365速发

In recent years, with the wide application of electronics and information technology in medical electrical equipment, as well as the rapid development of new communication technologies (such as personal communication systems, cellular phoness, etc.) in various fields of social life, the electromagnetic environment in which medical electrical equipment is used has become increasingly complex. On the one hand, during its use, it may be interfered by electromagnetic energy emission from surrounding electrical equipment, resulting in injury to patients; On the other hand, if its electromagnetic compatibility index fails to meet the requirements, it will also emit electromagnetic energy, which may affect the normal operation of radio communication services and other surrounding equipment. Therefore, electromagnetic compatibility index has increasingly become an important safety index of medical electrical equipment. Developed countries in the world have enforced the electromagnetic compatibility test standard of medical electrical equipment in the form of laws and regulations.

In this case, in order to better ensure the safety of public use of machinery, the State Food and Drug Administration organized the National Technical Committee for standardization of medical appliances, equivalent to the international electromagnetic compatibility test standard IEC 60601-1-2 for medical electrical equipment, and drafted the medical device industry standard YY 0505-2012 medical electrical equipment Part 1-2: safety general requirements, parallel standards, electromagnetic compatibility requirements and tests, It was issued on December 17, 2012 and will be officially implemented on January 1, 2014. This standard is a basic general safety standard that medical electrical equipment must comply with, and is parallel to GB 9706.1 medical electrical equipment Part 1: General requirements for safety.

In order to ensure the smooth implementation of the standards, the National Bureau has issued the notice on printing and distributing the working plan for the implementation of YY 0505-2012 medical device industry standards (sfyjbx [2012] No. 149) and the notice on relevant working requirements for the implementation of YY 0505-2012 medical device industry standards (sfyjbx [2012] No. 151), clarifying the specific requirements and schedule for the implementation of the standards. So far, the National Bureau has approved the ability of medical device testing institutions in Beijing, Shanghai, Guangzhou, Tianjin, Hangzhou, Wuhan Medical Device Quality Supervision and inspection center, Jiangsu Province, Shenzhen medical device testing institute and other medical device testing institutions to carry out electromagnetic compatibility testing of medical electrical equipment in accordance with the standard, providing technical support for the testing of related products.

According to the current preliminary statistics, the implementation of this standard will involve more than 11000 medical electrical equipment from 3-4000 medical device manufacturers at home and abroad. As the first person responsible for product safety, production enterprises should attach great importance to the release and implementation of standards, actively study the new standards, implement the new standards in the whole process of R & D and production, and ensure that products meet the requirements of the new standards. The food and drug administration department will do a good job of supervision and inspection after the implementation of the standard according to the regulations, and deal with the products whose safety indicators fail to meet the requirements according to the law.

The implementation of this standard will further improve the safety and effectiveness of China’s medical electrical equipment, protect public health and safety, eliminate backward products, promote product upgrading, improve the overall product quality and market competitiveness of China’s medical electrical equipment, and promote the healthy development of China’s medical device industry.