Electromagnetic Compatibility (EMC) Testing

The manufacturers must perform EMC testing on their medical electrical devices to ensure that the emissions of their product will not affect the proper operation of other medical and non-medical devices in the same environment, as well as to verify the normal operation of their product will not be affected by emissions from other products.

STEMart provides full compliance testing to relevant standard for Medical Electrical Equipment to evaluate the basic safety and essential performance in regard to emissions and immunity to electromagnetic disturbances.

Standards

• FDA
• Medical Devices Directive (93/42/EEC / 2007/42/EC)
• IEC 60601-1-2 , 4th edition

Electromagnetic Compatibility Testing

According to IEC 6060-1-2, the EMC testing provided by STEMart is divided in two parts: emissions testing and immunity testing. The EMC testing is applied on all operational modes of medical device, including all accessories, components, subsystems and non-medical equipment which is used in the medical device and can affect the ability of the medical device to meet the immunity pass/fail criteria.

• Emissions testing

STEMart provides emissions testing to evaluate the electromagnetic energy whether deliberately or accidentally released by medical electrical device into the environment.

• Conducted emissions
• Radiated emissions
• Harmonic current emission
• Voltage fluctuation/flicker
• Immunity testing

STEMart provides full range of immunity testing to identify the unacceptable loss, disruption, deviation, degradation or over-delivery of performance which affects the essential performance of medical device.

• Electro-static discharge (ESD) immunity
• Radiated field immunity
• Electrical fast transient (EFT)/burst immunity
• Surge immunity
• Conducted disturbances immunity
• Voltage dips/Interrupts immunity
• Power frequency magnetic field immunity

SETMart provides manufacturers with comprehensive EMC testing to ensure the normal operation of both their medical electrical device and other products in the same environment, such as professional healthcare facility environment, the home healthcare environment and special environments. If you want to learn more detail about our EMC testing service, or would like to consult with the experts at STEMart, please feel free to contact us.