Production Line Test Brasil - High Voltage Dielectric Strenght Test

#1
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!
 
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#2
I would agree with you that a short duration (say 5s) would be better for production line tests.
But what damage a 1min test may cause is rather dependent on what components you have in your mains part, specifically what filter components are in place. 1k5V is not actually that high so you may not find a problem (other than nuisance).
 
#3
I would agree with you that a short duration (say 5s) would be better for production line tests.
But what damage a 1min test may cause is rather dependent on what components you have in your mains part, specifically what filter components are in place. 1k5V is not actually that high so you may not find a problem (other than nuisance).
Thanks for you answer.
Yes you are also right. For our case is not so critical, and I don't expect nothing gets damaged.
For me is a little bit to understand what is the point in doing that if the test could be destructive. And if someone is facing similar issues with Brazil authorities...
 

rogerpenna

Involved In Discussions
#5
We have to perform a dielectric strength test of 1,5kV between L/N and PE during 60s for all the finished assembled devices
Look, I know next to nothing about electric and electronic tests, nor about medical equipment.

But the link mentions using that HP5500M equipment for the CERTIFICATION test, as an example
HP5500M – Ensaio de Rigidez Dielétrica | Entran Equipamentos


"Adicionalmente ao processo de certificação, os fabricantes de equipamentos médicos ficaram obrigados a realizar ensaios de segurança elétrica em todos os produtos fabricados."

Additionally to the certification process, manufacturers of medical equipment became obliged to perform electric security tests in ALL MANUFACTURED PRODUCTS.

This is determined by ABNT NBR IEC 60601-1

ABNT is the Technical Norms Association of Brazil.

here is the link to buying the norm directly from ABNT
ABNT Catalogo

Gee, it's quite expensive. R$28k!! (right now, due to exchange rates, it's about U$5600, but just 2 years ago, when U$1 = R$3, that would be U$9300!!)

I am used to the price of civil engineering norms, the most expensive ones are about U$50-U$100.

But then, this 60601-1 norm is 2771 pages long! And ABNT prices are based on the number of pages of their norms.

BUT... this Target company also sells ABNT norms. They have won several lawsuits against ABNT, because according to the constitution or something, technical norms can´t be monopolized or something.

So Target sells the same norms for a fraction of the price and legally.
ABNT NBR IEC 60601-1-6 NBRIEC60601-1-6 Equipamento eletromédico -

Apparently, R$37 only... U$ 7,5
 
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