Usability Evaluation Report
Contents
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 Section |
Title |
Document Section |
|---|---|---|
4.1.3 |
Information for Safety as it relates to Usability |
5.4 |
4.2 |
Usability Engineering File |
(all) |
1. Relevant Processes#
Usability Engineering and Evaluation activities are defined in the SOP Integrated Software Development.
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 |
|---|---|---|---|---|---|---|
5.2 Pass / Fail Counts of Tests#
Count the pass/fail results from the Usability Evaluation Protocol
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 understood by the users and whether it supported the correct use of the medical device.