Infusion pump system safety analysis based on fault tree and Markov analysis

摘要

Infusion pump is an instrument that can accurately control infusion velocity and ensure drug is safely injected into the body of patients. It is an intelligent device including safety-critical system. Manufacturers generally take advantage of the system security assessment method to evaluate itself safely. The Fault Tree and the Markov Analysis method are commonly used in system safety assessment, and the two methods both have different features at different stages [7]. It is guided by the IEC and GB standards. Based on the theory of medical device safety assessment method, related technologies & methods building the infusion pump, safety assessment system are studied to ensure the safety of equipment used, which can reduce the accident caused by medical apparatus and instruments.