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I would expect that any modern insulin pump is required to be protected very thoroughly against random malfunctions. Some certification authorities seem to requ
by gmueckl 5y ago
I would expect that any modern insulin pump is required to be protected very thoroughly against random malfunctions. Some certification authorities seem to require IEC 61508 (functional safety) as a prerequisite for IEC 60601 (safety of medical equipment). IEC 61508 kind of requires self-monitoring against malfunctions in a reliable way. This includes mechanisms for detecting random bit flips if these can cause potential harm.