Softening Standard Test Requirements for CE Marking

F

flyingfrisbee

#1
I was wondering in general how rigorously standard testing must be followed for CE marking. Can we make a reasonable argument for changing the standard tests in some cases?

For example our CPAP utilizes a medical hose to source oxygen to the oxygen mixer. We are performing testing in accordance with ISO 5359. I was wondering if we have to follow the standard exactly even if it is far out of the device specs, such as clause 4.4.14 pressure of the ISO 5369. Our device doesn't have a flowrate of 200L/m. At max it might be 30 L/m for our device. Do we still need to perform a pressure drop test at 200L/m, when the device won't get anywhere near this high?
 
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Marcelo

Inactive Registered Visitor
#2
Re: Softening Standard Requirements

Is the 200L/m in normal or fault condition? If it?s in fault condition, it does not care your device normally would be at 30.

Anyway, a general answer to your question is: from a risk management standpoint, requirements in a safety product standard are possible risk control measures to reduce risk (and testing is simply the verification of implementation and effectiveness of the risk control measure). Possible, not the best or even appropriate to any given device. So yes, you might change the requirements to better "fit" your device situation.

However, generally people are still too focused on blindly following standards, so depending on your assessor, you might have some problems having him accept that (but if you have a good assessor he will verify your rationale and if if it?s sound he will accept the deviation).
 
F

flyingfrisbee

#3
Re: Softening Standard Requirements

Thank you for your help. :thanx:

The standard doesn't mention single fault conditions in this particular test. Also, I don't think that our device could reach that high of a flow rate due to the valves and regulators.

I am guessing that I will have to do testing to confirm that it won't reach that pressure even in a single fault, so I can justify my claim of not needing to test for the pressure drop at a 200 L/m flow rate.
 

Marcelo

Inactive Registered Visitor
#4
Well, I don?t have the last version of ISO 5369 here, but the old versions do mention that the 200L/m pressure drop requirements is related to some lung ventilators that may require peak flows of 200L/m for up to 3 s (please verify in the rationale of the last version if it has this explanation). So it seems that maybe it?s not related to a fault condition.

If your CPAP does not work like this, that would be another good reason not the use the test as defined (you may than justify that your peak flow requirement is xxx, so you changed the testing to yyy).
 
F

flyingfrisbee

#5
The standard I have mentions lung ventilators as well including the 200L/m for 3s. We are not dealing with ventilators or high velocity flows.

I will do what you suggest for the testing. Thanks for your help.
 
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