Leakage Current test and Dielectric strength for Battery operated ECG device?

subbash

Involved In Discussions
#1
Hi All,

Is it required to perform leakage current test and Dielectric Strength test for battery operated ECG devices...?
 
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Marcelo

Inactive Registered Visitor
#2
To show compliance with the applicable leakage current test and Dielectric Strength test for a premarket review, for example, yes, it is.
 

subbash

Involved In Discussions
#3
To show compliance with the applicable leakage current test and Dielectric Strength test for a premarket review, for example, yes, it is.
Thanks for the reply Mr. Marcelo,

Since our device is a 3.7V battery powered ECG device, and is not connected to mains. Under the leakage current test, Patient leakage current test and Auxiliary leakage current test looks to be applicable for our device.

Section 8.7.2 of the standard mentions that Patient leakage current test and Auxiliary leakage current test are not measured in single fault condition. Hence we need not test at Single fault condition.

Please correct me if I have understood properly regarding the leakage current test.

Can you let me know how the Dielectric strength test is carried out for a battery powered medical device.
 

swathi.sp

Involved In Discussions
#5
Dear Folks,

Can any one let us know what are the electrical safety test need to perform in production line for Medical Devices.
 

Peter Selvey

Staff member
Super Moderator
#6
Because the ECG has conductive electrodes to the patient, you still need at least "Type F" isolation barrier between the ECG circuit and all other parts. Usually the same isolation is relied on to pass the defibrillator proof testing. Typically ECGs are rated "Type CF, defibrillator proof" so that means 1.5kV dielectric strength, 4mm spacing, and <50µA with 275Vrms on the applied part. All the voltage tests would be done with the "hot" part (e.g. 1.5kV/5kV defib/275Vrms) applied to the ECG electrodes with all operator accessible parts wrapped in foil and grounded. I/O ports may or may not need grounding in the test depending on use/instructions/risk management.

An exception might be if the device is body worn. In this case the requirements apply, but there are no operator accessible parts, so no part to be grounded. It then becomes a bit like a Faraday cage (the device is still "hot" but nowhere for the voltage to go), hence no isolation required.

For production test, there is no strict requirement. The regulations require that standards be applied both in design and production, but production tests are usually simplified because they only need to address the possibility of variability and/or mistakes in production. So for example, the test in design might be first defib test, humidity pre-conditioning, followed by 1min 1.5kV dielectric strength and leakage current test, followed by warm up to normal temps and then repeat dielectric strength and leakage current test, then apply component fault conditions and re-check leakage current.

In contrast a production test might be just 1.5kV for 5s as a spot check which confirms there are no assembly errors.
 
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