【英文标准名称】:StandardTestMethodforNon-DestructiveDetectionofLeaksinMedicalPackagingWhichIncorporatesPorousBarrierMaterialbyCO2TracerGasMethod
【原文标准名称】:CO2示踪气体法对用多孔防渗透材料的包装泄漏性进行无损检测的标准试验方法
【标准号】:ASTMF2228-2002(2007)
【标准状态】:现行
【国别】:
【发布日期】:2002
【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】:
【英文主题词】:basalflow;carbondioxide(CO2)leaktesting;flexiblepackaging;infraredCO2sensor;medicalpackaging;non-destructivetesting;packageintegritymonitoring;packageintegritytest;pass/failcriteria;pass/faillevels;permeabl
【摘要】:Harmfulbiologicalorparticulatecontaminantsmayenterthepackagethroughincompletesealsorimperfectionssuchaspinholesorcracksinthetrays.Afterinitialinstrumentset-upandcalibration,theoperationsofindividualtestsandtestresultsdonotneedoperatorinterpretation.Thenon-destructivenatureofthetestmaybeimportantwhentestinghighvalueaddedproducts.Leaktestresultsthatexceedthepermissiblethresholdsettingareindicatedbyaudibleorvisualsignalresponses,orboth,orbyothermeans.Thisnon-destructivetestmethodmaybeperformedineitherlaboratoryorproductionenvironments.Thistestingmaybeundertakenoneithera100%orastatisticalsamplingbasis.Thistestmethod,insingleinstrumentuseandcurrentimplementation,maynotbefastenoughtoworkonaproductionpackagingline,butiswellsuitedforstatisticaltestingaswellaspackagedevelopmentaldesignwork.1.1Thisnon-destructivetestmethoddetectsleaksinnon-porousrigidthermoformedtrays,aswellasthesealbetweentheporouslidandthetray.Thetestmethoddetectschannelleaksinpackagesassmallas100m(0.004in.)diameterinthesealaswellas50m(0.002in.)diameterpinholes,orequivalentlysizedcracksinthetray,subjecttotracegasconcentrationinthepackage,packagedesignandmanufacturingtolerances.Note18212;Thistestmethoddoesnotclaimtochallengetheporous(breathable)liddingmaterial.Anydefectsthatmayexistintheporousportionofthepackagewillnotbedetectedbythistestmethod.1.2ThevaluesstatedinSIunitsaretoberegardedasstandardunits.Valuesinparenthesesareforinformationonly.1.3Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C04
【国际标准分类号】:11_020;19_100
【页数】:5P.;A4
【正文语种】: