Designation:F3293−18StandardGuideforApplicationofTestSoilsfortheValidationofCleaningMethodsforReusableMedicalDevices1ThisstandardisissuedunderthefixeddesignationF3293;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisguideprovidesmethodsandconsiderationsforsimulatedsoilingofreusablemedicaldevicesforthepurposeofvalidatingcleaninginstructions.Techniquesforapplicationofsoil,aswellasincorporationofsoilbyvariousmeans(e.g.,actuationofdevices)willbedescribedinordertoassureworst-casecontaminationofthesurfacegeometryofmedicaldevices.1.2Units—ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.3Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafety,health,andenvironmentalpracticesanddeter-minetheapplicabilityofregulatorylimitationspriortouse.1.4Thisinternationalstandardwasdevelopedinaccor-dancewithinternationallyrecognizedprinciplesonstandard-izationestablishedintheDecisiononPrinciplesfortheDevelopmentofInternationalStandards,GuidesandRecom-mendationsissuedbytheWorldTradeOrganizationTechnicalBarrierstoTrade(TBT)Committee.2.ReferencedDocuments2.1ASTMStandards:2D1193SpecificationforReagentWaterD7225GuideforBloodCleaningEfficiencyofDetergentsandWasher-DisinfectorsF2809TerminologyRelatingtoMedicalandSurgicalMate-rialsandDevicesF3208GuideforSelectingTestSoilsforValidationofCleaningMethodsforReusableMedicalDevices2.2AAMIStandards:3AAMITIR30Acompendiumofprocesses,materials,testmethods,andacceptancecriteriaforcleaningreusablemedicaldevicesAAMIST79Comprehensiveguidetosteamsterilizationandsterilityassuranceinhealthcarefacilities2.3ISOStandard:4ISO10993-12Biologicalevaluationofmedicaldevices—Part12:Sampleprepara...
