ISO 11197, Venting of Medical Supply Units - cl. 201.11.2.2.101

Benjamin Weber

Trusted Information Resource
#1
Dear community,

I am struggling with the requirements and testing of clause 201.11.2.2.101 of ISO 11197:2019 regarding venting of compartments containing pipelines or terminal units for oxygen.

The requirement states that the "specific compartment shall be vented to atmosphere".

Then there is an example test method decribes: A simulated oxygen leakage (1 l/min through a 3 mm inner diameter hose) "at the entry point to the medical supply unit under test". This is quite straightforward.

My question is: Where should I measure the oxygen concentration? The standard says:
  • "the specific compartment shall be vented" and
  • "Compliance is checked by a simulated leakage test as defined in the example test method to show that the oxygen concentration within the medical supply unit is not greater than a volume fraction of 25%".
Thus I would place the sensor in the compartment where the pipelines / terminal units are located.

But from an engineering point of view and the corresponding requirements of IEC 60601-1, cl. 11.2.2 this is not really necessary, as long as there is no possible source of ignition. If the piping compartment and the electrical compartment are separated mechanically, I would rather be interested in the oxygen concentration inside the electrical compartment (sparks etc.) or even only close to socket outlets, switches etc.

Does somebody else have some toughts on this?
 
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Tidge

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#2
I have no specific experience with this standard or this type of device, but it is possible that electro-static discharge could be a concern in addition to implemented ignition sources.
 

Benjamin Weber

Trusted Information Resource
#3
Thank you very much! So far I didn't think about ESD. But your're right , this could lead to a fire, if the compartment is enriched with oxygen.
 
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