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1、EUROPEANSTANDARDEN14136NORMEEUROPÉENNEEUROPÄISCHENORMMay2004ICS11.100EnglishversionUseofexternalqualityassessmentschemesintheassessmentoftheperformanceofinvitrodiagnosticexaminationproceduresUtilisationdesprogrammesd'évaluationexternedelaVerwendungexternerQualitätssicher
2、ungsprogrammebeiqualitédansl'évaluationdelaperformancedesprocéduresderBewertungderDurchführungvondediagnosticinvitroUntersuchungsverfahreninderIn-vitro-DiagnostikThisEuropeanStandardwasapprovedbyCENon2March2004.CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulati
3、onswhichstipulatetheconditionsforgivingthisEuropeanStandardthestatusofanationalstandardwithoutanyalteration.Up-to-datelistsandbibliographicalreferencesconcerningsuchnationalstandardsmaybeobtainedonapplicationtotheCentralSecretariatortoanyCENmember.ThisEuropeanStandardexi
4、stsinthreeofficialversions(English,French,German).AversioninanyotherlanguagemadebytranslationundertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheCentralSecretariathasthesamestatusastheofficialversions.CENmembersarethenationalstandardsbodiesofAustria,Belgi
5、um,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal,Slovakia,Slovenia,Spain,Sweden,SwitzerlandandUnitedKingdom.EUROPEANCOMMITTEEFORSTANDARDIZATIONCOMITÉEU
6、ROPÉENDENORMALISATIONEUROPÄISCHESKOMITEEFÜRNORMUNGManagementCentre:ruedeStassart,36B-1050Brussels©2004CENAllrightsofexploitationinanyformandbyanymeansreservedRef.No.EN14136:2004:EworldwideforCENnationalMembers.EN14136:2004(E)ForewordThisdocument(EN14136:2004)hasbeenprepa
7、redbyTechnicalCommitteeCEN/TC140“Invitrodiagnosticmedicaldevices”,thesecretariatofwhichisheldbyDIN.ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofanidenticaltextorbyendorsement,atthelatestbyNovember2004,andconflictingnationalstandardssh
8、allbewithdrawnatthelatestbyNovember2004.ThisdocumenthasbeenpreparedunderamandategiventoCENbytheEuropean
