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What are the domestic and international EMC (electromagnetic compatibility) standards for extracorporeal membrane oxygenation (ECMO) machines?

Time:2025-06-10 Views:503次
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Extracorporeal membrane oxygenation (ECMO) machines, as critical life support devices, must comply with EMC standards GB 9706.1, YY 0505 (domestic), and IEC 60601-1-2 (international). ECMO includes a blood pump (usually a centrifugal pump), oxygenator, heater, and multi-parameter monitoring modules, requiring continuous operation for extended periods. Standards require absolute reliability of critical functions such as blood pump speed control, oxygenation flow rate, and blood temperature control in complex electromagnetic environments like ICUs filled with various medical devices. Any parameter drift or pump shutdown caused by interference could be life-threatening.