IEC 60601-1 Electrical safety testing - Dielectric Strength Test - 8.8.3

[subbash]

Dear all,

For a 3.7V battery powered ECG device.

Apart from the enclosure, do we need to subject ECG leads to Dielectric strength test as per section 8.8.3 of IEC 60601-1.

Thank you

 

[MedMartin]

Dear Subbash,

yes, the requirements for dielectric strength testing apply also to the leads.

Best regards
Martin

 

[subbash]

Dear Subbash,

yes, the requirements for dielectric strength testing apply also to the leads.

Best regards
Martin

@MedMartin thanks for the reply.

Any inputs on how the test is performed would be helpful.

Is this test performed similar to Defibrillator protection (Common mode and differential mode)...?

Thank you

 

[Pads38]

Dielectric tests on insulated parts are usually done using some metal foil, sized to approximate a human hand (or other body part if more appropriate for your device.
Ordinary kitchen aluminium foil works fine. If you have a hand-held part the foil can be wrapped around as if a hand was holding it.

 

[MedMartin]

@MedMartin thanks for the reply.

Any inputs on how the test is performed would be helpful.

Is this test performed similar to Defibrillator protection (Common mode and differential mode)...?

Thank you

Dear Subbash,

we normally use cable which is tested by our suppliers and do not perform the tests ourselfs.
But if I had to perform the test I would do it as Pads38 recommended using the aluminum foil.

Best regards
Martin

 

[Peter Selvey]

I think the test is not required.

In a mains operated device, the test agencies would not bother with parts <30Vdc. There are good reasons for this.

Also, even for mains operated devices, many mains parts (including cables) are not tested because they are already certified (as MedMartin mentioned).

For a battery operated device, there are no mains parts so some agencies test some <30Vdc parts. But that's inconsistent, and they are really just doing because they are afraid to leave a blank table.