EMC Testing for Medical Devices

emc testing, also known as Electromagnetic Compatibility (EMC) testing, is a comprehensive evaluation of the electromagnetic interference (EMI) level and electromagnetic immunity (EMS) of medical devices. It is one of the most critical indicators of product quality.

emc testing, also known as Electromagnetic Compatibility (EMC) testing, is a comprehensive evaluation of the electromagnetic interference (EMI) level and electromagnetic immunity (EMS) of medical devices. It is one of the most critical indicators of product quality.

Purpose of EMC Testing for Medical Devices

The primary objective is to assess the impact of electromagnetic radiation emitted by medical devices on the human body, public power grids, and other normally operating electrical equipment.
Additionally, it aims to improve the safety and effectiveness of medical devices, preventing device malfunction or failure caused by electromagnetic interference or emissions during use, which could harm patients and users.

EMC Standards for Medical Devices / IVD Products

Domestic Standards

• GB 9706.102

• GB/T 18268.1

• GB/T 18268.26

International Standards

• iec 60601-1-2

• IEC/EN 61326-1

• IEC/EN 61326-2-6

EMC Test Items for Medical Devices / IVD Products

EMI (Electromagnetic Interference) Testing

• Radiated Emission – Radiated Disturbance Test

• Conducted Emission – Conducted Disturbance Test

• Harmonic – Harmonic Current Disturbance Test

• Flicker – Voltage Fluctuation and Flicker Test

EMS (Electromagnetic Immunity) Testing

• ESD – Electrostatic Discharge Immunity Test

• RS – Radiated Radio Frequency Electromagnetic Field Immunity Test

• CS – Conducted Disturbance Immunity Test Induced by Radio Frequency Fields

• DIP – Voltage Dips, Short Interruptions and Voltage Variations Immunity Test

• SURGE – Surge (Impulse) Immunity Test

• EFT – Electrical Fast Transient/Burst Immunity Test

• PMS – Power Frequency Magnetic Field Immunity Test

General Sample Requirements

Complete prototype in normal working condition.
For the cost of medical device emc testing, please confirm with JJR customer service.