Benutzer:Oemmler/IEC 62304

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Vorlage:Use British (Oxford) English 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

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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]

Vorlage:Reflist

#62304 Category:Regulation of medical devices Category:Software development process Category:Medical software


Vorlage:Software-stub

  1. 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.
  2. 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.
  3. 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.
  4. 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]).