Maps to
IEC 62366: §4.2 USABILITY ENGINEERING FILE
ISO 13485: §4.2.4 Control of documents
Pre-QMSR Part 820 (legacy QSR): §820.40 Document controls.
Requirement text
The manufacturer shall establish and maintain a usability engineering file containing all usability engineering outputs and providing a record of the usability engineering activities performed. The file must be a traceable, complete record of the usability work for the device.
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.
Amendment 1 (IEC 62366-1:2015+AMD1:2020 CSV) made no substantive normative change to this clause. Changes were editorial: the normative reference to ISO 14971:2007 was updated to ISO 14971:2019 throughout the standard, ISO 13485 reference updated to 2016 edition, and defined-term capitalization conventions were applied consistently.
Atomic constraints
- •A usability engineering file must exist for the device, collecting all usability outputs in one retrievable location.
- •The file must include the Usability Evaluation Plan, Hazard-Related Use Scenarios, and Usability Evaluation Report.
- •The file must be maintained throughout the device lifecycle and updated when usability activities are conducted.
- •The file must enable traceability from use scenarios to evaluation activities and results.
Common gaps
Usability Engineering File incomplete or missing
majorApproximately 90% of human factors testing reports submitted to the FDA in 510(k) submissions are deficient because the submission includes only the final summative testing report. FDA expects the full Usability Engineering File including the Use-Related Risk Analysis, formative evaluation records, and the iterative design process that led to the final design.
Evidence signals
- •
FILE_EXISTS
Usability.*Evaluation.*Plan|Usability.*Evaluation.*Report|Usability.*File|Hazard.*Use.*Scenario
- •
CONTENT_MATCH
Does this document or set of documents collectively constitute a usability engineering file containing evaluation plans, hazard-related use scenarios, and evaluation results that provide a traceable record of all usability activities conducted?
Audit defense
The Usability Engineering File for [your product] consists of the Usability Evaluation Plan ([your document ID]), Hazard-Related Use Scenarios List, and Usability Evaluation Report. These documents collectively provide the IEC 62366-1 section 4.2 file, with traceability from use scenarios through evaluation results.