A Coloured Petri Nets Reference Model of Insulin Infusion Pump Control Systems: Assisting the Certification Process

Insulin infusion pumps are safety-critical systems that require the evaluation of government regulatory agencies (e.g., FDA) before commercialization. This paper presents a Coloured Petri Nets (CPN) reference model of insulin infusion pump control systems to assist manufacturers to generate safety evidence and evaluate quality for certification purposes. It also describes a case study on the ACCD-CHECK Spirit system version 2.XX to evaluate the CPN model. Therefore, the reference model is available and verified. Additionally, the case study is useful to show how manufacturers can reuse it during a certification process. The main contribution of this paper consists on a project artifact to decrease costs and development time of insulin infusion pump control systems, in addition to increase confidence on safety properties.