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Licensed Unlicensed Requires Authentication Published by De Gruyter August 25, 2017

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

  • Armin Janß EMAIL logo , Johannes Thorn , Malte Schmitz , Alexander Mildner , Jasmin Dell’Anna-Pudlik , Martin Leucker and Klaus Radermacher


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.

  1. 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).


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Received: 2017-4-17
Accepted: 2017-7-11
Published Online: 2017-8-25
Published in Print: 2018-2-23

©2017 Walter de Gruyter GmbH, Berlin/Boston

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