The IEC 60601-2-25 standard, prepared by the International Electrotechnical Commission (IEC), an affiliate of the International Organization for Standardization (ISO), is the electrocardiography intended to be used on its own or as part of a medical electrical system for the generation of diagnostic electrocardiogram reports. It describes the criteria for the basic safety and performance of its devices.
This standard has been published in our country by the Turkish Standards Institute 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.
Such devices intended for use in uncontrolled environmental conditions outside the hospital environment or doctor's office, such as ambulances, must comply with this special standard. Additional standards for medical electrical devices may apply for these usage environments.
Electrocardiographic medical electrical devices that are covered by IEC 60601-2-47 and are not intended to receive diagnostic electrocardiogram reports, and cardiac monitors that are not designed to receive diagnostic electrocardiographic reports within the scope of IEC 60601-2-27 are outside the scope of this standard.
A few standards that are indispensable and referred to during the implementation of the IEC 60601-2-25 standard are: IEC 60601-1-2 (general requirements for medical electrical equipment, basic safety and basic performance, assurance standard: electromagnetic compatibility) and IEC 60601-2 -2 (special requirements for basic safety and basic performance of medical electrical equipment, high-frequency surgical equipment and high-frequency surgical accessories).
Electrocardiography (shortly ECG) is the waveform that graphically records the electrical activities of the heart, namely the rhythm, frequency and rhythm of the heartbeats, through electrodes attached to the body. Electrocardiography device is an examination technique based on printing the contraction and relaxation phases of the heart, the electrical activity that occurs during the stimulation of the heart and the transmission of the stimulus.
Tests in accordance with IEC 60601-2-25 standard are also carried out by our organization within the scope of medical device tests.
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