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Internationally, the main electromagnetic compatibility standard for medical molecular analyzers is IEC 60601-1-2. Formulated by the International Electrotechnical Commission (IEC), this is a standard for the electromagnetic compatibility of medical electrical equipment. It requires that medical devices can work normally in the specified electromagnetic environment and, at the same time, suppress the electromagnetic interference generated by themselves within a reasonable range, so as to ensure the stability of the equipment's operation and its low interference to the surrounding electromagnetic environment.
The EN 55011 standard regulates the electromagnetic interference of industrial, scientific and medical equipment. It strictly specifies the limits for radiated and conducted interference of equipment, ensuring that medical molecular analyzers will not cause interference to other electronic devices during use.
Medical molecular analysis equipment must simultaneously comply with the following standards:
- Safety: IEC 60601-1 / GB 9706.1
- Electromagnetic compatibility: IEC 60601-1-2 / GB 9706.1-2
- Quality management: ISO 13485 / YY/T 0287