Considerations for Radiated Emissions Testing of Large Medical Equipment in the Frequency Range 1 – 6 GHz

Several standards must be fulfilled before putting medical devices on the market. The use of harmonized standards provides a level of assurance that the equipment will not deteriorate the performance of radio services and other equipment in the intended use environment. The standards for medical equipment from the IEC 60601 series play a crucial role in this certification process. This contribution focuses on the radiated emissions conformity requirements from IEC 60601-1-2 and CISPR 11, which impose limits to electromagnetic disturbances radiated from medical devices. The current versions of the medical standards do not yet address test requirements for radiated emissions in the frequency range 1 – 6 GHz for Group 1 equipment. Since the release of CISPR 11 Edition 7.0 in 2024-02, new requirements for radiated emissions in this frequency range were introduced. A simple adoption of established measurement methods known from CISPR 32 and CISPR 16-2-3, cannot be performed because large medical products, such as angiographic X-ray systems, ME systems for nuclear medicine, CT systems, etc., have large dimensions. Therefore, regular fully-anechoic rooms or absorber-lined semi-anechoic chamber test setups require major modifications such as reducing the amount of used floor absorbers. We analyze the radiation behavior of different large ME equipment and propose an adapted test setup suitable for these products. As a result, practical guidance for performing radiated emissions tests on large ME equipment is provided.