【英文标准名称】:StandardTestMethodtoDetermineEfficacyofDisinfectionProcessesforReusableMedicalDevices(SimulatedUseTest)
【原文标准名称】:可再利用医疗设备(模拟使用试验)消毒过程功效测定的标准试验方法
【标准号】:ASTME1837-1996(2007)
【标准状态】:现行
【国别】:美国
【发布日期】:1996
【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】:disinfectant;disinfectionprocesses;disinfector;elution;high-leveldisinfectant;recovery;reprocessing;reusablemedicalinstrument
【摘要】:1.1Thistestmethodisintendedtodescribeaprocedurefortestingtheeffectivenessofadisinfectionprocessforreprocessingreusablemedicaldeviceswhenitistestedwithachallengeofvegetativecellsincludingmycobacteria.Disinfectionnormallydealswithtestingactivityagainstvegetativecellsofbacteria,viruses,andfungi.Sincethistestmethodisprocessoriented,theusermaywishtoexamineavarietyoftestorganisms.1.2Thistestmethodisdesignedtoprovideareproducibleproceduretoverifytheeffectivenessofapreviouslyvalidateddisinfectantordisinfectionprocedureforreusablemedicalinstrumentsanddevices.1.3Thistestmethodisnotmeanttodefinetheeffectivenessoforvalidationoftheparticulardisinfectionprocessusedoritskinetics,butrather,itisdevisedtoconfirmtheeffectivenessofthedisinfectionprocessbysimulatingusesituationswithaparticulartestprocessusingmedicaldevicesandinstruments.Eithermanualormachinereprocessingcanbetested.1.4Thistestmethodisintendedforusewithreusablecleanedandpreviouslysterilizedordisinfected(highlevel)medicalinstrumentsanddevices.Endoscopesaredescribedinthistestmethodasaworst-caseexampleforcontaminationandsampling.Theselectedsterilizationordisinfectionprocesses,orboth,shouldhavebeenvalidatedpreviously,aswellastheeffectivenessofrinsingforresidualsterilant/disinfectantremovaldetermined.1.5Aninoculumwithhighnumbersofselectedmicroorganismsisappliedtobothtestandcontrol,cleanedandsterilized,ordisinfectedmedicalinstruments.Strainsofmicroorganismswitharecordedresistancetodisinfectantsareusedtocontaminatetheinstrumentsitesknownorsuspectedtobethemostdifficulttoreprocess.1.6Itisimpracticaltotestforrecoveryofsurvivorsbyimmersionofsomeinstruments,forexample,endoscopesorsomelaproscopicinstruments,ingrowthmediumbecauseofcomplexity,size,difficultyinlong-termincubation,ordeteriouseffectsresultingfromincubation.Elutionoforganismsfromtheinoculatedsurfaces,therefore,maybeperformedtoestimatethenumberofrecoverableorganisms.Immersioncanbeusedforsmallerinstruments.1.7Controlinstrumentsareinoculatedinthesamemannerasthetestinstrumentsandelutionorimmersionmethodsareperformedtodeterminethenumberoforganismsrecoverablefromtheinstrument.Forchanneleddevices,suchasendoscopestesting,thenumberoforganismsrecoverablefromtheinstrument(insideandoutside)willserveastheinitialcontrolcount.Itisexpectedthatsomefractionofthenumberoforganismsinoculatedwillbelostintheprocessofinoculation/drying.1.8Atestingprocedurecanbeperformedonacompletereprocessingcycleorcanbelimitedtojustthecleaningordisinfectionportionsofthecyclewhetherreprocessingisdoneinamachineormanually.1.9Afterthetestcyclehasbeencompleted,remaininginoculatedbacteriawillberecoveredfromtestinstrumentsusingthesameelutionproceduresasforthecontrolinstruments.1.10Efficacyofadisinfectioncycleorreprocessingcycle,oranypartthereof,maybedeterminedbycomparisonofthenumberofmicroorganismsrecoveredfromthecontrolinstrument(initialrecoverablecontrolcount)totherecoverydeterminedforthetestinstruments.1.11Aknowledgeofmicrobiologicaltechniquesisrequiredtoconducttheseprocedures.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C05
【国际标准分类号】:11_080_01
【页数】:5P.;A4
【正文语种】:英语