This is a question about the IEC 60601-1 standard and how it applies to non-medical devices.
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).
However, as part of this new system, I want to put an off-the-shelf serial-to-ethernet converter at the patient bedside. 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?
IEC 60601-1 applies to electromedicals, which are a particular class of medical device (MD). The EU MD Regulation 2017/745 says: "‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: — diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, — diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, — investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, — providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means."
So, if your SW is used for one or more of the above purposes, it is considered a MD, otherwise it isn't. If, for instance, it's used for real time monitoring of patient's conditions it's a MD, whereas if it only collects data for storing them in a DBMS in view of future use, processing or documentation, without any direct, immediate consequence on patient's care, it isn't, and neither MD Regulation nor IEC 60601-1 apply.
Notice however that, at least in the EU, compliance with technical norms, such as IEC 60601-1, is not mandatory, whereas compliance of MD with MD Regulation and/or Directives is mandatory.
Best regards
Angelo
As a member of IEC that has been contributing to the IEC 60601-series of standards, I might help a bit here. To be entrely sure you don't compromise electrical safety (in particular the leakage current values of the device) you'd best use a galvanically isolated data coupler. Isolated data couplers translating between a wide variety of data buses are commercially available from various sources.
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