IEC 62366-1

What is IEC 62366-1?

IEC 62366-1:2015 defines a process for analyzing, specifying, developing, and evaluating the usability of a medical device as it relates to safety. The standard treats usability engineering and human factors engineering as a structured lifecycle activity rather than a single test performed at the end of development.

The current consolidated requirements are IEC 62366-1:2015 with Amendment 1:2020 and the incorporated July 2016 corrigendum.

Which use-related risks does IEC 62366-1 address?

The process addresses risks associated with correct use and use error under normal use. It can help identify abnormal use, but it does not provide the process for assessing or controlling risks arising from abnormal use.

Manufacturers should define intended users, use environments and user-interface characteristics, identify hazard-related use scenarios, and select scenarios for summative evaluation. FDA’s separate human-factors framework uses the term “critical tasks.” Findings should inform design decisions and risk controls throughout development.

How does IEC 62366-1 connect with risk management?

Usability engineering connects user-interface analysis and evaluation to the device risk-management process. Use-related hazards, hazardous situations, foreseeable sequences of events, and risk controls should remain traceable rather than being maintained as a disconnected usability exercise.

Formative evaluations can uncover design weaknesses during development. A summative evaluation then supports the conclusion that the completed user interface can be used safely by the intended users under representative conditions.

Is IEC 62366-1 the same as FDA human factors guidance?

No. The standard and FDA guidance overlap in purpose, but U.S. submission expectations must be assessed separately. FDA’s May 2026 final guidance on the content of human factors information in marketing submissions uses a risk-based framework for deciding what information should be submitted.

Pure Global discusses the update in its FDA human factors guidance overview.

What documentation should manufacturers retain?

The usability engineering file should provide traceability from the use specification and safety-related user-interface characteristics through hazard analysis, risk controls, evaluation plans, results, and conclusions. It should explain why representative users, tasks, environments, and test conditions were selected.

For broader practical context, see Pure Global’s human factors in medical device manufacturing and usability testing overview.