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]


General requirements[edit]

Software development process[edit]

  • Software development planning
  • Software requirements analysis
  • Software architectural design
  • Software detailed design
  • Software unit implementation and verification
  • Software integration and integration testing
  • Software system testing
  • Software release

Effect of safety classification on required development process documentation[6][edit]

Software Documentation Class A Class B Class C
Software development planning X X X
Software requirements analysis X X X
Software architectural design X X
Software detailed design X
Software unit implementation and verification X X X
Software integration and integration testing X X
Software system testing X X X
Software release X X X
X - required

Software maintenance process[edit]

  • Establish software maintenance plan
  • Problem and modification analysis
  • Modification implementation

Software risk management process[edit]

  • Analysis of software contributing to hazardous situations
  • Risk control measures
  • Verification of risk control measures
  • Risk management of software changes
  • Security and reliability thru Software quality

Software configuration management process[edit]

Software problem resolution process[edit]

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. 
  5. ^ "IEC 62304:2006(en) Medical device software — Software life cycle processes". ISO. 2006. Retrieved 15 June 2017. 
  6. ^ "Developing Medical Device Software to IEC 62304 | MDDI Medical Device and Diagnostic Industry News Products and Suppliers". Retrieved 2017-06-15. 

External links[edit]