Course code BM 1109
Education period 1 & 2
Coordinator Dr.ir. D.H. Plettenburg
Requirements to pass:
Assessment consists of three parts: 1) Written examination, as well as, 2) an oral presentation (10 minutes) based on an organised visit to a hospital (topic to be approved by the lecturer) and 3) a short essay.
This course explains: 1) Physical and engineering principles involved in specific medical devices used in medicine; 2) clinical use of these devices by medical doctors, nurses and patients in the health care system; 3) regulations and standards concerning the clinical use of these medical devices.
The student is able:
*) To explain the physical and engineering principles involved in specific medical devices used in medicine, and to explain constraints put on these devices due to the application of these instruments to humans.
*) To describe international standards (ISO 13485, 14971), CE certification, legislation ('wet medisch-wetenschappelijk onderzoek met mensen'), requirements for biocompatibility (safety, materials, disinfection/sterilisation).
*) To explain the concept of health and its measures and determinants, the epidemiology of diseases, the role of technology in health care systems, and the evaluation of medical devices (quality and economic cost effectiveness).
*) To describe typical stages in the innovation process of medical devices; in particular, the design, testing and the evaluation of medical devices for certification for international standards.
*) To describe characteristics of fields of application of medical devices and particular the end-users in these fields, and how these translate into requirements for medical devices.
*) To illustrate the way clinical requirements for a medical device are translated into technical requirements with a format ready to fit a list of technical requirements.
*) To gain access to current information in the fields of medical technology, physiology, medicine and legislation on medical devices, and to evaluate the quality of the sources.