HereisaplaintextintroductionforISO11135:2014:ISO11135:2014specifiesrequirementsforthedevelopment,validationandroutinecontrolofanethyleneoxidesterilizationprocessformedicaldevices.Thisinternationalstandardprovidesguidanceontheuseofethyleneoxide(EO)asasterilizingagentforhealthcareproducts.ItoutlinestheessentialelementsthatneedtobeaddressedwhenestablishinganEOsterilizationprocess,includingprocesscharacterization,validation,andongoingmonitoring.Thestandardappliestobothindustrialandhealthcarefacilitysterilizationprocesses.Itcoversallstagesfrominitialprocessdevelopmentthroughroutinesterilizationoperations.ISO11135:2014emphasizestheimportanceofaqualitymanagementsystemapproachtoensureconsistentandeffectivesterilizationwhilemaintainingproductsafety.ThestandardisintendedformanufacturersandsterilizerswhoneedtodemonstratethatanEOsterilizationprocessmeetsdefinedsterilityassurancelevels.
