ИСТИНА

Ground based simulation studies of human space exploration become more and more international and complex involving many devices produced in different countries with different regulations. Many of these devices transfer data by Wi-Fi, Bluetooth and other wireless protocols. Electromagnetic compatibility (EMC) of experimental devices becomes crucial for success of studies and should be considered during planning of studies. Here we consider the main problems of such planning on the example of cardiovascular and respiratory biomedical equipment, because corruption of data of ECG, pulsoxymeters, blood pressure monitors is one of important consequences of EMC violation. To prevent any disturbances in the medical equipment functions, the International Electrotechnical Commission (IEC) published the new 4-th edition of the IEC 60601-1-2 standard with special attention to EMC and electromagnetic interferences. In this standard for the first time, they gave of three exploration environments: professional medical facilities, medical devices in homes and special environments. This subdivision implies differences in equipment usage and electromagnetic environment. The USA, Canada and EU in 2021 adopted the 4-th edition of IEC 60601-1-2 standard. Foreign producers of biomedical equipment for these countries follows the standard as well. However, some other countries did not adopt the 4-th edition of IEC 60601-1-2 standard. In March 2015 the 3-th edition of the IEC 60601-1-2:2007 standard was adopted in Russia as State Standard (GOST) R IEC 60601-1-2-2014. According to the 4-th edition of IEC 60601-1-2 standard, the tested equipment tolerates radio emission of up to 28 V/mV. Nevertheless, in the Russian equipment there is no such demand according to State Standard (GOST) R IEC 60601-1-2-2014. Therefore, the Russian equipment could be non-compatible with the current IEC requirements concerning EMC. Conclusion. One should pay special attention to electromagnetic compatibility of biomedical equipment including country and year of production as well as electromagnetic environment when planning complex ground based international studies of human space exploration. It seems reasonable to use biomedical equipment produced under the same 4-th edition of IEC 60601-1-2 standard, including Russian equipment produced for export to USA, Canada and EU.