T-012-028 Software Requirement Specification
Key
Instructions
Unique identifier of the Software Requirement (SR)
Name
Instructions
Name of software item, as defined in the software architecture, that are involved in the implementation of the Software Requirement (SR)
Description
Instructions
Detailed text describing the Software Requirement (SR)
Category
Instructions
The Software Requirement (SR) category as regard to the IEC 62304
- User interface
- Functional
- Maintenance
- Regulatory
- Installation
- Data and databases
- Alarms, warnings, and messages
- Input and output
- Security You can select more than one if applicable.
Risk control measure
Instructions
Indicates whether the Software Requirement (SR) serves as a risk control measure to mitigate or eliminate an identified risk. The value is 'Yes' if the SR is specifically implemented as a risk control, and 'No' otherwise
Creates risk ID
Instructions
This column lists the unique identifiers of risks that are generated as a result of the implementation or existence of the corresponding Software Requirement (SR)