All terms
Clinical & TrialsClinical Evidence
Use Error
User action or lack thereof that leads to a different result than intended by the manufacturer or expected by the user.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
Per IEC 62366-1, a use error is a user action or lack thereof while using a medical device that leads to a different result than that intended. It is not necessarily user 'error' - it often reflects design issues.What this means in practice
Use errors are addressed via design changes, mitigations, training, or labeling, evaluated through formative and summative usability studies.Cross-references
See also
Closely related context worth reading.
Primary references
3 sourcesLink health: 3 verified· last checked 2026-05-09
ISO·2FDA·1
- 1
IEC 62366-1VerifiedISOiso.org
- 2
ISO 14155 Standard PageVerifiedISOiso.org
- 3
FDA - Clinical Trials and Human Subject ProtectionVerifiedFDAfda.gov
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