Hi there,
I have a doubt regarding Production Line Tests of medical devices for Brazil market.
Until now I was focused on the European Market and my strategy to plan the Production Line Tests and the installation tests was the norm: IEC EN 62353. The idea was applying this norm and common sense to draw a test strategy which at the end of the day can ensure that my device is safe before connecting it to the patient.
But recently I was told that for the Brazil market there are higher standards. They take as a reference Annex K of TIR 62354:2009 (which is informative for rest of the world but compulsory for Brazil). And they have some requirements, that although they go clearly against common sense they have to be fulfilled.
I explained a bit further my case.
We have a Medical Device Class I supplied from Mains. Mains is just connected to our Power Supply which concert it to a DC Secondary Circuit.
Well according to an Audit from Brazil authorities we got a deviation.
We have to perform a dielectric strength test of 1,5kV between L/N and PE during 60s for all the finished assembled devices
I have tried to argument that this test can be destructive and that it is just a type test. But my collegues told me this is a fact and that's how Brazil wants it.
My approach would be to say - We could test 1,5Kv 1 or 10 seconds and that would be more than enough.
(I am even not sure if a dielectric strength test is needed as Production Line Test)
Does anybody now about this topic?
Is there anyway written this specific requirements, or they just come from Auditors
Even the TIR 62354:2009 does not specifically say that we have to applied this test voltages.
Thanks in advance!
I have a doubt regarding Production Line Tests of medical devices for Brazil market.
Until now I was focused on the European Market and my strategy to plan the Production Line Tests and the installation tests was the norm: IEC EN 62353. The idea was applying this norm and common sense to draw a test strategy which at the end of the day can ensure that my device is safe before connecting it to the patient.
But recently I was told that for the Brazil market there are higher standards. They take as a reference Annex K of TIR 62354:2009 (which is informative for rest of the world but compulsory for Brazil). And they have some requirements, that although they go clearly against common sense they have to be fulfilled.
I explained a bit further my case.
We have a Medical Device Class I supplied from Mains. Mains is just connected to our Power Supply which concert it to a DC Secondary Circuit.
Well according to an Audit from Brazil authorities we got a deviation.
We have to perform a dielectric strength test of 1,5kV between L/N and PE during 60s for all the finished assembled devices
I have tried to argument that this test can be destructive and that it is just a type test. But my collegues told me this is a fact and that's how Brazil wants it.
My approach would be to say - We could test 1,5Kv 1 or 10 seconds and that would be more than enough.
(I am even not sure if a dielectric strength test is needed as Production Line Test)
Does anybody now about this topic?
Is there anyway written this specific requirements, or they just come from Auditors
Even the TIR 62354:2009 does not specifically say that we have to applied this test voltages.
Thanks in advance!