IEC 62366 use-error severity

For a single hazardous use scenario: what harm, can the user detect it, can they recover.

Plausible harm if the use error occursNone / inconvenienceDelay to therapy or diagnosisNon-serious injuryDeath or serious injury

Can the user or system detect the error in time?YesNo / silent failure

Can they recover without specialized intervention?YesNo

Educational only. Not medical advice, not a regulatory determination, and not a substitute for qualified RA/QA, legal, clinical, or statistical counsel. IEC 62366 use-error severity does not submit to FDA, Notified Bodies, or IRBs.

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