BS EN ISO 11138-2-2017 Biological indicators for ethylene oxide sterilization processes

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1、BSENISO11138-2:2017BSIStandardsPublicationSterilizationofhealthcareproducts—BiologicalindicatorsPart2:Biologicalindicatorsforethyleneoxidesterilizationprocesses(ISO11138-2:2017)WB11885_BSI_StandardCovs_2013_AW.indd115/05/201315:06BSENISO11138-2:2017BRITISHSTANDARDNationalf

2、orewordThisBritishStandardistheUKimplementationofENISO11138-2:2017.ItsupersedesBSENISO11138-2:2009whichiswithdrawn.TheUKparticipationinitspreparationwasentrustedtoTechnicalCommitteeCH/198,SterilizationandAssociatedEquipmentandProcesses.Alistoforganizationsrepresentedonthis

3、committeecanbeobtainedonrequesttoitssecretary.Thispublicationdoesnotpurporttoincludeallthenecessaryprovisionsofacontract.Usersareresponsibleforitscorrectapplication.©TheBritishStandardsInstitution2017.PublishedbyBSIStandardsLimited2017ISBN9780580898327ICS11.080.01Complianc

4、ewithaBritishStandardcannotconferimmunityfromlegalobligations.ThisBritishStandardwaspublishedundertheauthorityoftheStandardsPolicyandStrategyCommitteeon30April2017.Amendments/corrigendaissuedsincepublicationDateTextaffectedDownloadFromhttp://bbs.infoeach.comEUROPEANSTANDAR

5、DENISO11138-2NORMEEUROPÉENNEEUROPÄISCHENORMMarch2017ICS11.080.20SupersedesENISO11138-2:2009EnglishVersionSterilizationofhealthcareproducts-Biologicalindicators-Part2:Biologicalindicatorsforethyleneoxidesterilizationprocesses(ISO11138-2:2017)Stérilisationdesproduitsdesanté-

6、IndicateursSterilisationvonProduktenfürdiebiologiques-Partie2:IndicateursbiologiquespourlaGesundheitsfürsorge-BiologischeIndikatoren-Teil2:stérilisationàl'oxyded'éthylène(ISO11138-2:2017)BiologischeIndikatorenfürSterilisationsverfahrenmitEthylenoxid(ISO11138-2:2017)ThisEur

7、opeanStandardwasapprovedbyCENon19January2017.CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuropeanStandardthestatusofanationalstandardwithoutanyalteration.Up-to-datelistsandbibliographicalreferencesconcerningsuchnat

8、ionalstandardsmaybeobtainedonapplicationtotheCEN-CENELECManagementCentreortoanyCENmember.