ENISO11135-1isaninternationalstandardthatspecifiesrequirementsforthedevelopment,validation,androutinecontrolofanethyleneoxidesterilizationprocessformedicaldevices.Itprovidesguidanceontheprinciplesandpracticesnecessarytoensuretheeffectivesterilizationofmedicaldevicesusingethyleneoxidegas.Thestandardcoversvariousaspectsofthesterilizationprocess,includingprocessdesign,validation,monitoring,andcontrol,toensurethatmedicaldevicesarerenderedsterileandsafeforuse.Itisapplicabletomedicaldevicemanufacturersandsterilizationfacilitiesthatutilizeethyleneoxideasasterilizingagent.Compliancewiththisstandardhelpsensurethesafetyandefficacyofsterilizedmedicaldevices,meetingregulatoryrequirementsinmanycountries.
