ENISO11138-3-2009

-,-,-EUROPEANSTANDARDNORMEEUROPENNEEUROPISCHENORMICS11.080.01ENISO11138-3May2009SupersedesENISO11138-3:2006EnglishVersionSterilizationofhealthcareproducts-Biologicalindicators-Part3:Biologicalindicatorsformoistheatsterilizationprocesses(ISO11138-3:2006)Strilisationdesproduitsdesant-Indicateursbiologiques-Partie3:Indicateursbiologiquespourlastrilisationlachaleurhumide(ISO11138-3:2006)SterilisationvonProduktenfrdieGesundheitsfrsorge-BiologischeIndikatoren-Teil3:BiologischeIndikatorenfrSterilisationsverfahrenmitfeuchterHitze(ISO11138-3:2006)ThisEuropeanStandardwasapprovedbyCENon19April2009.CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuropeanStandardthestatusofanationalstandardwithoutanyalteration.Up-to-datelistsandbibliographicalreferencesconcerningsuchnationalstandardsmaybeobtainedonapplicationtotheCENManagementCentreortoanyCENmember.ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).AversioninanyotherlanguagemadebytranslationundertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheCENManagementCentrehasthesamestatusastheofficialversions.CENmembersarethenationalstandardsbodiesofAustria,Belgium,Bulgaria,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal,Romania,Slovakia,Slovenia,Spain,Sweden,SwitzerlandandUnitedKingdom.2009CENEUROPEANCOMMITTEEFORSTANDARDIZATIONCOMITEUROPENDENORMALISATIONEUROPISCHESKOMITEEFRNORMUNGManagementCentre:AvenueMarnix17,B-1000BrusselsAllrightsofexploitationinanyformandbyanymeansreservedworldwideforCENnationalMembers.Ref.No.ENISO11138-3:2009:E-,-,-ENISO11138-3:2009(E)ContentsPageForeword.3AnnexZA(informative)RelationshipbetweenthisEuropeanStandardandtheEssentialRequirementsofEUDirective93/42/EEC.42ENISO11138-3:2009(E)ForewordThetextofISO11138-3:2006hasbeenpreparedbyTechnicalCommitteeISO/TC198“Sterilizationofhealthcareproducts”oftheInternationalOrganizationforStandardization(ISO)andhasbeentakenoverasENISO11138-3:2009byTechnicalCommitteeCEN/TC102“Sterilizersformedicalpurposes”thesecretariatofwhichisheldbyDIN.ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofanidenticaltextorbyendorsement,atthelatestbyNovember2009,andconflictingnationalstandardsshallbewithdrawnatthelatestbyMarch2010.Attentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectofpatentrights.CENand/orCENELECshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.ThisdocumentsupersedesENISO11138-3:2006.ThisdocumenthasbeenpreparedunderamandategiventoCENbytheEuropeanCommissionandtheEuropeanFreeTradeAssociation,andsupportsessentialrequirementsofECDirective.ForrelationshipwithECDirective,seeinformativeAnnexZA,whichisanintegralpartofthisdocument.AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsofthefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,Bulgaria,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal,Romania,Slovakia,Slovenia,Spain,Sweden,SwitzerlandandtheUnitedKingdom.EndorsementnoticeThetextofISO11138-3:2006hasbeenapprovedbyCENasaENISO11138-3:2009withoutanymodification.-,-,-3Clause(s)/sub-clause(s)ofthisENEssentialRequirements(ERs)ofDirective93/42/EECQualifyingremarks/Notes45,13TherequirementsofISO11138-1apply5.17.2,7.377.3910.1-,-,-ENISO11138-3:2009(E)AnnexZA(informative)RelationshipbetweenthisEuropeanStandardandtheEssentialRequirementsofEUDirective93/42/EECThisEuropeanStandardhasbeenpreparedunderamandategiventoCENbytheEuropeanCommissionandtheEuropeanFreeTradeAssociationtoprovideameansofconformingtoEssentialRequirementsoftheNewApproachDirective93/42/EEConmedicaldevices.OncethisstandardiscitedintheOfficialJournaloftheEuropeanCommunitiesunderthatDirectiveandhasbeenimplementedasanationalstandardinatleastoneMemberState,compliancewiththeclausesofthisstandardgiveninTableZAconfers,withinthelimitsofthescopeofthisstandard,apresumptionofconformitywiththecorrespondingEssentialRequirementsofthatDirectiveandassociatedEFTAregulations.TableZACorrespondencebetweenthisEuropeanStandardandDirective93/42/EEConmedicaldevicesWARNINGOtherrequirementsandotherEU-directivesmaybeapplicabletotheproduct(s)fallingwithinthescopeofthestandard.4INTERNATIONALSTANDARDISO11138-3Secondedition2006-07-01SterilizationofhealthcareproductsBiologicalindicatorsPart3:BiologicalindicatorsformoistheatsterilizationprocessesStrilisationdesproduitsdesantIndicateursbiologiquesPartie3:IndicateursbiologiquespourlastrilisationlachaleurhumideReferencenumberISO11138-3:2006(E)-,-,-ISO2006ISO11138-3:2006(E)PDFdisclaimerThisPDFfilemaycontainembeddedtypefaces.InaccordancewithAdobeslicensingpolicy,thisfilemaybeprintedorviewedbutshallnotbeeditedunlessthetypefaceswhichareembeddedarelicensedtoandinstalledonthecomputerperformingtheediting.Indownloadingthisfile,partiesacceptthereintheresponsibilityofnotinfringingAdobeslicensingpolicy.TheISOCentralSecretariatacceptsnoliabilityinthisarea.AdobeisatrademarkofAdobeSystemsIncorporated.DetailsofthesoftwareproductsusedtocreatethisPDFfilecanbefoundintheGeneralInforelativetothefile;thePDF-creationparameterswereoptimizedforprinting.EverycarehasbeentakentoensurethatthefileissuitableforusebyISOmemberbodies.Intheunlikelyeventthataproblemrelatingtoitisfound,pleaseinformtheCentralSecretariatattheaddressgivenbelow.ISO2006Allrightsreserved.Unlessotherwisespecified,nopartofthispublicationmaybereproducedorutilizedinanyformorbyanymeans,electronicormechanical,includingphotocopyingandmicrofilm,withoutpermissioninwritingfromeitherISOattheaddressbeloworISOsmemberbodyinthecountryoftherequester.ISOcopyrightofficeCasepostale56CH-1211Geneva20Tel.+41227490111Fax+41227490947E-WPublishedinSwitzerlandii-,-,-,-,-ISO11138-3:2006(E)ForewordISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISOmemberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmental,inliaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectrotechnicalCommission(IEC)onallmattersofelectrotechnicalstandardization.InternationalStandardsaredraftedinaccordancewiththerulesgivenintheISO/IECDirectives,Part2.ThemaintaskoftechnicalcommitteesistoprepareInternationalStandards.DraftInternationalStandardsadoptedbythetechnicalcommitteesarecirculatedtothememberbodiesforvoting.PublicationasanInternationalStandardrequiresapprovalbyatleast75%ofthememberbodiescastingavote.Attentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectofpatentrights.ISOshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.ISO11138-3waspreparedbyTechnicalCommitteeISO/TC198,Sterilizationofhealthcareproducts.Thissecondeditioncancelsandreplacesthefirstedition(ISO11138-3:1995),whichhasbeentechnicallyrevised.ISO11138consistsofthefollowingparts,underthegeneraltitleSterilizationofhealthcareproductsBiologicalindicators:Part1:GeneralrequirementsPart2:BiologicalindicatorsforethyleneoxidesterilizationprocessesPart3:BiologicalindicatorsformoistheatsterilizationprocessesPart4:BiologicalindicatorsfordryheatsterilizationprocessesPart5:Biologicalindicatorsforlow-temperaturesteamandformaldehydesterilizationprocessesiiiISO11138-3:2006(E)IntroductionISO11138-1specifiesproduction,labelling,testmethodsandperformancerequirementsforthemanufactureofbiologicalindicatorsincludinginoculatedcarriersandsuspensionsintendedforuseinvalidationandmonitoringofsterilizationprocesses.ThispartofISO11138givesspecificrequirementsforthosebiologicalindicatorsintendedforuseinmoistheatsterilizationprocesses.TheintentofprovidingrequirementsintheISO11138seriesofInternationalStandardsistoprovidegeneralrequirementsandrequirementsfortestmethods.ThisseriesofInternationalStandardsrepresentsthecurrent“state-of-the-art”accordingtotheexpertsrepresentingmanufacturers,usersandregulatoryauthoritiesinvolvedindevelopingthestandard.Theintentisnottopromotetheuseofbiologicalindicatorswheresuchuseisnotadvised,buttoprovidecommonrequirementsfortheproductionofthosebiologicalindicatorsknowntobeinusetoday.Standardsexistprovidingrequirementsforthevalidationandcontrolofmoistheatsterilization(seeISO17665).NOTESomecountriesorregionsmayhavepublishedstandardscoveringrequirementsforsterilizationorbiologicalindicators.Adviceonselection,useandinterpretationofresultswhenusingbiologicalindicatorscanbefoundinISO14161.-,-,-iv-,-,-INTERNATIONALSTANDARDISO11138-3:2006(E)SterilizationofhealthcareproductsBiologicalindicatorsPart3:Biologicalindicatorsformoistheatsterilizationprocesses1ScopeThispartofISO11138providesspecificrequirementsfortestorganisms,suspensions,inoculatedcarriers,biologicalindicatorsandtestmethodsintendedforuseinassessingtheperformanceofsterilizationprocessesemployingmoistheatasthesterilizingagent.MoistheatasthesterilizingagentisdefinedinthispartofISO11138asdrysaturatedsteam.Whileair-steammixturesmaybeusedinmoistheatsterilizationprocesses,themethodsandperformancerequirementsofthispartofISO11138mightnotbeapplicableforbiologicalindicatorsusedinsuchprocesses.NOTE1NOTE2RequirementsforvalidationandcontrolofmoistheatsterilizationprocessesareprovidedbyISO17665.Nationalorregionalregulationsmayproviderequirementsforworkplacesafety.2NormativereferencesThefollowingreferenceddocumentsareindispensablefortheapplicationofthisdocument.Fordatedreferences,onlytheeditioncitedapplies.Forundatedreferences,thelatesteditionofthereferenceddocument(includinganyamendments)applies.ISO11138-1:2006,SterilizationofhealthcareproductsBiologicalindicatorsPart1:GeneralrequirementsISO18472,SterilizationofhealthcareproductsBiolgicalandchemicalindicatorsTestequipment3TermsanddefinitionsForthepurposesofthisdocument,thetermsanddefinitionsgiveninISO11138-1apply.4GeneralrequirementsTherequirementsofISO11138-1apply.1ISO11138-3:2006(E)5Testorganism5.1ThetestorganismsshallbesporesofGeobacillusstearothermophilusorotherstrainsofmicroorganismofdemonstratedequivalentperformanceasrequiredbythispartofISO11138.NOTE1BacillusstearothermophilushasbeenreclassifiedasGeobacillusstearothermophilus.NOTE2GeobacillusstearothermophilusATCC7953(NCTC10007,DSM22andCIP52.81),ATCC12980(equivalenttoNRRLB-4419),havebeenfoundtobesuitable.5.2IfatestorganismotherthanGeobacillusstearothermophilusorBacillussubtilisATCC35021(5230)isused,thesuitabilityoftheresistanceofthattestorganismshallbedetermined.NOTEForprocessesatlessthan121C,microorganismssuchasBacillussubtilisATCC35021(5230)couldbeused,particularlyinsterilizationofheat-sensitiveliquids.6SuspensionTherequirementsofISO11138-1apply.7Carrierandprimarypackaging7.1ThesuitabilityofthecarrierandprimarypackagingmaterialsforbiologicalindicatorsforuseinmoistheatsterilizationprocessesshallbedemonstratedinaccordancewiththerequirementsofISO11138-1:2006,5.2andAnnexB.7.2a)b)c)d)Theexposureconditionsforestablishingcomplianceshallbe:minimumexposuretemperature:W5Cabovethemanufacturersstatedmaximumtemperature;sterilizingagent:drysaturatedsteam;ifthebiologicalindicatorisintendedforuseinamoistheatprocessnotusingdrysaturatedsteam,e.g.anair/steammixture,theappropriateairsteammixtureshouldbeusedandnotedasanexceptiontothispartofISO11138;maximumexposuretemperature:asstatedbythemanufacturer;ifnotstatedbythemanufacturer,atemperatureof140Cshallbeused;exposuretime:W30min.NOTETheseconditionshavebeenselectedtorepresentarealisticchallengetothecarrierwhileremainingwithinthepracticallimitsofamoistheatsterilizationprocess.8InoculatedcarriersandbiologicalindicatorsTherequirementsofISO11138-1apply.99.1PopulationandresistanceThemanufacturershallstatetheresistancecharacteristicsinaccordancewithISO11138-1:2006,Theviablecountshallbestatedwithincrementsu0,110nperunit,(e.g.permlofsuspension,perinoculatedcarrierorperbiologicalindicator).9.32Forinoculatedcarriersandbiologicalindicators,theviablecountshallbeW1,0105.-,-,-,-,-ISO11138-3:2006(E)9.4TheresistanceshallbeexpressedastheDvalueinminutesat121C.TheDvalueofeachbatch/lotofbiologicalindicatorsorinoculatedcarriersshallbestatedinminutestoonedecimalplaceat121C.9.5Suspensions,inoculatedcarriersorbiologicalindicatorscontainingGeobacillusstearothermophilussporesshallhaveaD121valueofW1,5minwhentestedaccordingtotheconditionsgiveninAnnexA.OthermicroorganismsshallhaveDvaluessupportingtheapplication.Thezvalueofthetestorganismsinthesuspension,ontheinoculatedcarrierorinthebiologicalindicatorshallbedeterminedatnotlessthanthreetemperatures,intherangeof110Cto130C.Thesedatashallbeusedtocalculatethezvalue,whichshallbeW6C(seeAnnexB).9.6TheresistanceofabiologicalindicatormayalsobeindicatedbythetermFBIOvalue(see11138-1:2006,3.7).TheresistancecharacteristicsspecifiedinthispartofISO11138andanyotherpartofISO11138applytothespecifictestconditionsstatedinthestandards.9.7DvaluesaredeterminedaccordingtomethodsgiveninAnnexesCandDofISO11138-1:2006.9.8DeterminationofDvalueandsurvival-killresponsecharacteristicsrequirestheuseofaresistometerapplyingtheresistometerprocessparameters(seeAnnexA).9.9NOTEThesurvival-killwindowcanbecalculatedusingtheformulae