BS EN 591-2001 专业用体外诊断仪器的使用说明

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1、BRITISHSTANDARDBSEN591:2001InstructionsforuseforinvitrodiagnosticinstrumentsforprofessionaluseTheEuropeanStandardEN591:2001hasthestatusofaBritishStandardICS11.040.55ÒÑÝÑÐÇ×ÒÙÉ×ÌØÑËÌÞÍ×ÐÛÎÓ×ÍÍ×ÑÒÛÈÝÛÐÌßÍÐÛÎÓ×ÌÌÛÜÞÇÝÑÐÇÎ×ÙØÌÔßÉBSEN591:2001NationalforewordThisBritishStandardistheofficia

2、lEnglishlanguageversionofEN591:2001.ItsupersedesBSEN591:1995whichiswithdrawn.TheUKparticipationinitspreparationwasentrustedtoTechnicalCommitteeCH/69,Invitrodiagnosticsystems,whichhastheresponsibilityto:—aidenquirerstounderstandthetext;—presenttotheresponsibleEuropeancommitteeanyenqui

3、riesontheinterpretation,orproposalsforchange,andkeeptheUKinterestsinformed;—monitorrelatedinternationalandEuropeandevelopmentsandpromulgatethemintheUK.Alistoforganizationsrepresentedonthiscommitteecanbeobtainedonrequesttoitssecretary.Cross-referencesTheBritishStandardswhichimplementi

4、nternationalorEuropeanpublicationsreferredtointhisdocumentmaybefoundintheBSIStandardsCatalogueunderthesectionentitled“InternationalStandardsCorrespondenceIndex”,orbyusingthe“Find”facilityoftheBSIStandardsElectronicCatalogue.ABritishStandarddoesnotpurporttoincludeallthenecessaryprovis

5、ionsofacontract.UsersofBritishStandardsareresponsiblefortheircorrectapplication.CompliancewithaBritishStandarddoesnotofitselfconferimmunityfromlegalobligations.ThisBritishStandard,havingbeenpreparedundertheSummaryofpagesdirectionoftheHealthandEnvironmentSectorThisdocumentcomprisesafr

6、ontcover,aninsidefrontcover,theENtitlepage,Committee,waspublishedpages2to11andabackcover.undertheauthorityoftheStandardsCommitteeandTheBSIcopyrightdatedisplayedinthisdocumentindicateswhenthecomesintoeffectondocumentwaslastissued.15May2001AmendmentsissuedsincepublicationAmd.No.DateCom

7、ments©BSI05-2001ISBN0580372324EUROPEANSTANDARDEN591NORMEEUROPÉENNEEUROPÄISCHENORMMarch2001ICS11.100SupersedesEN591:1994EnglishversionInstructionsforuseforinvitrodiagnosticinstrumentsforprofessionaluseNoticesd'utilisationdesinstrumentspourlediagnosticinGebrauchsanweisungenfürGerätefür

8、in-vitro-vit