Choosing the optimal method for measuring the temperature of medical devices parts during certification tests

Abstract

The issues of choosing the optimal method for measuring the temperature of medical devices parts during their certification in accordance with the requirements of the general standard DSTU EN 60601-1:2019 are considered. Such measurements should be provided both during the normal operation of medical devices and for conditions of a single violation. It is proposed to carry out a preliminary temperature assessment of the medical device’s internal components using a thermal imager, which makes it possible to determine the components of the devices with a higher temperature. Furthermore, only then carry out an accurate temperature measurement of certain product components using a set of calibrated thermocouples of the TXA (K) type connected to a modern data acquisition and switching system. This greatly simplifies the process of measuring the temperature of medical devices parts and reduces its complexity. Practical examples of such tests are given.