Maps to
QMSR / ISO 13485: §820.30(g)
ISO 13485: §7.1
IEC 62366: §5.3
Requirement text
The manufacturer shall identify known and reasonably foreseeable hazards and hazardous situations that are associated with the device user interface, considering hazards that could arise from use errors, from user interface characteristics related to safety, and from the use environment.
What changed
IEC 62366-1:2015 replaced the 2007 first edition with a major restructuring. The standard was split into Part 1 (normative requirements) and Part 2 (IEC TR 62366-2, informative guidance and methods). The scope broadened to include hazards of all types including psychological hazards, not just direct physical hazards.
The standard introduced a formative/summative evaluation framework not present in 2007. The 2007 requirement to identify primary operating functions was removed — instead, the 2015 version mandates identification and evaluation of hazard-related use scenarios. A concept of User Interface of Unknown Provenance (UOUP) was added, allowing simplified evaluation for legacy or off-the-shelf interfaces based on post-market data.
Amendment 1 (2020) further refined the standard: it updated the ISO 14971 reference to the 2019 edition, introduced bidirectional exchange between risk management and usability engineering (previously one-directional), added training as a third priority risk control measure alongside information for safety, introduced the concept of 'use difficulty' (close calls and observed problems that don't result in actual use errors), and replaced 'action error' with 'physical mismatch' to encourage broader analysis of use problems.
Atomic constraints
- •UI-related hazards must be identified and documented in the risk management file.
- •Hazardous situations arising from foreseeable use errors must be analyzed.
- •The analysis must consider hazards arising from the use environment (distractions, emergency conditions, etc.).
- •UI-related hazards must be linked to the ISO 14971 risk analysis (Risk Table).
- •Both single-use errors and sequences of use errors leading to harm must be considered.
Common gaps
Incomplete identification of hazard-related use scenarios
majorManufacturers identify obvious use errors but miss less intuitive scenarios, particularly cognitive errors, misinterpretation of displayed information, and 'negative transfer' errors where experience with a previous version or competitor device leads to dangerous mistakes on the new interface.
Use difficulties not captured (post-2020 amendment)
moderateThe 2020 amendment requires identification of not only use errors but also 'use difficulties' — close calls and situations where problems in use were observed but no actual use error was committed. Many manufacturers only document actual errors and miss these near-miss signals that indicate latent design weaknesses.
Evidence signals
- •
FILE_EXISTS
Hazard.*Use.*Scenario|Risk.*Table|FMEA|Usability.*Risk
- •
CONTENT_MATCH
Does this document identify specific hazardous situations arising from user interface interactions or foreseeable use errors, with analysis of the probability and potential harm associated with each scenario?
Audit defense
UI-related hazardous situations for [your product] are documented in the Hazard-Related Use Scenarios list (Doc ID: [your document ID]) and cross-referenced in the Risk Table. Hazard identification considered the use environment, foreseeable use errors, and potential harm sequences described in the Use Specification.