Data flow testing as model checking
Proceedings of the 25th International Conference on Software Engineering
Testing real-time embedded software using UPPAAL-TRON: an industrial case study
Proceedings of the 5th ACM international conference on Embedded software
Model-driven Development of Complex Software: A Research Roadmap
FOSE '07 2007 Future of Software Engineering
Safety analysis of software product lines using state-based modeling
Journal of Systems and Software
HCMDSS-MDPNP '07 Proceedings of the 2007 Joint Workshop on High Confidence Medical Devices, Software, and Systems and Medical Device Plug-and-Play Interoperability
Model-Driven architecture for hard real-time systems: from platform independent models to code
ECMDA-FA'05 Proceedings of the First European conference on Model Driven Architecture: foundations and Applications
Challenges in the regulatory approval of medical cyber-physical systems
EMSOFT '11 Proceedings of the ninth ACM international conference on Embedded software
A safety case pattern for model-based development approach
NFM'12 Proceedings of the 4th international conference on NASA Formal Methods
A systematic approach to justifying sufficient confidence in software safety arguments
SAFECOMP'12 Proceedings of the 31st international conference on Computer Safety, Reliability, and Security
A simulink hybrid heart model for quantitative verification of cardiac pacemakers
Proceedings of the 16th international conference on Hybrid systems: computation and control
Proceedings of the 5th ACM SIGCHI symposium on Engineering interactive computing systems
FSTPA-I: a formal approach to hazard identification via system theoretic process analysis
Proceedings of the ACM/IEEE 4th International Conference on Cyber-Physical Systems
Platform dependent code generation of real-time embedded software
Proceedings of the ACM/IEEE 4th International Conference on Cyber-Physical Systems
Formal analysis of Fresenius infusion pump (FIP)
Proceedings of the ACM/IEEE 4th International Conference on Cyber-Physical Systems
Towards a framework for safety analysis of body sensor networks
BodyNets '13 Proceedings of the 8th International Conference on Body Area Networks
Platform-dependent code generation for embedded real-time software
Proceedings of the 2013 International Conference on Compilers, Architectures and Synthesis for Embedded Systems
Analysing interactive devices based on information resource constraints
International Journal of Human-Computer Studies
Safety-critical medical device development using the UPP2SF model translation tool
ACM Transactions on Embedded Computing Systems (TECS)
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This paper presents our effort of using model-driven engineering to establish a safety-assured implementation of Patient-Controlled Analgesic (PCA) infusion pump software based on the generic PCA reference model provided by the U.S. Food and Drug Administration (FDA). The reference model was first translated into a network of timed automata using the UPPAAL tool. Its safety properties were then assured according to the set of generic safety requirements also provided by the FDA. Once the safety of the reference model was established, we applied the TIMES tool to automatically generate platform-independent code as its preliminary implementation. The code was then equipped with auxiliary facilities to interface with pump hardware and deployed onto a real PCA pump. Experiments show that the code worked correctly and effectively with the real pump. To assure that the code does not introduce any violation of the safety requirements, we also developed a testbed to check the consistency between the reference model and the code through conformance testing. Challenges encountered and lessons learned during our work are also discussed in this paper.