Usability Engineering - Related International Standards
The following non-harmonised international standards are related to Usability Engineering for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| IEC 62366-1:2015+AMD1:2020 | Medical devices - Part 1: Application of usability engineering to medical devices | active | Link | |
| IEC/TR 62366-2:2016 | Medical devices - Part 2: Guidance on the application of usability engineering to medical devices | active | 5, 22, 22.1, 5(a), 5(b) | Link |