Abstract
In safety critical systems, the manufacturers should provide compelling and comprehensible arguments to demonstrate that their system is well designed and safety of the system to the public is guaranteed. These arguments are usually represented by an assurance case. However, one of challenging issues facing the safety critical industry is how to produce an assurance case that provides a set of well-structured arguments connecting safety requirements and a body of evidence produced during software development. In this paper, we take the medical systems industry into account to illustrate how an assurance case can be generated when a software process is employed. In particularly, we consider the Generic Insulin infusion Pump (GIIP) to show how an assurance case can be produced via during a popular software development process, called Rational Unified Process (RUP).
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Medical devices—Application of risk management to medical devices, ISO 14971
US Food and Drug Administration, Guidance for Industry and FDA Staff-Total Product Life Cycle: Infusion Pump- Premarket Notification[510 (k)] Submissions. April 2010
Kelly, T., Weaver, R.: The Goal Structuring Notation—A Safety Argument Notation, in dependable systems and networks 2004 workshop on assurance cases (2004)
Kruchten, P.: The Rational Unified Process: An Introduction. Addison-Wesley Professional, Amsterdam (2003)
FDA, Generic Insulin Infusion Pump Functional Specifications (2011)
Adelard. The Adelard Safety Case Editor—ASCE. http://adelard.co.uk/software/asce/ (2003)
Bishop, P.G., Bloomfield, R.E.: The SHIP Safety Case Approach, in Safe Comp 95, pp. 437–451. Springer, London (1995)
Zielczynski, P.: Requirements Management Using IBM Rational RequisitePro. IBM Press, Upper Saddle River (2008)
Leroux, D., Nally, M., Hussey, K.: Rational software architect: a tool for domain-specific modeling. IBM Syst. J. 45(3), 555–568 (2006)
Langari, A., Maibaum, T.: Safety Cases: A Review of Challenges (2013)
Hawkins, R., Kelly, T., Knight, J., Graydon, P.: A New Approach to Create Clear Safety Arguments, In Nineteenth Safety-Critical Systems Symposium. Southampton, UK (2011)
Jee, E., Lee, I., Sokolsky, O.: Assurance Cases in Model-Driven Development of the Pacemaker Software, LNCS 6416 (2010)
Rushby, J.: Formalization in Safety Cases. In Eighteenth Safety-Critical Systems Symposium, pp. 3–17 (2010)
CD ISO, Road vehicles-Functional safety, International Standard ISO/FDIS, vol. 26262 (2011)
Birch, J.: Safety cases and their role in ISO 26262 functional safety assessment. In Computer Safety, Reliability, and Security, pp. 154–165. Springer (2013)
Westman, J., Nyberg, M., Törngren, M.: Structuring safety requirements in ISO 26262 using contract theory. In Computer Safety, Reliability, and Security. pp. 166–177, Springer (2013)
Stürmer, I., Salecker, E., Pohlheim, H.: Reviewing software models in compliance with ISO 26262. In Computer Safety, Reliability, and Security. pp. 258–267, Springer (2012)
OMG. Structured Assurance Case Metamodel (SACM)—Version 1.0. http://www.omg.org/spec/SACM/
Johnston, S.: Rational UML Profile for business modeling, IBM Developer Works. http://www.ibm.com/developerworks/rational/library/5167.html, (2004)
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Lin, CL., Shen, W. (2015). Generation of Assurance Cases for Medical Devices. In: Lee, R. (eds) Computer and Information Science. Studies in Computational Intelligence, vol 566. Springer, Cham. https://doi.org/10.1007/978-3-319-10509-3_10
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DOI: https://doi.org/10.1007/978-3-319-10509-3_10
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