INMETRO 350 Dielectric Strength Test to IEC 60601-1 clauses 18, 19 and 20

C

chudsonvt

#1
Hello,

The Brazilian INMETRO #350 states that all units off of the production line are to be tested to IEC 60601-1 clauses 18, 19 and 20.

Now I have a power supply that passes type testing in UL 60601-1 due to the sub-clauses that allow for components to be removed. In this case, they are Y-caps between primary and secondary windings to chassis. However, this is not possible in production testing.

Is it possible to meet INMETRO without needing to test to the full voltage required for reinforced insulation from Mains to Applied Part? What I mean is could we test only to basic insulation requirements and provide a waiver?
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#2
Hello chudsonvt and welcome to the Cove!

This is one of the cases in which the requirement of Portaria 350, as it´s now, really should not be applied the way it is.

In my opinion, the only way to resolve this is doing as you say, meaning, testing one part of the insulation and giving a rationale for not testing the other.

However, you will need to discuss this with your certification body (and convince them).
 
C

chudsonvt

#3
I will have to investigate the possibility. Thank you for your reply. I will post the results for others future reference.
 

Roland chung

Quite Involved in Discussions
#4
Hi Marcelo,

It seems that INMETRO 350 requires all electrical medical devices to be tested to clause 19 and 20 during the routine tests. Is it possible for internally powered equipment, such as blood pressure monitors to skip these safety tests?
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#5
It seems that INMETRO 350 requires all electrical medical devices to be tested to clause 19 and 20 during the routine tests. Is it possible for internally powered equipment, such as blood pressure monitors to skip these safety tests?
No, it's not possible.

However, you only apply the applicable testing performed during the device design, in principle (and in practice people are applying only some tests, for example, in the case of class I/II devices, only the external tests. Unfortunately this is not possible for internally powered only devices).

On the other hand, for Portaria 54, we included the requirement to use IEC 62354 Annex D, which may be a better option.
 

Roland chung

Quite Involved in Discussions
#6
Thanks, Marcelo.

Actually, for battery powered equipment without low-resistance connection to patient and internal dangerous voltage, the worst case would be the direct touch of contact points of the battery. That means leakage current and dielectric strength tests make no sense.
 

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