ASTM F2095-2007e1 有或无约束板的挠性包装件压力下降泄漏试验的标准试验方法
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【英文标准名称】:StandardTestMethodsforPressureDecayLeakTestforFlexiblePackagesWithandWithoutRestrainingPlates
【原文标准名称】:有或无约束板的挠性包装件压力下降泄漏试验的标准试验方法
【标准号】:ASTMF2095-2007e1
【标准状态】:现行
【国别】:美国
【发布日期】:2007
【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】:flexiblepackaging;leaktest;medicalpackaging;pressuredecaytesting;restrainingplatetest;ISO-11607;Decayleaktest;Nonporouspackaging;Pressuretesting--packaging/containers;Restrainingmaterials/systems/tests;ISO-11607
【摘要】:Thesetestmethodsprovidearapid,simpletoapplymethodtodetectsmallleaksinflexiblepackagesealsorwallsattheleakratelevelofgreaterthan1x00D7;10x2212;4sccs,thusprovidingameasureofpackageintegrity.Porousbarrierfilmpackagesmadenon-porouswithanimpermeablefilmformingcoatingmaydemonstratelateralleakagethroughthebarriermaterial.Verificationofleakagedifferencesfrombackgroundleakagemustbeincludedinvalidationmethods.Theuseofcalibratedholesizesororificesmaybeappropriatetodetermineleakagesensitivityorbarrierintegrityforthesematerials.Whiletheoreticalleakratesensitivitycanbeestablishedbycalculation,thetestmeasurementisinpressureunitsandthemeasuringinstrumentmustbecalibrated,certified,andverifiedwiththeseunits.Thepressuredecaymethodofleaktestingisaphysicalmeasureofpackageintegrity.WhentestingmedicalpackagingwhichmustconformtoISO11607x2013;1:2006standards,itmaynecessarytoverifytheresultsofthepressuredecaytestmethodwithothersterilepackageintegritytestmethods.TestMethodAallowspackagestobepressurizedwithoutrestraint.InTestMethodAthepouch,tray,orothertypepackagewillcontainavolumeofairdefinedbyitsmechanicalconfigurationanditsabilitytoresistinternalpressureapplied.Thistestmethodrequiresthatthepackagereachastablevolumeconfiguration(stopstretching)tomakeameasurement.TestMethodBallowstheuseofrigidrestrainingplatesagainstthewallsofthepackagetolimititsvolumeandstabilizethepackagevolume.1.1Thesetestmethodscoverthemeasurementofleaksinnonporousfilm,foil,orlaminateflexiblepouchesandfoil-sealedtrays,whichmaybeemptyorenclosesolidproduct.Ifproductisenclosed,sealsorsurfacescannotbeincontactwithwater,oils,orotherliquid.1.2Thesetestmethodswilldetectleaksatarateof1x00D7;10x2212;4sccs(standardcubiccentimetrespersecond)orgreater,inflexiblepackages.Thelimitationofleakrateisdependentonpackagevolumeastested.1.3Thefollowingtestmethodsareincluded:1.3.1TestMethodA8212;PressureDecayLeakTestforFlexiblePackagesWithoutRestrainingPlates1.3.2TestMethodB8212;PressureDecayLeakTestforFlexiblePackagesWithRestrainingPlates1.4Thesetestmethodsaredestructiveinthattheyrequireentryintothepackagetosupplyaninternalpressureofgas,typicallyairornitrogen,althoughothergasesmaybeused.Theentryconnectionintotheflexiblepackagemustbeleak-tight.1.5Forporouspackages,see9.3.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:A82
【国际标准分类号】:55_040
【页数】:6P.;A4
【正文语种】:英语
【原文标准名称】:有或无约束板的挠性包装件压力下降泄漏试验的标准试验方法
【标准号】:ASTMF2095-2007e1
【标准状态】:现行
【国别】:美国
【发布日期】:2007
【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】:flexiblepackaging;leaktest;medicalpackaging;pressuredecaytesting;restrainingplatetest;ISO-11607;Decayleaktest;Nonporouspackaging;Pressuretesting--packaging/containers;Restrainingmaterials/systems/tests;ISO-11607
【摘要】:Thesetestmethodsprovidearapid,simpletoapplymethodtodetectsmallleaksinflexiblepackagesealsorwallsattheleakratelevelofgreaterthan1x00D7;10x2212;4sccs,thusprovidingameasureofpackageintegrity.Porousbarrierfilmpackagesmadenon-porouswithanimpermeablefilmformingcoatingmaydemonstratelateralleakagethroughthebarriermaterial.Verificationofleakagedifferencesfrombackgroundleakagemustbeincludedinvalidationmethods.Theuseofcalibratedholesizesororificesmaybeappropriatetodetermineleakagesensitivityorbarrierintegrityforthesematerials.Whiletheoreticalleakratesensitivitycanbeestablishedbycalculation,thetestmeasurementisinpressureunitsandthemeasuringinstrumentmustbecalibrated,certified,andverifiedwiththeseunits.Thepressuredecaymethodofleaktestingisaphysicalmeasureofpackageintegrity.WhentestingmedicalpackagingwhichmustconformtoISO11607x2013;1:2006standards,itmaynecessarytoverifytheresultsofthepressuredecaytestmethodwithothersterilepackageintegritytestmethods.TestMethodAallowspackagestobepressurizedwithoutrestraint.InTestMethodAthepouch,tray,orothertypepackagewillcontainavolumeofairdefinedbyitsmechanicalconfigurationanditsabilitytoresistinternalpressureapplied.Thistestmethodrequiresthatthepackagereachastablevolumeconfiguration(stopstretching)tomakeameasurement.TestMethodBallowstheuseofrigidrestrainingplatesagainstthewallsofthepackagetolimititsvolumeandstabilizethepackagevolume.1.1Thesetestmethodscoverthemeasurementofleaksinnonporousfilm,foil,orlaminateflexiblepouchesandfoil-sealedtrays,whichmaybeemptyorenclosesolidproduct.Ifproductisenclosed,sealsorsurfacescannotbeincontactwithwater,oils,orotherliquid.1.2Thesetestmethodswilldetectleaksatarateof1x00D7;10x2212;4sccs(standardcubiccentimetrespersecond)orgreater,inflexiblepackages.Thelimitationofleakrateisdependentonpackagevolumeastested.1.3Thefollowingtestmethodsareincluded:1.3.1TestMethodA8212;PressureDecayLeakTestforFlexiblePackagesWithoutRestrainingPlates1.3.2TestMethodB8212;PressureDecayLeakTestforFlexiblePackagesWithRestrainingPlates1.4Thesetestmethodsaredestructiveinthattheyrequireentryintothepackagetosupplyaninternalpressureofgas,typicallyairornitrogen,althoughothergasesmaybeused.Theentryconnectionintotheflexiblepackagemustbeleak-tight.1.5Forporouspackages,see9.3.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:A82
【国际标准分类号】:55_040
【页数】:6P.;A4
【正文语种】:英语
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