Table of Contents

FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 Principles
5 USABILITY ENGINEERING PROCESS
Annex A (informative) - General guidance and rationale
ANNEX B (informative) - Examples of possible HAZARDOUS
        SITUATIONS related to USABILITY
Annex C (normative) - Evaluation of a USER INTERFACE OF
        UNKNOWN PROVENANCE (UOUP)
Annex D (informative) - Types of MEDICAL DEVICE use,
        with examples
Annex E (informative) - Reference to the essential principles
Bibliography

Abstract

Defines 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	International Electrotechnical Committee
Pages
ISBN
Committee	TC 62