【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】:
基本信息
| 标准名称： | 铣刀 直齿三面刃铣刀 D=50~200mm |
| 中标分类： |
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| 替代情况： | HB 689-79 |
| 发布日期： | 1993-02-22 |
| 实施日期： | 1993-05-01 |
| 首发日期： | 1900-01-01 |
| 作废日期： | 1900-01-01 |
| 出版日期： | 1900-01-01 |
| 页数： | 8页 |
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