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What are the domestic and international EMC (electromagnetic compatibility) standards for glycated hemoglobin analyzers?

Time:2025-07-22 Views:502次
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Glycated hemoglobin analyzers (e.g., HPLC, immunoturbidimetric, enzymatic methods) must comply with GB 9706.1, YY 0505 (domestic), and IEC 60601-1-2 (international) EMC standards. Used for diabetes monitoring, they require accurate and reproducible results. For HPLC, the high-pressure pump and detector (UV/fluorescence) must operate stably; for immunoturbidimetric methods, the optical detection system must be interference-resistant. The standards require that key components of the instrument (e.g., pumps, detectors) maintain stable performance under electromagnetic interference, with no abnormal fluctuations in chromatograms or absorbance values, ensuring the reliability of HbA1c percentage values.