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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 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.
Cross-references
Related terms
Shared paths + categoryStandards
ISO 14971
International standard for the application of risk management to medical devices.
Risk & Usability Deep DiveStandards Stack for Medical Devices
Clinical & Trials
Human Factors Engineering(HFE)
Engineering discipline focused on safe and effective device use by intended users.
Risk & Usability Deep Dive · adjacent
Standards
IEC 62304
Lifecycle requirements for medical device software.
Standards Stack for Medical Devices · adjacent
Standards
ISO 10993-1
Biological evaluation of medical devices within a risk management process.
Standards Stack for Medical Devices · adjacent
Standards
IEC 60601-1
General requirements for basic safety and essential performance of medical electrical equipment.
Standards Stack for Medical Devices
Standards
IEC 60601-1-2
EMC requirements for medical electrical equipment.
Standards Stack for Medical Devices
Latest in MedTech
Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
ISO·1FDA·1IEC·1
- 1IEC 62366-1:2015VerifiedISOiso.org
- 2FDA Human Factors GuidanceVerifiedFDAfda.gov
- 3IEC Webstore - Medical EquipmentVerifiedIECwebstore.iec.ch
Inline markers like [1] jump to the matching reference above.