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?
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?