INTRODUCTION

Medical practice is increasingly using medical devices for observation and treatment of patients. Use errors caused by inadequate medical device usability have become an increasing cause for concern. Many of the medical devices developed without applying a usability engineering process are non-intuitive, difficult to learn and to use. As healthcare evolves, less skilled users including patients themselves are now using medical devices and medical devices are becoming more complicated. In simpler times, the user of a medical device might be able to cope with an ambiguous, difficult-to-use user interface. The design of a usable medical device is a challenging endeavour, yet many organizations treat it as if it were just “common sense”. The design of the user interface to achieve adequate (safe) usability requires a very different skill set than that of the technical implementation of that interface.

The usability engineering process is intended to achieve reasonable usability, which in turn is intended to minimise use errors and to minimise use-associated risks. Some, but not all, forms of incorrect use are amenable to control by the manufacturer. The usability engineering process is related to the risk management process as indicated in Figure A.1.

This International Standard describes a usability engineering process, and provides guidance on how to implement and execute the process to provide safety in medical devices. It is intended to be useful not only for manufacturers of medical devices, but also for technical committees responsible for the preparation of particular medical device standards.

Amendment 1 updates the standard to add urgently needed requirements to deal with legacy devices where the user interface design is of unknown provenance.

BS EN 62366:2008+A1:2015

Medical devices. Application of usability engineering to medical devices

Published:

30 Apr 2008

Withdrawn:

17 Jul 2018