Biocompatibility Use Case
The Biocompatibility use case documents the biological evaluation of your device. Each analysis is linked to the Part/Component it examines and to the Laboratory that conducted it.
Knowledge Topics
The use case is active once your product contains these Knowledge Topics:
- Parts/Components Analysis
- Laboratories
These Knowledge Topics are optional. Add them to your product to enable the relations that use them:
- Parts/Components
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 |
|---|---|---|---|---|---|
| Parts/Components Analysis | Analysis Of | Parts/Components | No | Yes | Select the Part/Component that is analyzed in this analysis. |
| Conducted In | Laboratories | No | Yes | Select the Laboratory where this analysis is conducted. |
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:
- General Use Case – Parts/Components
- Risk Management – Parts/Components
- Software Engineering – Parts/Components
- Sterile – Parts/Components