EN 50527-2-3 Test for Active Implantable Medical Devices

Medical Device Tests

EN 50527-2-3 Test for Active Implantable Medical Devices

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of EN 50527-2-3 testing. This standard provides the specific evaluation procedure for workers with implanted neurostimulatory systems (NS) of the type used specifically for spinal cord stimulation (SCS).

EN 50527-2-3 Test for Active Implantable Medical Devices

It is recognized that implantable neurostimulators have been developed for a wide variety of clinical applications, but the SCS devices covered in this document represent the largest segment of implantable neurostimulator applications to date.

The purpose of the specific assessment is to determine the risk for workers with implanted SCS devices from exposure to electromagnetic fields (EMF) in the workplace. Evaluation includes the possibility of clinically significant effects.

This document does not address risks from contact currents or effects on any associated non-implantable devices (eg Patient Programmers). The techniques described in different approaches can also be used for the evaluation of public spaces.

The frequency range to be observed is from 0 Hz to 3 GHz. No interference is expected with devices covered in this document above 3 GHz.

EUROLAB assists manufacturers with EN 50527-2-3 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.

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