Software of unknown provenance (SOUP)

SOUP includes operating systems, libraries and open-source components. IEC 62304 requires each SOUP item to be identified with its version, its requirements specified and its known anomalies evaluated.

SOFTWARE ITEM that is already developed and generally available and that has not been developed for the purpose of being incorporated into the MEDICAL DEVICE (also known as “off-the-shelf software”) or SOFTWARE ITEM previously developed for which adequate records of the development PROCESSES are not available NOTE A MEDICAL DEVICE SOFTWARE SYSTEM in itself cannot be claimed to be SOUP.

IEC 62304:2006+AMD1:2015, clause 3.29