Usability Evaluation Report
The Usability Evaluation report describes the results of all (formative and
summative) Usability Evaluations.
Mapping of Standard Requirements to Document Sections
IEC 62366-1:2015 Document
Section Title Section
4.1.3 Information for Safety as it relates to 5.4
Usability
4.2 Usability Engineering File (all)
1. Relevant Processes
Usability Engineering and Evaluation activities are defined in the SOP Inte-
grated Software Development.
2. Related Documents
• List of Hazard-Related Use Scenarios
• Usability Evaluation Report
3. Summary of Formative Evaluations
3.1 Formative Evaluation 1
4. Summary of Summative Evaluation
4.1 Methods
Copy-paste this section from the Usability Evaluation Plan (5.2
Planning (Setting)).
4.2 Overview over Tests
Copy-paste this table from the Usability Evaluation Protocol.
App State / Acceptance Hazards en-
ID Description
Environment InstructionsCriteria Observations
countered
5.2 Pass / Fail Counts of Tests
Count the pass/fail results from the Usability Evaluation Protocol
1
Test ID Description Total Count Pass Count Fail Count
5.3 Use Errors and Hazards
Test ID Description Use Error Potential Hazard
5.4 Information for Safety
Describe whether information for safety could correctly be perceived
and understanded by the users and whether it supported the correct
use of the medical device.
5.5 Other Findings
6. Qualitative Participant Feedback
7. Conclusion
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