1、 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 otherwi
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10、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 E
11、LECTROTECHNICAL 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.1
12、0 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 US
13、ABILITY 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 r
14、elates 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 Prepar
15、e 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
16、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
