K
Hi everyone
,
we're having some trouble identifying the right wording to explain to our lab that the defib protection for our device is not necessary. the lab is doing testing for us for IEC 60601-1, -1-2, -1-11, -2-25 and -2-47. The lab asked us to comment on how the essential requirement 201.8.5.5.1 of the 60601-2-25 was guaranteed or to provide rationale for it being not applicable.
We have a product with a disposable sensor and a small wearable ECG monitor that clips onto the sensor (no lead wires). Our NB auditor did not comment on whether defib protection is necessary or not when he saw the symbols we used and the lab's report. We've come up with a few arguments to give back to the lab but i wanted to see if anyone here has any experience and can help us out.
Thanks a lot!
Krystle
, we're having some trouble identifying the right wording to explain to our lab that the defib protection for our device is not necessary. the lab is doing testing for us for IEC 60601-1, -1-2, -1-11, -2-25 and -2-47. The lab asked us to comment on how the essential requirement 201.8.5.5.1 of the 60601-2-25 was guaranteed or to provide rationale for it being not applicable.
We have a product with a disposable sensor and a small wearable ECG monitor that clips onto the sensor (no lead wires). Our NB auditor did not comment on whether defib protection is necessary or not when he saw the symbols we used and the lab's report. We've come up with a few arguments to give back to the lab but i wanted to see if anyone here has any experience and can help us out.
Thanks a lot!
Krystle