The international standard IEC 62304 - medical device software - software life cycle processes 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) and the United States (US), and therefore can be used as a benchmark to comply with regulatory requirements from both these markets.
Video IEC 62304
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.
Maps IEC 62304
Contents
General requirements
- Quality management system
- Risk management
- Software safety classification
Software development process
- 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
Software maintenance process
- Establish software maintenance plan
- Problem and modification analysis
- Modification implementation
Software risk management process
- Analysis of software contributing to hazardous situations
- Risk control measures
- Verification of risk control measures
- Risk management of software changes
- Security and reliability thru Software quality
Software configuration management process
Software problem resolution process
See also
- 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
External links
- "IEC 62304" at International Electrotechnical Commission
Source of article : Wikipedia
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