Edition 3.1 2013-10 CONSOLIDATED VERSION CONSOLIDÉE

1 IEC 60601-1-6.. Edition 2013 -10. CONSOLIDATED . VERSION . VERSION . CONSOLID E colour inside PREVIEW COPY. This is a preview Edition of an AAMI guidance document and is Medical electrical equipment . intended to allow potential purchasers to evaluate the content Part 1-6: General requirements for basic safety and essential performance . of the document before making a purchasing decision. Collateral standard: Usability For a complete copy of this AAMI document, contact AAMI at Appareils lectrom dicaux . +1-877-249-8226 or visit Partie 1-6: Exigences g n rales pour la s curit de base et les performances essentielles Norme collat rale: Aptitude l'utilisation IEC 60601-1-6:2010+A1: 2013 . THIS PUBLICATION IS COPYRIGHT PROTECTED. Copyright 2013 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, 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 either IEC or IEC's member National Committee in the country of the requester.

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6 Just Published d taille les nouvelles publications parues. Si vous d sirez nous donner des commentaires sur Disponible en ligne et aussi une fois par mois par email. cette publication ou si vous avez des questions contactez-nous: IEC 60601-1-6.. Edition 2013 -10. CONSOLIDATED . VERSION . VERSION . CONSOLID E colour inside PREVIEW COPY. This is a preview Edition of an AAMI guidance document and is Medical intended electrical to equipment . allow potential purchasers to evaluate the content Part 1-6: General requirements for basic of the document before making safety and essential a purchasing performance . decision. Collateral standard: Usability For a complete copy of this AAMI document, contact AAMI at +1-877-249-8226. Appareils lectrom dicaux or visit Partie 1-6: Exigences g n rales pour la s curit de base et les performances essentielles Norme collat rale: Aptitude l'utilisation INTERNATIONAL.

7 ELECTROTECHNICAL. COMMISSION. COMMISSION. ELECTROTECHNIQUE. INTERNATIONALE. ICS ISBN 978-2-8322-1186-1. Warning! Make sure that you obtained this publication from an authorized distributor. Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agr . Registered trademark of the International Electrotechnical Commission Marque d pos e de la Commission Electrotechnique Internationale PREVIEW COPY. This is a preview Edition of an AAMI guidance document and is intended to allow potential purchasers to evaluate the content of the document before making a purchasing decision. For a complete copy of this AAMI document, contact AAMI at +1-877-249-8226 or visit IEC 60601-1-6.. Edition 2013 -10. redline VERSION . VERSION redline . colour inside PREVIEW COPY. This is a preview Edition of an AAMI guidance document and is Medical electrical equipment.

8 Intended to allow potential purchasers to evaluate the content Part 1-6: General requirements for basic safety and essential performance . of the document before making a purchasing decision. Collateral standard: Usability For a complete copy of this AAMI document, contact AAMI at Appareils lectrom dicaux . +1-877-249-8226 or visit Partie 1-6: Exigences g n rales pour la s curit de base et les performances essentielles Norme collat rale: Aptitude l'utilisation IEC 60601-1-6:2010+A1: 2013 . 2 60601-1-6 IEC:2010+A1: 2013 . CONTENTS. FOREWORD .. 3. INTRODUCTION .. 6. INTRODUCTION TO THE AMENDMENT .. 7. 1 Scope, object and related standards .. 9. * Scope .. 9. Object .. 9. Related standards .. 9. IEC 60601-1 .. 9. Particular standards .. 9. 2 Normative references .. 9. 3 Terms and definitions .. 10. 4 General requirements .. 10. * Conditions for application to ME EQUIPMENT .. 10.

9 * U SABILITY E NGINEERING PROCESS for ME EQUIPMENT .. 11. 5 * Replacement of requirements given in IEC 62366 .. 11. PREVIEW COPY. Annex A (informative) General guidance and rationale .. 12. Annex B (informative) Mapping between the elements of IEC 60601-1-6:2006 and the This isina IEC. related elements preview Edition 62366:2007 of an AAMI guidance document and is .. 14. intended to allow potential purchasers to evaluate the content Annex C (informative) References to items of USABILITY provided in IEC 62366:2007. and their use inof thestandards other document before making a purchasing decision.. 22. Bibliography .. 25. For a complete copy of this AAMI document, contact AAMI at Index of defined terms used with this collateral standard .. 27. +1-877-249-8226 or visit Table Mapping between the elements of IEC 60601-1-6:2006 and the related elements in IEC 62366:2007+A1 4).

10 14. Table References to items of USABILITY in IEC 62366 and their use in other standards .. 22. 60601-1-6 IEC:2010+A1: 2013 3 . INTERNATIONAL ELECTROTECHNICAL COMMISSION. _____. MEDICAL ELECTRICAL EQUIPMENT . Part 1-6: General requirements for basic safety and essential performance . Collateral standard: Usability FOREWORD. 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as IEC. Publication(s) ).