Benutzer:Oemmler/IEC 62304
IEC 62304
Vorlage:Use British (Oxford) English The international standard IEC 62304 – medical 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
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
- International Electrotechnical Commission (IEC)
- List of IEC standards
- IEC 60601
- ISO 14971
- Time-triggered system (a software architecture that is used in many safety-critical systems)
References
External links
#62304 Category:Regulation of medical devices Category:Software development process Category:Medical software
- ↑ International Electrotechnical Commission: Medical device software – Software life cycle processes (PDF) In: INTERNATIONAL IEC STANDARD 62304 First edition 2006-05. International Electrotechnical Commission. 2006. Abgerufen im 2 June 2012.
- ↑ Staff: European standards Medical devices. In: European Commission. European Commission's Directorate General for Enterprise and Industry. 26 March 2012. Abgerufen im 2 June 2012.
- ↑ Staff: Recognized Consensus Standards. In: FDA US Food and Drug Administration. US Department of Health & Human Services. 20 August 2012. Abgerufen im 26 January 2015.
- ↑ Ken Hall: Developing Medical Device Software to IEC 62304. June 1, 2010. Abgerufen am 11. Dezember 2012.
