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IEC 60601-2-25 Electrocardiographs Testing

Medical electrical equipment – Part 2-25: the basic safety and essential performance of electrocardiographs

IEC 60601-2-25 Scope:

IEC 60601 2 25 and EN 60601 2 25 testing  applies to the basic safety and essential performance of electrocardiographs as defined in 201.3.63 intended by themselves or as a part of an ME system, for the production of ECG reports for diagnostic purposes, hereinafter referred to as medical electronic equipment.

Not included within the scope of IEC 60601-2-25 are:

  • The part of medical electronic equipment that provides vectorcardiographic loops;
  • Ambulatory electrocardiographic medical electronic equipment covered by IEC 60601-2-47 where not intended for obtaining ECG reports for diagnostic purposes;
  • Cardiac monitors covered by IEC 60601-2-27 where not intended for obtaining ECG reports for diagnostic purposes.

NOTE 1 For example, medical electronic equipment includes:

  • Direct-writing electrocardiographs;
  • Other medical electronic equipment that produce ECG reports for diagnostic purposes, e.g. patient monitors, defibrillators, exercise testing devices;
  • Electrocardiographs having a display that is remote from the patient (e.g. via phone lines, networks or storage media).

These medical electronic equipment or medical equipment systems are within the scope of IEC 60601-2-25 excluding transmission media.

NOTE 2 Medical electronic equipment that provide selection between diagnostic and monitoring functions shall meet the requirements of the appropriate standard when configured for that function. Medical electronic equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician’s office, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply to medical electronic equipment for those environments of use.

Keystone Compliance assists manufacturers with IEC 60601-2-25 and EN 60601-2-25 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-2-25 test lab needs.