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1、EUROPEANSTANDARDENISO13485NORMEEUROPEENNEEUROPAISCHENORMFebruary2012ICS03.120.10;11.040.01SupersedesENISO13485:2003EnglishversionMedicaldevices-Qualitymanagementsystems-Requirementsforregulatorypurposes(ISO13485:2003)DispositifsmOdicaux-SystemesdemanegementdelaMedizinprodukte-Qualitatsman
2、agementsysteme-qualitO-ExigencesadesfinsrOglementaires(ISOAnforderungenfurregulatorischeZwecke(ISO13485:2003)13485:2003)ThisEuropeanStandardwasapprovedbyCENon24January2012.CENandCENELECmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuro
3、peanStandardthestatusofanationalstandardwithoutanyalteration.Up-to-datelistsandbibliographicalreferencesconcerningsuchnationalstandardsmaybeobtainedonapplicationtotheCEN-CENELECManagementCentreortoanyCENandCENELECmember.ThisEuropeanStandardexistsinthreeofficialversions(English,French,Germ
4、an).AversioninanyotherlanguagemadebytranslationundertheresponsibilityofaCENandCENELECmemberintoitsownlanguageandnotifiedtotheCEN-CENELECManagementCentrehasthesamestatusastheofficialversions.CENandCENELECmembersarethenationalstandardsbodiesandnationalelectrotechnicalcommitteesofAustria,Bel
5、gium,Bulgaria,Croatia,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal,Romania,Slovakia,Slovenia,Spain,Sweden,Switzerland,TurkeyandUnitedKingdom.EIELECCEN-CENELECManagement
6、Centre,AvenueMarnix17,B-1000Brussels©2012CEN/CENELECAllrightsofexploitationinanyformandbyanymeansreservedRef.No.ENISO13485:2012EworldwideforCENnationalMembersandforCENELECMembers.ENISO13485:2012(E)ContentsPageForeword3AnnexZA(informative)RelationshipbetweenthisEuropeanStandardandtheConfor
7、mityAssessmentRequirementsofEUDirective90/385/EEC5AnnexZB(informative)RelationshipbetweenthisEuropeanStandardandtheConformityAssessmentRequirementsofEUDirective93/42/EEC10AnnexZC(informative)RelationshipbetweenthisEuropeanStandardandtheConformityAssessmentRequiremen
