| 词条 | IEC 62304 | ||||||||||||||||||||||||||||||||||||||||||
| 释义 |
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 softwareThe 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] Contents[5]General requirements
Software development process
Effect of safety classification on required development process documentation[6]
Software maintenance process
Software risk management process
Software configuration management process
Software problem resolution process
See also
References1. ^{{cite web|title=Medical device software – Software life cycle processes|url=http://webstore.iec.ch/preview/info_iec62304%7Bed1.0%7Den_d.pdf|work=INTERNATIONAL IEC STANDARD 62304 First edition 2006-05|publisher=International Electrotechnical Commission|accessdate=2 June 2012|author=International Electrotechnical Commission|format=PDF|year=2006}} 2. ^{{Cite web|url=https://web.archive.org/web/20121104013821/http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/medical-devices/|title=Medical devices - European standards - Enterprise and Industry|date=2012-11-04|access-date=2018-07-26}} 3. ^{{cite web|title=Recognized Consensus Standards|url=http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=30279|work=FDA US Food and Drug Administration|publisher=US Department of Health & Human Services|accessdate=26 January 2015|author=Staff|date=20 August 2012}} 4. ^{{cite journal |url=http://www.mddionline.com/article/developing-medical-device-software-iec-62304 |title=Developing Medical Device Software to IEC 62304 |last=Hall |first=Ken |work=EMDT - European Medical Device Technology |date=June 1, 2010 |accessdate=2012-12-11}} 5. ^{{Cite web|url=https://www.iso.org/|title=IEC 62304:2006(en) Medical device software — Software life cycle processes|last=|first=|date=2006|website=ISO|archive-url=|archive-date=|dead-url=|accessdate=15 June 2017}} 6. ^{{Cite web|url=http://www.mddionline.com/article/developing-medical-device-software-iec-62304|title=Developing Medical Device Software to IEC 62304 {{!}} MDDI Medical Device and Diagnostic Industry News Products and Suppliers|website=www.mddionline.com|language=en|access-date=2017-06-15}} External links
4 : IEC standards|Regulation of medical devices|Software development process|Medical software |
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