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IEC 60601-2-26 Electroencephalographs Testing

Medical electrical equipment – Part 2-26: the basic safety and essential performance of electroencephalographs

IEC 60601-2-26 Scope:

IEC 60601 2 26 and EN 60601 2 26 testing applies to basic safety and essential performance of electroencephalographs (EEG) as defined in 201.3.63, hereafter referred to as medical electronic equipment. IEC 60601-2-26 is applicable to medical electronic equipment used in a clinical environment (e.g., hospital, physician’s office, etc.).

EN 60601-2-26 does not cover requirements for other equipment used in electroencephalography such as:

  • Phono-photic stimulators;
  • Electroencephalographic telemetry;
  • EEG data storage and retrieval;
  • Medical electronic equipment particularly intended for monitoring during electro-convulsive therapy;
  • Ambulatory electroencephalographic recorders.

Hazards inherent in the intended physiological function of medical electronic equipment or medical equipment systems within the scope of this standard are not covered by specific requirements in IEC 60601-2-26 except in 7.2.13 and 8.4.1 of the general standard.

Keystone Compliance assists manufacturers with IEC 60601-2-26 and EN 60601-2-26 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-2-26 test lab needs.