Designation:E1837−96(Reapproved2014)StandardTestMethodtoDetermineEfficacyofDisinfectionProcessesforReusableMedicalDevices(SimulatedUseTest)1ThisstandardisissuedunderthefixeddesignationE1837;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.INTRODUCTIONWhenspecialtestsdesignedtoregisterorvalidateadisinfectionprocesscurrentlyareused,theprocedures,theirstatisticalconsiderations(usuallyallnegativesatagiventimepoint),andthephysicalproblemsofapplyingorganismstosurfaces,suchassuturesandunglazedporcelaincarriers,maycauseinaccurateandconfusingresults.Practical,in-usetestingofreprocessingtechniquesandconditionsareneeded.Exaggeratedconditionsfortestingcanbeachievedwiththeuseofactualinstrumentscontaminatedwithhighnumbersoforganisms.Theadditionofserumasanorganicloadorhardwatermineralsasaninorganicloadcanbemadetoenhanceworst-caseconditions.Whentheseelementsarecoupledwiththeprocessing,asactuallyperformed,theresultisastructuredtestthatisasimulated-useprocedure.Thistestmethodisdesignedtoincorporateseveralelementsofreprocessing,includingcleaning,rinsing,anddisinfection(includingoptionaltreatmentoftheinternalchannelsofdevices,suchasendoscopes)withaterminalalcoholrinseratherthanexaminingonlytheeffectivenessoftheentiredisinfectionprocess.Asimulated-usetesttoexaminetheeffectivenessofreprocessingproceduresisvaluablebecauseseveralincidentsofcontaminationofinstrumentsinusehavebeenrecordedwithvegetativecellsofbacteria,forexample,Pseudomonasandthemycobacteria.Whenthisprocedureisperformedwitharepresentativemycobacterialculture,itisnecessarytouseanonpathogenicstrainsuchasMycobacteriumterrae(isolatedfromsoil)thatcanbemanipulatedonanopenbench.ThisstrainisusedintuberculocidaltestinginEurope,andpublishedinformationshowscomparableresistancetoantimicrobialsasthatdisplayedbyhumantuberculosisstr...
