In recent years, with the widespread application of electronics and information technology in medical electrical equipment, and the rapid development of new communication technologies (such as personal communication systems, cellular phones, etc.) in various fields of social life, medical electrical equipment is used in The electromagnetic environment is increasingly complex.
The resulting image includes the interference of electromagnetic waves emitted by other surrounding electrical equipment during the use of medical electrical equipment, causing harm to patients; on the other hand, if its electromagnetic compatibility indicator does not meet the requirements, it will also emit electromagnetic energy itself , May affect the normal operation of radio communications services and other surrounding equipment.
China's State Food and Drug Administration has officially released a new standard for electromagnetic compatibility of medical electrical equipment (YY 0505-2012). The new standard is scheduled to be implemented on January 1, 2014. The implementation of this standard will involve more than 11,000 medical electrical equipment in 3-4 thousand medical device manufacturing enterprises in China. For products that fail to meet the safety guidelines, the State Food and Drug Administration will deal with them in accordance with laws and regulations.
The implementation of the new standard will bring about a round of anti-interference redesign requirements for medical equipment, such as the choice of power supply for the equipment, the layout of the PCB version, the structural design of the system, etc., and the addition of isolation devices, magnetic rings, inductors Components. In addition, for the original different electronic systems can also be adjusted in terms of software, such as working frequency, working mode and abnormal state handling measures.
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