Summative Evaluation Use Case
The Summative Evaluation use case documents summative usability evaluations according to IEC 62366-1 (5.5 and 5.9). Tasks are linked to the hazard-related use scenarios, hazardous situations and harms they cover, and participants to the User Profile they represent.
Knowledge Topics
The use case is active once your product contains these Knowledge Topics:
- Tasks Covered SE
- Participants SE
These Knowledge Topics are optional. Add them to your product to enable the relations that use them:
- Use Scenarios
- Hazardous Situation
- Harm
- User Profiles
Relationships
The diagram shows how the Knowledge Topics of this use case are connected. An arrow points from the source to the target Knowledge Topic. An arrow with two arrowheads marks a bidirectional relationship.
Each row is one trace column on the source Knowledge Topic. Allow Multiple shows whether a record can be linked to more than one target record. Bidirectional relations are also shown on the target Knowledge Topic.
| Source Knowledge Topic | Relation Name | Target Knowledge Topic | Allow Multiple | Bidirectional | Description | Additional Fields |
|---|---|---|---|---|---|---|
| Tasks Covered SE | Linked HRUS | Use Scenarios | Yes | No | Select the Hazard-Related Use Scenario(s) — Use Scenarios where 'is Hazard-related' = true — that this Task validates. | |
| Linked Hazardous Situation | Hazardous Situation | Yes | No | Select the Hazardous Situations this Task exposes. | ||
| Linked Harm | Harm | Yes | No | Select the Harms reachable from this Task. | Severity | |
| Participants SE | Linked User Group | User Profiles | No | No | Select the User Profile this Participant represents. |
Additional Fields are extra columns that show a field of the linked record, such as the severity of a linked Harm.
Integration with Other Use Cases
Knowledge Topics that belong to more than one use case connect those use cases. This use case shares Knowledge Topics with:
- Active Device – Hazardous Situation
- Clinical Evaluation – Harm
- Essential Performance – Hazardous Situation
- Formative Evaluation – User Profiles
- General Use Case – User Profiles
- Requirements – Use Scenarios
- Risk Management – Hazardous Situation, Harm
- Software Engineering – Hazardous Situation
- Usability Engineering – Use Scenarios, Hazardous Situation, Harm, User Profiles