Designation:D8179−18StandardGuideforCharacterizingDetergentsfortheCleaningofClinically-usedMedicalDevices1ThisstandardisissuedunderthefixeddesignationD8179;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Detergentsplayacriticalroleinthecleaningofclinically-usedmedicaldevices,buttherearefewconsensusmethodsfordescribingthekeycharacteristicsofthesedeter-gents.Thisguideidentifiesconsensusstandards,ASTMandothers,usedtocharacterizedetergentsinotherapplications,whichcanalsobeusedtocharacterizedetergentsusedtocleanclinically-usedmedicaldevices.1.2Inidentifyingthesetestmethods,manufacturersofdetergentscanreferencethisguidetocharacterizetheirdeter-gents.1.3Byidentifyingapplicabletestmethods,gapsmaybeidentifiedwheredevelopmentofnewstandardizedtestmeth-odsneedtobedevelopedtocharacterizedetergentsintendedtocleanmedicaldevices.1.4Byidentifyingapplicabletestmethodsthatareusedandresultsreportedbydetergentmanufacturers,testresultscanbesharedandmayleadinthefuturetodevelopmentofperfor-mancecriteriaforthekeycharacteristicsofdetergent.1.5ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.6Exclusions:1.6.1Thisguideisnotintendedfordetergentsformulatedtoremoveresiduesasaresultofthemanufacturingprocess.1.6.2Thisguidedoesnotprovideinformationrelatedtodisinfectionordisinfectingagentsthatmightbepartofadetergentformulation.1.7Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafety,health,andenvironmentalpracticesanddeter-minetheapplicabilityofregulatorylimitationspriortouse.1.8Thisinternationalstandardwasdevelopedinaccor-dancewithinternationallyrecognizedprinciplesonstandard-izationestablishedintheDecisiononPrinciplesforthe...
