IEC EN 80601-2-26 Medical Electrical Equipment - Test for Basic Safety of Electroencephalographs

Medical Device Tests

IEC EN 80601-2-26 Medical Electrical Equipment - Test for Basic Safety of Electroencephalographs

EUROLAB, together with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of IEC EN 80601-2-26 testing. This standard applies to the basic safety and basic performance of electroencephalographs and hereinafter also referred to as me equipment or me system.

IEC EN 80601-2-26 Medical Electrical Equipment - Test for Basic Safety of Electroencephalographs

This standard applies to electroencephalographs intended for use in a professional healthcare facility, emergency medical services setting, or home healthcare setting.

This standard does not cover requirements for other equipment used in electroencephalography, such as:

  • Phono-photic stimuli;
  • EEG data storage and retrieval;
  • ME EQUIPMENT is for monitoring purposes, especially during electroconvulsive therapy.

If an article or sub-article is specifically intended to apply only to my equipment or only to my systems, the title or content of that article or sub-section will say so. If this is not the case, the item or subclause as follows applies to both my equipment and my systems.

The item or sub-clause applies to my equipment by default. For me equipment that is not fully integrated into the me equipment but has the corresponding safety measure or function implemented in a me system instead, the me equipment manufacturer specifies in the accompanying documentation what functionality and safety requirements are met by the me system to comply with this document.

Hazards inherent in the intended physiological function of me equipment or me systems covered in this document are not covered by the specific requirements in this document.

EUROLAB assists manufacturers with IEC EN 80601-2-26 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.

Get Offer Now

To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.

WhatsApp