This preview is downloaded from www.sis.se. Buy the entire standard via https://www.sis.se/std-567674 INTERNATIONAL IEC STANDARD 60601-1 Third edition 2005-12 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance This English-language version is derived from the original bilingual publication by leaving out all French-language pages. Missing page numbers correspond to the French- language pages. Reference number IEC 60601-1:2005(E) Copyright © IEC, 2005, Geneva, Switzerland. All rights reserved. Sold by SIS under license from IEC and SEK. No part of this document may be copied, reproduced or distributed in any form without the prior written consent of the IEC. This preview is downloaded from www.sis.se. Buy the entire standard via https://www.sis.se/std-567674 Publication numbering As from 1 January 1997 all IEC publications are issued with a designation in the 60000 series. For example, IEC 34-1 is now referred to as IEC 60034-1. 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Buy the entire standard via https://www.sis.se/std-567674 INTERNATIONAL IEC STANDARD 60601-1 Third edition 2005-12 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance © IEC 2005 Copyright - all rights reserved No part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from the publisher. International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland Telephone: +41 22 919 02 11 Telefax: +41 22 919 03 00 E-mail: [email protected] Web: www.iec.ch PRICE CODE Commission Electrotechnique Internationale XN International Electrotechnical Commission Международная Электротехническая Комиссия For price, see current catalogue Copyright © IEC, 2005, Geneva, Switzerland. All rights reserved. Sold by SIS under license from IEC and SEK. No part of this document may be copied, reproduced or distributed in any form without the prior written consent of the IEC. This preview is downloaded from www.sis.se. Buy the entire standard via https://www.sis.se/std-567674 60601-1 IEC:2005 – 3 – CONTENTS FOREWORD.........................................................................................................................21 INTRODUCTION...................................................................................................................25 1 Scope, object and related standards...............................................................................29 1.1 * Scope .................................................................................................................29 1.2 Object ...................................................................................................................29 1.3 * Collateral standards............................................................................................29 1.4 * Particular standards............................................................................................31 2 * Normative references...................................................................................................31 3 * Terminology and definitions .........................................................................................39 4 General requirements.....................................................................................................79 4.1 * Conditions for application to ME EQUIPMENT or ME SYSTEMS..................................79 4.2 * RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS ..............................79 4.3 * ESSENTIAL PERFORMANCE .....................................................................................81 4.4 * EXPECTED SERVICE LIFE ........................................................................................81 4.5 * Equivalent safety for ME EQUIPMENT or ME SYSTEMS .............................................83 4.6 * ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT .................................83 4.7 * SINGLE FAULT CONDITION for ME EQUIPMENT...........................................................83 4.8 Components of ME EQUIPMENT ...............................................................................85 4.9 * Use of COMPONENTS WITH HIGH-INTEGRITY CHARACTERISTICS in ME EQUIPMENT .......85 4.10 * Power supply ......................................................................................................87 4.11 Power input ...........................................................................................................89 5 * General requirements for testing ME EQUIPMENT ...........................................................91 5.1 * TYPE TESTS..........................................................................................................91 5.2 * Number of samples .............................................................................................91 5.3 Ambient temperature, humidity, atmospheric pressure...........................................91 5.4 Other conditions ....................................................................................................91 5.5 Supply voltages, type of current, nature of supply, frequency ................................93 5.6 Repairs and modifications .....................................................................................93 5.7 * Humidity preconditioning treatment .....................................................................93 5.8 Sequence of tests .................................................................................................95 5.9 * Determination of APPLIED PARTS and ACCESSIBLE PARTS .......................................95 6 * Classification of ME EQUIPMENT and ME SYSTEMS ...........................................................99 6.1 General .................................................................................................................99 6.2 * Protection against electric shock.........................................................................99 6.3 * Protection against harmful ingress of water or particulate matter ......................101 6.4 Method(s) of sterilization .....................................................................................101 6.5 Suitability for use in an OXYGEN RICH ENVIRONMENT ..............................................101 6.6 * Mode of operation .............................................................................................101 Copyright © IEC, 2005, Geneva, Switzerland. All rights reserved. Sold by SIS under license from IEC and SEK. No part of this document may be copied, reproduced or distributed in any form without the prior written consent of the IEC. This preview is downloaded from www.sis.se. Buy the entire standard via https://www.sis.se/std-567674 60601-1 IEC:2005 – 5 – 7 ME EQUIPMENT identification, marking and documents ...................................................101 7.1 General ...............................................................................................................101 7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts ..........................105 7.3 Marking on the inside of ME EQUIPMENT or ME EQUIPMENT parts ...........................113 7.4 Marking of controls and instruments ....................................................................117 7.5 Safety signs ........................................................................................................119 7.6 Symbols ..............................................................................................................121