Next year from the ventilator and other medical electrical equipment shall comply with the electromagnetic compatibility standards
Recent years, with the electronics, the extensive application of information technology in medical electrical equipment, as well as new communication technologies (such as personal communications systems, cellular phones, etc.) the rapid development in various fields of social life, Medical electrical equipment - not only will emit electromagnetic energy, but also in its use environment may be affected by interference around communications equipment and other electromagnetic energy emitted, resulting in injury to the patient's. Therefore, the world's developed countries have adopted laws and regulations in the form of mandatory testing standards for electromagnetic compatibility of medical electrical equipment, such as the European Union since 1998 to enforce electromagnetic compatibility of medical electrical equipment testing standards.
Organization of national medical appliance standards technical committee in order to better ensure the safety of patients, the State Food and Drug Administration drafted the recently released YY0505-2012 "Medical Electrical Equipment Part 1 to Part 2: General requirements for safety tied to standard electromagnetic compatibility requirements and test the standards of the medical device industry. The standard will be implemented from January 1, 2014.
State Food and Drug Administration medical device regulatory Secretary Wang Lanming said, from the current statistics, the standard will involve three or four thousand domestic and foreign medical equipment manufacturing enterprises, about 11,000 more than medical electrical products. The implementation of the standard will help improve the safety and effectiveness of medical electrical equipment, help prevent non-compliance with electromagnetic compatibility standard products into the Chinese market, and is conducive to enhancing medical electrical equipment in China overall product quality and market competitiveness. The same time, will also help with international standards to facilitate the import and export trade, and promote the development of China's medical equipment industry.
In order to ensure the smooth implementation of the standards, the National Board has clarified the specific requirements and timing. Class Ⅲ apply for registration for the first time since January 1, 2014, Medical equipment in the declaration of the registration shall be submitted to the relevant test report issued by the medical device testing institutions. Currently, the country has been in Beijing, Shanghai, Guangzhou, Tianjin, Hangzhou, Wuhan Medical Device Quality Supervision and Inspection Center, Jiangsu Province, Shenzhen medical device testing and other medical equipment testing organizations to obtain the seizure of the standard qualifications, in accordance with the relevant called for electromagnetic compatibility testing to provide a strong technical support.
If you have any questions, please feel free to contact us.
Organization of national medical appliance standards technical committee in order to better ensure the safety of patients, the State Food and Drug Administration drafted the recently released YY0505-2012 "Medical Electrical Equipment Part 1 to Part 2: General requirements for safety tied to standard electromagnetic compatibility requirements and test the standards of the medical device industry. The standard will be implemented from January 1, 2014.
State Food and Drug Administration medical device regulatory Secretary Wang Lanming said, from the current statistics, the standard will involve three or four thousand domestic and foreign medical equipment manufacturing enterprises, about 11,000 more than medical electrical products. The implementation of the standard will help improve the safety and effectiveness of medical electrical equipment, help prevent non-compliance with electromagnetic compatibility standard products into the Chinese market, and is conducive to enhancing medical electrical equipment in China overall product quality and market competitiveness. The same time, will also help with international standards to facilitate the import and export trade, and promote the development of China's medical equipment industry.
In order to ensure the smooth implementation of the standards, the National Board has clarified the specific requirements and timing. Class Ⅲ apply for registration for the first time since January 1, 2014, Medical equipment in the declaration of the registration shall be submitted to the relevant test report issued by the medical device testing institutions. Currently, the country has been in Beijing, Shanghai, Guangzhou, Tianjin, Hangzhou, Wuhan Medical Device Quality Supervision and Inspection Center, Jiangsu Province, Shenzhen medical device testing and other medical equipment testing organizations to obtain the seizure of the standard qualifications, in accordance with the relevant called for electromagnetic compatibility testing to provide a strong technical support.
If you have any questions, please feel free to contact us.
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