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info_iec60601-2-35{ed1.0}b

info_iec60601-2-35{ed1.0}b

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Published by StanVarembe
International Standards of the International Electrotechnical Commission (IEC)
International Standards of the International Electrotechnical Commission (IEC)

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Published by: StanVarembe on Feb 15, 2013
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12/20/2013

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NORMEINTERNATIONALE
CEIIEC
INTERNATIONALSTANDARD
601-2-35
Première éditionFirst edition1996-10
©
CEI 1996 Droits de reproduction réservés
  
Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite niutilisée sous quelque forme que ce soit et par aucun procédé,électronique ou mécanique, y compris la photocopie et lesmicrofilms, sans l'accord écrit de l'éditeur.No part of this publication may be reproduced or utilizedin any form or by any means, electronic or mechanical,including photocopying and microfilm, without permissionin writing from the publisher
Bureau central de la Commission Electrotechnique Internationale 3, rue de Varembé Genève, Suisse
 
Commission Electrotechnique InternationaleInternational Electrotechnical CommissionCODE PRIXPRICE CODE
Pour prix, voir catalogue en vigueur For price, see current catalogue 
X
Appareils électromédicaux –Partie 2:Règles particulières de sécurité pour couvertures,coussins et matelas chauffants destinés auréchauffage des patients en usage médicalMedical electrical equipment –Part 2:Particular requirements for the safety of blankets,pads and mattresses, intended for heatingin medical use
 
 – 2 601-2-35 © CEI:1996
SOMMAIRE
Pages
AVANT-PROPOS............................................................................................................6INTRODUCTION.............................................................................................................8
Articles
SECTION UN: GÉNÉRALITÉS1Domaine d'application et objet..................................................................................102Terminologie et définitions........................................................................................123Prescriptions générales............................................................................................165Classification............................................................................................................166Identification, marquage et documentation................................................................16SECTION DEUX: CONDITIONS D'ENVIRONNEMENTSECTION TROIS: PROTECTION CONTRE LES RISQUES DE CHOCS ÉLECTRIQUES17Séparation................................................................................................................2219C
OURANTS DE FUITE
permanents et
COURANT AUXILIAIRE PATIENT
.................................22SECTION QUATRE: PROTECTION CONTRE LES RISQUES MÉCANIQUES21Résistance mécanique.............................................................................................24SECTION CINQ: PROTECTION CONTRE LES RISQUES DUSAUX RAYONNEMENTS NON DÉSIRÉS OU EXCESSIFS36Compatibilité électromagnétique...............................................................................26SECTION SIX: PROTECTION CONTRE LES RISQUES D'IGNITIONDE MÉLANGES ANESTHÉSIQUES INFLAMMABLESSECTION SEPT: PROTECTION CONTRE LES TEMPÉRATURES EXCESSIVESET LES AUTRES RISQUES42Températures excessives.........................................................................................2644Débordements, renversements, fuites, humidité, pénétration de liquides,nettoyage, stérilisation, désinfection et compatibilité.................................................2846Erreurs humaines.....................................................................................................3049Coupure de l'alimentation.........................................................................................30
 
601-2-35 © IEC:1996
3
CONTENTS
Page
FOREWORD ..................................................................................................................7INTRODUCTION ............................................................................................................9
Clause
SECTION ONE – GENERAL1 Scope and object...................................................................................................... 112 Terminology and definitions .....................................................................................133 General requirements............................................................................................... 175Classification............................................................................................................176 Identification, marking and documents .....................................................................17SECTION TWO – ENVIRONMENTAL CONDITIONSSECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS17 Separation ...............................................................................................................2319 Continuous
LEAKAGE CURRENTS
and
PATIENT
 
AUXILIARY CURRENTS
..............................23SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS21 Mechanical strength .................................................................................................25SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTEDOR EXCESSIVE RADIATION36 Electromagnetic compatibility ...................................................................................27SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITIONOF FLAMMABLE ANAESTHETIC MIXTURESSECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURESAND OTHER SAFETY HAZARDS42 Excessive temperatures ...........................................................................................2744 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization,disinfection and compatibility ...................................................................................2946 Human errors ..........................................................................................................3149 Interruption of the power supply ...............................................................................31

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