The IEC 60601-2-37 standard, prepared by the International Electrotechnical Commission (IEC), an organization affiliated to the International Standards Organization (ISO), describes the criteria for the basic safety and performance of electrical medical devices used in ultrasonic diagnosis.
This standard has been published in our country by the Turkish Standards Institute with the following title: TS EN 60601-2-37 Electrical medical devices - Part 2-37: Specific features for the safety of ultrasonic medical diagnosis and imaging equipment.
The stan in questionWhile designing the dart, the main approach to the safety of ultrasonic diagnostic devices was to comply with the IEC 60601-2 xx series standards applied to other diagnostic methods such as X-ray equipment and magnetic resonance systems.
As the complexity of output indicators and controls in ultrasonic medical diagnosis and imaging equipment increases, the safety standard becomes more important. Therefore, for all these diagnostic methods, it is the operator's responsibility to understand the risk of exit from ultrasonic diagnostic devices and act appropriately to obtain the necessary diagnostic information with the lowest risk to the patient.
Today, medical imaging devices and systems have a very important place in the diagnosis and treatment of diseases. Medical imaging is making the internal structure of the human body visible with technological possibilities. Ultrasonic imaging, x-ray, computed tomography and magnetic resonance are among the four basic methods of studies in this field. High frequency sound waves are used in ultrasonographic imaging and sound energy is transformed into images.
The main standard referred to during the implementation of the IEC 60601-2-37 standard and is in an indispensable position is the following: IEC 62359 (test methods for determining thermal and mechanical indices related to ultrasonic, field characterization, medical diagnostic ultrasonic fields).
Tests in accordance with IEC 60601-2-37 standard are also carried out by our organization within the scope of medical device tests.
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