What is this standard about?
Medical devices are increasingly used to observe and treat patients, and are becoming more complicated. Yet at the same time, they’re now often used by less-skilled individuals, including by patients themselves. To eliminate user error devices need to be intuitive and easy to use. These qualities can be developed efficiently by the use of a usability engineering process during the device’s development. This standard helps manufacturers improve usability by setting out an appropriate usability engineering process.
Who is this standard for?
Manufacturers of medical equipment and systems.
Why should you use this standard?
It specifies a process with which manufacturers can analyse, specify, develop and evaluate the usability of a medical device as it relates to safety in normal use. The process is intended to identify and minimize use errors and thereby reduce use-associated risks.
What’s changed since the last update?
This amended standard replaces BS EN 62366-1:2015. Since that document’s publication experts have identified several inaccuracies which warranted correction, although note that the amendment makes no fundamental changes to the usability engineering process as set out in the 2015 standard.