CTS/CSE Waveforms Testing - Partial Recognition of IEC 60601-2-25 Standard by FDA

[subbash]

Dear all,

As shown in the attached file. IEC 60601-2-25 is partially recognized by FDA. The CTS and CSE Amplitude and wave durations are not recognized. So does this mean, Its not a necessity to test for CTS/CSE waveforms amplitude and duration measurements.

Any insights into this would help.

 

[Al Rosen]

What they are saying is they want you to use another standard for those requirements. You cut off the "article listed below". Possibly this one

 

[subbash]

What they are saying is they want you to use another standard for those requirements. You cut off the "article listed below". Possibly this one

Thank you

 

[shrikanth]

It appears that the question is about the method of selecting the outliers before calculating the standard deviation .
It is worthwhile to draw out measurements using the CAL ECGs and check if all the results meet the accuracy requirement for amplitude and duration. If all measurements meet the requirements, the question of selecting outliers may never arise. Isn't it so?