ASTM E2755-2010 成人用手清洁配方的除菌效果测定的标准试验方法

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【英文标准名称】:StandardTestMethodforDeterminingtheBacteria-EliminatingEffectivenessofHandSanitizerFormulationsUsingHandsofAdults
【原文标准名称】:成人用手清洁配方的除菌效果测定的标准试验方法
【标准号】:ASTME2755-2010
【标准状态】:现行
【国别】:美国
【发布日期】:2010
【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】:E35.15
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:
【英文主题词】:alcohol-basedhandrub;antimicrobial;contaminant;efficacy;handantiseptic;handsanitizer;healthcarepersonnelhandwash;Serratiamarcescens;Staphylococcusaureus
【摘要】:Handhygieneisconsideredoneofthemostimportantmeasuresforpreventingthespreadofinfectiousmicroorganisms.Handsanitizersreducethemicrobialloadonthehandswithouttheuseofsoapandwater,andarethusanimportanttoolinthepracticeofgoodhandhygiene.Handsanitizersarerecommendedforuseonhandsthatarenotvisiblysoiled.Theyareformulatedtobeappliedfullstrengthtodryhands,x201C;rubbedinx201D;untildry,andarenotrinsedoff.Thistestmethodisspecificallydesignedtoevaluatethebacteria-eliminatingactivityofhandsanitizersfromexperimentally-contaminatedhands.ItisintendedtobeanalternativetoTestMethodE1174,whichwasdesignedprimarilytoevaluateantimicrobialhandwashingagentsthatarelatheredwiththeaidofwaterandthenrinsedoff.WhenusingTestMethodE1174toevaluatehandsanitizers,inadequatedryingofthehandsaftercontaminationdilutesthetestproductandcancompromiseactivity,leadingtoanunderestimationofeffectiveness.Byapplyingahighertitertestbacteriasuspensioninasmallervolume,soilloadonthehandsisminimizedandhandsarecompletelydrypriortoapplicationofthetestmaterial.Thesemodificationsresultinabetterapproximationofthein-useconditionsforhandsanitizersandthusprovideamorereliableindicationoftheirperformanceinthefield.Thistestmethodcanbeusedtotestanyformofhandsanitizer,includinggels,rubs,sprays,foams,andwipesaccordingtolabeldirectionsattypicalx201C;in-usex201D;doses.Susceptibilitytobiocidescanvaryamongdifferentspeciesofbacteriaandmajordifferenceshavebeennotedbetweengram-negativeandgram-positiveorganisms.Thistestmethodprovidestheoptiontouseeitheragram-negativebacterium(Serratiamarcescens)oragram-positivebacterium(Staphylococcusaureus)asthetestorganism.S.marcescensisusedasatestorganisminbothTestMethodE1174andTestMethodE2276.S.aureusisahighlyrelevantpathogeninhealthcare,institutional,andcommunitysettings.Moreover,handsareanimportantvehicleinthetransferofS.aureusbetweenpeopleandtheenvironment,andinthetransferbetweenindividuals.ThistestmethodmaybeusedasanalternativetoTestMethodE2276,whichlimitsthetestbacteriatothefingerpadsanddoesnotincorporateactualuseconditionssuchasfrictionduringhanddecontamination.TheinvestigatorshouldbeawareofpotentialhealthrisksassociatedwiththeuseoftheseorganismsandprecautionssimilartothosereferencedinSection8shouldbetaken.1.1Thistestmethodisdesignedtodeterminetheactivityofhandsanitizers(alsoknownashandrubs,hygienichandrubs,orhandantiseptics)againsttransientbacterialfloraonthehands.1.2Performanceofthisprocedurerequirestheknowledgeofregulationspertainingtotheprotectionofhumansubjects(see21CFRParts50and56).1.3Thistestmethodshouldbeperformedbypersonswithtraininginmicrobiology,infacilitiesdesignedandequippedforworkwithpotentiallyinfectiousagentsatbiosafetylevel2.