The students

• can name the devices used in clinical practice and explain their basic hardware design, physics and the underlying physiological and anatomical processes.
• are able to assess and evaluate the advantages and disadvantages, the risk potential and the benefits of the various devices.
• can name the legal framework for the development, placing on the market and operation of medical devices and implants and explain it using case studies.
• are able to provide an overview of the normative requirements for safety and functional standards.

ILV Electronische und Physikalische Grundlagen, 1. Semester (4 SWS, 5 ECTS Credits)

The module covers the following topics/contents:

• Principles, physiological contextual embedding and technical-physical description of selected medical devices, systems and procedures (e.g. devices for assessing hearing and vision, various medical implants, surgical devices, pacemakers and ICDs, ventilators, basic features of dialysis)
• Overview of the hierarchy of laws & standards, Medical Device Regulation, Medical Device Act & Medical Device Operator Ordinance Austria, standards for quality management, technical safety and functional requirements and hardware design in medical technology, CE declaration of conformity, IT security in the healthcare sector

• EUR-Lex: MDR 2017/745
• Legal information system of the federal government RIS: MPG, MPBV, DSGVO, KAKuG
• ÖVE/STANDARD EN ISO 13485:2022
• ÖVE/ÖNORM EN 60601 series of standards and insights into their supplementary standards
• OVE EN IEC 80001-1:2021
• R. Kramme (ed.): "Medizintechnik: Verfahren - Systeme - Informationsverarbeitung", 5th edition, Springer, 2017;
• U. Morgenstern, M. Kraft (eds.): "Biomedical Engineering - Fascination, Introduction, Overview", Volume 1, De Gruyter, 2014;
• S. Silbernagl, A. Despopoulos: "Taschenatlas Physiologie", 8th edition, Georg Thieme Verlag KG, 2012;

• Lecture,
• Case processing

Integrated module with final examination:

• Cooperation,
• Exercises,
• Presentation,
• written thesis