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!
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!