A case study on applying formal methods to medical devices: Computer-aided resuscitation algorithm

International Journal on Software Tools for Technology Transfer

Volumn 5, Issue 4, 2004, Pages 320-330

  Jetley, Raoul Praful ^a   Carlos, Cohan ^a   Iyer, S Purushothaman ^a  

^a North Carolina State University   (United States)

Author keywords

Model checking; Novice users of formal methods based tools; Safety critical systems; Software for medical devices; Software requirements analysis

Indexed keywords

DEVICE FUNCTIONALITY; ELECTROCARDIOGRAM ANALYSIS; FUNCTIONAL COMPLEXITY; MEDICAL DEVICES; NOVICE USER; REQUIREMENTS DOCUMENT; SAFETY CRITICAL SYSTEMS; SOFTWARE REQUIREMENTS ANALYSIS;

ALGORITHMS; LASER SURGERY; MODEL CHECKING; PACEMAKERS; REQUIREMENTS ENGINEERING; RESUSCITATION; TOOLS;

BIOMEDICAL EQUIPMENT;

EID: 84897585136     PISSN: 14332779     EISSN: 14332787     Source Type: Journal    
DOI: 10.1007/s10009-003-0137-2     Document Type: Article

References (14)

1. Barroca LM, McDermid JA (1992) Formal methods: use and relevance for the development of safety critical systems. Comput J 35(6): 579-599.
2. Bengtsson J, Larsen KG, Larsson F, Pettersson P, Yi W (1995) UPPAAL - a tool suite for automatic verification of real-time systems. In: Proceedings of the 4th DIMACS workshop on verification and control of hybrid systems, New Brunswick, NJ, 22-24 October 1995.
3. Bengtsson J, Larsen KG, Larsson F, Pettersson P, Yi W, Weise C (1998) New generation of UPPAAL. In: Proceedings of the international workshop on software tools for technology transfer, Aalborg, Denmark, 12-13 July 1998.
4. Bowen JP, Stavridou V (1993) Safety-critical systems, formal methods and standards. IEE/BCS Softw Eng J 8(4): 189-209.
5. Coleman T (2001) Basic physiological concepts. http://physiology. umc. edu/WORKSHOP/BASCPHYS/BASCPHYS. HTM.
6. FDA, Center for Devices and Radiological Health (1998) Guidance for FDA reviewers and industry guidance for the content of premarket submissions for software contained in medical devices, 29 May. http://www. fda. gov/cdrh/ode/57. html.
7. FDA, Center for Devices and Radiological Health (1999) Guidance for industry, FDA reviewers and compliance on off-the-shelf software use in medical devices, 9 September. http://www. fda. gov/cdrh/ode/guidance/585. html.
8. FDA, Center for Devices and Radiological Health (2002) General principles of software validation; final guidance for industry and FDA staff, 11 January. http://www. fda. gov/cdrh/comp/guidance/938. html.
9. Glass RL (1980) Software vs. hardware errors. IEEE Comput 23(12): pages.
10. Holzmann GJ (1997) The model checker SPIN. IEEE Trans Softw Eng 23(5): 279-295.
11. Iyer RK, Velardi P (1985) Hardware-related software errors: measurement and analysis. IEEE Trans Softw Eng 11(2): 223-231.
12. Larsen KG, Pettersson P, Yi W (1997) UPPAAL in a nutshell. Int J Softw Tools Technol Transfer 1: 134-152.
13. Leveson N, Turner CS (1993) An investigation of the Therac-25 accidents. IEEE Comput 25(7): 18-41.
14. MathWorks, Inc (1992) SIMULINK: a program for simulting dynamical systems. http://www. mathworks. com.