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1、EUROPEANSTANDARDEN1041NORMEEUROPÉENNEEUROPÄISCHENORMAugust2008ICS01.110;11.040.01;11.120.01SupersedesEN1041:1998EnglishversionInformationsuppliedbythemanufacturerofmedicaldevicesInformationsfourniesparlefabricantdedispositifsBereitstellungvonInformationendurchdenHerst
2、ellervonmédicauxMedizinproduktenThisEuropeanStandardwasapprovedbyCENon4July2008.CENandCENELECmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuropeanStandardthestatusofanationalstandardwithoutanyalteration.Up-to-date
3、listsandbibliographicalreferencesconcerningsuchnationalstandardsmaybeobtainedonapplicationtotheCENManagementCentreortoanyCENorCENELECmember.ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytranslationundertheresp
4、onsibilityofaCENand/orCENELECmemberintoitsownlanguageandnotifiedtotheCENManagementCentrehasthesamestatusastheofficialversions.CENandCENELECmembersarethenationalstandardsbodiesandnationalelectrotechnicalcommittees,respectively,ofAustria,Belgium,Bulgaria,Cyprus,CzechRep
5、ublic,Denmark,Estonia,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal,Romania,Slovakia,Slovenia,Spain,Sweden,SwitzerlandandUnitedKingdom.CENManagementCentre:CENELECCentralSecretariat:rued
6、eStassart,36B-1050BrusselsruedeStassart,35B-1050Brussels©2008CEN/CENELECAllrightsofexploitationinanyformandbyanymeansreservedRef.No.EN1041:2008EworldwideforCENnationalMembersandforCENELECMembers.EN1041:2008(E)ContentsPageForeword.......................................
7、.......................................................................................................................3Introduction........................................................................................................................................
8、.................41Scope....................................................................................................