Software Engineering Use Case
The Software Engineering use case supports the software life cycle according to IEC 62304: software requirements, software items and units, interfaces, segregation and the integration, regression and system tests. It connects to System Requirements, Design Output, Hazardous Situations and Risk Control Measures from the Requirements and Risk Management use cases.
Knowledge Topics
The use case is active once your product contains these Knowledge Topics:
- Software Requirements
- Software Items
- Software Units
- Integration Tests
- Regression Tests
- Segregation
- System Tests
- Interfaces
These Knowledge Topics are optional. Add them to your product to enable the relations that use them:
- System Requirements
- Hazardous Situation
- Risk Control Measures
- Parts/Components
- Design Output
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 Tests | Verifies | Software Requirements | Yes | No | Select the Software Requirements that are verified by this System Test. |
| Software Requirements | Derived From | System Requirements | Yes | No | Select the System Requirements from which this Software Requirement is derived. |
| Integration Tests | Tests | Software Items | Yes | No | Select the Software Items that are tested by this Integration Test. |
| Regression Tests | Reran | Integration Tests | Yes | No | Select the Integration Tests that are rerun by this Regression Test. |
| After implementation of | Software Items | Yes | No | Select the Software Items after the implementation of which this Regression Test is performed. | |
| Software Items | Part Of | Software Items | No | No | Select the parent Software Item of this Software Item. |
| Causes | Hazardous Situation | Yes | No | Select the Hazardous Situations that this Software Item can cause. | |
| Segregation | Between | Software Items | Yes | No | Select the Software Items that are segregated by this Segregation. |
| Corresponds to | Risk Control Measures | No | No | Select the Risk Control Measure that corresponds to this Segregation. | |
| Software Units | Part Of | Software Items | No | No | Select the Software Item that this Software Unit is part of. |
| Interfaces | Connects (Software) | Software Items | Yes | No | Select the Software Items that are connected by this Interface. |
| Connects (Hardware) | Parts/Components | Yes | No | Select the Hardware Components that are connected by this Interface. | |
| Needs to fulfill | Software Requirements | Yes | No | Select the Software Requirements that this Interface needs to fulfill or that this interface contributes to. | |
| Design Output | Related to SWR * | Software Requirements | Yes | Yes | Select the Software Requirements that are related to this Design Output. |
* Only available if the target Knowledge Topic is part of your product.
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, Risk Control Measures
- Biocompatibility – Parts/Components
- Essential Performance – System Requirements, Hazardous Situation
- General Use Case – Parts/Components
- Requirements – System Requirements, Risk Control Measures, Design Output
- Risk Management – Hazardous Situation, Risk Control Measures, Parts/Components
- Sterile – Parts/Components
- Summative Evaluation – Hazardous Situation
- Usability Engineering – Hazardous Situation