Abstract
Creating a sound argumentation of why a system is sufficiently safe is a major part of the assurance process. Today, compiling a safety case and maintaining its validity after changes are time-consuming manual work. By using the concept provided by Digital Dependability Identities (DDI), we present a systematic approach for creating a model-connected safety argument that is formally related to safety models such as hazard and risk assessment, safety analysis, architecture, safety requirements or validation. The comprehensively traced DDI model provides the traceability basis to guide argument-driven safety engineering processes. Flaws in arguments or evidence emerging through changes in the product development process are addressed by DDI-based automation. The case study described in this paper evaluates the DDI approach based on the publicly available safety assurance documentation of a Generic Infusion Pump (GIP) system. The evaluation demonstrates that DDIs can capture the relevant safety aspects of the GIP system.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Notes
- 1.
Dependability Engineering Innovation for Cyber-Physical Systems: www.deis-project.eu/.
- 2.
- 3.
References
International Electrotechnical Commission: IEC 62304:2006 – Medical device software – Software life cycle processes (2006)
Kelly, T.P.: Systematic approach to safety case management. In: Proceedings of SAE World Congress (2004)
Schneider, D., et al.: WAP: digital dependability identities. In: Proceedings of IEEE International Symposium on Software Reliability Engineering (ISSRE), pp. 324–329 (2015)
Wei, R., Kelly, T.P., et al.: Model Based System Assurance Using the Structured Assurance Case Metamodel (2019). https://arxiv.org/pdf/1905.02427
Reich, J., Zeller, M., Schneider, D.: Automated evidence analysis of safety arguments using digital dependability identities. In: Romanovsky, A., Troubitsyna, E., Bitsch, F. (eds.) SAFECOMP 2019. LNCS, vol. 11698, pp. 254–268. Springer, Cham (2019). https://doi.org/10.1007/978-3-030-26601-1_18
Kansas State University: Open Patient-Controlled Analgesia Infusion Pump System Requirements 1.0.0. (Report: SanToS TR 2018-4-1) (2018)
Gleirscher, M., Carlan, C.: Arguing from hazard analysis in safety cases: a modular argument pattern. In: IEEE 18th International Symposium on High Assurance Systems Engineering (HASE), Singapore, pp. 53–60 (2017)
Pohl, K., Hönninger, H., Achatz, R., Broy, M. (eds.): Model-Based Engineering of Embedded Systems – The SPES 2020 Methodology. Springer, Heidelberg (2012). https://doi.org/10.1007/978-3-642-34614-9
de la Vara, J.L., et al.: Model-based specification of safety compliance needs for critical systems: a holistic generic metamodel. Inf. Softw. Technol. 72, 16–30 (2016)
International Standardization Organization: ISO 14971:2019 – Medical devices – Application of risk management to medical devices (2019)
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2020 Springer Nature Switzerland AG
About this paper
Cite this paper
Reich, J., Frey, J., Cioroaica, E., Zeller, M., Rothfelder, M. (2020). Argument-Driven Safety Engineering of a Generic Infusion Pump with Digital Dependability Identities. In: Zeller, M., Höfig, K. (eds) Model-Based Safety and Assessment. IMBSA 2020. Lecture Notes in Computer Science(), vol 12297. Springer, Cham. https://doi.org/10.1007/978-3-030-58920-2_2
Download citation
DOI: https://doi.org/10.1007/978-3-030-58920-2_2
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-030-58919-6
Online ISBN: 978-3-030-58920-2
eBook Packages: Computer ScienceComputer Science (R0)