Software Safety Classification and Architectural Impact

IEC 62304 software safety classification impacts medical device architecture by scaling architectural segregation, interface contracts, and testing rigor according to Class A, B, or C risk levels. This prevents over- or under-engineering safety controls.

Implement architectural segregation for Class C medical device software by deriving classification from hazard analysis and establishing strict boundaries. This guides implementation of memory protection and validated inter-process communication to contain failures.

Re-evaluate software safety classification upon functional changes to the medical device software. This ensures architectural segregation, interface contracts, and verification rigor remain correctly scaled to the updated hazard analysis.

Evaluate SOUP and third-party tools by assessing their impact on Class B and Class C software items. This ensures pre-existing components do not compromise strict interface contracts and segregation boundaries required by the safety classification.

Yes, IEC 62304 classification requires establishing clear traceability between hazards, risk controls, and the implemented software architecture. This aligns evidence and verification rigor with the determined safety class.