The Usability Evaluation Report provides a summary of the results from all usability evaluation activities, including both formative and summative assessments.
Mapping Standard Requirements to Document Sections
| IEC 62366-1:2015 Section | Title | Document Section |
|---|---|---|
| 4.1.3 | Information for Safety related to Usability | 4.5 |
| 4.2 | Usability Engineering File | (all) |
1. Relevant Processes
Usability Engineering and Evaluation procedures are outlined in the SOP Integrated Software Development.
2. Related Documents
- Hazard-Related Use Scenarios List
- Usability Evaluation Protocol
- Usability Evaluation Plan
3. Overview of Formative Evaluations
3.1 Formative Evaluation 1
4. Overview of Summative Evaluation
4.1 Methods
This section should be copied from the Usability Evaluation Plan (5.2 Planning (Setting)).
4.2 Summary of Tests
Copy this table from the Usability Evaluation Protocol.
| ID | Description | App State / Environment | Instructions | Acceptance Criteria | Observations | Hazards encountered |
|---|---|---|---|---|---|---|
4.3 Pass / Fail Test Summary
Count and summarize the pass/fail outcomes from the Usability Evaluation Protocol.
| Test ID | Description | Total Count | Pass Count | Fail Count |
|---|---|---|---|---|
4.4 Use Errors and Associated Hazards
| Test ID | Description | Use Error | Potential Hazard |
|---|---|---|---|
4.5 Safety Information
Explain whether users were able to correctly perceive and comprehend safety information and if it aided them in using the medical device properly.