EBME Forums Forums Maintenance Technical Assistance BS EN 60601

It is Friday afternoon and my brain has failed me.
Which is the collateral section of the 60601 standard that deals with medical systems? i.e. connecting several components together not necessarily in the same room.
many thanks
Robert

BS EN 60601-1:2006+A1:2013 is the current standard in which ME Systems are covered in section 14 (page 226). There is also some useful information in Annex I.

Section 14 starts off with:



So for example an ECG system used in a cardiac interventional suite may have a section within the patient environment that meets 60601-1 but have an operator workstation designed for use in a control room outside of the patient environment.

The section in the control room, outside the patient environment, would not need to conform to 60601-1 (only 60950 if PC based) but would need appropriate safety measures taking into account the connections between the parts inside the patient environment.

This would typically involve using optical coupling between the PC parts in the control room and the patient environment parts (with 4KV isolation).

Some would consider just sticking a isolation transformer on the PC in the control room but this may not eliminate all risks associated with the direct electrical connections between the two systems, as it only addresses the leakage current. (What happens if a fault occurs on the PC data lines and applies mains to the data port? Will RFI/EMI be coupled into the patient environment?)

Of course you would also need to refer to other collateral standards such as 60601-1-2 (EMC) and any others, such as 60601-2-43 for interventional x-ray systems and so on.

Mike
Thanks, I thought there used to be specific collateral standard but may be the reason I cannot find it is that it has been incorporated in to the base standard.
Robert