The IEC 60601-1-3 standard, prepared by the International Electrotechnical Commission (IEC), an affiliate of the International Standards Organization (ISO), describes the criteria for the basic safety and basic performance of medical electrical equipment and medical electrical systems. This standard has been published in our country by the Turkish Standards Institute with the following title: TS EN 60601-1-3 Electrical medical devices - Part 1: General rules for safety - Section 1.3 Auxiliary standard: General rules for radiation protection in diagnostic X-ray equipment.
This standard of coverage applies to X-ray equipment and devices used to diagnose, plan or direct medical procedures of a patient's radiological images. The purpose of this assurance standard is to establish general protection criteria against X-radiation in X-ray equipment to keep the irradiation of patients, operators, employees, other people at acceptable levels. While doing this, the expected benefit from radiological procedures should not be ignored. Special standards may contain appropriate values and measures for the requirements described in this assurance standard.
The IEC 60601-1-3 standard only takes into account radiation protection elements associated with X-radiation.
Diagnostic imaging devices include a large number of electrical equipment that fall within the scope of X-ray devices. The common feature of these is that they have almost very similar operating principles. Almost all of these devices are based on X-ray machine, more precisely on cathode ray tubes (X-ray tubes). Know after X-ray machineComputerized tomography devices have emerged, but x-rays are still in use. Because many diseases can be diagnosed with x-rays. In this way, patients are exposed to less ionizing radiation.
Tests in accordance with IEC 60601-1-3 standard are also carried out by our organization within the scope of medical device tests.
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