The conditions for placing to the market of the medical devices are regulated on national and regional level. For putting to the market of the medical device, the product has to go through on a market authorization procedure.
The manufacturer has to prove the safety and effectiveness of the medical device as the minimal requirement, as the life and health of the patient can be highly affected by the medical device.
A documentation has to be compiled for all medical devices for proving the regulatory requirements. In this documentation the test report of proving safety of the device has to be attached.
In case of electrical medical equipment, the general requirement for basic safety and essential performance is established in the EN 60601 and IEC 60601 standard series.
- Product testing according to EN/IEC 60601-1 requirements
- Product testing according to EN/IEC 60601-2-XX product standards
- Evaluation of the documentation required by the above mentioned standards
- Detailed test report by using Test Report Form issued by IEC.
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