1、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 safetyCollatera
2、l 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
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15、Second 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
16、 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 les
17、including 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 In
18、ternationaleCODE 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 defi
19、nition.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 A
20、UXILIAIRE 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
21、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
22、 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 prot
23、ection-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.
24、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 EXCESSI
25、VE 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
26、 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
