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1ISO11135-2014Sterilizationofhealth-careproducts̶Ethyleneoxide̶Requirementsforthedevelopment,validationandroutinecontrolofasterilizationprocessformedicaldevices医疗保健产品灭菌——环氧乙烷——医疗器械灭菌过程开发、确认和常规控制要求1Scope范围1.1Inclusions包含内容ThisInternationalStandardspecifiesrequirementsforthedevelopment,validationandroutinecontrolofanethyleneoxidesterilizationprocessformedicaldevicesinboththeindustrialandhealthcarefacilitysettings,anditacknowledgesthesimilaritiesanddifferencesbetweenthetwoapplications.本标准规定了医疗器械产品在工业与医疗保健机构的环氧乙烷灭菌过程的开发、验证和常规控制的要求，并承认这两个领域之间灭菌过程开发、确认的常规控制的异同。NOTE1.Amongthesimilaritiesarethecommonneedforqualitysystems,stafftraining,andpropersafetymeasures.Themajordifferencesrelatetotheuniquephysicalandorganizationalconditionsinhealthcarefacilities,andtotheinitialconditionofreusablemedicaldevicesbeingpresentedforsterilization.注1．其中,相同之处在于质量体系、人员培训及适当的安全措施的通用要求。主要的区别涉及到医疗保健机构的独特的硬件环境和组织条件，以及供灭菌的可重复使用医疗器械的初始条件。NOTE2.Healthcarefacilitiesdifferfrommedicaldevicemanufacturersinthephysicaldesignofprocessingareas,intheequipmentused,andintheISO11135-2014availabilityofpersonnelwithadequatelevelsoftrainingandexperience.Theprimaryfunctionofthehealthcarefacilityistoprovidepatientcare;medicaldevicereprocessingisjustoneofamyriadofactivitiesthatareperformedtosupportthatfunction.注2．医疗器械制造商与医疗机构的主要不同点在于灭菌区域的硬件设计、所使用的设备，以及有技能和经充分培训的人员的可用性方面。卫生保健机构的基本功能是为病人提供医疗保健;医疗器械的再处理仅是支持医疗保健功能的无数活动之一。NOTE3.Intermsoftheinitialconditionofmedicaldevices,medicaldevicemanufacturersgenerallysterilizelargenumbersofsimilarmedicaldevicesthathavebeenproducedfromvirginmaterial.Healthcarefacilities,ontheotherhand,musthandleandprocessbothnewmedicaldevicesandreusablemedicaldevicesofdifferentdescriptionsandwithvaryinglevelsofbioburden.Theyarethereforefacedwiththeadditionalchallengesofcleaning,evaluating,preparingandpackagingamedicaldevicepriortosterilization.InthisInternationalStandard,alternativeapproachesandguidancespecifictohealthcarefacilitiesareidentifiedassuch.注3．就医疗器械的初始条件而言，医疗器械制造商通常灭菌大量的从原始材料开始生产的类似的医疗器械。另一方面，卫生保健机构必须同时处理和加工有着不同生物负载水平的新的医疗器械和再次使用的医疗器械。因此，医疗保健机构的灭菌产品面临着在灭菌前清洗、评估、准备和包装医疗器械的额外挑战。在本标准，确定了针对医疗保健机构的灭菌过程开发、确认和控制的方法或指南。NOTE4.EOgasanditsmixturesareeffectivesterilantsthatareprimarilyusedforheat-and/ormoisture-sensitivemedicaldevicesthatcannotbemoistheatsterilized.注4.EO气体及其混合物是一种主要用于对湿热敏感而不能用湿热进行灭菌的医疗器械灭菌的有效的灭菌剂。NOTE5.AlthoughthescopeofthisInternationalStandardislimitedtomedicaldevices,itspecifiesrequirementsandprovidesguidancethatcanbeISO11135-2014applicabletootherhealthcareproducts.注5尽管本标准限定于医疗器械，但标准规定的要求和提供的指南同样适用于其他医疗保健产品。1.2Exclusions不适用1.2.1ThisInternationalStandarddoesnotspecifyrequirementsforthedevelopment,validationandroutinecontrolofaprocessforinactivatingthecausativeagentsofspongiformencephalopathiessuchasscrapie,bovinespongiformencephalopathyandCreutzfeldt-Jakobdisease.Specificrecommendationshavebeenproducedinparticularcountriesfortheprocessingofmaterialspotentiallycontaminatedwiththeseagents.本标准没有对海绵状脑病的致病因子(如痒病、牛绵状脑病和克-雅病)的灭活过程的开发、确认和常规控制作出规定。有些国家已有了处理可能受此类因子污染的材料的推荐资料。NOTE，SeeISO22442-1,ISO22442-2andISO22442-3.注，见ISO22442-1,ISO22442-2和ISO22442-31.2.2ThisInternationalStandarddoesnotdetailaspecifiedrequirementfordesignatingamedicaldeviceassterile.本标准未详细论述确定医疗器械为无菌的规定要求。2NOTEAttentionisdrawntonationalorregionalrequirementsfordesignatingmedicaldevicesas“sterile”.SeeforexampleEN556–1orANSI/AAMIST67.须注意国家和地区确定医疗器械‘无菌’的要求，见如EN556-1或ANSI/AAMIST67。1.2.3ThisInternationalStandarddoesnotspecifyaqualitymanagementsystemforthecontrolofallstagesofproductionofmedicaldevices.本标准未对医疗器械生产各个阶段的控制的质量管理体系作出规定。NOTETheeffectiveimplementationofdefinedanddocumentedproceduresisnecessaryforthedevelopment,validationandroutinecontrolofaISO11135-2014sterilizationprocessformedicaldevices.Suchproceduresarecommonlyconsideredtobeelementsofaqualitymanagementsystem.ItisnotarequirementofthisInternationalStandardtohaveafullqualitymanagementsystemduringmanufactureorreprocessing.Thenecessaryelementsarenormativelyreferencedatappropriateplacesinthetext(see,inparticular,Clause4).Attentionisdrawntothestandardsforqualitymanagementsystems(seeISO13485)thatcontrolallstagesofproductionorreprocessingofmedicaldevices.Nationaland/orregionalregulationsfortheprovisionofmedicaldevicesmightrequiretheimplementationofafullqualitymanagementsystemandtheassessmentofthatsystembyathirdparty.建立医疗器械灭菌过程的开发、确认和常规控制的文件化的，并能有效实施的程序是必需的，这样的程序文件通常被认为是质量管理体系的要素。在制造和再加工期间有一个充分的质量管理体系不是本标准的要求，必需的要素在接下来的适当地方(见第4章)被规范性引用。须注意控制医疗器械生产和再加工各个过程的质量管理体系的标准(见ISO13485)。国家和/或地区的法规可能对医疗器械质量管理体系及其第三方评价作出了规定。1.2.4ThisInternationalStandarddoesnotspecifyrequirementsforoccupationalsafetyassociatedwiththedesignandoperationofEOsterilizationfacilities.本标准没有对与环氧乙烷灭菌机构的设计和与操作有关的职业安全要求作出规定。NOTE1Forfurtherinformationonsafety,seeexamplesintheBibliography.Nationalorregionalregulationsmayalsoexist.注1，有关安全性的进一步的信息，请参阅‘参考文献’。国家或地区性法规也可能有明确规定。NOTE2EOistoxic,flammableandexplosive.AttentionisdrawntothepossibleexistenceinsomecountriesofregulationsgivingsafetyrequirementsforhandlingEOandforpremisesinwhichitisused.注2，EO有毒，易燃，易爆。需注意，有些国家的