[Patient safety in medical technology research].
The message of this article is that patient safety must be an essential part of thinking and planning in research for medical technology. Which aspects must be considered already in an early phase of any project are presented. The most important standards are listed briefly. Then the topics technical safety and electromagnetic compatibility (EMC), clinical evaluation, risk analysis, biological evaluation of materials, ergonomics, the special aspects of medical devices that include pharmacological components, and the requirements of software packages and implemented algorithms are discussed.
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Institut für Biomedizinische Technik, Universität Karlsruhe (TH), Kaiserstrasse 12, 76131, Karlsruhe, Deutschland. od@ibt.uni-karlsruhe.de
D035843:Biomedical Research / Q000592:standards*; D001709:Biotechnology / Q000295:instrumentation* / Q000592:standards*; D004869:Equipment Safety / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D005858:Germany; D017751:Safety Management