Modul: medical engineering safety and medical product legislation

Modul no. :n/a
ECTS credits:7.5
Expenditure of time:81h contact time + 144h self study
Modul type:compulsory module
Duration:2 semester
Requirements:A successful participation at the modules of the first study section is recommended.
Objectives:The course teaches an overview over technical safety aspects and regulatory affairs concerning the design, manufacturing and application of medical devices.
Contents:Safety hazards caused by electric current, indirect currents, safety measures, double protection, measuring procedures concerning electrical safety. European medical device directive (MDD), German medical device act (MPG), risk analysis, application of harmonized standards, conformity assessment procedures, quality management for manufacturers of medical devices.
Applicability:Compulsory module for this course of studies and an elective module for other study paths.
Teaching methods:Lecture and laboratory training.
Further information:- Kramme, Rüdiger: Medizintechnik; Springer Medizin Verlag; 3. Auflage; 2007, ISBN 978-3-540-34102-4
- Uhlig, Hans-Peter: Elektrische Anlagen in medizinischen Einrichtungen; Hüthig & Pflaum Verlag; 2013, ISBN 978-3-8101-0307-9
- Lekscha, Thomas: Kommentierte Zusammenstellung von Fachbegriffen aus der elektromedizinischen Messtechnik; 2012,
Grin Verlag für akademische Texte, ISBN 978-3-640-34130-6
Individual courses:medical product legislation in semester 6
medical engineering safety in semester 7
medical engineering safety lab in semester 7