IEC 62304

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The international standard IEC 62304medical device software – software life cycle processes[1] 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)[2] and the United States (US),[3] and therefore can be used as a benchmark to comply with regulatory requirements from both these markets.

Implications of IEC 62304 for software[edit]

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.[4]

See also[edit]


  1. ^ 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. 
  2. ^ Staff (26 March 2012). "European standards Medical devices". European Commission. European Commission's Directorate General for Enterprise and Industry. Retrieved 2 June 2012. 
  3. ^ Staff (20 August 2012). "Recognized Consensus Standards". FDA US Food and Drug Administration. US Department of Health & Human Services. Retrieved 26 January 2015. 
  4. ^ Hall, Ken (June 1, 2010). "Developing Medical Device Software to IEC 62304". EMDT - European Medical Device Technology. Retrieved 2012-12-11. 

External links[edit]