OR.NET - Approaches for risk analysis and measures of dynamically interconnected medical devices

OpenAccess Series in Informatics

Volumn 36, Issue , 2014, Pages 133-136

  Kühn, Franziska ^a   Leucker, Martin ^a   Mildner, Alexander ^b  

^a UNIVERSITY OF LÜBECK   (Germany)

^b Graduate School for Computing in Medicine and Life Science University of Lübeck ^*  (Germany)

Author keywords

Development method; Medical device interconnection; Modular risk analysis; OR.NET

Indexed keywords

DYNAMICS; EMBEDDED SYSTEMS; RISK ANALYSIS; RISK ASSESSMENT; RISK MANAGEMENT;

COMMON STANDARDS; CURRENT SITUATION; DEVELOPMENT METHOD; GAP ANALYSIS; MEDICAL DEVICES; MEDICAL PRODUCTS; OR.NET; STAND-ALONE DEVICES;

BIOMEDICAL EQUIPMENT;

EID: 84905659548     PISSN: 21906807     EISSN: None     Source Type: Conference Proceeding    
DOI: 10.4230/OASIcs.MCPS.2014.133     Document Type: Conference Paper

References (5)

1. Janko Ahlbrandt, Johannes Dehm, Rainer Röhrig, Christian Wrede, and Michael Imhoff. Gemeinsames Positionspapier zur IEC 80001-1 - Risikomanagement für medizinische Netzwerke in der Intensiv- und Notfallmedizin. Technical report, DIVI, DGMBT, VDE, 2012.
2. International Electrotechnical Commission. EN IEC 60601-1:2006 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, 2006.
3. Armin Gärtner. Medizinproduktesicherheit Band 5: Medizinische Netzwerke und Software als Medizinprodukt. TÜV Media GmbH, Cologne, Germany, 2010.
4. Council of the european communities. Council directive 93/42/eec of 14 june 1993 concerning medical devices (amended by directive 2007/47/ec of 5 september 2007, June 1993.
5. Dieter H. Müller, Thorsten Tietjen, André Decker. FMEA-Praxis - Das Komplettpaket für Training und Anwendung. Carl Hanser Verlag, München, Germany, 2011.