IEC 62366 — Usability engineering for medical devices
From use specification to summative evaluation: the usability engineering process for every device type — electrical, software and IVD.
IEC 62366-1:2015+AMD1:2020 — IEC Webstore ↗From use error to risk control — traceable
62366-1 interlocks usability with ISO 14971 risk management. medairon helps you document use errors, risk controls and evidence in a traceable way — start free.
What is IEC 62366 and who must apply it?
For: The usability engineering process for all medical devices — and why 62366-2 is guidance only, not a requirement.
The usability engineering process step by step
For: From the use specification through hazard-related use scenarios to UI design and evaluation.
Formative vs. summative evaluation
For: The practical distinction that prompts the most questions — iterative learning during development versus the final safety validation.
IEC 62366 vs. FDA human factors engineering
For: Same goal, different vocabulary: the terminology bridge between EU usability engineering and FDA HFE.
How does IEC 62366 relate to 14971, MDR and 60601-1-6?
For: Use errors as a hazard source for the risk file — and the convergence point with 60601 for electrical devices.
What does an auditor check for IEC 62366?
For: A complete usability engineering file and end-to-end traceability from use errors to risk controls and summative test results.