【英文标准名称】:StandardTestMethodforDeterminingtheVirus-EliminatingEffectivenessofLiquidHygienicHandwashandHandrubAgentsUsingtheFingerpadsofAdultVolunteers
【原文标准名称】:利用成人自愿者试验液体卫生洗手剂的去除病毒有效性的标准试验方法
【标准号】:ASTME1838-2002
【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】:E35.15
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:
【英文主题词】:cellculture;cytotoxicity;eluent;fingerpads;germicidalsoap;hygienichandwashing;infectioncontrol;influenzavirus;invivotesting;organicload;poliovirus;rhinovirus;rotavirus;skinflora;standardhardwater;virus;viruselution
【摘要】:Thisinvivoprocedureisdesignedtotesttheabilityofhygienichandwashagentstoreducelevelsofselectedinfectiousvirusesfromexperimentallycontaminatedfingerpadsofadultvolunteers.Sincethetwothumbpadsandalleightfingerpadscanbeusedinanygiventest,itallowsfortheincorporationofinputviruscontrol(two),amountofvirusremainingaftertheinoculumhasbeenallowedtodry(two),viruseliminatedaftertreatmentwithacontrolorreferencesolution(two),anduptofourreplicatestoassessthevirus-eliminatingefficiencyoftheproductundertest.Nomorethan100x03BC;Lofthevirussuspensionarerequiredtocompleteonetest.Theresultsoftestingwiththistestmethodmayformthebasisforconfirmatorytestsusingasuitablewhole-handtestprotocol.Thistestmethodisdesignedtobeperformedbyatrainedindividual,whoisresponsibleforchoosingtheappropriatehostsystemforthetestvirusandapplyingthetechniquesnecessaryforpropagationandmaintenanceofhostandtestvirus.Forareferencetext,refertoSchmidtandEmmons(7).Whereas,thistestmethodrelatestotestingwithvirusesofhumanorigin,itcanbereadilyadaptedtoworkwithbacteria,fungi,protozoaandbacteriophages.Infectiousmicroorganismsleftonhandsafterwashingcanbereducedfurtherbydryingthewashedhandswithpaper,cloth,orwarmair(8).Astepforthedryingoffingerpadsafterexposuretothecontrolortestsolution,therefore,hasnotbeenincludedtoavoidvirusremovalbythedryingprocessitself.Thistestmethodisnotmeantforusewithsurgicalhandscrubsorpreoperativeskinpreps.Theamountofvirusoneachfingerpadafterthedryingoftheinoculumshouldnotbelessthan104infectiousunitsthatwouldpermitthedetectionofuptoa4log10reductionintheinfectivitytiterofthevirusbyagivenproductundertheconditionsofthistestmethod.1.1Humanskindoesnotcarryvirusesasapartofitsresidentflora.Handstransientlycontaminatedwithviruses,however,canactasvehiclesforthespreadofmanytypesofviralinfections.Hygienichandwashingismeanttoreducetheloadofvirusesandothertransientmicroorganismsonhands,therebyreducingtheriskofdiseasetransmission.Suchreductioninthevirusloadmaybeduetoacombinationofvirusinactivationandremovalofinfectiousvirusfromtheskin.1.2Standardtestmethodstoassessthecapacityofhygienichandwashandhandrubagentstoreduceviruslevelsonhandsarenotpresentlyavailable.Thistestmethod,therefore,hasbeendesignedtodeterminethecomparativevirus-eliminatingeffectivenessofgermicidalornon-germicidalformulations.Thistestmethodisnotmeantforusewithsurgicalhandscrubsorpreoperativeskinpreps.Note18212;Thetestmethodshouldbeperformedbypersonswithtraininginvirologyinfacilitiesdesignedandequippedforworkwithinfectiousagentsatbiosafetylevel2(5).1.3Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:G73
【国际标准分类号】:11_080_01
【页数】:6P.;A4
【正文语种】: