EN 60601-1-4

General requirements for safety; supplementary standard: programmable electrical medical systems

As an independent standard, this is now only to be applied in correspondence with the 2nd edition of DIN E 6060N1-1. This standard has been integrated into the basic standard as of the 3rd edition.  

"Embedded software" is mostly encountered in the form of so-called firmware. The functional applications control, regulate and monitor various technical processes, partly also in medical devices. If safety-critical functions, including essential performance characteristics, are also affected, your documentation regarding the development life cycle and the associated risk management process is predominantly formally reviewed.