TS EN 60601-2-25 Electrical Medical Equipment - Part 2-25: Specific Features for Basic Safety and Required Performance of Electrocardiographs

The TS EN 60601-2-25 standard, developed by the International Electrotechnical Commission (IEC), an organization affiliated to the International Standards Organization (ISO), describes the characteristics and test methods for the safety and performance of electrocardiography 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 60601-2-25 Electrical medical equipment - Part 2-25: Specific features for the basic safety and required performance of electrocardiographs.

The aforementioned standard applies to the basic safety and performance of electrocardiograph devices intended for the acquisition of electrocardiogram reports used for diagnostic purposes, either themselves or as part of the medical electrical system. Equipment intended for use in extreme or uncontrolled environmental conditions outside the hospital or doctor's office, such as ambulances and air transport, must comply with this special standard. Additional standards specific to electrical medical equipment are also applied for these usage environments.

Equipment not covered by this standard includes:

• Part of medical electrical equipment that provides vectorcardiographic cycles
• Ambulatory electrocardiographic medical electrical equipment not intended to receive diagnostic electrocardiogram reports and covered by the IEC 60601-2-47 standard
• Cardiac monitors covered by IEC 60601-2-27

Medical equipment covered by this standard are:

• Direct writing electrocardiograph devices
• Other electrical medical equipment (e.g. patient monitors, defibrillators, exercise testers) generating electrocardiographic reports for diagnostic purposes
• Electrocardiographs with a screen away from the patient (for example, via telephone lines, networks or storage media)

Within the scope of laboratory services, our organization also provides safety and performance testing services of electrocardiography devices, which are among electrical medical devices, in TS EN 60601-2-25 standard.