Can a Surge test fail to a test level and still considered as Compliant?

J

joshidileep

#1
Dear all,
Can anyone help me in understanding a situation cited below:
During our 60601-1-2 testing, Surge test failed at 2KV and the System shut down. However by risk assessment it was concluded that as the system shut off (failed safe), Basic safety was not compromised and did not hamper the essential performance, it was decided to consider surge failure as not a failure and still compliant to Surge test requirement.
my query is:
1. Is it acceptable
2. Do we need to inform this to the end user of the system. and if yes how?

Thanks with regards
Dileep Joshi
 
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#2
I personally can't help, but here is a quick "Bump" - My Thanks in advance to anyone who can help with this one.
 
H

hcrook

#3
1) This is acceptable if you're not saying that system shall withstand 2kV surge (line to ground?), which is what it sounds like you've concluded based on your risk management.

If the system has been designed to pass 2kV surge and you have that as a traceable requirement, even though Basic Safety wasn't affected Essential Performance would be and I don't think this would be compliant in that case.

2) This should be addressed in your Intended Use documentation.
 
#4
This is rather dependant upon how you have classified your Essential Performance.

The Compliance Criteria, at 6.2.1.10, state that 'resets' and 'cessation of intended operation' shall not be allowed.

But that applies only if they are associated with Essential Performance - you would have to argue that your device has no Essential Performance (not catching fire is considered Basic Safety!).

Regulators and test houses are usually very reluctant to allow the "no Essential Performance" argument - they would suggest that a medical device with no Essential Performance has no medical purpose, so is not a medical device!

If you have some inherent sensitivity to surge you might be able to use the justification set out in 6.2.1.1
Lower IMMUNITY COMPLIANCE LEVELS are allowed provided they are justified based on significant physical, technological or physiological limitations.
Look to the part 2 Particular Standards for guidance on this allowance.

In such a case I would expect to see prominent warnings within the Operators Manual and Risk Management would have to carefully take this into account, along with probabilities that the device would only be connected to 'low-surge' mains supplies (perhaps you, as manufacturer, supervise the installation process and supplies are only ever dedicated supplies fed from local hospital sub-stations).

Or you could add some extra surge protection!

(Clause numbering is from the 2007 version).
 
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