWProducefamily:NEWReusablemedicaldevice:NEWSingleusemedicaldevice:NEWSLR:newmethodtocalculateSterilebarriersystem:NEWSterilizationspecialist:NEWTestforsterility:NEWVirginmaterial:NEW4Qualitymanagementsystem4.1Documentation4.1.1=20074.1.1,procedurefordevelopment,validation,routinecontrolandproductreleaseshallbespecified.4.1.2=20074.1.2,reviewedandapprovedbydesignatedpersonnel,documentandrecordaccordingtoISO13485Noeffect4.2Managementresponsibility4.2.1=20074.2.1,responsibilityandauthorityshallbespecifiedaccordingtoISO134854.2.2=20074.2.2,organizationwithseparatequalitymanagementsystemAddHCF’sresponsibilityNoeffect4.3Productionrealization4.3.1=20074.3.1,purchasingprocedure4.3.2=20074.3.2,procedureforidentificationandtraceability4.3.3=20074.3.3,qualitymanagementsystemforcalibrationNoeffect4.4Measurement,analysisandimprovement=20074.4,procedurefornonconformingproductandforcorrection,correctiveactionandpreventiveaction.Noeffect5Sterilizingagentcharacterization5.1GeneralNEWPurpose5.2Sterilizingagent=20075.1,composition,storageDescriptionchangewhilethecontentkeepthesame5.3Microbicidaleffectiveness=20075.2,recognizedrangeofEOanddiluents,otherwisemicrobicidaleffectivenessshallbedeveloped.5.4Materialeffects=20075.3,EO’seffectonmaterialsusedtoMedicalDevice.DELETEthedescriptionofrecording5.5Safetyandenvironment5.5.1,NEW,MSDSofEOanddiluentsneeded,healthandsafetyofpersonnel5.5.2=20075.4.1,environmentprotect5.5.3=20075.4.2,userofEO6Processandequipmentcharacterization6.1General6.1.1,NEW,purpose6.1.2,NEW,ifasterilizationprocessexisting,thenignorethis6.2Processcharacterization6.2.1,NEW,Processcharacterizationshallincludea),identifyingthephaseforEOcycleb),identifyingthevariablesforeachphasec)documentthevariables6.2.2=20076.1.2,phaseofsterilizationa),preconditioningb),sterilizationcyclec),aeration6.2.3,NEW,variablesforpreconditioninga),timeb),tempc),humidityd),transfertime6.2.4,NEW,variableforsterilizationcyclea),exposuretimeb),tempc),humidityd),EOconcentratione),pressure6.2.5,NEW,variableforaeration,noteforaerationvariablea),timeb),tempDELETE20076.1.1DELETE20076.1.3thecharacterizationofsterilizationcycleDELETE20076.1.4thecontrolledtreatmentconditionDELETE20076.1.5toleranceDELETE20076.1.6meansofmonitoringandcontrollingRangeofvariableandequipmentshallbedocumented6.3Equipmentcharacterization6.3.1=20076.2.1,specificationofequipmentshallincludea),thepreconditioningareab),thesterilizerc),theaerationarea6.3.2=20076.2.2,specificationshallincludea)=2007a),descriptionofequipment,ancillaryitems,materialofconstructionb)2007b),descriptionofmeansofdeliveringsterilizingagenttochamberc)=2007c),descriptionofmeansofdeliveringothergasorsteamtochamberd)=2007e),descriptionofinstrumentationformonitoring,controllingandrecordinge)=2007f),faultrecognitionf)=2007g),safetyfeatureg)=2007h),installationrequirement6.3.3=20076.2.3,softwareshallbepreparedandvalidatedtomeetitsspecification6.3.4=20076.2.4,meanstoensurefailureincontrolfunctiondoesnotleadtofailureinrecordingwhichleadtoafakepositive7Productdefinition7.1General7.1.1,NEW,purpose:definetheproducttobesterilizedpriortothesterilization,includingthemicrobiologicalqualityandpackage7.1.2=20077.1.1+7.1.27.1.320077.1.3,productshallbedesignedtoallowtheremovalofairandEO,etc,DELETEthemostdifficult-to-sterilizedlocationforproduct7.1.4=20077.1.4,packageshallbedesignedtoallowtheremovalofairandEO,etc7.1.5,NEW,loadconfigurationshallbedesignedtoallowtheremovalofairandEO,etc7.1.620077.1.5,Itcanbeachievedby3waystodemonstratethespecifiedsterilizationprocessiseffectiveinsterilizingthemostdifficult-to-sterilizelocationwithintheproductinsteadofmaybe.7.2Productsafety,qualityandperformance7.2.1=20077.2.1,themostchallengingprocessparameterofproductandpackage.7.2.220077.2.2,evaluatemultiplecycle’seffectonproduct,DELETEISO176647.2.3=20077.2.3,establishthebiologicalsafetyofproductenduredthecycle7.2.4=20077.2.4,reducetheEOresidual7.3Microbiologicalquality7.3.1=20077.3.1,systemtocontrolmicrobiologicalqualityandcleanliness.Addquotationofbacterialendotoxinsrelatedstandardandliterature.7.3.2=20077.3.2,system’seffectivenessforsingleandreusablemedicaldeviceshallbedemonstrated.7.420077.4,documentationshallbed