IEC 62304: “Medical device software – Software life cycle processes”

This international standard 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
  • 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