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[edit]
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]
Contents[5][edit]
General requirements[edit]
Software development process[edit]
- Software development planning
- Software requirements analysis
- Software architectural design
- Software detailed design
- Software unit implementation and verification
- Software integration and integration testing
- Software system testing
- Software release
Effect of safety classification on required development process documentation[6][edit]
| Software documentation | Class A | Class B | Class C |
|---|---|---|---|
| Software development planning | X | X | X |
| Software requirements analysis | X | X | X |
| Software architectural design | X | X | |
| Software detailed design | X | ||
| Software unit implementation | X | X | X |
| Software unit verification | X | X | |
| Software integration and integration testing | X | X | |
| Software system testing | X | X | X |
| Software release | X | X | X |
| X - required | |||
Software maintenance process[edit]
- Establish software maintenance plan
- Problem and modification analysis
- Modification implementation
Software risk management process[edit]
- Analysis of software contributing to hazardous situations
- Risk control measures
- Verification of risk control measures
- Risk management of software changes
- Security and reliability through software quality
Software configuration management process[edit]
- Configuration identification
- Change control
- Configuration status accounting
Software problem resolution process[edit]
- Prepare problem reports
- Investigate the problem
- Advise relevant parties
- Use change control process
- Maintain records
- Analyse problems for trends
- Verify software problem resolution
- Test documentation contents
See also[edit]
- International Electrotechnical Commission (IEC)
- List of IEC standards
- IEC 60601
- ISO 14971
- ISO 13485
- ISO 9001
- International Standards for automating the software structural quality
- Time-triggered system (a software architecture that is used in many safety-critical systems)
References[edit]
- ^ International Electrotechnical Commission (2006). "Medical device software – Software life cycle processes" (PDF). INTERNATIONAL IEC STANDARD 62304 First edition 2006-05. International Electrotechnical Commission. Retrieved 2 June 2012.
- ^ "Medical devices - European standards - Enterprise and Industry". 2012-11-04. Archived from the original on 2012-11-04. Retrieved 2018-07-26.
- ^ Staff (20 August 2012). "Recognized Consensus Standards". FDA US Food and Drug Administration. US Department of Health & Human Services. Retrieved 26 January 2015.
- ^ Hall, Ken (June 1, 2010). "Developing Medical Device Software to IEC 62304". EMDT - European Medical Device Technology. Retrieved 2012-12-11.
- ^ "IEC 62304:2006(en) Medical device software — Software life cycle processes". ISO. 2006. Retrieved 15 June 2017.
- ^ "Developing Medical Device Software to IEC 62304 | MDDI Medical Device and Diagnostic Industry News Products and Suppliers". www.mddionline.com. June 2010. Retrieved 2017-06-15.
External links[edit]
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