IEC EN 61326 Report for Electrical and Laboratory Equipment

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.