ISO11135-2014中文翻译版

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1、ISO11135-2014Sterilizationofhealth-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ThisInternationalStandardspecifiesrequirem

2、entsforthedevelopment,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

3、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,andtotheinitialconditionofreusable

4、medicaldevicesbeingpresentedforsterilization.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,andintheISO1113

5、5-2014availabilityofpersonnelwithadequatelevelsoftrainingandexperience.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

6、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.Healthcarefaciliti

7、es,ontheotherhand,musthandleandprocessbothnewmedicaldevicesandreusablemedicaldevicesofdifferentdescriptionsandwithvaryinglevelsofbioburden.Theyarethereforefacedwiththeadditionalchallengesofcleaning,evaluating,preparingandpackagingamedicaldevicepriortosterilizati

8、on.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，