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    IEC 62366-1

    Application of usability engineering to medical devices.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed September 19, 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. The process covers preparing the use specification, identifying user interface characteristics related to safety, identifying hazards and hazardous situations from use, selecting hazard-related use scenarios, establishing a user interface specification and evaluation plan, and performing formative and summative evaluations. Amendment 1:2020 updated the standard. IEC TR 62366-2 provides additional guidance, and FDA's human factors guidance takes a broadly similar approach.
    What the regulation says
    IEC 62366-1 provides a framework for manufacturers to manage usability engineering processes, aiming to reduce risks associated with use errors in medical devices. Both the FDA (referencing its Human Factors Guidance) and the EU MDR (Annex I, General Requirements) expect manufacturers to apply usability engineering principles to ensure device safety and effectiveness. This standard is often applied in conjunction with risk management standard ISO 14971.

    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.

    Examples

    • A manufacturer designs an insulin pump and uses IEC 62366-1 to identify potential use errors, such as incorrect dose setting, through formative evaluations with target users.
    • During the development of a surgical robot, the manufacturer conducts summative usability testing according to IEC 62366-1 to confirm that users can safely and effectively operate the device in a simulated clinical environment.
    • A company developing a mobile health application for medication management applies usability engineering principles from IEC 62366-1 to ensure the interface is intuitive and minimizes the risk of medication errors.
    Common pitfalls
    • •Ignoring human factors early in the design process can lead to costly redesigns and delays in market approval.
    • •Failing to adequately document usability engineering activities can result in regulatory deficiencies.
    • •Confusing user interface testing with comprehensive human factors validation can leave critical use errors unaddressed.
    • •Underestimating the diversity of users and use environments can lead to an incomplete understanding of potential use-related risks.

    Frequently asked questions

    The primary goal is to enhance medical device safety by addressing potential use errors through a structured usability engineering process.

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    Sources

    3 sources

    Every citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.

    Tier 1Binding law and standards· 2Tier 2Regulator guidance and consensus· 1
    Link health: 3 verified· last checked 2026-06-20
    ISO·1FDA·1IEC·1
    1. 1
      IEC 62366-1:2015
      Tier 1 Verified
      ISOiso.org
    2. 2
      FDA Human Factors Guidance
      Tier 2 Verified
      FDAfda.gov
    3. 3
      IEC Webstore - Medical Equipment
      Tier 1 Verified
      IECwebstore.iec.ch

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