Safety integrity level (SIL)-based functional safety assessment is widely required in designing safety functions and checking their validity of electrical/electronic/programmable electronic (E/E/PE) safety-related systems after being issued IEC 61508 in 2010. For the hardware of E/E/PE safety-related systems, quantitative functional safety assessment based on target failure measures is needed for deciding or allocating the level of SIL. On the other hand, IEC 61508 does not provide any quantitative safety assessment method for allocating SIL for the software of E/E/PE safety-related systems because the software failure is treated as a systematic failure in IEC 61508. We discuss the needfulness of quantitative safety assessment for software of E/E/PE safety-related systems and propose mathematical fundamentals for conducting quantitative SIL-based safety assessment for the software of E/E/PE safety-related systems by applying the notion of software reliability modeling and assessment technologies. We show numerical examples for explaining how to use our approaches.
Epinephrine Use in Endoscopic Ear Surgery: Quantitative Safety Assessment