The international standard IEC 62304 – medical device software – software life cycle processes is a standard which specifies life cycle requirements for the development of medical software and software within medical devices. It is harmonized by the European Union (EU) and the United States (US), and therefore can be used as a benchmark to comply with regulatory requirements from both these markets.
Implications of IEC 62304 for software
The IEC 62304 standard calls out certain cautions on using software, particularly software of unknown pedigree or provenance, called SOUP in the standard. 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.
- 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.
- Staff (26). "European standards Medical devices". European Commission. European Commission's Directorate General for Enterprise and Industry. Retrieved 2 June 2012.
- Staff (9). "Recognized Consensus Standards". FDA US Food and Drug Administration. US Department of Health & Human Services. Retrieved 2 June 2012.
- Hall, Ken (June 1, 2010). "Developing Medical Device Software to IEC 62304". EMDT - European Medical Device Technology. Retrieved 2012-12-11.