YY9706 Medical Electrical Equipment Electromagnetic Compatibility Testing

Beijing Yizongsuo EMC Testing Center (Institute of Instrumentation Technology and Economy of Machinery Industry, Measurement Control Equipment and Systems Laboratory / Machinery Industry Measurement Control Equipment and Network Quality Testing Center) holds qualifications for electromagnetic compatibility testing of medical electrical equipment, including CNAS and CMA accreditations, and issues formal test reports.

Electromagnetic compatibility testing for medical electrical equipment is conducted in accordance with the YY 9706.102-2021 standard (equivalent to IEC 60601-1-2:2014), which is a specialized standard for electromagnetic compatibility (EMC) of medical electrical equipment, specifying test items and methods. The following is an overview of its main electromagnetic compatibility test items and methods:

I. Electromagnetic Emission (EMI) Test Items

1. Conducted Emission (CE)
• Standard Reference: GB/T 6113.201 (CISPR 11)
• Frequency Range: 150 kHz ~ 30 MHz
• Method: Measure disturbance voltage at power terminals using an Artificial Mains Network (LISN).
2. Radiated Emission (RE)
• Standard Reference: GB/T 6113.201 (CISPR 11)
• Frequency Range: 30 MHz ~ 1 GHz (if equipment frequency > 1 GHz, extend to 6 GHz)
• Method: Measure radiated disturbance field strength of equipment and cables using an antenna and receiver in an anechoic chamber.
3. Harmonic Current Emission
• Standard Reference: GB 17625.1 (IEC 61000-3-2)
• Method: Measure harmonic components of the input current (e.g., 2nd to 40th harmonics).
4. Voltage Fluctuations and Flicker
• Standard Reference: GB 17625.2 (IEC 61000-3-3)
• Method: Evaluate the impact of equipment on voltage fluctuations and flicker in the power grid.

II. Immunity (EMS) Test Items

1. Electrostatic Discharge Immunity (ESD)
• Standard Reference: GB/T 17626.2 (IEC 61000-4-2)
• Test Level: Contact discharge ±6 kV, air discharge ±8 kV
• Method: Apply electrostatic pulses to the equipment enclosure and operating parts to verify immunity.
2. Radiated RF Immunity (RS)
• Standard Reference: GB/T 17626.3 (IEC 61000-4-3)
• Frequency Range: 80 MHz ~ 2.7 GHz
• Field Strength: 3 V/m (10 V/m for life-support equipment)
• Method: Radiate an RF field using an antenna in an anechoic chamber to assess whether equipment performance is affected.
3. Conducted RF Immunity (CS)
• Standard Reference: GB/T 17626.6 (IEC 61000-4-6)
• Frequency Range: 150 kHz ~ 80 MHz
• Level: 3 V (unmodulated)
• Method: Inject disturbance signals into power lines/signal lines via a coupling clamp or CDN.
4. Electrical Fast Transient/Burst Immunity (EFT/Burst)
• Standard Reference: GB/T 17626.4 (IEC 61000-4-4)
• Test Level: ±2 kV for power ports, ±1 kV for signal ports
• Method: Apply fast transient bursts to power and signal lines.
5. Surge Immunity (Surge)
• Standard Reference: GB/T 17626.5 (IEC 61000-4-5)
• Test Level: Line-to-line ±1 kV, line-to-ground ±2 kV
• Method: Simulate lightning or switching surges impacting power ports.
6. Voltage Dips and Interruptions Immunity
• Standard Reference: GB/T 17626.11 (IEC 61000-4-11)
• Test Conditions: Voltage dips to 70%/0% (duration cycles optional)
• Method: Create voltage dips or interruptions using a power simulator.
7. Power Frequency Magnetic Field Immunity
• Standard Reference: GB/T 17626.8 (IEC 61000-4-8)
• Field Strength: 3 A/m (or higher, e.g., for life-support equipment)
• Method: Place equipment in a power frequency magnetic field to assess immunity.

III. Special Requirements

• Life-Support Equipment: Must meet more stringent test levels (e.g., radiated immunity 10 V/m).
• Performance Criteria:
• Class A: Normal performance during test;
• Class B: Temporary performance degradation with self-recovery;
• Class C: Requires operator intervention to recover (but must not compromise safety).

IV. Test Environment

• Emission tests must be conducted in an anechoic chamber or open area;
• Immunity tests must be performed under typical use configurations (including cable layout and accessories).

This standard ensures the safe operation of medical equipment in electromagnetic environments while minimizing interference with other devices. Specific test parameters may be adjusted based on equipment type and intended use environment.

Beijing Yizongsuo EMC Testing Center (Institute of Instrumentation Technology and Economy of Machinery Industry, Measurement Control Equipment and Systems Laboratory / Machinery Industry Measurement Control Equipment and Network Quality Testing Center) is located at No. 397A, Guang'anmenwai Street, Xicheng District, Beijing. It is equipped with a 3-meter anechoic chamber, electrostatic test instruments, surge and burst test instruments, and a full range of EMC testing equipment, as well as capabilities for high/low temperature testing and IP68/IP69 protection level testing.