Features of Design of Medical Electronic Devices

Abstract

The design features of medical electronic devices are considered. It is shown that the development of medical electronics is not an easy task and the designer must be prepared to face problems and regulations that are more strict than for household appliances, due to the fact that the failure of these devices to work properly can lead to tragic consequences, up to death. A number of difficulties that arise in the process of designing medical equipment is shown, which is presented in the form of a hierarchy of decisions. The main standards for designing devices of such type are given, among which there are IEC-60601-1-1 and IEC-60601-1-2 that deserve special attention, since compliance with their requirements is crucial for certification and release to the market of manufactured equipment. The use of a risk management matrix is proposed, which is used to provide quantitative indicators for each possible risk associated with a medical device in any mode of operation and possible malfunction.