环氧乙烷灭菌在医疗器械行业的应用

.4120061210Vol.12No.10StandardandTesting1006-6586(2006)10-0041-04TH771+.4A2006-09-13()C2H4O44EthyleneOxideEOETO10.7[1](600~800mg/l)75%[2]3%(MSDS)200533255~7201010005%205025%[3](ISO)1994EN550ISO1113520001212()EthyleneOxideSterilizationAppliedinMedicalDeviceIndustryHUANGJin1WANGXiang-rong21ShenzhenGaokejianMedicalCorporation2YejuMedicalShenzhenCorporationAbstract:Thisarticleintroducestheinternationalandnationalstandardsregardingethyleneoxidesterilizationofmedicaldevice;sterilizationvalidationprocessaccordingtothesestandards;andbioburden,shortdurationcycle,etcaspectsduringthesterilizationvalidation.Asterilizationprocess,whichcomplieswithinternationalandnationalstandards,isprerequisitetomarketingsterilemedicaldeviceglobally.Keywords:EthyleneOxide,SterilizationValidation,Bioburden,ShortDurationCycle.4220061210Vol.12No.10StandardandTestingGB18279:2000(1)(EN)(Manufacturer)OEMMDD(MedicalDeviceDirective)ISO13485:2003(NotifyBody)ISO1348511EN550:1994Sterilizationofmedicaldevices-Validationandroutinecontrolofethyleneoxidesterilization2EN1422:1997SterilizersformedicalpurposeEthyleneoxidesterilizers--Requirementandtestmethod3ISO13485:2003Medicaldevices-Qualitymanagementsystems–Requirementsforregulatorypurposes4ISO11135:1994Medicaldevices-Validationandroutinecontrolofethyleneoxidesterilization5ISO10993-7:1995Biologicalevaluationofmedicaldevices-Part7:Ethyleneoxidesterilizationresiduals6ISO11138-2:1994Sterilizationofhealthcareproduces-Biologicalindicators-Part2:Biologicalindicatorsforethyleneoxidesterilization7EN1174Sterilizationofmedicaldevices-Estimationofthepopulationofmicro-organismsonproduct8YY/T0287-20039GB18279-200010GB18281.2-2000211GB16868.7-2001712GB15980-19952000[4]EO(bioburden)GB18279I.()II.III.IV.V.VI.VII.VIII.IX.X.XI.XII.//A(.4320061210Vol.12No.10StandardandTesting)BCDEFGHIJKL(IQ)(OQ)()M(1)EN14222FDAFDA2()()1234(2)(shortdurationcycle)GB18279B4.3:D90%()I5D1(3)(bioburden)(SterilityAssuranceLevelSAL=10-6)(106)GB15980-19954.3.1≤10cfu/≤100cfu/≤100cfu≤100cfu/g≤1000cfu/(g)IIIIEN1174(correctionfactor).4420061210Vol.12No.10StandardandTesting(1ml)(3)31234513.1*1032.2*1032.4*1035.2*1031.6*1032.9*10321.8*1021.1*102703.1*1026014631.4*1034515901903484502530951543111152447412381251657001867344184.3%[1]()[2]()(=1300&sid=2)[3]2006()[4]200020001221()544021605mm10mm20mm44404cm2cm1cm95Wu48.5cm130~45ms63cmx42cmx12cm20Kg[1],,,2000[2]NOMOSMIMIC3(20)