Jump to ContentJump to Main Navigation
Show Summary Details
More options …

Merhof, Dorit

Biomedical Engineering / Biomedizinische Technik

Joint Journal of the German Society for Biomedical Engineering in VDE and the Austrian and Swiss Societies for Biomedical Engineering and the German Society of Biomaterials

Editor-in-Chief: Dössel, Olaf

Editorial Board: Augat, Peter / Habibović, Pamela / Haueisen, Jens / Jahnen-Dechent, Wilhelm / Jockenhoevel, Stefan / Knaup-Gregori, Petra / Leonhardt, Steffen / Plank, Gernot / Radermacher, Klaus M. / Schkommodau, Erik / Stieglitz, Thomas / Boenick, Ulrich / Jaramaz, Branislav / Kraft, Marc / Lenarz, Thomas / Lenthe, Harry / Lo, Benny / Mainardi, Luca / Micera, Silvestro / Penzel, Thomas / Robitzki, Andrea A. / Schaeffter, Tobias / Snedeker, Jess G. / Sörnmo, Leif / Sugano, Nobuhiko / Werner, Jürgen /


IMPACT FACTOR 2018: 1.007
5-year IMPACT FACTOR: 1.390

CiteScore 2018: 1.24

SCImago Journal Rank (SJR) 2018: 0.282
Source Normalized Impact per Paper (SNIP) 2018: 0.831

Online
ISSN
1862-278X
See all formats and pricing
More options …
Volume 63, Issue 1

Issues

Volume 57 (2012)

Extended device profiles and testing procedures for the approval process of integrated medical devices using the IEEE 11073 communication standard

Armin Janß
  • Corresponding author
  • Chair of Medical Engineering, Helmhotz-Institute for Biomedical Engineering, RWTH Aachen University, Aachen, Germany
  • Email
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Johannes Thorn
  • Institute for Software Engineering and Programming Languages, University of Lübeck, Lübeck, Germany
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Malte Schmitz
  • Institute for Software Engineering and Programming Languages, University of Lübeck, Lübeck, Germany
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Alexander Mildner
  • Institute for Software Engineering and Programming Languages, University of Lübeck, Lübeck, Germany
  • UniTransferKlinik Lübeck, Lübeck, Germany
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Jasmin Dell’Anna-Pudlik
  • Chair of Medical Engineering, Helmholtz-Institute for Biomedical Engineering of the RWTH Aachen University, Aachen, Germany
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Martin Leucker
  • Institute for Software Engineering and Programming Languages, University of Lübeck, Lübeck, Germany
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Klaus Radermacher
  • Chair of Medical Engineering, Helmholtz-Institute for Biomedical Engineering of the RWTH Aachen University, Aachen, Germany
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
Published Online: 2017-08-25 | DOI: https://doi.org/10.1515/bmt-2017-0055

Abstract

Nowadays, only closed and proprietary integrated operating room systems (IORS) from big manufacturers are available on the market. Hence, the interconnection of components from third-party vendors is only possible with increased time and costs. In the context of the German Federal Ministry of Education and Research (BMBF)-funded project OR.NET (2012–2016), the open integration of medical devices from different manufacturers was addressed. An integrated operating theater based on the open communication standard IEEE 11073 shall give clinical operators the opportunity to choose medical devices independently of the manufacturer. This approach would be advantageous especially for hospital operators and small- and medium-sized enterprises (SME) of medical devices. Actual standards and concepts regarding technical feasibility and the approval process do not cope with the requirements for a modular integration of medical devices in the operating room (OR), based on an open communication standard. Therefore, innovative approval strategies and corresponding certification and test procedures, which cover actual legal and normative standards, have to be developed in order to support the future risk management and the usability engineering process of open integrated medical devices in the OR. The use of standardized device and service profiles and a three-step testing procedure, including conformity, interoperability and integration tests are described in this paper and shall support the manufacturers to integrate their medical devices without disclosing the medical devices’ risk analysis and related confidential expertise or proprietary information.

Keywords: approval strategies; conformity assessment; device and service profiles; interoperability tests; medical device integration; modular risk management; open communication standard IEEE 11073; usability engineering; validation

References

  • [1]

    Benzko J, Janß A, Dell’Anna J, Radermacher K. Man-machine interfaces in the operating room. In: Proceedings of the 48th DGBMT Annual Conference, Hannover, 2014; 59: 430.Google Scholar

  • [2]

    Birkle M, Benzko J, Shevchenko N. Das Projekt OR.NET – Sichere dynamische Vernetzung in OP und Klinik. Deutsche Zeitschrift für klinische Forschung, Innovation und Praxis 2012; 11/12: 41–45.Google Scholar

  • [3]

    DIN EN 80001-1:2011-11, VDE 0756-1:2011-11. Application of risk management for IT-networks incorporating medical devices – part 1: roles, responsibilities and activities (IEC 80001-1:2010). German version EN 80001-1:2011.Google Scholar

  • [4]

    DIN EN ISO 14971. Medical devices – application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01). German version EN ISO 14971:2012.Google Scholar

  • [5]

    DIN EN 60601-1:2013-12, VDE 0750-1:2013-12. Medical electrical equipment – part 1: general requirements for basic safety and essential performance (IEC 60601-1:2005+Cor.:2006+Cor.:2007+A1:2012). German version EN 60601-1:2006+Cor.:2010+A1:2013.Google Scholar

  • [6]

    IEC 60601-1-6. Medical electrical equipment – Part 1–6: general requirements for basic safety and essential performance - collateral standard: Usability (IEC 60601-1-6:2016).Google Scholar

  • [7]

    IEC 62366. Medical devices – application of usability engineering to medical devices (IEC 62366:2016).Google Scholar

  • [8]

    Janß A, Benzko J, Merz P, Dell’Anna J, Strake M, Radermacher K. Development of medical device UI-profiles for reliable and safe human-machine-interaction in the integrated operating room of the future. In: Proceedings of the 5th International Conference on Applied Human Factors and Ergonomics, Krakau, 2014: 1855–1860.Google Scholar

  • [9]

    Janß A, Merz P, Dell’Anna J, Strake M, Radermacher K. Application of medical device user interface profiles for human-risk analysis of open integrated OR systems. In: Proceedings of the 49th DGBMT Annual Conference, Lübeck, 2015; 60: 300.Google Scholar

  • [10]

    Kasparick M, Schlichting S, Golatowski F, Timmermann F. Medical DPWS: New IEEE 11073 Standard for safe and Interoperable Medical Device Communication. In: 2015 IEEE Conference on Standards for Communications and Networking (CSCN) (CSCN’15), Tokyo, Japan, 2015: 223–228.Google Scholar

  • [11]

    Knipp P, Janß A. Regulatory approval route and strategy for open networked medical devices. In: Proceedings of the 49th DGBMT Annual Conference, Lübeck, 2015; 60: 300.Google Scholar

  • [12]

    Kuehn F, Leucker M, Mildner A. OR.NET – approaches for risk analysis and measures of dynamically interconnected medical devices. In: 5th Workshop on Medical Cyber-Physical Systems: OASIcs, Schloss Dagstuhl-Leibniz-Zentrum fuer Informatik, Berlin, 2014; 36: 133–136.Google Scholar

  • [13]

    MEDDEV, Konsenspapiere von verschieden Arbeitsgruppen der EG-Kommission, als Leitlinien für die Anwendung der EG-Richtlinien im Bereich der Medizinprodukte. http://ec.europa.eu/healthoder, http://www.meddev.info/.

  • [14]

    Mildner A, Janß A, Dell’Anna J, Merz P, Leucker M, Radermacher K. Device- and service profiles for integrated or systems based on open standards. Curr Dir Biomed Eng 2015; 1: 538–542.Google Scholar

  • [15]

    Mildner A, Janß A, Dell’Anna J, Merz P, Leucker M, Radermacher K. Development of device- and service-profiles for a safe and secure interconnection of medical devices in the integrated open OR. In: Seehusen F, editor. Proceedings of the Risk Assessment and Risk Driven Testing, Third International Workshop, RISK 2015, Berlin, 2015; 9488: 65–74.CrossrefGoogle Scholar

  • [16]

    Richtlinie 93/42/EWG des Europäischen Parlaments und des Rates vom 14. Juni 1993 über Medizinprodukte (in: Medical Device Directive).Google Scholar

About the article

Received: 2017-04-17

Accepted: 2017-07-11

Published Online: 2017-08-25

Published in Print: 2018-02-23


Research funding: This research work has been funded in part within the projects “OR.NET – Secure and Dynamic Networking in Operating Room and Hospital” (German Federal Ministry of Education and Research – BMBF; Grant 16KT1203) and the project “ZiMT – Certifiable Integrated Medical Technology and IT Systems based on Open Standards in the Operating Room and Hospital” (State of North-Rhine Westphalia and the European Commission – European Regional Development Fund (EFRE); Grant EFRE-0800454).


Citation Information: Biomedical Engineering / Biomedizinische Technik, Volume 63, Issue 1, Pages 95–103, ISSN (Online) 1862-278X, ISSN (Print) 0013-5585, DOI: https://doi.org/10.1515/bmt-2017-0055.

Export Citation

©2017 Walter de Gruyter GmbH, Berlin/Boston.Get Permission

Citing Articles

Here you can find all Crossref-listed publications in which this article is cited. If you would like to receive automatic email messages as soon as this article is cited in other publications, simply activate the “Citation Alert” on the top of this page.

[1]
Johann Berger, Max Rockstroh, Erik Schreiber, Yukishige Yoshida, Jun Okamoto, Ken Masamune, Yoshihiro Muragaki, and Thomas Neumuth
International Journal of Computer Assisted Radiology and Surgery, 2019
[2]
Philipp Schleer, Sergey Drobinsky, Matias de la Fuente, and Klaus Radermacher
International Journal of Computer Assisted Radiology and Surgery, 2019

Comments (0)

Please log in or register to comment.
Log in