IEC 62304 is an international standard titled:
“Medical device software – Software life cycle processes”
It defines the requirements for the software development life cycle of medical device software, whether the software is a component of a medical device or a standalone product (also known as Software as a Medical Device, SaMD).
Quality Attributes Required or Emphasized
The standard does not explicitly use the term “quality attributes” in the ISO 25010 sense, but several critical attributes are clearly emphasized through required processes:
Attribute | Relevance in IEC 62304 |
---|---|
Safety | Central concern. Risk management must be integrated throughout the software lifecycle. |
Reliability | Required via verification, validation, and robust maintenance processes. |
Maintainability | Emphasis on change control, problem resolution, and proper documentation. |
Traceability | End-to-end traceability between requirements, implementation, tests, and risk controls. |
Usability | Not a core focus, but indirectly relevant for safety and effectiveness. |
Security | Not directly addressed in depth (older version), but relevant under risk control. |
Note: The latest version of the standard encourages integration with ISO 14971 (Risk Management) and IEC 62366 (Usability Engineering) for comprehensive coverage.
References
Official Standards Documents
- t.b.d
Related Standards
- ISO 14971 - Application of risk management to medical devices
- IEC 62366 - Medical devices - Application of usability engineering to medical devices
Additional Resources
- t.b.d