Benutzer:Oemmler/IEC 62304
IEC 62304[Bearbeiten | Quelltext bearbeiten]
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[Bearbeiten | Quelltext bearbeiten]
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[Bearbeiten | Quelltext bearbeiten]
- 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[Bearbeiten | Quelltext bearbeiten]
External links[Bearbeiten | Quelltext bearbeiten]
#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 am 2. Juni 2012.
- ↑ Staff: European standards Medical devices. In: European Commission. European Commission's Directorate General for Enterprise and Industry, 26. März 2012, abgerufen am 2. Juni 2012.
- ↑ Staff: Recognized Consensus Standards. In: FDA US Food and Drug Administration. US Department of Health & Human Services, 20. August 2012, abgerufen am 26. Januar 2015.
- ↑ Ken Hall: Developing Medical Device Software to IEC 62304. In: EMDT - European Medical Device Technology. 1. Juni 2010 (mddionline.com [abgerufen am 11. Dezember 2012]).