Designation:E1766−15StandardTestMethodforDeterminationofEffectivenessofSterilizationProcessesforReusableMedicalDevices1ThisstandardisissuedunderthefixeddesignationE1766;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thistestmethodcoversareproducibleprocedurefortestingprocessesusedtosterilizereusablemedicaldevices(instruments).Thistestmethodisnotdesignedtovalidateasterilizationprocess,buttestsanestablishedsterilizationcycleorprocess.Itisapracticaltestoftheeffectivenessofasterilizationprocessappliedtoreusablemedicaldevices.Bac-terialsporesmoreresistanttotheteststerilantthanthenaturalbioburdenoftheinstrumentareusedasthetestorganisms.Commerciallyavailableliquidsuspensionsofbacterialsporesareusedtoinoculatetheinstruments.1.2Thistestmethodisintendedforreusablemedicaldevicescleanedinaccordancewiththedevicemanufacturer’sinstructionsandpreparedforsterilizationinaccordancewiththeinstructionsforthesterilizationprocessbeingused.1.3Thistestmethodassumesthatcleaned,reusablemedicaldeviceswillbefreeofvisiblesoilbutmayhaveremainingadherentbioburden.Aworst-casebioburdencanberepresentedbysuspensionsofbacterialendospores,whicharecommer-ciallyavailableformonitoringchemicalorphysicalsteriliza-tionprocesses.Theseendosporesshouldhaveaverifiableresistance(Dvalue)tothespecificprocessandsterilantbeingevaluated.21.4Itisimpracticaltotestforthesterilityofsomedevicesbyimmersioningrowthmediumbecauseoftheircomplexity,size,andavailability(forlong-termincubation)oradverseeffectsonthedevicesfromlong-termimmersion.Therefore,elution,rinsing,orswabbingtechniquesareusedtorecovertestorganismsfrominoculateddevices.1.5Arecoverycontrolwillbeincludedbyinoculationofatestdeviceanduseoftheelutionmethodswithoutapplyingthesterilizationprocessbeingtested.Aminimalrecoveryof106colony-formingunit(C...
