ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Pa英文版

《ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Pa英文版》由会员上传分享，免费在线阅读，更多相关内容在行业资料-天天文库。

1、Designation:F1929−15StandardTestMethodforDetectingSealLeaksinPorousMedicalPackagingbyDye1PenetrationThisstandardisissuedundertheÞxeddesignationF1929;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumber

2、inparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.31.Scope2.2ANSIStandards:Z1.4SamplingProceduresandTablesforInspectionby1.1ThistestmethoddeÞnesmaterialsandproceduresthatAttributeswilldetectandlocateal

3、eakequaltoorgreaterthanachannelformedbya50µm(0.002in.)wireinpackageedgeseals3.Terminologyformedbetweenatransparentmaterialandaporoussheet3.1wicking—themigrationofaliquidintothebodyofamaterial.AdyepenetrantsolutionisappliedlocallytothesealÞbrousmaterial.Thisisdistinctfromaleakas

4、deÞnedinedgetobetestedforleaks.AftercontactwiththedyepenetrantTerminologyF17.foraspeciÞedtime,thepackageisvisuallyinspectedfordyepenetration.3.2dyepenetrant—anaqueoussolutionofadyeandasurfactantdesignedtopenetrateandindicateadefectlocation1.2Threedyeapplicationmethodsarecovered

5、inthistestinthetimepriortotheonsetofwickingwhichcouldmaskitsmethod:injection,edgedip,andeyedropper.presence.1.3Thesetestmethodsareintendedforuseonpackages3.3channel—refertodeÞnitioninF17.withedgesealsformedbetweenatransparentmaterialandaporoussheetmaterial.Thetestmethodsarelimi

6、tedtoporous4.SignificanceandUsematerialswhichcanretainthedyepenetrantsolutionand4.1Harmfulbiologicalorparticulatecontaminantsmaypreventitfromdiscoloringthesealareaforaminimumof5enterthemedicalpackagethroughleaks.Theseleaksareseconds.Uncoatedpapersareespeciallysusceptibletoleakag

7、efrequentlyfoundatsealsbetweenpackagecomponentsoftheandmustbeevaluatedcarefullyforusewitheachtestmethod.sameordissimilarmaterials.Leaksmayalsoresultfroma1.4Thesetestmethodsrequirethatthedyepenetrantpinholeinthepackagingmaterial.solutionhavegoodcontrasttotheopaquepackagingmateri

8、al.4.2Itistheobjectiveofthistestmethodtovisuallyobserv