Due to the rapid developments in computer and electronic technologies, the range and number of high-tech medical devices has increased. In this process, computerized tomography devices, magnetic resonance devices, ultrasonic imaging systems, color ultrasonic fiber endoscopes, laser devices of various specifications and many more new technologies related to health have emerged and are widely used.
The Medical Device Regulation published by the Ministry of Health in 2002 contains rules for the identification and classification of medical devices. In the annex of this revised regulation (Annex IX), the classification of medical devices shall be based on the period of use of the devices, their ability to be reused, whether they are reusable, the energy source they use, their therapeutic properties, whether they depending on whether to be used.
All medical devices are equipped with electrical and electronic systems. In this regard, the low voltage regulation and the electromagnetic compatibility regulations in force during the production of these devices must be complied with. Especially for medical devices with CE marking, LVD and EMC tests should be performed and the products must be subjected to some conformity checks.
The CE marking is also used to ensure the free movement of medical devices. These products are CE marked. health, safety, environment and consumer protection, and thus, the circulation of medical devices in European Union countries without hindrance.
In particular, the use of medical devices in the environment in which they affect or affect other devices may have irreversible consequences. As a result, human health is at stake and human health may be at risk because of these influences.
Medical devices are also affected by electromagnetic waves in four ways, and EMC tests and controls must be performed in all four ways:
- Radiated emission tests
- Emission measurements
- Conducted emission tests
- Emission measurements
With these tests and measurements, it is proved that the electromagnetic effects of medical devices are within the limit values specified in legal regulations and related standards and do not cause any harm.