IEC 62304 software safety class

Class A / B / C follows from the severity of harm a software failure can cause, after considering hardware risk controls.

Can a software failure cause injury or damage to health?No — failure is a nuisance or data inconvenience onlyYes — some injury is possible

Can it cause death or serious injury?NoYes

Is there a hardware risk control that the software cannot defeat?No independent hardware controlYes — hardware interlock / independent monitor

Educational only. Not medical advice, not a regulatory determination, and not a substitute for qualified RA/QA, legal, clinical, or statistical counsel. IEC 62304 software safety class does not submit to FDA, Notified Bodies, or IRBs.

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