Medical devices. Guidance on the application of usability engineering to medical devices
Also Known As:
What is this standard about?
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 difficult to use. They can also include design shortcomings that can allow use errors and potentially lead to harm. This standard therefore provides medical devices manufacturers with guidance on how to integrate usability engineering principles and user interface design practices into their overall medical device processes.
Who is this standard for?
- Medical devices manufacturers – this document provides them with guidance on how to integrate usability engineering principles and user interface design practices into their overall medical device development processes
- Medical devices patients – particularly as healthcare evolves and less skilled users including the patients themselves are now using medical devices and those medical devices are becoming more complicated
Why should you use this standard?
The guidance provided in it applies to all medical devices, including:
- Those used by laypersons and/or healthcare professionals
- Medical devices that perform one function or several
- User interfaces in the form of hardware, software, documentation and packaging
- Medical devices of all shapes and sizes and that may or may not require training before use
The document recognizes that all medical devices involving human interaction present opportunities for optimization through the application of usability engineering.
It covers the quality of user interactions with medical devices which can be very varied: attaching accessories to a medical device and interpreting warnings, as well as understanding relevant aspects for the proper use of the medical device by reading the accompanying documentation.
What’s changed since the last update?
When the revision of BS EN 62366:2008 started, a decision was made by the joint working group that the existing document would be broken into two parts. Therefore, together with BS EN 62366-1:2015, this document supersedes BS EN 62366:2008+A1:2015.
BS EN 62366-1:2015 contains updated normative requirements for the application of usability engineering to medical devices.
| Descriptors | Medical technology, Hazards, Medical instruments, Ergonomics, Equipment safety, Design, Medical equipment, Instructions for use |
| ICS Codes | 11.040.01 - Medical equipment in general |
| Language(s) | English |
| ISBN | 978 0 580 85673 0 |
| File Size | 3.9 MB |
