EMC China Lab

IEC EN 61326 Report for Electrical and Laboratory Equipment

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Update time : 2025-01-23

Medical or EMC directives can be used for EMC compliance of the CE mark in Europe. To demonstrate CE compliance, you may need to check existing compliance evidence. Below is a brief summary of the impact of changes in EN 61326-1 and EN 61326-2-6 on the CE declaration.

 

EMC testing for medical devices can be more complex than for other products. For example, risk assessments for performance deviations. An example of a risk assessment might be an ESD discharge, which causes an infusion pump to change its dosing method. Each discharge leads to a higher rate than what the doctor had set, which would present an unacceptable risk for the patient. However, if the discharge only causes a brief flicker of the LED indicator, this might be considered an acceptable risk for the patient.

 

The EN/IEC 61326 series standards cover a wide range of environments, with various test levels and requirements.

 

As part of the EN/IEC 61326-x series standards, we test the following devices:

1. Electrical measurement and portable medical testing equipment

2. Controlled electromagnetic (EM) devices

3. Electrical laboratory equipment, including IVD (in vitro diagnostics)

4. Home healthcare devices

 

IEC 61326-x Testing Services at China JJR Laboratory

1. Electrostatic Discharge (ESD)

2. Radiofrequency (RF) Immunity

3. Magnetic Field Immunity

4. Voltage Dips and Interruptions on Power Lines

5. Electrical Fast Transients/Surge Immunity

6. Conducted RF Immunity

7. RF Radiated Emissions

8. RF Conducted Emissions

9. Electrostatic Discharge (ESD)

10. CISPR11 Testing

 

For more information about EN/IEC 61326 testing and EMC services for laboratory equipment, please contact our hardware engineers.


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