ASTM E1054-2008 评估抗菌剂灭活的标准试验方法

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【英文标准名称】:StandardTestMethodsforEvaluationofInactivatorsofAntimicrobialAgents
【原文标准名称】:评估抗菌剂灭活的标准试验方法
【标准号】:ASTME1054-2008
【标准状态】:现行
【国别】:美国
【发布日期】:2008
【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】:antimicrobialagents;antimicrobialeffectivenessevaluations;inactivation;neutralization;neutralizertoxicity;Antimicrobialformulations/testing;Effectivenesstesting;Inactivators;Microbialenvironments;Neutralization;Neutralizertoxicity;Quenc
【摘要】:Theeffectivenessofantimicrobialagentsincorporatedintodisinfectants,sanitizers,andantisepticsismeasuredbytheirabilitytokillmicroorganismswithinaspecifiedcontacttime.Hence,accuratedeterminationofantimicrobialeffectivenessrequirescompleteandimmediateinactivation(neutralization)oftheantimicrobialagent.Inefficientorincompleteneutralizationwillpermitkillingorinactivationofmicroorganismstocontinuebeyondtheexperimentalexposuretime,resultinginanoverestimationofantimicrobialactivity.Theneutralizationmethodscommonlyusedinantimicrobialeffectivenessevaluationsarechemicalinactivation,dilution,andfiltration.Allcriticalparametersofanantimicrobialeffectivenessevaluationx2014;forexample,media,equipment,microorganism(s),andtemperatureofsolutionsx2014;mustbeduplicatedwhenevaluatinganeutralizationproceduretobeused.Theneutralizationevaluationmustincludeatleastthreereplications(fivereplicationsinSection9)sothatastatisticalanalysisoftherecoverydatacanbeperformed.Thenumberofreplicatesusedintheevaluationdependsonthestatisticalsignificancerequiredfortheexpectedresults,thevariabilityencounteredinthedata,andtherelativeeffectivenessoftheneutralizationprocedure.Alimitationoftheseevaluationproceduresisthattheyusemicroorganismsthathavenotbeenexposedtoanantimicrobialagent.Underexperimentalconditions,cellsexposedtoneutralizationproceduresarelikelytobedamagedtodifferentdegreesbytheantimicrobialagent.Sublethalinjurymaybeafactorinrecovery,andtheroleoftheneutralizationprocedureinrecoveryofinjuredorganismsshouldbeexamined.Thismethodisnotintendedtoassessinjuredorganismrecovery.Note38212;Ideally,allmicroorganismsusedintheantimicrobialeffectivenessevaluationshouldbetestedintheneutralizationassay.However,representativeorganismsmaybeselectedfortesting,asjudgedappropriatebytheinvestigator.Theinvestigatoriscautionedthatfailuretoidentifyneutralizerefficacyandtoxicityforallmicroorganismscouldresultinexaggeratedmicrobialreductionsinanantimicrobialeffectivenessevaluation.Also,forastudytestingmultipleantimicrobialformulations,andinwhichsampleswillcontainmultiplespeciesofmicroorganisms(forexample,skinflora)thatareexposedtotheformulations,asingleprocedureand/orcombinationofagentssuitableforneutralizingtheantimicrobialactivitiesofthemultipleformulationsmustbeusedfortesting.1.1Thesetestmethodsareusedtodeterminetheeffectivenessofproceduresandagentsforinactivating(neutralizing,quenching)themicrobicidalpropertiesofantimicrobialagents,andtoensurethatnocomponentsoftheneutralizingproceduresandagents,themselves,exertaninhibitoryeffectonmicroorganismstargetedforrecovery.Note18212;Knowledgeofmicrobiologicalandstatisticaltechniquesisrequiredfortheseprocedures.Thesemethodsarenotsuitablewhentestingthevirucidalactivityofmicrobicides(seeTestMethodE1482).1.2ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.3Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C51
【国际标准分类号】:71_100_35
【页数】:7P.;A4
【正文语种】:英语