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    IEC 62366-1

    Application of usability engineering to medical devices.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    IEC 62366-1:2015 specifies a process for a manufacturer to analyze, specify, develop, and evaluate the usability of a medical device as it relates to safety, addressing use errors that could lead to harm.

    What this means in practice

    Usability engineering and human factors validation are required by FDA and EU MDR. Failure to adequately address use-related risks is a frequent cause of submission deficiencies and post-market events.

    Cross-references

    Uses

    Concepts or artefacts this term builds on.

    Contains

    Sub-elements or required artefacts of this term.

    See also

    Closely related context worth reading.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ISO·1FDA·1IEC·1
    1. 1
      IEC 62366-1:2015
      Verified
      ISOiso.org
    2. 2
      FDA Human Factors Guidance
      Verified
      FDAfda.gov
    3. 3
      IEC Webstore - Medical Equipment
      Verified
      IECwebstore.iec.ch

    Inline markers like [1] jump to the matching reference above.