IEC_60601-1-1.pdf

NORMECEIINTERNATIONALEIECINTERNATIONAL60601-1-1STANDARDDeuxieme editionSecond edition2000-12Appareils electromedicaux-Partie 1-1:Regles generales de securite-Norme collaterale:Regles de securitepour systemes electromedicauxMedical electrical equipmentPart 1-1:General requirements for safetyCollateral standard:Safety requirementsfor medical electrical systemsIECNumero de referenceReference numberCE1/1EC60601-1-1:2000Numerotation des publicationsPublication numberingDepuis le 1er janvier 1997,les publications de la CElsont numerotees a partir de 60000.Ainsi,la CEI 34-1As from 1 January 1997 all IEC publications areissued with a designation in the 60000 series.Fordevient la CEI 60034-1.example,IEC 34-1 is now referred to as IEC 60034-1.Editions consolideesConsolidated editionsLes versions consolidees de certaines publications de laCEI incorporant les amendements sont disponibles.ParThe IEC is now publishing consolidated versions of itsexemple,les numeros dedition 1.0,1.1 et 1.2 indiquentpublications.For example,edition numbers 1.0,1.1and 1.2 refer,respectively,to the base publicationrespectivement la publication de base,la publication dethe base publication incorporating amendment 1 andbase incorporant lamendement 1,et la publication debase incorporant les amendements 1 et 2.the base publication incorporating amendments 1and 2.Informations supplementairesFurther information on IEC publicationssur les publications de la CEILe contenu technique des publications de la CEl estconstamment revu par la CEI afin quil reflete IetatThe technical content of IEC publications is keptactuel de la technique.Des renseignements relatifs aunder constant review by the IEC,thus ensuring thatthe content reflects current technology.Informationcette publication,y compris sa validite,sont dispo-nibles dans le Catalogue des publications de la CElrelating to this publication,including its validity,is(voir ci-dessous)en plus des nouvelles editions,available in the IEC Catalogue of publicationsamendements et corrigenda.Des informations sur les(see below)in addition to new editions,amendmentsand corrigenda.Information on the subjects undersujets a letude et Iavancement des travaux entreprisconsideration and work in progress undertaken by thepar le comite detudes qui a labor cette publicationainsi que la liste des publications parues,sonttechnical committee which has prepared thisegalement disponibles par lintermediaire de:publication,as well as the list of publications issued,is also available from the following:.Site web de la CEl(www.iec.ch).IEC Web Site(www.iec.ch).Catalogue des publications de la CEl.Catalogue of IEC publicationsLe catalogue en ligne sur le site web de la CEl(www.iec.ch/catlg-f.htm)vous permet de faire desThe on-line catalogue on the IEC web siterecherches en utilisant de nombreux criteres,(www,iec.ch/catig-e.htm)enables you to searchcomprenant des recherches textuelles,par comiteby a variety of criteria including text searches,technical committees and date of publication.Ondetudes ou date de publication.Des informationsline information is also available on recentlyen ligne sont egalement disponibles sur lesnouvelles publications,les publications rempla-issued publications,withdrawn and replacedcees ou retirees,ainsi que sur les corrigenda.publications,as well as corrigenda.IEC Just PublishedIEC Just PublishedCe resume des dernieres publications parues(www.iec.ch/JP.htm)est aussi disponible parThis summary of recently issued publicationscourrier electronique.Veuillez prendre contact(www.iec.ch/JP.htm)is also available by email.avec le Service client(voir ci-dessous)pour plusPlease contact the Customer Service Centre(seedinformations.below)for further information.Service clientsCustomer Service CentreSi vous avez des questions au sujet de cettepublication ou avez besoin de renseignementsIf you have any questions regarding thissupplementaires,prenez contact avec le Servicepublication or need further assistance,pleaseclients:contact the Customer Service Centre:Email:custserviec.chTel:+41229190211Email:custserviec.chFax:+41229190300Tel:+41 22 919 02 11Fax:+41229190300NORMECEIINTERNATIONALEIECINTERNATIONAL60601-1-1STANDARDDeuxieme editionSecond edition2000-12Appareils electromedicaux-Partie 1-1:Regles generales de securite-Norme collaterale:Regles de securitepour systemes electromedicauxMedical electrical equipment-Part 1-1:General requirements for safety-Collateral standard:Safety requirementsfor medical electrical systems IEC 2000 Droits de reproduction reservs-Copyright-all rights reservedAucune partie de cette publication ne peut etre reproduite ni No part of this publication may be reproduced or utlized iaucun procede.any form or by any means,electronic or mechanical,lectronique ou mecanique,y compris la photocopie et lesincluding photocopying and microfilm,without permission imicrofilms,sans laccord ecrit de Iediteur.writing from the publisher.Intemational Electrotechnical Commission3,rue de Varembe Geneva,SwitzerlandTelefax:+4122919 0300e-mail:inmailiec.chIEC web site http:/www.iec.chCommission Electrotechnique InternationaleCODE PRIXIECInternational Electrotechnical CommissionPRICE CODEUMemyHapoAHa neKTpoTeXHecHa HoMCCHPour prx,voir catalogue en vigueurFor price,see current catalogue-2-60601-1-1CEI:2000SOMMAIREPagesAVANT-PROPOSSECTION UN-GENERALITESArticles1Domaine dapplication et objet2Terminologie et definition.03Prescriptions generales.126Identification,marquage et documentationSECTION DEUX-CONDITIONS DENVIRONNEMENT10Conditions denvironnement.SECTION TROIS-PROTECTION CONTRE LES RISQUES DE CHOCS ELECTRIQUES16ENVELOPPES et CAPOTS DE PROTECTION.17Separation.619COURANTS DE FUITE permanents et COURANT AUXILIAIRE PATIENT.18SECTION QUATRE-PROTECTION CONTRE LES RISQUES MECANIQUES22Parties en mouvement.20SECTION CINQ-PROTECTION CONTRE LES RISQUES DUS AUX RAYONNEMENTSNON DESIRES OU EXCESSIFSSECTION SIX-PROTECTION CONTRE LES RISQUES DIGNITIONDE MELANGES ANESTHESIQUES INFLAMMABLESSECTION SEPT-PROTECTION CONTRE LES TEMPERATURES EXCESSIVESET AUTRES RISQUES44Dbordements,renversement,fuite,humidit，pntration de liquides,nettoyage,strilisation,dsinfection et compatibilit.2049Coupure de lalimentation20SECTION HUIT-PRECISION DES CARACTERISTIQUES DE FONCTIONNEMENTET PROTECTION CONTRE LES CARACTERISTIQUES DE SORTIEPRESENTANT DES RISQUESSECTION NEUF-FONCTIONNEMENT ANORMAL ET CONDITIONS DE DEFAUT;ESSAIS DENVIRONNEMENT52Fonctionnement anormal et conditions de defaut.22SECTION DIX-REGLES DE CONSTRUCTION56Composants et ensembles.2257PARTIES RELIEES AU RESEAU,composants et montage.2258Mise a la terre de protection-Bornes et raccordement.2459Construction et montage.2460601-1-1IEC:2000-3-CONTENTSPageFOREWORDSECTION ONE-GENERALClause1Scope and object.2Terminology and definitions.113General requirements.36Identification,marking and documents.15SECTION TWO-ENVIRONMENTAL CONDITIONS10Environmental conditions.17SECTION THREE-PROTECTION AGAINST ELECTRIC SHOCK HAZARDS16ENCLOSURES and PROTECTIVE COVERS.1717Separation.19Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS.19SECTION FOUR-PROTECTION AGAINST MECHANICAL HAZARDS22Moving parts.21SECTION FIVE-PROTECTION AGAINST HAZARDS FROM UNWANTEDOR EXCESSIVE RADIATIONSECTION SIX-PROTECTION AGAINST HAZARDS OF IGNITIONOF FLAMMABLE ANAESTHETIC MIXTURESSECTION SEVEN-PROTECTION AGAINST EXCESSIVE TEMPERATURESAND OTHER SAFETY HAZARDS44Overflow,spillage,leakage,humidity,ingress of liquids,cleaning,sterilization,disinfection and compatibility.2149Interruption of the power supply21SECTION EIGHT-ACCURACY OF OPERATING DATA ANDPROTECTION AGAINST HAZARDOUS OUTPUTSECTION NINE-ABNORMAL OPERATION AND FAULT CONDITIONS;ENVIRONMENTAL TESTS52Abnormal operation and fault conditions23SECTION TEN-CONSTRUCTIONAL REQUIREMENTS56Components and general assembly.2357MAINS PARTS,components and layout2358Protective earthing-Terminals and connections.2559Construction and layout.25