Current Edition Checked October 24, 2026
Edition 1.1 (2015 with Amendment 1:2020) is current. FDA’s 2016 human factors guidance covers similar ground for US submissions.
What It Covers
A usability engineering process that treats use error as a design input: who uses the device, where, for what, and which use scenarios could lead to harm.
Who It Applies To
All medical device manufacturers, for the user interface of every device, including labeling and training materials.
Key Requirements
- A use specification: intended users, use environments, and the user interface.
- Known use problems and hazard-related use scenarios identified and linked to risk management.
- A user interface specification, with formative evaluations during design.
- A summative evaluation showing the final design is safe to use, and a usability engineering file.
What an Auditor Asks to See
- The use specification and the hazard-related use scenarios.
- Formative and summative evaluation protocols, participants, and results.
- Traceability from use errors observed to design or labeling changes.
Where Systems Fall Short
- A summative test run on a prototype that differs from what shipped.
- Use errors from complaints never fed back into the scenarios.
How QES Helps
Usability files tied into the risk file and the complaint system, so field use errors reach the design.
Related Standards
Sources. IEC Webstore — IEC 62366-1 (opens in a new tab); Greenlight Guru — ISO standards for medical devices (2026) (opens in a new tab). Status checked October 24, 2026. This page summarizes IEC 62366-1; it does not reproduce or replace it. Buy the standard from its publisher, or read the regulation in its official text, before relying on a detail. Not legal advice.