IEC EN 60601-2-25 Medical Electrical Equipment, Part 2-25: Special Requirements for Basic Safety and Basic Performance of Electrocardiographs

Medical Device Tests

IEC EN 60601-2-25 Medical Electrical Equipment, Part 2-25: Special Requirements for Basic Safety and Basic Performance of Electrocardiographs

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of IEC EN 60601-2-25 test. IEC 60601-2-25 applies to the essential safety and essential performance of electrocardiographs designed on their own or as part of a medical electrical system for the generation of diagnostic electrocardiogram reports.

IEC EN 60601-2-25 Medical Electrical Equipment, Part 2-25: Special Requirements for Basic Safety and Basic Performance of Electrocardiographs

Equipment intended for use in extreme or uncontrolled environmental conditions outside the hospital environment or doctor's office, such as ambulance and air transport, shall comply with this specific standard. Additional standards for Medical electrical equipment may apply for these use environments.

Not covered by this particular standard are:

  • Part of medical electrical equipment that provides vectorcardiographic loops;
  • Ambulatory electrocardiographic medical electrical equipment within the scope of IEC 60601-2-47 is not intended to receive diagnostic electrocardiogram reports;
  • Cardiac monitors within the scope of IEC 60601-2-27 that are not intended for diagnostic electrocardiographic reports.

It provided the opportunity to combine the first editions of IEC 60601-2-25 and IEC 60601-2-51 into a single standard. Both reformatting and technical changes were made. This second edition of IEC 60601-2-25 constitutes a technical revision of both standards.

EUROLAB assists manufacturers with IEC EN 60601-2-25 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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