An applied part declared fit for direct application to the heart is type CF; an applied part whose patient connection is meant to carry electrical energy or an electrophysiological signal into or out of the patient is type BF or CF; any other applied part is type B, BF or CF; and a part identified under 4.6 as needing applied-part requirements is treated as type B unless the risk management process shows a need for BF or CF; compliance is checked by inspection.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.