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1、EUROPEANSTANDARDEN50061NORMEEUROPÉENNEMay1988EUROPÄISCHENORMUDC615.817:616.12:621.313:614.8Descriptors:Medicalelectricalequipment;surgicalimplants;pacemakers;definitions;marking;tests;performancetestsEnglishversionSafetyofimplantablecardiacpacemakersSécuritédesst
2、imulateurscardiaquesSicherheitimplantierbarerHerzschrittmacherimplantablesThisEuropeanStandardwasratifiedbyCENELECon1March1988.CENELECmembersareboundtocomplywiththerequirementsoftheCENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuropeanStandard
3、thestatusofanationalstandardwithoutanyalteration.Up-to-datelistsandbibliographicalreferencesconcerningsuchnationalstandardsmaybeobtainedonapplicationtotheCENELECCentralSecretariatortoanyCENELECmember.ThisEuropeanStandardexistsinthreeofficialversions(English,Frenc
4、h,German).AversioninanyotherlanguagemadebytranslationundertheresponsibilityofaCENELECmemberintoitsownlanguageandnotifiedtoCENELECCentralSecretariathasthesamestatusastheofficialversions.CENELECmembersarethenationalelectrotechnicalcommitteesofAustria,Belgium,Denmar
5、k,Finland,France,Germany,Greece,Iceland,Ireland,Italy,Luxemburg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom.CENELECEuropeanCommitteeforElectrotechnicalStandardizationComitéEuropéendeNormalisationElectrotechniqueEuropäischesKomiteefürElekt
6、rotechnischeNormungCentralSecretariat:ruedeStassart35,B-1050Brussels©CENELEC1988.CopyrightreservedtoallCENELECmembersRef.No.EN50061:1988EEN50061:1988BriefhistoryPage8ProtectionagainstenvironmentalTheEuropeanStandard50061waspreparedstress15byTC62ofCENELEC;itwassub
7、mittedto8.1Vibrationtest15theCENELECmembersforformalvoteandacceptanceasaEuropeanStandard(EN)8.2Shocktest15byCENELEC.8.3Temperaturecycle159Electricalsafetyrequirements16Technicaltext9.1Pulseratelimit16ThetextoftheEuropeanStandard50061was9.2Electricalneutralityofan
8、approvedbyallCENELECmemberswiththeimplantedpacemaker16exceptionofAustriaandNorwayon1March1988.10MeasurementofpulsegeneratorThefollowingdateswerefixed:character
