Medical Devices in oxygen rich environment

#1
Hi all,

According to section 11.2.2.1 in 60601-1 3rd edition, a medical device should be tested to determine whether a source of ignition exists.
I've consulted with a few laboratories and have been told that this test is very uncommon and most of them don't do it.
As far as I understand part of the ORs are considered oxygen rich environment.
The intention is to use a non-invasive medical device in ORs.
Does anyone know whether there is a "safe" distance between the device and the patient's body that is considered enough to not need to do this test?
Do you have other recommendations to deal with this issue? perhaps a scientific paper providing guidelines?

Thanks!
 
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pziemlewicz

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#2
Hi all,
Do you have other recommendations to deal with this issue? perhaps a scientific paper providing guidelines?
I'm not sure of your product class, however FDA requires a warning in IFU for Electrosurgical tools:
"DO NOT USE in the presence of flammable anesthetics or oxidizing gases (such as nitrous oxide and oxygen) or in close proximity to volatile solvents (such as ether or alcohol), as explosion may occur."

See pg 21. 510(k) Submissions for Electrosurgical Devices for General Surgery
 

Peter Selvey

Staff member
Moderator
#3
Flammable anaesthetics is covered by 11.4. It's the one that is very rare and the labs are unlikely to want to deal with it.

Clause 11.2 covers use with oxygen which is very common, as it's normal to provide patients with 100% oxygen for a bunch of medical reasons. Most ORs, ICU and many general purpose rooms will have an wall supply oxygen outlet. Examples of devices are infant incubators, warmers, humidifiers, even simple CPAPs. These are devices that are somehow directly in the path of the oxygen flow to the patient. The test labs should know how to handle devices with oxygen.

It does not apply to the room. You would have to pump in a lot of oxygen to raise and keep the oxygen level in a room from 21% to 25%.

The term "environment" in the definition (oxygen enriched environment) might be a bit misleading, it is a poor choice of words, there might be some history there. It refers to the areas inside equipment that are exposed to >25% oxygen in normal or fault condition. This "environment" is usually restricted to limited sections of the device as deliberate design strategy to minimize the risk and make it simple to assess.

Anyway, this "environment" does not refer the room or any area around the patient.

Another thing to keep in mind is that enriched oxygen is not as dangerous as it might sound. You need a few things to go wrong to start a serious fire.
 
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