Essential Performance Use Case
The Essential Performance use case supports the analysis of essential performance according to IEC 60601-1: performance limits, means of protection, leakage currents, EMC immunity levels and the clinical function analysis. It reuses System Requirements, Risks and Verification from the Requirements and Risk Management use cases.
Knowledge Topics
The use case is active once your product contains these Knowledge Topics:
- Performance Limits
- Means of Protection
- Leakage Currents
- EMC Immunity Levels
- Clinical Function Analysis
These Knowledge Topics are optional. Add them to your product to enable the relations that use them:
- System Requirements
- Risks
- Verification
- Failure Modes
- Applied Parts
- Hazardous Situation
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 |
|---|---|---|---|---|---|
| System Requirements | Related Risk | Risks | Yes | No | Select the risks whose occurrence would compromise this essential performance. |
| Has Performance Limit | Performance Limits | Yes | Yes | Select one or more performance limits defined for this essential performance. | |
| Failure Modes | Protected by | Means of Protection | Yes | No | The second protection that survives a single fault. |
| Leakage Currents | Applies to | Applied Parts | Yes | Yes | The applied parts that this leakage current applies to. |
| Applied Parts | Has Leakage Current | Leakage Currents | No | Yes | The leakage currents that apply to this applied part. |
| EMC Immunity Levels | Related to | Clinical Function Analysis | Yes | No | The clinical functions that are related to this EMC immunity level. |
| Clinical Function Analysis | Corresponds to | Hazardous Situation | Yes | No | The hazardous situations that correspond to this clinical function analysis. |
| Leads to | System Requirements | Yes | No | The essential performances that are affected by this clinical function analysis. |
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 – Means of Protection, Hazardous Situation
- Requirements – System Requirements, Verification
- Risk Management – Risks, Verification, Failure Modes, Hazardous Situation
- Software Engineering – System Requirements, Hazardous Situation
- Summative Evaluation – Hazardous Situation
- Usability Engineering – Hazardous Situation