IEC 62304

IEC 62304 – medical device software – software life cycle processes^[1] is an international standard published by the International Electrotechnical Commission (IEC). The standard specifies life cycle requirements for the development of medical software and software within medical devices. It has been adopted as national standards and therefore can be used as a benchmark to comply with regulatory requirements.

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.^[2]

Source:^[3]

• Quality management system
• Risk management
• Software safety classification

• 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

• Establish software maintenance plan
• Problem and modification analysis
• Modification implementation

• 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

• Configuration identification
• Change control
• Configuration status accounting

• 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

• International Electrotechnical Commission (IEC)
• List of IEC standards
• IEC 60601 - safety and essential performance of medical electrical equipment
• ISO 14971 — application of risk management to medical devices
• ISO 13485 — medical devices, quality management systems: requirements for regulatory purposes
• ISO 9001 — quality management systems: requirements
• International Standards for automating the software structural quality
• Therac-25 a computer-controlled radiation therapy machine which was one prompt for IEC 62304
• Time-triggered system (a software architecture that is used in many safety-critical systems)

• "IEC 62304" at International Electrotechnical Commission

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