BS EN ISO 11138-1-2017 General requirements

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1、BSENISO11138-1:2017BSIStandardsPublicationSterilizationofhealthcareproducts—BiologicalindicatorsPart1:Generalrequirements(ISO11138-1:2017)WB11885_BSI_StandardCovs_2013_AW.indd115/05/201315:06BSENISO11138-1:2017BRITISHSTANDARDNationalforewordThisBritishStandardistheUKimplementationo

2、fENISO11138-1:2017.ItsupersedesBSENISO11138-1:2006whichiswithdrawn.TheUKparticipationinitspreparationwasentrustedtoTechnicalCommitteeCH/198,SterilizationandAssociatedEquipmentandProcesses.Alistoforganizationsrepresentedonthiscommitteecanbeobtainedonrequesttoitssecretary.Thispublica

3、tiondoesnotpurporttoincludeallthenecessaryprovisionsofacontract.Usersareresponsibleforitscorrectapplication.©TheBritishStandardsInstitution2017.PublishedbyBSIStandardsLimited2017ISBN9780580898310ICS11.080.20;11.080.01CompliancewithaBritishStandardcannotconferimmunityfromlegalobliga

4、tions.ThisBritishStandardwaspublishedundertheauthorityoftheStandardsPolicyandStrategyCommitteeon30April2017.Amendments/corrigendaissuedsincepublicationDateTextaffectedDownloadFromhttp://bbs.infoeach.comEUROPEANSTANDARDENISO11138-1NORMEEUROPÉENNEEUROPÄISCHENORMMarch2017ICS11.080.20S

5、upersedesENISO11138-1:2006EnglishVersionSterilizationofhealthcareproducts-Biologicalindicators-Part1:Generalrequirements(ISO11138-1:2017)Stérilisationdesproduitsdesanté-IndicateursSterilisationvonProduktenfürdiebiologiques-Partie1:Exigencesgénérales(ISO11138-Gesundheitsfürsorge-Bio

6、logischeIndikatoren-Teil1:1:2017)AllgemeineAnforderungen(ISO11138-1:2017)ThisEuropeanStandardwasapprovedbyCENon19January2017.CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuropeanStandardthestatusofanationalstandardwithoutany

7、alteration.Up-to-datelistsandbibliographicalreferencesconcerningsuchnationalstandardsmaybeobtainedonapplicationtotheCEN-CENELECManagementCentreortoanyCENmember.ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytranslationundert

8、heresponsibilityofaCENmemb