【英文标准名称】:StandardTestMethodforMicrobialRankingofPorousPackagingMaterials(ExposureChamberMethod)
【原文标准名称】:多孔包装材料的微生物分等的标准试验方法(开放室法)
【标准号】:ASTMF1608-2000(2009)
【标准状态】:现行
【国别】:美国
【发布日期】:2000
【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】:F02.15
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:
【英文主题词】:biologicalbarrier;medicalpackaging;microbialbarrier;microbial-challenge;porouspackaging;sterilebarrier;sterilepackaging;Airbornemicroorganisms;Bacteria/bacterialcontrol;Biologicaldataanalysis;Exposurechambermethod;Logreduction
【摘要】:Theexposure-chambermethodisaquantitativeprocedurefordeterminingthemicrobial-barrierpropertiesofporousmaterialsundertheconditionsspecifiedbythetest.Dataobtainedfromthistestareusefulinassessingtherelativepotentialofaparticularporousmaterialtocontributetothelossofsterilitytothecontentsofthepackageversusanotherporousmaterial.Thistestmethodisnotintendedtopredicttheperformanceofagivenmaterialinaspecificsterile-packagingapplication.Themaintenanceofsterilityinaparticularpackagingapplicationwilldependonanumberoffactors,including,butnotlimitedtothefollowing:Thebacterialchallenge(numberandkindsofmicroorganisms)thatthepackagewillencounterinitsdistributionanduse.Thismaybeinfluencedbyfactorssuchasshippingmethods,expectedshelflife,geographiclocation,andstorageconditions.Thepackagedesign,includingfactorssuchasadhesionbetweenmaterials,thepresenceorabsenceofsecondaryandtertiarypackaging,andthenatureofthedevicewithinthepackage.Therateandvolumeexchangeofairthattheporouspackageencountersduringitsdistributionandshelflife.Thiscanbeinfluencedbyfactorsincludingthefree-airvolumewithinthepackageandpressurechangesoccurringasaresultoftransportation,manipulation,weather,ormechanicalinfluences(suchasroomdoorclosuresandHVACsystems).Themicrostructureofaporousmaterialwhichinfluencestherelativeabilitytoadsorborentrapmicroorganisms,orboth,underdifferentair-flowconditions.1.1Thistestmethodisusedtodeterminethepassageofairbornebacteriathroughporousmaterialsintendedforuseinpackagingsterilemedicaldevices.Thistestmethodisdesignedtotestmaterialsunderconditionsthatresultinthedetectablepassageofbacterialsporesthroughthetestmaterial.1.1.1Around-robinstudywasconductedwithelevenlaboratoriesparticipating.EachlaboratorytestedduplicatesamplesofsixcommerciallyavailableporousmaterialstodeterminetheLRV.MaterialstestedunderthestandardconditionsdescribedinthistestmethodreturnedaveragevaluesthatrangefromLRV1.7to4.3.1.1.2Resultsofthisround-robinstudyindicatethatcautionshouldbeusedwhencomparingtestdataandrankingmaterials,especiallywhenasmallnumberofsamplereplicatesareused.Inaddition,furthercollaborativework(suchasdescribedinPracticeE691)shouldbeconductedbeforethistestmethodwouldbecondsideredadequateforpurposesofsettingperformancestandards.1.2Thistestmethodrequiresmanipulationofmicroorganismsandshouldbeperformedonlybytrainedpersonnel.TheU.S.DepartmentofHealthandHumanServicespublicationBiosafetyinMicrobiologicalandBiomedicalLaboratories(CDC/NIH-HHSPublicationNo.84-8395)shouldbeconsultedforguidance.1.3ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:A82
【国际标准分类号】:55_040
【页数】:9P.;A4
【正文语种】:英语