Table of Contents

FOREWORD<br>INTRODUCTION<br>1 Scope and purpose<br>2 Normative references<br>3 Terms and definitions<br>4 Mapping between the requirements of IEC 62366-1 <br>&nbsp;&nbsp;&nbsp;and the guidance of IEC TR 62366-2<br>5 Background and justification of the USABILITY <br>&nbsp;&nbsp;&nbsp;ENGINEERING program<br>6 How to implement a USABILITY ENGINEERING program<br>7 Overview of the USABILITY ENGINEERING PROCESS<br>8 Prepare the USE SPECIFICATION<br>9 Identify USER INTERFACE characteristics related <br>&nbsp;&nbsp;&nbsp;to SAFETY and potential USE ERRORS<br>10 Identify known or foreseeable HAZARDS and HAZARDOUS <br>&nbsp;&nbsp;&nbsp;SITUATIONS<br>11 Identify and describe HAZARD-RELATED USE SCENARIOS<br>12 Select the HAZARD-RELATED USE SCENARIOS for SUMMATIVE <br>&nbsp;&nbsp;&nbsp;EVALUATION<br>13 Establish USER INTERFACE SPECIFICATION<br>14 Establish USER INTERFACE EVALUATION plan<br>15 Design and implement the USER INTERFACE and training<br>16 Perform FORMATIVE EVALUATIONS<br>17 Perform SUMMATIVE EVALUATION<br>18 Document the USABILITY ENGINEERING project<br>19 POST-PRODUCTION review and analysis<br>Annex A (informative) - Recommended reading list<br>Annex B (informative) - External resources to identify <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;known problems<br>Annex C (informative) - Developing USABILITY GOALS for <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;commercial purposes<br>Annex D (informative) - USABILITY ENGINEERING project <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;end products<br>Annex E (informative) - USABILITY ENGINEERING methods<br>Annex F (informative) - USABILITY ENGINEERING studies <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;in clinical settings<br>Annex G (informative) - USER PROFILE<br>Annex H (informative) - USE ENVIRONMENT descriptions<br>Annex I (informative) - USER INTERFACE REQUIREMENTS<br>Annex J (informative) - Model the USER INTERFACE<br>Annex K (informative) - USABILITY TEST sample size<br>Annex L (informative) - Identifying distinct USER groups<br>Bibliography<br>Index of defined terms

Abstract

Gives background information and provides guidance that addresses specific areas that experience suggests can be helpful for those implementing a USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS both as defined in IEC 62366-1:2015 and as supporting goals other than SAFETY.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Electrotechnical Committee
Pages
ISBN
Committee	TC 62