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 Section | Title | Document Section |
|---|---|---|
| 4.1.3 | Information for Safety as it relates to Usability | 4.5 |
| 4.2 | Usability Engineering File | (all) |
1. Relevant Processes
Usability Engineering and Evaluation activities are defined in the SOP Integrated Software Development.
2. Related Documents
- List of Hazard-Related Use Scenarios
- Usability Evaluation Protocol
- Usability Evaluation Plan
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.
| ID | Description | App State / Environment | Instructions | Acceptance Criteria | Observations | Hazards encountered |
|---|---|---|---|---|---|---|
4.3 Pass / Fail Counts of Tests
Count the pass/fail results from the Usability Evaluation Protocol
| Test ID | Description | Total Count | Pass Count | Fail Count |
|---|---|---|---|---|
4.4 Use Errors and Hazards
| Test ID | Description | Use Error | Potential Hazard |
|---|---|---|---|
4.5 Information for Safety
Describe whether information for safety could correctly be perceived and understood by the users and whether it supported the correct use of the medical device.
4.6 Other Findings
5. Qualitative Participant Feedback
6. Conclusion
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