ECG device without ECG REPORTS - IEC 60601-2-25: 2011

#1
Hello,

I have an device that performs signal acquisition of the ECG signals, but does not generate an ECG report ("It's just the acquisition module, without printer, display or software interface"). The software that will generate the ECG report will not be owned by me.

Would IEC 60601-2-25 apply to my device? Would the tests be possible?

Note: For knowledge follows the scope of the standard:
IEC 60601-2-25: 2011 applies to the basic safety and essential performance of electrocardiographs intended by themselves or as part of a medical electrical system, for the production of electrocardiogram reports for diagnostic purposes.
 
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#2
I'm not familiar with that particular standard, but from the scope (as you have written) it reads as if your device is intended to be "part of a ME system, for the production of electrocardiogram reports for diagnostic purposes". The individual elements of the particular standard may not apply to your specific device, but I wouldn't assume that none of them apply without consulting the text of the standard.
 
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