IEC 62304
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
<templatestyles src="Asbox/styles.css"></templatestyles>
 |
This software article is a stub. You can help Wikipedia by expanding it. |
