Mapping Standard Requirements to Document Sections
| IEC 62366-1:2015 Section | Title | Document Section |
|---|---|---|
| 4.2 | Usability Engineering File | (all) |
| 4.3 | Tailoring of the Usability Engineering effort | (all) |
1. User Group and Testing Environment
Detail the user group here, such as physicians with expertise in a specific area.
Additionally, describe the setting where the user testing takes place. Ensure that both the user group and environment align with what has been outlined in your Intended Use. For example, if your application is meant for emergency physicians working in a brightly lit hospital, the usability test should reflect a similar scenario.
2. Preparation Process
Outline any preparations made for users before testing. This should be based on the real-world context in which users will operate the device. For example, if users are likely to read the manual beforehand, provide them with a copy and some time to review it. More realistically, tests may focus on how users engage with the device without prior instruction.
If formal training is necessary before using the device, it should be conducted prior to the test.
3. Task List
This section lists all tasks for users to complete during testing. It serves as the primary table that can be copied for each user, with observations and encountered hazards recorded individually for each participant.
Using a spreadsheet application (e.g., Google Sheets) is highly recommended for better organization and data handling.
| ID | Description | App State / Environment | Instructions | Acceptance Criteria | Observations | Hazards encountered |
|---|---|---|---|---|---|---|
4. User Protocols
Duplicate the table above for each user and complete it during testing. Record the names, ages, or other relevant characteristics of the users.
User 1 (Name, Age)
| ID | Description | App State / Environment | Instructions | Acceptance Criteria | Observations | Hazards encountered |
|---|---|---|---|---|---|---|
User 2 (Name, Age)
| ID | Description | App State / Environment | Instructions | Acceptance Criteria | Observations | Hazards encountered |
|---|---|---|---|---|---|---|