BS EN 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices
Many medical devices are non-intuitive and difficult to use because they have been developed without attention to human factors. This is a growing cause for concern because less skilled users, including patients, are now using medical devices more often – and the devices are becoming more complicated.
So BS EN 62366-1 sets out a usability engineering process for medical devices, to aid in designing user interfaces that are straightforward and efficient.
Previously, usability engineering for medical devices was covered in BS EN 62366:2008, but now that document has been fully revised into two parts:
- Part 1, now published, contains updated normative requirements for the application of usability engineering to medical devices.
- Part 2, a technical report currently in preparation, will contain guidance, with a broader focus not only on safety but also on how usability relates to accuracy, completeness, efficiency and user satisfaction.
This reduces the size of the normative standard and allows the guidance document to be updated more frequently to keep pace with the state of the art in usability engineering.
BS EN 62366-1 will be essential reading for manufacturers of medical equipment and systems, helping you to minimise user errors and so reduce risks.
(Kindly note that this standard supersedes a recently published amendment, BS EN 62366:2008+A1:2015.)