Skip to main content

2015 | OriginalPaper | Buchkapitel

Requirement Engineering for Functional Alarm System for Interoperable Medical Devices

verfasst von : Krishna K. Venkatasubramanian, Eugene Y. Vasserman, Vasiliki Sfyrla, Oleg Sokolsky, Insup Lee

Erschienen in: Computer Safety, Reliability, and Security

Verlag: Springer International Publishing

Aktivieren Sie unsere intelligente Suche um passende Fachinhalte oder Patente zu finden.

search-config
loading …

Abstract

This paper addresses the problem of high-assurance operation for medical cyber-physical systems built from interoperable medical devices. Such systems are different from most cyber-physical systems due to their “plug-and-play” nature: they are assembled as needed at a patient’s bedside according to a specification that captures the clinical scenario and required device types. We need to ensure that such a system is assembled correctly and operates according to its specification. In this regard, we aim to develop an alarm system that would signal interoperability failures. We study how plug-and-play interoperable medical devices and systems can fail by means of hazard analysis that identify hazardous situations that are unique to interoperable systems. The requirements for the alarm system are formulated as the need to detect these hazardous situations. We instantiate the alarm requirement generation process through a case-study involving an interoperable medical device setup for airway-laser surgery.

Sie haben noch keine Lizenz? Dann Informieren Sie sich jetzt über unsere Produkte:

Springer Professional "Wirtschaft+Technik"

Online-Abonnement

Mit Springer Professional "Wirtschaft+Technik" erhalten Sie Zugriff auf:

  • über 102.000 Bücher
  • über 537 Zeitschriften

aus folgenden Fachgebieten:

  • Automobil + Motoren
  • Bauwesen + Immobilien
  • Business IT + Informatik
  • Elektrotechnik + Elektronik
  • Energie + Nachhaltigkeit
  • Finance + Banking
  • Management + Führung
  • Marketing + Vertrieb
  • Maschinenbau + Werkstoffe
  • Versicherung + Risiko

Jetzt Wissensvorsprung sichern!

Springer Professional "Technik"

Online-Abonnement

Mit Springer Professional "Technik" erhalten Sie Zugriff auf:

  • über 67.000 Bücher
  • über 390 Zeitschriften

aus folgenden Fachgebieten:

  • Automobil + Motoren
  • Bauwesen + Immobilien
  • Business IT + Informatik
  • Elektrotechnik + Elektronik
  • Energie + Nachhaltigkeit
  • Maschinenbau + Werkstoffe




 

Jetzt Wissensvorsprung sichern!

Springer Professional "Wirtschaft"

Online-Abonnement

Mit Springer Professional "Wirtschaft" erhalten Sie Zugriff auf:

  • über 67.000 Bücher
  • über 340 Zeitschriften

aus folgenden Fachgebieten:

  • Bauwesen + Immobilien
  • Business IT + Informatik
  • Finance + Banking
  • Management + Führung
  • Marketing + Vertrieb
  • Versicherung + Risiko




Jetzt Wissensvorsprung sichern!

Literatur
1.
Zurück zum Zitat Arney, D., Weininger, S., Whitehead, S.F., Goldman, J.M.: Supporting medical device adverse event analysis in an interoperable clinical environment: design of a data logging and playback system. In: ICBO (2011) Arney, D., Weininger, S., Whitehead, S.F., Goldman, J.M.: Supporting medical device adverse event analysis in an interoperable clinical environment: design of a data logging and playback system. In: ICBO (2011)
2.
Zurück zum Zitat ASTM 2761: Medical devices and medical systems – essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) (2013) ASTM 2761: Medical devices and medical systems – essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) (2013)
3.
Zurück zum Zitat Avizienis, A., Laprie, J., Randell, B., Landwehr, C.: Basic concepts and taxonomy of dependable and secure computing. IEEE Trans. Dependable Secure Comput. 1(1), 11–33 (2004)CrossRef Avizienis, A., Laprie, J., Randell, B., Landwehr, C.: Basic concepts and taxonomy of dependable and secure computing. IEEE Trans. Dependable Secure Comput. 1(1), 11–33 (2004)CrossRef
4.
Zurück zum Zitat Clarke, M., Bogia, D., Hassing, K., Steubesand, L., Chan, T., Ayyagari, D.: Developing a standard for personal health devices based on 11073. In: EMBS (2007) Clarke, M., Bogia, D., Hassing, K., Steubesand, L., Chan, T., Ayyagari, D.: Developing a standard for personal health devices based on 11073. In: EMBS (2007)
5.
Zurück zum Zitat Hatcliff, J., King, A., Lee, I., Macdonald, A., Fernando, A., Robkin, M., Vasserman, E., Weininger, S., Goldman, J.M.: Rationale and architecture principles for medical application platforms. In: ICCPS (2012) Hatcliff, J., King, A., Lee, I., Macdonald, A., Fernando, A., Robkin, M., Vasserman, E., Weininger, S., Goldman, J.M.: Rationale and architecture principles for medical application platforms. In: ICCPS (2012)
7.
Zurück zum Zitat IEC. Medical electrical equipment - Part 1–8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (2008) IEC. Medical electrical equipment - Part 1–8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (2008)
8.
Zurück zum Zitat IEC. Application of risk management for IT-networks incorporating medical devices - Part 2–5: Application guidance - Guidance for distributed alarm systems (2014) IEC. Application of risk management for IT-networks incorporating medical devices - Part 2–5: Application guidance - Guidance for distributed alarm systems (2014)
10.
Zurück zum Zitat Kang, W., Wu, P., Rahmaniheris, M., Sha, L., Berlin, R., Goldman, J.: Towards organ-centric compositional development of safe networked supervisory medical systems. In: CBMS (2013) Kang, W., Wu, P., Rahmaniheris, M., Sha, L., Berlin, R., Goldman, J.: Towards organ-centric compositional development of safe networked supervisory medical systems. In: CBMS (2013)
11.
Zurück zum Zitat King, A., Arney, D., Lee, I., Sokolsky, O., Hatcliff, J., Procter, S.: Prototyping closed loop physiologic control with the medical device coordination framework. In: SEHC (2010) King, A., Arney, D., Lee, I., Sokolsky, O., Hatcliff, J., Procter, S.: Prototyping closed loop physiologic control with the medical device coordination framework. In: SEHC (2010)
12.
Zurück zum Zitat Lesh, K., Weininger, S., Goldman, J., Wilson, B., Himes, G.: Medical device interoperability – assessing the environment. In: HCMDSS-MDPnP (2007) Lesh, K., Weininger, S., Goldman, J., Wilson, B., Himes, G.: Medical device interoperability – assessing the environment. In: HCMDSS-MDPnP (2007)
13.
Zurück zum Zitat Prisaznuk, P.J.: ARINC 653 role in integrated modular avionics (IMA). In: DASC (2008) Prisaznuk, P.J.: ARINC 653 role in integrated modular avionics (IMA). In: DASC (2008)
14.
Zurück zum Zitat Tolk, A., Diallo, S., Turnitsa, C.: Applying the levels of conceptual interoperability model in support of integratability, interoperability, and composability for system-of-systems engineering. Journal of Systemics, Cybernetics and Informatics, vol. 5, no. 5 (2007) Tolk, A., Diallo, S., Turnitsa, C.: Applying the levels of conceptual interoperability model in support of integratability, interoperability, and composability for system-of-systems engineering. Journal of Systemics, Cybernetics and Informatics, vol. 5, no. 5 (2007)
Metadaten
Titel
Requirement Engineering for Functional Alarm System for Interoperable Medical Devices
verfasst von
Krishna K. Venkatasubramanian
Eugene Y. Vasserman
Vasiliki Sfyrla
Oleg Sokolsky
Insup Lee
Copyright-Jahr
2015
DOI
https://doi.org/10.1007/978-3-319-24255-2_19