Enumeration Values
| Level | ID | Display Name | Description |
|---|
| 1 | system | System | Top-level product definition. Represents the complete medical device or system under analysis. |
| 2 | subsystem | Subsystem | Major functional grouping within the system. Typically corresponds to a distinct functional module (e.g., power supply, user interface, fluid delivery). |
| 3 | assembly | Assembly | An integrated unit composed of multiple subassemblies or components. Represents a physically assembled unit within a subsystem. |
| 4 | subassembly | Subassembly | A sub-unit within an assembly. Groups related components that form a functional sub-module. |
| 5 | component | Component | Individual part at the lowest decomposition level. Represents a single physical or logical element (e.g., sensor, valve, circuit board). |
Hierarchy Diagram
Configuration Details
| Property | Value |
|---|
| Field ID | systemElementType |
| Alias | elementType |
| Used by | System Element work item type |
| Source file | .polarion/tracker/fields/systemElementType-enum.xml |
Usage in the Solution
The system element type hierarchy is central to several solution features:
- Product decomposition — System elements use hierarchical
parent links combined with this type to model the full device structure. Each level can have functions, failure modes, and risk records allocated to it.
- DFMEA scoping — The DFMEA risksheet uses the subsystem field on documents to scope failure mode analysis to a specific decomposition level. See DFMEA Risksheet Configuration.
- Component RTM — The PowerSheet Component RTM constrains requirements traceability to the current document’s subsystem context.
- IEC 60601-1 compliance — The five-level decomposition supports the system decomposition requirements of IEC 60601-1 for medical electrical equipment.
The DFMEA risksheet resolves the parent systemElement of each function to display the component column. Functions are allocated to system elements via the allocatedTo link role, enabling component-scoped failure mode analysis.
