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1、Designation:E2314?03(Reapproved2014)StardTestMethodfDeterminationofEffectivenessofCleaningProcessesfReusableMedicalInstrumentsUsingaMicrobiologicMethod(SimulatedUseTest)1ThisstardisissuedunderthefixeddesignationE2314then

2、umberimmediatelyfollowingthedesignationindicatestheyearofiginaladoptioninthecaseofrevisiontheyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperepsilon()indicatesaneditialchangesincethelastrevi

3、sionreapproval.INTRODUCTIONCleaningisacknowledgedasthecriticalfirststepinthereprocessingofreusablemedicalinstruments.Atestmethodtoexaminetheefficacyreproducibilityofcleaningprocedureswouldbevaluableinoptimizingdecontamin

4、ationofmedicalinstrumentsaswellasincreasingthemarginofsafetyofsubsequentdisinfectionsterilizationprocedures.Thistestmethodisameansofdeterminingtheefficacyoftheinstrumentmanufacturer’scleaninginstructions.Inthissimulatedu

5、setestcleaningstepsareperfmedwiththeinstrumentsinacontrolledlabatyenvironment.Withinthisenvironmentvariousparametersmaybeexaggeratedtocreatewstcaseconditionsfthetest.Amongthesearetheamounttypeofganicsoilmicroganismsconta

6、minatingtheinstruments.Thetestmethodwasdevelopedprimarilyflargemedicalinstrumentsinstrumentswithinternalchannelsrecesses(fexampleflexibleendoscopes)butmaybeusedfanyresuablemedicalinstruments.Itemploysbothdirectinoculatio

7、nsamplingmethodsfexternalsurfacesindirectinoculationsamplingmethodsflessaccessibleinternalchannels.Cleaningisdefinedastheremovaloffeignmaterialsmostoftenmixturesofganicsoil(fexampleprotein)microganismsfrommedicalinstrume

8、nts.Bacterialendospesarethepreferredmicroganismsinthissimulatedtestbecausetheywouldbemeresistanttothepotentialmicrobiocidaleffectsofthecleaningprocessessolutions.Thismethodexaminesthereductioninthenumberofspesasatracerof

9、feignmaterialsnotnecessarilythereductioninganicsoildirectly.Thistestmaybedesignedtoeitherexaminetheefficacyofacompletecleaningcycleconsistingofseveralintegratedstepsindividualcleaningstepsuchasprecleaningmanualcleaningau

10、tomatedcleaningrinsing.1.Scope1.1Thistestmethodiswrittenprincipallyflargemedicalinstrumentsinstrumentswithinternalchannelsrecesses(fexampleflexibleendoscopes)butmaybeusedfanyresuablemedicalinstruments.1.2Thistestmethodde

11、scribesaprocedureftestingtheefficacyofacleaningprocessfreusablemedicalinstrumentsartificiallycontaminatedwithmixturesofmicroganismssimulatedsoil.1.3Thetestmethodutilizesbacterialspesastracersffeignmaterialsquantifiesthei

12、rremovalasameansofdeterminingtheefficacyofacleaningprocess.1.4Thetestmethodisdesignedfusebymanufacturersofmedicalinstrumentsdevices.Howeveritmayalsobeemployedbyotherindividualswhohaveaknowledgeoftheinstrumentstechniquesa

13、ccesstoappropriatefacilities.1.5Wstcaseconditionscanberepresentedbyexaggeratingaspecifictestparameterotherwiseintentionallysimulatinganextremeconditionsuchasperfmingthetestwithoutcleaningsolutionsutilizinginstrumentswhic

14、harenotnew.1.6Thetestprocedureisdevisedtodeterminetheefficacyofacleaningprocessasappliedtoaparticularinstrumentgroupofinstrumentsbysimulatingactualusesituations.1.7Thetestproceduremaybeperfmedontestinstrumentsusingacompl

15、etecleaningcyclebelimitedto1ThistestmethodisunderthejurisdictionofASTMCommitteeE35onPesticidesAntimicrobialsAlternativeControlAgentsisthedirectresponsibilityofSubcommitteeE35.15onAntimicrobialAgents.Currenteditionapprove

16、dOct.12014.PublishedDecember2014.iginallyapprovedin2003.Lastpreviouseditionapprovedin2008asE2314–03(2008).DOI:10.1520E231403R14.Copyright?ASTMInternational100BarrHarbDrivePOBoxC700WestConshohockenPA194282959.UnitedStates

17、14.2Bothcontrolinstrumentstestinstrumentsareusedinthistestmethod.Pritoinoculationallinstrumentsarecleanedreprocessed.Aninoculumwithhighnumbersoftargetmicroganismssuspendedintestsoilisappliedtobothcontroltestinstruments.4

18、.3Itisimpracticaltodetermineinoculumrecoverybyimmersionoflargemedicalinstrumentsinstrumentswithinternalchannelsrecesses(fexampleflexibleendoscopes)inelutionfluidbecauseoftheircomplexitysizeriouseffectsfromimmersion.There

19、ferinsingswabbingtechniquesareusedtorecovertargetmicroganismsfromthesetypesofinoculatedinstruments.4.4Controlinstrumentsareusedtodeterminethenumberofganismswhichcanberecoveredfromtheinstruments.Atleasttwocontrolinstrumen

20、tsareinoculatedinthesamemannerasthetestinstrumentshowevercleaningisnotperfmed.Anappropriaterecoverymethod(see4.3)isthenusedtodeterminethelevelofinoculumrecoverablefromtheinstruments.Atleast106CFUrecoverableperinstrumenta

21、rerequired.Faninstrumentwithlumensthetotalnumberofganismsrecoveredfrombothinsideoutsidesurfacesoftheinstrumentwillbedefinedasthecontrolinstrumentrecovery.4.5AftertheTestCyclehasbeencompletedusingthetestinstrumentstheinoc

22、ulatedtargetmicroganismsremainingontheseinstrumentsarerecoveredusingthesameelutionrecoveryquantitationproceduresusedtodeterminethenumberoftargetmicroganismsonthecontrolinstruments.Bycomparingthistestinstrumentrecoverytot

23、hecontrolinstrumentrecoverytheefficacyofthecleaningprocessmaybecalculated.5.SignificanceUse5.1Thistestmethodisdesignedtoevaluatetheeffectivenessofcleaningreusablemedicalinstrumentsusingaspecifiedcleaningprocess.5.2Thiste

24、stmethodmaybeusedtodeterminetheeffectivenessofcleaningprocessesofrecesseshingedsitesluminaotherdifficulttoreprocessareasofreusablemedicalinstruments.5.3Thistestmethodmayalsobeusedtoverifytheclaimsfanyptionofthecleaningcy

25、cle.5.4Therecoveryofsurvivingmicroganismsmaybeaccomplishedusingswabbingrinsingtotalimmersionofinstruments.5.5Theefficacyoftheelutionmethodslossoftheappliedinoculummaybeassessedbyrecoveryoftargetganismsfromcontrolinstrume

26、ntsthathavenotbeensubjectedtothecleaningprocess.6.Apparatus6.1Syringes10to50mLsterile.6.2SterileCottonDacronSwabs.6.3SterilePetriDishes.6.4SterileTubestohold10mL.6.5SterileBottlestohold50mLsterileflaskstohold250to500mL.6

27、.6SterilizationDevicefthemedicalinstrumentsbeingexamined.Alternativelysuppliesfhighleveldisinfectionrecommendedbytheinstrumentmanufacturer.6.7WaterBathwhichcanmaintaintemperaturefrom20to5062C.6.8Incubat(s)whichmaintain37

28、62C(fB.atrophaeusfmerlyknownasBacillussubtilissubspeciesniger)temperatureappropriatefedtargetganism.6.9MembraneFilters0.45mfiltersupptsfthefilters.6.10ColonyCounter.6.11DisposablePlasticPipettesvarioussizes.6.12ReusableM

29、edicalInstrumentsreprocessedpritoeachuse.6.13CleaningDevicesaccessiesapparatustobeusedintheTestCyclefreprocessingbetweenusesasspecifiedbythemanufacturerofthetestinstrument.6.14VtexMixerSonicat.6.15VacuumPump.6.16ShakerSt

30、irrer.7.Reagents7.1Media:7.1.1SterileUSPFluidD(ElutionFluid)containingpolysbate80.Alternativelysterileelutionfluidsolutioncontaining0.4gKH2PO410.1gNa2HPO41.0gisooctylphenoxypolyethoxyethanol(TritonX100)preparedin1LofType

31、IIIbetterASTMwateradjustedtopH7.8.Neutralizersappropriatefthecleaningsolutionmaybeaddedtoeitherofthesesolutions.7.1.2SoybeanCaseinDigestBrothUSPwithwithoutappropriateneutralizersfthespecifictestcleaningchemical(s)inthecl

32、eaningsolution.7.1.3SoybeanCaseinDigestAgarUSPsingledoublestrengthwithwithoutappropriateneutralizersin10to50mLtubesbottlestemperedto4862C.7.1.4SterileSalinePhosphateBufferfrinsingmembranefilters.7.2Targetganisms—Stardize

33、dsuspensionsofBacillusatrophaeusendospes(ATCC9372)containingnominally108CFUmLshouldbeused.Stardizedbacterialspesuspensionsarecommerciallyavailable.Theiginofthespestrainproductionstageexpirationdatesshouldbeidentified.Bac

34、terialendospesarepreferredasthetargetstrainbecausetheywouldbemeresistanttopotentialmicrobiocidaleffectsofthecleaningsolutions.Ifothermicroganismsareusedappropriatechangesingrowthmediaconditionsshouldbemade(alsoseerequire

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