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EtOsterilizationisahighlyregulatedprocess,anddevicemanufacturers,hospitalsandthird-partysterilizersmustfollowrigorousSterilant(EO/EtO)Injection& Dwell.IntroducesthevalidatedsterilityassurancelevelofEOtothesterilizationload.Preconditioningthemedicaldevicesatadefinedtemperatureandhumidity priortoEOexposurehelpsincontrollingtherelativehumidityoftheprod-uctandreducesthedurationofthesterilizationcycleBacterialEndotoxinTestInhibition Enhancement–ValidationoftheBETReferences:ANSI/AAMI/ISOSterilizationofhealthcareproducts–Ethyleneoxide–PartRequirementsfordevelopment, validation,androutinecontrolofasterilizationprocessformedicaldevicesSterilizationofhealth-careproducts Ethyleneoxide Requirementsforthe development,validationandroutinecontrolofasterilizationprocessformedicaldevicesScopeInclusionsThisInternationalStandardspecifiesrequirementsforthe development,validationandroutinecontrolINTRODUCTIONToday,EOsterilizationisdescribedasthemostcost-effective,low-temperaturesterilization processavailable,witharecognizedhistoryofreliabilityTheaimofEOsterilizationprocessincludesphasessuchaspreconditioning,sterilizationcycle,and aeration.Sterilantisinjectedintothesterilizationchambertoapre-determinedpressure.SterilantisinjectedintothesterilizationchambertoapreBacterial EndotoxinTestTheguidancepresentedcomplieswithISO,Sterilizationofhealthcareproducts–ethyleneoxide–PartRequirementsforthedevelopment, validationandroutinecontrolofaHowever,onlyrecentlyhasitsusesignificantlyemerged,basedonitsrangeofapplicationsinthefieldofnewmedicalGuidance ontheapplicationofISOISO–Sterilizationofhealthcareproducts–EthyleneOxideItsabouttheusageofETOforISOspecifiesrequirementsforthe development,validationandroutinecontrolofanethyleneoxidesterilizationprocessformedicaldevicesinboththeindustrialandEthyleneoxide(EO)isawellknownsterilizingagent(AlsocontainscomprehensiveGuidancesection)EthyleneOxide(EtO)gasisoneofthemostcommonwaystosterilizemedicaldevices,a processwhichiscriticalforpreventinginfectionsandensuringpatientshavesafesurgeriesandmedicaltreatments.Ethyleneoxidegas(EOG)sterilizationprocedure wasregardedasthelastcandidateofsterilizationpro-cedureduetotoxicgasresidueemberAuthors:SandeepGoyalIntroducesthevalidatedsterilityassurance levelofEOtothesterilizationloadAbstractPreconditioningthemedicaldevicesatadefinedtemperatureandhumiditySterilant(EO/EtO)Injection&DwellThe most, ETOSterilizationandPackagingRochesterInstituteofTechnologyThesterilizationloaddwells(exposuretothesterilant)foraspecifiedamountoftime EOsterilizationprocessincludesphasessuchaspreconditioning,sterilizationcycle,andaerationRequirementsfordevelopment,validationandroutinecontrolofa sterilizationprocessformedicaldevicesInhibitionEnhancement–ValidationoftheBETReferences:ANSI/AAMI/ISOSterilizationofhealthcareproducts–Ethyleneoxide–PartUCTIONThefollowinghandbookprovidesaframeworkforthevalidationandroutineoperationofethyleneoxide(EO)sterilization processes.