Medical Device EMC Test Items & Standards

Main Reference Standards

◆ CISPR 11/EN 55011/GB 4824:

   "Industrial, Scientific, and Medical (ISM) Radio-Frequency Equipment - Electromagnetic Disturbance Characteristics - Limits and Methods of Measurement"

◆ IEC 60601-1-2/YY 0505:

   "Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests"

◆ IEC 61326-1/GB T18268.1:

   "Electrical Equipment for Measurement, Control, and Laboratory Use - EMC Requirements - Part 1: General Requirements"

◆ IEC 61326-2-6/GB T18268.26:

   "Electrical Equipment for Measurement, Control, and Laboratory Use - EMC Requirements - Part 26: Specific Requirements - In Vitro Diagnostic (IVD) Equipment"

◆ IEC 61000-3-2/GB 17625.1:

   "Electromagnetic Compatibility - Limits - Limits for Harmonic Current Emissions (Equipment Input Current ≤16A per Phase)"

◆ IEC 61000-3-3/GB 17625.2:

   "Electromagnetic Compatibility - Limits - Limitation of Voltage Changes, Voltage Fluctuations, and Flicker in Public Low-Voltage Supply Systems, for Equipment with Rated Current ≤16A and Subject to Conditional Connection"

EMI Test Items

◆ Conducted Disturbance Voltage, 150kHz-30MHz, Quasi-Peak/Average

◆ Radiated Disturbance (Magnetic Field), 9kHz-30MHz, Quasi-Peak

◆ Radiated Disturbance (Electric Field), 150kHz-1GHz, Quasi-Peak; 1GHz-18GHz, Peak/Weighted

◆ Harmonic Current Emission Test, According to IEC 61000-3-2

◆ Voltage Fluctuation and Flicker Test, According to IEC 61000-3-3

EMS Test Items

◆ Electrostatic Discharge Immunity, Contact Discharge 6kV, Air Discharge 8kV

◆ Radiated Radio-Frequency Electromagnetic Field Immunity, Maximum Test Field Strength 10V/m

◆ Electrical Fast Transient/Burst Immunity, Maximum Test Level 2kV

◆ Surge Immunity, Maximum Test Level 2kV

◆ Radio-Frequency Conducted Immunity, Maximum Test Level 10V

◆ Power Frequency Magnetic Field Immunity, Maximum Test Field Strength 3A/m

◆ Voltage Dips, Short Interruptions, and Voltage Variations Immunity, According to IEC 61000-4-11