TS EN 60601-2-26 Electrical Medical Devices - Part 2-26: Specific Features for Basic Safety and Required Performance of Electroencephalography Devices

The TS EN 60601-2-26 standard, developed by the International Electrotechnical Commission (IEC), an affiliate of the International Standards Organization (ISO), describes the features and test methods for the safety and performance of electroencephalography devices among electrical medical devices. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN 60601-2-26 Electrical medical devices - Part 2-26: Specific features for the basic safety and required performance of electroencephalography devices.

This standard applies to the basic safety and basic performance of electroencephalograph devices used in the clinical setting, for example in a hospital, practice and similar healthcare facility. The mentioned standard does not cover the requirements for other equipment used in the electroencephalography process (such as phono-photic stimulators, electroencephalographic telemetry, EEG data storage and retrieval, and ambulatory electroencephalographic recorders).

Electroencephalography is a brain graphic method. In this method, brain wave activity is measured and monitored by electrical method. Since no electrical current is given to the patient during the procedure, no pain or ache is felt. This method is known as brain electrode pulling among the people. By examining the records obtained with the measurements, deviations compared to normal are detected and many dysfunctions of the brain are diagnosed.

The EN 60601-2-26 standard includes features for the safety and performance of electroencephalograph devices that perform the measurements. Hazards inherent in the intended physiological function of medical equipment or physical systems covered by this standard are not covered by the requirements of this standard.

The standards referred to as normative in the application of this standard are: IEC 60601-1 and IEC 60601-2-27.

Within the scope of laboratory services, our organization also provides security and performance testing services of electroencephalography devices, which are among electrical medical devices, in TS EN 60601-2-26 standard.