Safety models: an analytical tool for risk analysis of medical device systems

摘要

Markov chain models of software use have been used successfully to test software and analyze the expected use of software systems. It is possible to augment a Markov chain usage model of the expected use of a medical system including hardware, software, and human components with information about the occurrence of hazardous conditions and the mitigation of hazardous conditions. This augmented Markov chain usage model, called a Safety model, presents significant opportunities for the quantitative analysis of aspects of system safety.