IEO ISO IEC TR 62366-2 Edition 1.02016-04 TECHNICAL REPORT colour inside Medical devices - Part 2: Guidance on the application of usability engineering to medical devices IEC TR 62366-2:2016-04(en) International Electrotechnical Commission nitted without license from IHS THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright @ 2016 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication, piease contact the address below or yourlocal IEC memberNational Committee for furtherinformation. IEC Central Office Tel.: +41 22 919 02 11 3, rue de Varembé Fax:+41229190300 CH-1211 Geneva 20 [email protected] Switzerland www.iec.ch Aboutthe IEC International Standards for all electrical, electronic and related technologies. About IEC publications The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the IECCatalogue-webstore.iec.ch/catalogue Electropedia - www.electropedia.org The stand-alone application for consulting theentire The world's leading online dictionary of electronic and bibliographical information on IEC International Standards, electrical terms containing morethan 30 000o terms and Technical Specifications, Technical Reports andother definitions in English and French, with equivalent terms in 15 documents. Available for PC, Mac OS, Android Tablets and additional languages.Also known as the International iPad. Electrotechnical Vocabulary (IEV) online. IECpublicationssearch-www.iec.ch/searchpub IECGlossary-std.iec.ch/glossary The advanced search enables to find IEC publications by a More than 60 000 electrotechnical terminology entries in variety of criteria (referencenumber, text,technical English and French extracted from the Terms and Definitions committee,...). It also gives information on projects, replaced clause of IEC publications issued since 2002.Some entries and withdrawn publications. have been collected from earlier publications of IEC TC 37, 77, 86 and CISPR IECJustPublished-webstore.iec.ch/justpublished Stay up to date on all new IEC publications. Just Published IEC Customer Service Centre - webstore.iec.ch/csc details all new publications released. Available online and If you wish to give us your feedback on this publication or also once a month by email. need further assistance,please contact the Customer Service Centre: [email protected]. International Electrotechnical Commission Not for Resale, 2016/7/20 09:00:47 Licensee=Guangdong Provinicial Academy of Standardization 5944055 No reproduction or networking permitted without license from IHS TEC ISO IEC TR 62366-2 Edition 1.02016-04 TECHNICAL REPORT colour inside Medical devices- Part 2: Guidance on the application of usability engineering to medical devices INTERNATIONAL ELECTROTECHNICAL COMMISSION ICS 11.040.01 ISBN 978-2-8322-3346-7 Warning! Make sure that you obtained this publication from an authorized distributor. International Electrotechnical Commission Licensee=Guangdong Provinicial Academy of Standardization 5944055 ted without licensefrom IHS - 2 - IEC TR 62366-2:2016 @ IEC 2016 CONTENTS FOREWORD 6 INTRODUCTION.. .8 Scope and purpose... .9 1.1 Scope.. 1.2 Purpose ... .9 2 Normative references... .10 3 Terms and definitions . 11 4 Mapping between the requirements of IEC 62366-1 and the guidance of IEC TR 62366-2.. 14 5 Background and justification of the USABILITY ENGINEERING program 5.1 How SAFETY relates to USABILITY .14 5.2 Reasons to invest in USABILITY ENGINEERING ... 6 How to implement a USABILITY ENGINEERING program ..16 6.1 Effective USABILITY ENGINEERING programs .16 6.2 Effective USABILITY ENGINEERING projects and plans.... 6.3 Apply an appropriate level of USABILITY ENGINEERING expertise 6.4 Ensure the necessary res