MEDICAL ELECTRICAL DEVICES ACCORDING TO EN 60601 AND REPAIR MEDICAL OPERATING MATERIALS ACCORDING TO EN 62353
According to EN 60601 / EN 62353, various electrical tests must be carried out to ensure the safety and performance of medical electrical devices. The key tests include:
- Insulation Resistance Test: This test measures the resistance between the active parts and the protective conductor to ensure that no unwanted short circuits or leakage currents occur.
- Leakage Current Measurement: In this test, the current flowing through the patient is measured to ensure that it remains within permissible limits and poses no danger to the patient.
- Protective Conductor Resistance Test: This test checks the resistance of the protective conductor to ensure that it is sufficiently low-ohmic and provides a safe current path in the event of a fault.
- High Voltage Test: In this test, the device undergoes a high-voltage test to ensure that it can withstand the specified voltage values without experiencing breakdowns or insulation failures.
- Functional Test: In this test, the various functions of the medical device are tested to ensure that it operates properly and meets the requirements.
These tests aim to ensure the safety, reliability, and performance of medical electrical devices in accordance with the requirements of EN 60601 / EN 62353.
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