ASTM F1980-2016 Standard Guide for Accelerated Aging of Sterile Barrier Systems

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1、ThisinternationalstandardwasdevelopedinaccordancewithinternationallyrecognizedprinciplesonstandardizationestablishedintheDecisiononPrinciplesfortheDevelopmentofInternationalStandards,GuidesandRecommendationsissuedbytheWorldTradeOrganizationTechnicalBarrierstoTrade(TBT)Comm

2、ittee.Designation:F1980−16StandardGuideforAcceleratedAgingofSterileBarrierSystemsforMedical1DevicesThisstandardisissuedundertheÞxeddesignationF1980;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anu

3、mberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scopepriatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.1.1Thisguideprovidesinformationfordevelopi

4、ngaccel-eratedagingprotocolstorapidlydeterminetheeffects,ifany,2.ReferencedDocumentsduetothepassageoftimeonthesterileintegrityofthesterile2barriersystem(SBS),asdeÞnedinANSI/AAMI/ISO2.1ASTMStandards:11607Ð1:2006andthephysicalpropertiesoftheircomponentD4332PracticeforConditi

5、oningContainers,Packages,orpackagingmaterials.PackagingComponentsforTestingE337TestMethodforMeasuringHumiditywithaPsy-1.2Informationobtainedusingthisguidemaybeusedtochrometer(theMeasurementofWet-andDry-BulbTem-supportexpirationdateclaimsformedicaldevicesterilebarrierperatu

6、res)systems.F17TerminologyRelatingtoFlexibleBarrierPackaging1.3TheacceleratedagingguidelineaddressesthesterileF1327TerminologyRelatingtoBarrierMaterialsforMedi-3barriersystemsinwholewithorwithoutdevices.ThesterilecalPackaging(Withdrawn2007)barriersystemmaterialanddeviceint

7、eractioncompatibilityF2097GuideforDesignandEvaluationofPrimaryFlexiblethatmayberequiredfornewproductdevelopmentorthePackagingforMedicalProductsresultingevaluationisnotaddressedinthisguide.2.2AAMIStandards:ANSI/AAMI/ISO11607Ð1:2006,PackagingforTerminally1.4Real-timeagingpro

8、tocolsarenotaddressedinthis4SterilizedMedicalDevicesguide;however,itisessentialthatreal-t