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

Time:2025-07-22 Views:502次
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Coagulation analyzers (e.g., for PT and APTT testing) must comply with GB 9706.1, YY 0505 (domestic), and IEC 60601-1-2 (international) EMC standards. They detect the blood coagulation process using magnetic bead, optical, or electrostatic methods, and include reagent refrigeration, precise sample loading, incubation, and detection modules. Standards require accurate interpretation of coagulation endpoints (e.g., changes in light intensity, amplitude of magnetic bead movement), unaffected by transient interference from the movement of the sample needle motor, reagent pump, or electromagnet (magnetic bead method), ensuring the accuracy of coagulation time measurement.