ASTM F1929-1998(2004) 用染色渗透液检测多孔医疗包装汽封泄漏的标准试验方法
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【英文标准名称】:StandardTestMethodforDetectingSealLeaksinPorousMedicalPackagingbyDyePenetration
【原文标准名称】:用染色渗透液检测多孔医疗包装汽封泄漏的标准试验方法
【标准号】:ASTMF1929-1998(2004)
【标准状态】:现行
【国别】:
【发布日期】:1998
【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】:F02.40
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:染色渗透液;多孔包装;汽封泄漏;软包装
【英文主题词】:Dyepenetrant;flexiblepackaging;porouspackaging;sealleaks
【摘要】:Harmfulbiologicalorparticulatecontaminantsmayenterthedevicethroughleaks.Theseleaksarefrequentlyfoundatsealsbetweenpackagecomponentsofthesameordissimilarmaterials.Leaksmayalsoresultfromapinholeinthepackagingmaterial.Thisdyepenetrantprocedureisapplicableonlytoindividualleaksinapackageseal.Thepresenceofanumberofsmallleaks,asfoundinporouspackagingmaterial,whichcouldbedetectedbyothertechniques,willnotbeindicated.Thereisnogeneralagreementconcerningthelevelofleakagethatislikelytobedeleterioustoaparticularpackage.However,sincethesetestsaredesignedtodetectleakage,componentsthatexhibitanyindicationofleakagearenormallyrejected.Sinceleaksmaychangeinsizewithdifferentambientconditions,comparisonsbetweenteststationsarenotconclusive.Thereforethismethodisusuallyemployedasago,no-gotest.Thedyesolutionwillwickthroughanyporousmaterialovertime,butusuallynotwithinthemaximumtimesuggested.Ifwickingdoesoccur,itmaybeverifiedbyobservingtheporoussideofthesubjectsealarea.Thedyewillhavediscoloredthesurfaceofthematerial.Whenpuncturingthepackagingtoallowinjectionofthedyepenetrantsolution,careshouldbetakennottopunctureotherpackagesurfaces.Puncturingofthepackageisfacilitatedifitisdoneadjacenttoadummydeviceinsidethepackage.Thedevicewillprovideatentingeffectthatwillseparatethetwosidesofthepackage,reducingthechanceofaccidentalpunctureofbothsides.1.1Thistestmethoddefinesmaterialsandaprocedurethatwilldetectandlocatealeakequalorgreaterthanachannelformedbya50956;m(0.002in.)wireinpackageedgesealsformedbetweenatransparentfilmandaporoussheetmaterial.Adyepenetrantsolutionisappliedlocallytothesealedgetobetestedforleaks.Aftercontactwiththedyepenetrantforaspecifiedtime,thepackageisvisuallyinspectedfordyepenetration.1.2Thistestmethodisintendedforuseonpackageswithedgesealsformedbetweenatransparentfilmandaporoussheetmaterial.Thistestmethodislimitedtoporousmaterialswhichcanretainthedyepenetrantsolutionandpreventitfromdiscoloringtheentiresealareaforaminimumof20s.Uncoatedpapersareespeciallysusceptibletoleakageandmustbeevaluatedcarefullyfrousewiththistestmethod.1.3Thistestmethodrequiresthatthedyepenetranthavegoodcontrasttotheopaquepackagingmaterial.1.4ThevaluesstatedinSIunitsaretoberegardedasthestandard.Thevaluesgiveninparenthesesareforinformationonly.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C30
【国际标准分类号】:55_040
【页数】:3P.;A4
【正文语种】:
【原文标准名称】:用染色渗透液检测多孔医疗包装汽封泄漏的标准试验方法
【标准号】:ASTMF1929-1998(2004)
【标准状态】:现行
【国别】:
【发布日期】:1998
【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】:F02.40
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:染色渗透液;多孔包装;汽封泄漏;软包装
【英文主题词】:Dyepenetrant;flexiblepackaging;porouspackaging;sealleaks
【摘要】:Harmfulbiologicalorparticulatecontaminantsmayenterthedevicethroughleaks.Theseleaksarefrequentlyfoundatsealsbetweenpackagecomponentsofthesameordissimilarmaterials.Leaksmayalsoresultfromapinholeinthepackagingmaterial.Thisdyepenetrantprocedureisapplicableonlytoindividualleaksinapackageseal.Thepresenceofanumberofsmallleaks,asfoundinporouspackagingmaterial,whichcouldbedetectedbyothertechniques,willnotbeindicated.Thereisnogeneralagreementconcerningthelevelofleakagethatislikelytobedeleterioustoaparticularpackage.However,sincethesetestsaredesignedtodetectleakage,componentsthatexhibitanyindicationofleakagearenormallyrejected.Sinceleaksmaychangeinsizewithdifferentambientconditions,comparisonsbetweenteststationsarenotconclusive.Thereforethismethodisusuallyemployedasago,no-gotest.Thedyesolutionwillwickthroughanyporousmaterialovertime,butusuallynotwithinthemaximumtimesuggested.Ifwickingdoesoccur,itmaybeverifiedbyobservingtheporoussideofthesubjectsealarea.Thedyewillhavediscoloredthesurfaceofthematerial.Whenpuncturingthepackagingtoallowinjectionofthedyepenetrantsolution,careshouldbetakennottopunctureotherpackagesurfaces.Puncturingofthepackageisfacilitatedifitisdoneadjacenttoadummydeviceinsidethepackage.Thedevicewillprovideatentingeffectthatwillseparatethetwosidesofthepackage,reducingthechanceofaccidentalpunctureofbothsides.1.1Thistestmethoddefinesmaterialsandaprocedurethatwilldetectandlocatealeakequalorgreaterthanachannelformedbya50956;m(0.002in.)wireinpackageedgesealsformedbetweenatransparentfilmandaporoussheetmaterial.Adyepenetrantsolutionisappliedlocallytothesealedgetobetestedforleaks.Aftercontactwiththedyepenetrantforaspecifiedtime,thepackageisvisuallyinspectedfordyepenetration.1.2Thistestmethodisintendedforuseonpackageswithedgesealsformedbetweenatransparentfilmandaporoussheetmaterial.Thistestmethodislimitedtoporousmaterialswhichcanretainthedyepenetrantsolutionandpreventitfromdiscoloringtheentiresealareaforaminimumof20s.Uncoatedpapersareespeciallysusceptibletoleakageandmustbeevaluatedcarefullyfrousewiththistestmethod.1.3Thistestmethodrequiresthatthedyepenetranthavegoodcontrasttotheopaquepackagingmaterial.1.4ThevaluesstatedinSIunitsaretoberegardedasthestandard.Thevaluesgiveninparenthesesareforinformationonly.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C30
【国际标准分类号】:55_040
【页数】:3P.;A4
【正文语种】:
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