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.[2]
Time-triggered system (a software architecture that is used in many safety-critical systems)
References
^International Electrotechnical Commission (2006).
"Medical device software – Software life cycle processes"(PDF). INTERNATIONAL IEC STANDARD 62304 First edition 2006-05. International Electrotechnical Commission. Retrieved 2 June 2012.