How does IEC-60601-1 apply to a non-medical device in the patient vicinity?

[medicollector]

I am developing a system which is not a medical device. It is a data system for collection of vital signs from patient monitors in a hospital. It is not a medical device per the FDA's own definition (see MDDS rule).

As part of this new system, I want to put an off-the-shelf serial-to-ethernet converter at the patient bedside (such as the IOLAN SDS1 M Secure Device Server). This device will connect to the RS232 port on the patient monitor and transmit the RS232 data (encrypted, of course) across the network to my server.

I am confused about how 60601-1 applies to such a design. To save costs, I'd prefer to use a non-60601-compliant serial-to-ethernet converter. Could I just power it using a 60601-compliant power supply?

And the loaded question is: Would my system need to be tested for 60601-1 compliance in order to be sold to a hospital?

 

[Peter Selvey]

Technically a non-601 power supply is OK as long as additional measures are taken to make sure the leakage meets the 601 limits inside the patient environment. In the standard they talk about extra earth bonding or isolation transformers to limit the leakage, but one of the simplest methods would be to select a double insulated power supply that already has low leakage (<0.1mA to the secondary in normal condition), and make sure it is powered directly from a wall socket, not from expander board (i.e. via the instructions for use, installation section).

From memory the standard for power supplies might have a 0.25mA leakage but most manufacturers will stay well below that, so it's possible to find one that is <0.1mA off the shelf.

You could also just source a 601 power supply anyway, which should be below the 0.1mA limit.

The system itself does not need to meet 601 standard. However make sure the power supply meets the relevant standards for a power supply. And if the power supply has an instructions for use, make sure to include that as part of the package you supply to the end user.

This is a quick summary/interpretation of Clause 16 in the 601 standard.