Setup for testing against ISO14708 clause 16 (protection of the patient from herms caused by heat)

#1
Hello,

We have to proove that our AIMD cannot be a source of harm of the patient because it would heat. ISO14708 states that temperature of the outer sufarce of the AIMD shall not raise of more than 2°C ; or it also propose to use CEM43.
My question is: do we have to execute the test with the AIMD in air (which would be a worst-case) ? A colleague of mine told me, that in another project, they immersed the AIMD in a saline solution... but I could not find any mention of this test setup in any of the 14708 standards :(

Immersing the AIMD in a saline solution (or even water) could make sense as human body is in majority water but which volume of water should I immerse the AIMD in ?
Our device is quite small, immersing it in 25cc would not make sense ...

Any input on how to determine the volume of water , in this make sense to you ??

Any reason why it does not make sense?

Thank you

Vincent
 
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