Abstract
Formal methods have emerged as an alternative approach to ensuring quality and correctness of highly critical systems, overcoming limitations of traditional validation techniques such as simulation and testing. We propose a refinement-based methodology for complex medical systems design, which possesses all the required key features. A refinement-based combined approach of formal verification, model validation using a model-checker and refinement chart is proposed in this methodology for designing a high-confidence medical device. Furthermore, we show the effectiveness of this methodology for the design of a cardiac pacemaker system.
- Abrial, J.-R. 2010. Modeling in Event-B: System and Software Engineering. Cambridge University Press. Google Scholar
Digital Library
- Abrial, J.-R., Börger, E., and Langmaack, H. Eds. 1996. Formal Methods for Industrial Applications, Specifying and Programming the Steam Boiler Control. Lecture Notes in Computer Science Series, vol. 1165, Springer.Google Scholar
- Alur, R. 2007. Verification and integration of real-time control software. In Next Generation Design and Verification Methodologies for Distributed Embedded Control Systems, S. Ramesh and P. Sampath Eds., Springer, 47--49.Google Scholar
- Baier, C. and Katoen, J.-P. 2008. Principles of Model Checking. MIT Press. Google Scholar
Digital Library
- Barold, S. S., Stroobandt, R. X., and Sinnaeve, A. F. 2004. Cardiac Pacemakers Step by Step. Futura Publishing.Google Scholar
- Bjørner, D. 2006. Software Engineering: Vol 1 Abstraction and Modelling - Vol 2 Specification of Systems and Languages - Vol 3 Domains, Requirements, and Software Design. Texts in Theoretical Computer Science. An EATCS Series.Google Scholar
- Bjørner, D. and Henson, M. C. Eds. 2007. Logics of Specification Languages. EATCS Textbook in Computer Science. Springer.Google Scholar
- Boston Scientific. 2007. Pacemaker system specification. Tech. rep.Google Scholar
- Bowen, J. and Stavridou, V. 1993. Safety-critical systems, formal methods and standards. Softw. Engin. J. 8, 4, 189--209.Google Scholar
Cross Ref
- Butler, R. W. 1996. An introduction to requirements capture using PVS: Specification of a simple autopilot. NASA Tech. Memo. 110255, NASA Langley Research Center, Hampton, VA. Google Scholar
Digital Library
- Cansell, D. and Méry, D. 2007. The Event-B Modeling Method: Concepts and Case Studies. In Logics of Specification Languages, D. Bjørner and M. C. Henson Eds., Springer, 33--140.Google Scholar
- Carchiolo, V., Malgeri, M., and Mangioni, G. 2000. Hardware/software synthesis of formal specifications in codesign of embedded systems. ACM Trans. Des. Autom. Electron. Syst. 5, 399--432. Google Scholar
Digital Library
- Carchiolo, V., Malgeri, M., and Mangioni, G. 2003. A tool for performance evaluation in a formal codesign framework. Simulation 79, 9, 494--514.Google Scholar
Cross Ref
- Clarke, E. M., Grumberg, O., and Peled, D. 1999. Model Checking. MIT Press. Google Scholar
Digital Library
- ClearSy. Atelier B. http://www.clearsy.com.Google Scholar
- Dotti, F. L., Iliasov, A., Ribeiro, L., and Romanovsky, A. 2009. Modal systems: Specification, refinement and realisation. In Proceedings of the 11th International Conference on Formal Engineering Methods. Lecture Notes in Computer Science, vol. 5885, Springer, 601--619. Google Scholar
Digital Library
- EB2ALL. 2011. Automatic code generation from Event-B to many Programming Languages. http://eb2all.loria.fr/.Google Scholar
- Ellenbogen, K. A. and Wood, M. A. 2005. Cardiac Pacing and ICDs 4th Ed. Blackwell.Google Scholar
- Epstein, A. E., Dimarco, J. P., et al. 2008. ACC/AHA/HRS 2008 Guidelines for device-based therapy of cardiac rhythm abnormalities. Circulation 117, 21, 2820--2840.Google Scholar
Cross Ref
- Fohler, G. 1992. Realizing changes of operational modes with a pre run-time scheduled hard real-time system. In Proceedings of the 2nd International Workshop on Responsive Computer Systems. Springer, 287--300.Google Scholar
- Gamma, E., Helm, R., Johnson, R., Vlissides, R., and Gamma, P. 1994. Design Patterns: Elements of Reusable Object-Oriented Software design Patterns. Addison-Wesley Professional Computing. Google Scholar
Digital Library
- Goldman, B. S., Noble, E. J., Heller, J. G., and Covvey, D. 1974. The pacemaker challenge. Can. Med. Assoc. J. 110, 1, 28--31.Google Scholar
- Gomes, A. O. and Oliveira, M. V. M. 2009. Formal specification of a cardiac pacing system. In Proceedings of the 2nd World Congress on Formal Methods. 692--707. Google Scholar
Digital Library
- Harel, D. 1987. Statecharts: A visual formalism for complex systems. Sci. Comput. Program. 8, 3, 231--274. Google Scholar
Digital Library
- Henzinger, T. A., Jhala, R., Majumdar, R., and Sutre, G. 2003. Software verification with BLAST. In Software verification with BLAST. In Proceedings of the 10th International Conference on Model Checking Software. Springer, 235--239. Google Scholar
Digital Library
- Hesselson, A. 2003. Simplified Interpretations of Pacemaker ECGs. Blackwell Publishers.Google Scholar
- Hoare, C., Misra, J., Leavens, G. T., and Shankar, N. 2009. The verified software initiative: A manifesto. ACM Comput. Surv. 41, 4, 1--8. Google Scholar
Digital Library
- Hoare, T. 2003. The verifying compiler: A grand challenge for computing research. J. ACM 50, 1, 63--69. Google Scholar
Digital Library
- Jackson, D. 2002. Alloy: A lightweight object modelling notation. ACM Trans. Softw. Engin. Methodol. 11, 2, 256--290. Google Scholar
Digital Library
- Jahanian, F. and Mok, A. K. 1994. Modechart: A specification language for real-time systems. IEEE Trans. Softw. Engin. 20, 12, 933--947. Google Scholar
Digital Library
- Jetley, R., Purushothaman Iyer, S., and Jones, P. 2006. A formal methods approach to medical device review. Comput. 39, 4, 61--67. Google Scholar
Digital Library
- Jetley, R. P., Carlos, C., and Iyer, S. P. 2004. A case study on applying formal methods to medical devices: Computer-aided resuscitation algorithm. Int. J. Softw. Tools Technol. Trans. 5, 4, 320--330. Google Scholar
Digital Library
- Keatley, K. L. 1999. A review of the fda draft guidance document for software validation: guidance for industry. Qual. Assur. 7, 1, 49--55.Google Scholar
Cross Ref
- Leavens, G. T., Abrial, J.-R., Batory, D., Butler, M., Coglio, A., Fisler, K., Hehner, E., Jones, C., Miller, D., Peyton-Jones, S., Sitaraman, M., Smith, D. R., and Stump, A. 2006. Roadmap for enhanced languages and methods to aid verification. In Proceedings of the 5th International Conference on Generative Programming and Component Engineering. ACM, 221--235. Google Scholar
Digital Library
- Lee, I., Pappas, G. J., Cleaveland, R., Hatcliff, J., Krogh, B. H., Lee, P., Rubin, H., and Sha, L. 2006. High-confidence medical device software and systems. Comput. 39, 4, 33--38. Google Scholar
Digital Library
- Love, C. J. 2006. Cardiac Pacemakers and Defibrillators. Landes Bioscience Publishers.Google Scholar
- Macedo, H. D., Larsen, P. G., and Fitzgerald, J. 2008. Incremental development of a distributed real-time model of a cardiac pacing system using VDM. In Proceedings of the 15th International Symposium On Formal Methods. Springer, 181--197. Google Scholar
Digital Library
- Magee, J. H. 2003. Validation of medical modeling & simulation training devices and systems. Stud. Health Technol Inf. 94, 196--8.Google Scholar
- Malmivuo, J. 1995. Bioelectromagnetism. Oxford University Press. ISBN 0-19-505823-2.Google Scholar
- Méry, D. and Singh, N. K. 2009. Pacemaker’s functional behaviors in Event-B. Res. rep. http://hal.inria.fr/inria-00419973/en/.Google Scholar
- Méry, D. and Singh, N. K. 2010a. EB2C: A tool for Event-B to C conversion support. In Proceedings of the International Conference on Software Engineering and Formal Methods.Google Scholar
- Méry, D. and Singh, N. K. 2010b. Real-time animation for formal specification. In Complex Systems Design & Management, M. Aiguier, F. Bretaudeau, and D. Krob Eds., Springer 49--60.Google Scholar
- Méry, D. and Singh, N. K. 2010. Formal development of two-electrode cardiac pacing system. Technical Rep. http://hal.archives-ouvertes.fr/inria-00465061/en/.Google Scholar
- Méry, D. and Singh, N. K. 2010. Trustable formal specification for software certification. In Proceedings of the 4th International Symposium on Leveraging Applications, T. Margaria and B. Steffen Eds., Lecture Notes in Computer Science Series, vol. 6416. Springer, 312--326. Google Scholar
Digital Library
- Méry, D. and Singh, N. K. 2011. Functional behavior of a cardiac pacing system. International J. Discrete Event Control Syst. 1, 2, 129--149.Google Scholar
- Miller, S. P. 1998. Specifying the mode logic of a flight guidance system in core and scr. In Proceedings of the 2nd Workshop on Formal Methods in Software Practice. ACM, New York, NY, 44--53. Google Scholar
Digital Library
- NITRD. High-Confidence Medical Devices: Cyber-Physical Systems for 21st Century Health Care. http://www.nitrd.gov/About/MedDevice-FINAL1-web.pdf.Google Scholar
- ProB. The ProB animator and model checker for the B method. http://www.stups.uni-duesseldorf.de/ProB/overview.php/.Google Scholar
- Project RODIN. 2004. Rigorous open development environment for complex systems. http://rodin-bsharp.sourceforge.net/.2004--2007.Google Scholar
- Real, J. and Crespo, A. 2004. Mode change protocols for real-time systems: A survey and a new proposal. Real-Time Syst. 26, 2, 161--197. Google Scholar
Digital Library
- Rehm, J. 2010. Proved development of the real-time properties of the IEEE 1394 Root Contention Protocol with the event-B method. Int. J. Softw. Tools Technol. Trans. 12, 1, 39--51. Google Scholar
Digital Library
- Smith, D. R. 2008. Generating programs plus proofs by refinement. In Verified Software: Theories, Tools, Experiments. Springer, 182--188. Google Scholar
Digital Library
- Walters, H. 1990. Hybrid implementations of algebraic specifications. In Algebraic and Logic Programming, H. Kirchner and W. Wechler Eds., Lecture Notes in Computer Science, vol. 463, Springer, 40--54. Google Scholar
Digital Library
- Woodcock, J. 2006. IEEE Comput. 39, 10, 57--64. Google Scholar
Digital Library
- Woodcock, J. and Banach, R. 2007. The verification grand challenge. J. Univ. Comput. Sci. 13, 5, 661--668.Google Scholar
Index Terms
Formal Specification of Medical Systems by Proof-Based Refinement
Recommendations
How to verify and exploit a refinement of component-based systems
PSI'06: Proceedings of the 6th international Andrei Ershov memorial conference on Perspectives of systems informaticsIn order to deal with the verification of large systems, compositional approaches postpone in part the problem of combinatorial explosion during model exploration. The purpose of the work we present in this paper is to establish a compositional ...
Critical systems development methodology using formal techniques
SoICT '12: Proceedings of the 3rd Symposium on Information and Communication TechnologyFormal methods have emerged as an alternative approach to ensuring the quality and correctness of the high confidence critical systems, overcoming limitations of the traditional validation techniques such as simulation and testing. This paper presents a ...
Analysis of DSR protocol in event-B
SSS'11: Proceedings of the 13th international conference on Stabilization, safety, and security of distributed systemsThis paper presents an incremental formal development of the Dynamic Source Routing (DSR) protocol in Event-B. DSR is a reactive routing protocol, which finds a route for a destination on demand, whenever communication is needed. Route discovery is an ...






Comments