Hi,

We are manufacturing a device with multiple applied parts. Some of these are Cardiac Floating (CF) and some would be Body Floating (BF) if seen independently.

Should we mark each applied part connection with CF / BF or would it be most appropriate to mark the entire device with CF and have all applied parts tested as CF?

Guess I will lask my NB, just wanted to hear some other voices first.

best regards

t.

Should we mark each applied part connection with CF / BF or would it be most appropriate to mark the entire device with CF and have all applied parts tested as CF?


:caution:IEC60601-1 3 ed. 7.2.10 Applied parts
...The relevant symbol shall be marked adjacent to or on the connector for the APPLIED PART, unless either:
– there is no such connector, in which case the marking shall be on the APPLIED PART; or
– the connector is used for more than one APPLIED PART and the different APPLIED PARTS have different classifications, in which case each APPLIED PART shall be marked with the relevant symbol...

Hope this helps.
I.

Thanks, but our device got 3 groups of connectors for 3 different applied part. Should each type of applied part be marked differently?

regards
t.

You should mark each connector according to the type of the applied part connected. If two types of the applied parts (BF and CF) are connected to one connector then you should mark each applied part according to the type of the part.