Table of Contents

FOREWORD<br>INTRODUCTION<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 Principles<br>5 USABILITY ENGINEERING PROCESS<br>Annex A (informative) - General guidance and rationale<br>ANNEX B (informative) - Examples of possible HAZARDOUS<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;SITUATIONS related to USABILITY<br>Annex C (normative) - Evaluation of a USER INTERFACE<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;OF UNKNOWN PROVENANCE (UOUP)<br>Annex D (informative) - Types of MEDICAL DEVICE use,<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;with examples<br>Annex E (informative) - Reference to the essential principles<br>Bibliography<br>Index of defined terms<br>Annex ZA (normative) - Normative references to<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;international publications with their<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;corresponding European publications

Abstract

Describes a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	British Standards Institution
Pages
ISBN
Committee	CH/62/1
Supersedes	BS EN 62366 : 2008 14/30244508 DC : 0