【英文标准名称】:StandardTestMethodforNon-DestructiveDetectionofLeaksinNon-sealedandEmptyMedicalPackagingTraysbyCO2TracerGasMethod
【原文标准名称】:CO2示踪气体法对不密封的及空的医用包装盘泄漏性进行无损检测的标准试验方法
【标准号】:ASTMF2227-2002(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】:carbondioxide(CO2)leaktesting;flexiblepackaging;infraredCO2sensor;medicalpackageintegritytest;non-destructivetesting;packageintegritymonitoring;pass/failcriteria;permeablepackaging;pinholeleaks;porouspacka
【摘要】:Harmfulbiologicalorparticulatecontaminantsmayenterthepackagethroughimperfectionssuchaspinholesorcracksintrays.Afterinitialinstrumentset-upandcalibration,theoperationsofindividualtestsandtestresultsdonotneedoperatorinterpretation.Leaktestresultsthatexceedthepermissiblethresholdsettingareindicatedbyaudibleorvisualsignalresponses,orboth,orbyothermeans.Thisnon-destructivetestmethodmaybeperformedineitherlaboratoryorproductionenvironmentsandmaybeundertakenoneithera100%orastatisticalsamplingbasis.Thistestmethod,insingleinstrumentuseandcurrentimplementation,maynotbefastenoughtoworkonaproductionpackagingline,butiswellsuitedforstatisticaltestingaswellaspackagedevelopmentaldesignwork.1.1Thisnon-destructivetestmethoddetectspinholeleaksintrays,assmallas50m(0.002in.)indiameter,orequivalentlysizedcracks,subjecttotracegasconcentrationinthetray,traydesignandmanufacturingtolerances.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】:4P.;A4
【正文语种】: