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.

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.^[2]

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 through software quality

Software configuration management process

• Configuration identification
• Change control
• Configuration status accounting

Software problem resolution process

• 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