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IEC 60601-1-2 Radiated Immunity Test - Diagnostic ECG device


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We are planning to test our portable 3.7V Battery operated Diagnostic ECG device for Electromagnetic Compliance.

As per Radiated Immunity Test requirement mentioned IEC 60601-2-25, Section, the test should be carried out by feeding CAL20110 waveform and the following compliance criteria should be satisfied.


As per my discussion with a test lab representative, observing for any disturbances in ECG waveform will be done during the test and if there is any disturbance, waveform should reappear within 10 or 15 seconds. ECG waveform will be captured after the test and evaluated.

I would like to know if the above procedure followed would satisfy the standard requirements.

Any inputs would be helpful.

Thank you
That would be Criteria B !
Unless the RMF justification is strong enough to show some extra-ordinary benefit to cover the residual risk of 'Incorrect Diagnosis' in such an environment, Criteria A is preferred.
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