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【英文标准名称】:StandardGuideforAcceleratedAgingofSterileBarrierSystemsforMedicalDevices
【原文标准名称】:医疗装置用无菌阻隔系统加速老化的标准指南
【标准号】:ASTMF1980-2007
【标准状态】:现行
【国别】:
【发布日期】:2007
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:F02.50
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:老化;老化试验;医疗产品;包装件;保存期限;无菌的;无菌
【英文主题词】:acceleratedaging;Arrheniusreactionrate;Q10;shelf-life
【摘要】:1.1Thisguideprovidesinformationfordevelopingacceleratedagingprotocolstorapidlydeterminetheeffects,ifany,duetothepassageoftimeonthesterileintegrityofthesterilebarriersystem(SBS),asdefinedinANSI/AAMI/ISO11607-1:2006andthephysicalpropertiesoftheircomponentpackagingmaterials.1.2Informationobtainedusingthisguidemaybeusedtosupportexpirationdateclaimsformedicaldevicesterilebarriersystems.1.3Theacceleratedagingguidelineaddressesthesterilebarriersystemsinwholewithorwithoutdevices.Thesterilebarriersystemmaterialanddeviceinteractioncompatibilitythatmayberequiredfornewproductdevelopmentortheresultingevaluationisnotaddressedinthisguide.1.4Real-timeagingprotocolsarenotaddressedinthisguide;however,itisessentialthatreal-timeagingstudiesbeperformedtoconfirmtheacceleratedagingtestresultsusingthesamemethodsofevaluation.1.5Methodsusedforsterilebarriersystemvalidation,whichincludethemachineprocess,theeffectsofthesterilizationprocess,environmentalchallenge,distribution,handling,andshippingevents,arebeyondthescopeofthisguide.1.6Thisguidedoesnotaddressenvironmentalchallengingthatstimulatesextremeclimacticconditionsthatmayexistintheshippingandhandlingenvironment.RefertoPracticeD4332forstandardconditionsthatmaybeusedtochallengethesterilebarriersystemtorealisticextremesintemperatureandhumidityconditions.SeeTerminologyF1327foradefinitionof"environmentalchallenging."1.7Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C04
【国际标准分类号】:11_080_30
【页数】:7P.;A4
【正文语种】: