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Core Certification: IEC 60601 Series
Medical-grade power supplies must be certified to IEC 60601 (or the corresponding national standard GB 9706.1). This standard imposes strict requirements on electrical safety, electromagnetic compatibility (EMC), and environmental adaptability, ensuring the safety of the power supply when used near patients or in contact with the human body.
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Key Safety Indicators
The certification focuses on: leakage current (patient leakage current must be below 100μA), insulation level (at least 2 Means of Patient Protection, MOPP), ground continuity, and enclosure fire protection rating. The power supply is also required to feature low ripple, high isolation withstand voltage (typically ≥4000VAC), and the ability to withstand abnormal operating conditions without generating harmful radiation.
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Common Markings and Selection Recommendations
Certified power supplies will be marked with “60601-1” or “GB 9706.1” along with the applied part type (BF/CF). During procurement, be sure to verify third-party test reports and avoid substituting with ordinary industrial power supplies. Only power supplies that have passed complete medical certification can be safely used in equipment such as patient monitors and ventilators.