Standards Specific to Single Channel ECG Medical Device

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Rini_simon

#1
Can anyone please help with which particular standard must be considered for Hand-held single channel ECG which records ECG trace by placing right and left thumb on the electrodes to diagnose AF(Atrial Fibrillation). There are no lead wires or patient cables but it has two electrodes on the hand-held unit itself..
 
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Peter Selvey

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#2
There is no standard in the IEC series. The current ECG standards (IEC 60601-2-25, IEC 60601-2-27 and IEC 60601-2-47) are all intended for different applications. Although some agencies or regulatory reviewers might reference these standards, if you check the scope you will find (I am 99% sure) your device is excluded.

Instead you would be back to basics drawing up your own standard. In this regard, the ECG standards provide a valuable reference and many of the requirements could be derived from the standards or modified for your application. IEC 60601-2-47 is the closest standard so it might be the best reference.

I would go through each requirement and decide if it is appropriate, appropriate with modification, or not relevant for your application. For example, tests require the ability to handle ±300mVdc offset without distortion. The 300mVdc comes from ECG electrodes. Maybe if there are no electrodes, the dc offset will be smaller, ±50mV is reasonable. You should still test, but limits are modified for your application.

For AF, maybe frequency response of 0.67 - 40Hz could be modified to 1.5Hz - 30Hz if it can be shown that AF is limited to certain frequencies and the motion artifact needs heavier filtering.

For arrhythmia detection, you could ignore all database tests in IEC 60601-2-47 except those focusing on arrhythmia.

Again, you don't need to use these standards, but you need to meet the high level regulatory requirement which is to have evidence that your device detects AF (as defined by you) under expected normal conditions of use.
 
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