ASTM E2314-2003(2008) 用微生物方法测定可再度使用医疗器械清洁过程的效力的试验方法(模拟使用测试)

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【英文标准名称】:StandardTestMethodforDeterminationofEffectivenessofCleaningProcessesforReusableMedicalInstrumentsUsingaMicrobiologicMethod(SimulatedUseTest)
【原文标准名称】:用微生物方法测定可再度使用医疗器械清洁过程的效力的试验方法(模拟使用测试)
【标准号】:ASTME2314-2003(2008)
【标准状态】:现行
【国别】:美国
【发布日期】:2003
【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】:cleaning;cleaningsolution;endoscope;recoveryandelution;reprocessing;reusablemedicalinstrument;Cleaningagents/processes(medical/surgicalapplications);Effectivenesstesting;Recoveryandelution;Reprocessingmedicalinstruments;Reusabl
【摘要】:Thistestmethodisdesignedtoevaluatetheeffectivenessofcleaningreusablemedicalinstrumentsusingaspecifiedcleaningprocess.Thistestmethodmaybeusedtodeterminetheeffectivenessofcleaningprocessesofrecesses,hingedsites,lumina,orotherdifficult-to-reprocessareasofreusablemedicalinstruments.Thistestmethodmayalsobeusedtoverifytheclaimsforanyportionofthecleaningcycle.Therecoveryofsurvivingmicroorganismsmaybeaccomplishedusingswabbing,rinsing,ortotalimmersionofinstruments.Theefficacyoftheelutionmethodsorlossoftheappliedinoculummaybeassessedbyrecoveryoftargetorganismsfromcontrolinstrumentsthathavenotbeensubjectedtothecleaningprocess.1.1Thistestmethodiswrittenprincipallyforlargemedicalinstrumentsorinstrumentswithinternalchannelsorrecesses(forexample,flexibleendoscopes)butmaybeusedforanyresuablemedicalinstruments.1.2Thistestmethoddescribesaprocedurefortestingtheefficacyofacleaningprocessforreusablemedicalinstrumentsartificiallycontaminatedwithmixturesofmicroorganismsandsimulatedsoil.1.3Thetestmethodutilizesbacterialsporesastracersforforeignmaterialsandquantifiestheirremovalasameansofdeterminingtheefficacyofacleaningprocess.1.4Thetestmethodisdesignedforusebymanufacturersofmedicalinstrumentsanddevices.However,itmayalsobeemployedbyotherindividualswhohaveaknowledgeoftheinstruments,techniquesandaccesstoappropriatefacilities.1.5Worst-caseconditionscanberepresentedbyexaggeratingaspecifictestparameterorotherwiseintentionallysimulatinganextremeconditionsuchasperformingthetestwithoutcleaningsolutionsorutilizinginstrumentswhicharenotnew.1.6Thetestprocedureisdevisedtodeterminetheefficacyofacleaningprocessasappliedtoaparticularinstrumentorgroupofinstrumentsbysimulatingactualusesituations.1.7Thetestproceduremaybeperformedontestinstrumentsusingacompletecleaningcycleorbelimitedtoparticularphasesofthecyclesuchasprecleaning,manualcleaning,automatedcleaning,orrinsing.1.8Thetestprocedureisnormallyperformedonanumberofexternalandinternalsites,butitmayberestrictedtooneparticularsiteontheinstrument.1.9Aknowledgeofmicrobiologicalandaseptictechniquesandfamiliaritywiththeinstrumentsisrequiredtoconducttheseprocedures.Note18212;Becausecontaminationofthesurfacesofinstrumentsmayoccurasaresultofrinsingwithtapwater,bacteria-freewatershouldbeusedforallrinsingwhenawaterrinsestepispartofthecleaningdirections.Note28212;Testmethodstodeterminetheeffectivenessofcleaningmedicalinstrumentshasonlyrecentlybeenactivelydebated,andresearcheffortsareintheirinfancy.Becausepublishedexperimentalresultsarescarce,itisprematuretodictateexperimentalreagents,conditionsoracceptancecriteria.Note38212;Thetotaleliminationofthetargetorganismsisnotthegoalofcleaning.Therefore,therewillalmostalwaysbeanumberofmicroorganismssurvivingonthetestinstrumentsunlessoneofthesolutionsorprocessesdisinfectsorsterilizesthetestinstrument.Theresultsofvariousclinicalandlaboratorytestssuggestthatcleaningprocessesalonecanproducea102to104log10reductioninbioburden.Theexactreductionwilldependuponthepreciseexperimentalconditions.Thecriteriaforjudgingcleanlinessshouldbedeterminedandrecordedbeforeinitiationoft......
【中国标准分类号】:C30
【国际标准分类号】:11_080_99
【页数】:6P.;A4
【正文语种】:英语