The IEC 60601-2-44 standard, prepared by the International Electrotechnical Commission (IEC), an affiliate of the International Organization for Standardization (ISO), describes the criteria for the basic safety and basic performance of computed axial tomography scanning devices, also known as CT (computed tomography) scanning. . This standard has been published in our country by the Turkish Standards Institute with the following title: TS EN 60601-2-44 Electrical medical equipment - Part 2-44: Specific features for the basic safety and required performance of X-ray equipment for computed tomography.
The scope of this standard is limited to CT scanners, which include X-ray sources and imaging detectors and are intended for use on both the head and the body. For X-ray generators used in these scanners, high voltage generators XIt includes safety requirements that it is integrated with the rail tube assembly.
The IEC 60601-2-44 standard describes the requirements for repeatability, linearity, stability and accuracy due to its relationship to the quality and quantity of ionizing radiation generated.
The operation of computed tomography devices is mainly based on the x-ray machine. Its use has increased significantly in many countries in recent years. Computed tomography or computed axial tomography scanning uses X-rays to create a detailed image of various structures inside the body. These scans produce two-dimensional images of a part of the body. However, it produces a more detailed picture than an X-ray image. It even detects tissues within a solid organ. That's why computed tomography devices are a powerful device that helps diagnose the disease. On the other hand, since it is an ionizing radiation source, there is a potential danger of causing cancer. Nevertheless, it has an important place among medical devices.
Tests in accordance with IEC 60601-2-44 standard are also carried out by our organization within the scope of medical device tests.
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