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1、EUROPEANSTANDARDENISO15223-1NORMEEUROPÉENNEEUROPÄISCHENORMJuly2012ICS01.080.20;11.040.01SupersedesEN980:2008EnglishversionMedicaldevices-Symbolstobeusedwithmedicaldevicelabels,labellingandinformationtobesupplied-Part1:Generalrequirements(ISO15223-1:2012)Dispositifsmédicaux-S
2、ymbolesàutiliseraveclesMedizinprodukte-BeiAufschriftenvonMedizinproduktenétiquettes,l'étiquetageetlesinformationsàfournirrelatifszuverwendendeSymbole,Kennzeichnungundzulieferndeauxdispositifsmédicaux-Partie1:ExigencesgénéralesInformationen-Teil1:AllgemeineAnforderungen(ISO(I
3、SO15223-1:2012)15223-1:2012)ThisEuropeanStandardwasapprovedbyCENon24May2012.CENandCENELECmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuropeanStandardthestatusofanationalstandardwithoutanyalteration.Up-to-datelistsandbib
4、liographicalreferencesconcerningsuchnationalstandardsmaybeobtainedonapplicationtotheCEN-CENELECManagementCentreortoanyCENandCENELECmember.ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytranslationundertheresponsibilit
5、yofaCENandCENELECmemberintoitsownlanguageandnotifiedtotheCEN-CENELECManagementCentrehasthesamestatusastheofficialversions.CENandCENELECmembersarethenationalstandardsbodiesandnationalelectrotechnicalcommitteesofAustria,Belgium,Bulgaria,Croatia,Cyprus,CzechRepublic,Denmark,Est
6、onia,Finland,FormerYugoslavRepublicofMacedonia,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal,Romania,Slovakia,Slovenia,Spain,Sweden,Switzerland,TurkeyandUnitedKingdom.CEN-CENELECManagementCentre:Avenu
7、eMarnix17,B-1000Brussels©2012CEN/CENELECAllrightsofexploitationinanyformandbyanymeansreservedRef.No.ENISO15223-1:2012EworldwideforCENnationalMembersandforCENELECMembers.BSENISO15223-1:2012ENISO15223-1:2012(E)ForewordThisdocument(ENISO15223-1:2012)hasbeenpreparedbyTechnicalCo
8、mmitteeISO/TC210"Qualitymanagementandcorrespondinggeneralaspectsformedicald