Functional connection between ME and non-medical equipment in different rooms

F

FairyFeet

Hi all,

I am new to this forum (and the 60601 world !). This forum is really helpful.

We are planning to buy and install a central reverse osmosis system (water treatment system) for our dialysis equipments. The system will be installed in a separated non-medical room.

For sure, the dialysis machine fall into the scope of 60601, but we are struggling to determine if the reverse osmosis system also fall into the 60601 scope (as a MEE or as a non-medical equipment in a ME System).

Its only link with the patient is through the piping system that brings the water to the dialysis machine.. which has an applied part. Is the piping connection considered as a ''functional connection'' in this situation?

The intended use of the system (as described by the manufacturer) is to provide ultra pure water to a dialysis machine.


Thanks !

* MEDICAL ELECTRICAL SYSTEM
ME SYSTEM
combination, as specified by its MANUFACTURER, of items of equipment, at least one of which is ME EQUIPMENT to be inter-connected by FUNCTIONAL CONNECTION or by use of a MULTIPLE SOCKET-OUTLET

3.33
* FUNCTIONAL CONNECTION
connection, electrical or otherwise, including those intended to transfer signals, data, power or substances
Click to expand...
 
P

Pads38

Moderator
I would suggest that the water pipe is a FUNCTIONAL CONNECTION.

Which would indicate you have a SYSTEM, with a device (the RO machine) that, itself, is not an medical device.

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