It is still alarming to me to hear that certain entities are promoting that a "type of network is termed "medical grade utility", or that a network needs some sort of certain regulatory approval.
This is not true in my opinion, in fact it could be construed as mis-leading. What is true, is that the medical device company if they decide incorporate their wired/or wireless medical device as a part of any infrastructure and/or design does need to test, validate, and verify that the product works as per the intended use. It all in the minds of the regulatory agency reviewer about risk analysis. Example: Would be a patient monitoring company. The patient monitoring company decides to not have a closed network, but actually make their WLAN network a part of the enterprise wired and wired network. Then the patient monitoring company needs to work with what ever provider of say WLAN infrastructure, or other and provide validation testing both in the lab and in an actual clinical site. They need to demonstrate in the case of other application traffic, (data, voice, and video), that their application works as intended in a safe, reliable, and repeatedable manner based upon the best of industry practices. In the case of patient monitoring which is a real time application, then this means the right persistence of waveform data from the patient monitor to the central station, the right annunciation of alarms, and the correct and timely recordings. This also needs to show how this is scaled, i.e. adding more devices and traffic will not effect the operation of the application as intended. If say that design changes in the future (for instance another manufacture of access points), then the medical device manufacture does need to also test on this,(to the same level as described) but then this becomes an internal letter to file.
I am speaking from experience going through this process several times.
