IEC_TR_62366-2-2016.pdf

IEC TR 62366-2 Edition 1.0 2016-04 TECHNICAL REPORT Medical devices Part 2:Guidance on the application of usability engineering to medical devices IEC T R 62366-2:2016-04(en)colourinside 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 or by any means,electronic or mechanical,including photocopying and microfilm,without permission in writing from either IEC or IECs 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,please contact the address below or your local IEC member National Committee for further information.IEC Central Office Tel.:+41 22 919 02 11 3,rue de Varemb Fax:+41 22 919 03 00 CH-1211 Geneva 20 infoiec.ch Switzerland www.iec.ch A bout the IEC The International Electrotechnical Commission(IEC)is the leading global organization that prepares and publishes 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 latest edition,a corrigenda or an amendment might have been published.IEC Catalogue-webstore.iec.ch/catalogue The stand-alone application for consulting the entire bibliographical infor mation on IEC Inter national Standards,Technical Specifications,Technical Reports and other documents.Available for PC,Mac OS,Andr oid Tablets and iPad.IEC publications search-www.iec.ch/searchpub The advanced search enables to find IEC publications by a variety of criter ia(r efer ence number,text,technical committee,).It also gives information on pr ojects,replaced and w ithdr awn publications.IEC Just Published-webstore.iec.ch/justpublished Stay up to date on all new IEC publications.Just Published details all new publications released.Available online and also once a month by email.Electropedia-www.electropedia.org The w or lds leading online dictionary of electronic and electr ical ter ms containing more than 30 000 terms and definitions in English and French,w ith equivalent ter ms in 15 additional languages.Also known as the Inter national Electr otechnical Vocabulary (IEV)online.IEC Glossary -std.iec.ch/glossary Mor e than 60 000 electrotechnical terminology entries in English and Fr ench extr acted fr om the Terms and Definitions clause of IEC publications issued since 2002.Some entr ies have been collected fr om ear lier publications of IEC TC 37,77,86 and CISPR.IEC Customer Serv ice Centre-webstore.iec.ch/csc If you w ish to give us y our feedback on this publication or need further assistance,please contact the Customer Ser vice Centr e:csciec.ch.IEC TR 62366-2 Edition 1.0 2016-04 TECHNICAL REPORT 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 y ou obtained this publication from an authorized distributor.colourinside 2 IEC TR 62366-2:2016 IEC 2016 CONTENTS FOREWORD.6 INTRODUCTION.8 1 Scope and purpose.9 1.1 Scope.9 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.14 5.1 How SAFETY relates to USABILITY.14 5.2 Reasons to invest in USABILITY ENGINEERING.15 6 How to implement a USABILITY ENGINEERING program.16 6.1 Effective USABILITY ENGINEERING programs.16 6.2 Effective USABILITY ENGINEERING projects and plans.16 6.3 Apply an appropriate level of USABILITY ENGINEERING expertise.17 6.4 Ensure the necessary resources are available and well timed.18 6.5 RISK MANAGEMENT as it relates to USABILITY ENGINEERING.18 6.5.1 RISK ANALYSIS.18 6.5.2 RISK CONTROL.19 6.5.3 Information for SAFETY.20 6.5.4 Overall evaluation of RESIDUAL RISK.22 6.6 USABILITY ENGINEERING FILE.22 6.7 Tailoring the USABILITY ENGINEERING effort.23 7 Overview of the USABILITY ENGINEERING PROCESS.24 8 Prepare the USE SPECIFICATION.27 8.1 Initiate USE SPECIFICATION.27 8.2 Analyse the intended USERS,anticipated USER TASKS and intended USE ENVIRONMENTS.28 8.2.1 Intended USERS.28 8.2.2 Anticipated USER TASKS.30 8.2.3 Intended USE ENVIRONMENT.30 8.3 Finalize the USE SPECIFICATION.30 8.4 Recommended methods for developing the USE SPECIFICATION.31 8.4.1 General.31 8.4.2 Contextual inquiry and observation.31 8.4.3 Interview and survey techniques.31 8.4.4 Expert reviews.32 8.4.5 Advisory panel reviews.32 8.4.6 USABILITY TESTS.32 9 Identify USER INTERFACE characteristics related to SAFETY and potential USE ERRORS.32 9.1 General.32 9.2 TASK ANALYSIS.33 9.3 FUNCTION ANALYSIS.33 9.4 Identify and analyse known problems.35 IEC TR 62366-2:2016 IEC 2016 3 10 Identify known or foreseeable HAZARDS and HAZARDOUS