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Evaluation of medical electric devices
The most important safety technical regulation standard of electric medical devices is the international IEC 60601 standard series, on which the European (EN) and Hungarian (MSZ EN) standards are built.
The EN 60601-1basic standard in this series contains the general requirement regulation for the normal operation of the device or for any failure in the device, including the handling of dangers and the acceptable limit of risks.
The two important suitability- evaluation standard groups that belong to the basis standard have to be applied together with the EN 60601-1 basic standard to evaluate the suitability of the given device:
1.The additional standards for the EN 60601-1-x standard series deal with such requirements that beyond the basic standard evaluate the device or the device – assembly completely, such as the programmable therapeutic electrical system, or the protection against X-ray radiation, the usefulness, or the suitability of the therapeutic warning/alarming systems.
2. Product standards group: the EN 60601-2-x series determine/define the special requirements for the given medical device. Such devices are defibrillators, patient monitors, EKG devices, operating tables etc.
TÜV Rheinland (organization registered in Brussels - Notified Body 1007) examines electric medical devices, makes development measuring and provides international certification.