IEC 62304 – medical device software – software life cycle processes[1] is an international standard published by the International Electrotechnical Commission (IEC).
The standard specifies life cycle requirements for the development of medical software and software within medical devices.
It has been adopted as national standards and therefore can be used as a benchmark to comply with regulatory requirements.
The IEC 62304 standard calls out certain cautions on using software, particularly SOUP (software of unknown pedigree or provenance).
The standard spells out a risk-based decision model on when the use of SOUP is acceptable, and defines testing requirements for SOUP to support a rationale on why such software should be used.