IEC 62304

Applicable for Reference Software Lifecycle Process Class Class Class A B C SOP

PRIMARY LIFECYCLE PROCESESS

5 5.1 5.1.1 5.1.2 5.1.3 5.1.4 5.1.5 5.1.6 5.1.7 5.1.8 5.1.9 5.1.10 5.1.11 5.2 5.2.1 5.2.2 5.2.3 5.2.4 5.2.5 5.2.6 5.3 5.3.1 5.3.2 5.3.3 5.3.4 5.3.5 5.3.6 5.4 5.4.1 5.4.2 5.4.3 5.4.4 5.5 SOFTWARE DEVELOPMENT Process Development Planning Activity Software development plan task Software Development Plan Maintenance Software development plan reference to SYSTEM requirements task Software development standard, methods and tools task Software integration and integration testing planning task Software VERIFICATION planning task Software RISK MANAGEMENT planning task Documentation planning task Software configuration management planning task Supporting Item Control task Software Controlled before Verification Requirements Analysis Activity Define software requirements from SYSTEM requirements task Software requirements content task Include RISK CONTROL measures in software requirements task Update RISK ANALYSIS task Update SYSTEM requirements task Verify software requirements task Architectural Design Activity Transform software requirements into an ARCHITECTURE task Develop an ARCHITECTURE for the interfaces of SOFTWARE ITEMS task Specify functional and performance requirements of SOUP item task Specify SYSTEM hardware and software required by SOUP item task Identify segregation necessary for SAFETY task Verify software ARCHITECTURE task Detailed Design Activity Refine SOFTWARE ITEMS into SOFTWARE UNITS task Develop detailed design for each SOFTWARE UNIT task Develop detailed design for interfaces task Verify detailed design task Software Coding Activity X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

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5.5.1 5.5.2 5.5.3 5.5.4 5.5.5 5.6 5.6.1 5.6.2 5.6.3 5.6.4 5.6.5 5.6.6 5.6.7 5.6.8 5.7 5.7.1 5.7.2 5.7.3 5.7.4 5.7.5 5.8 5.8.1 5.8.2 5.8.3 5.8.4 5.8.5 5.8.6 5.8.7 5.8.8 6 6.1 6.2 6.2.1 6.2.1.1 6.2.1.2 6.2.1.3 6.2.2 6.2.3 6.2.4 6.2.5

Implement each SOFTWARE UNIT task Establish SOFTWARE UNIT VERIFICATION PROCESS task SOFTWARE UNIT acceptance criteria task Additional software code acceptance criteria task Software unit verification Integration and Testing Activity Integrate SOFTWARE UNITS task Verify software integration task Test Integrated Software task Integration testing content task Verify integration test procedures task Conduct regression tests task Integration test record contents task Use software problem resolution PROCESS task System Testing Activity Establish tests for software requirements task Use software problem resolution PROCESS task Retest after changes task Verify SOFTWARE SYSTEM testing task SOFTWARE SYSTEM test record contents task Software Release Activity Ensure software VERIFICATION is complete task Document known residual anomalies task Evaluate known residual anomalies task Document released VERSIONS task Document how released software was created task Ensure activities and tasks are complete task Archive software task Assure repeatability of software release task SOFTWARE MAINTENANCE Process Establish software maintenance plan task Problem and Modification Analysis Activity Document and evaluate feedback task Monitor feedback task Document and evaluate feedback task Evaluate PROBLEM REPORTS affects on SAFETY task Use software problem resolution PROCESS task Analyze change requests task Change request approval task Communicate to users and regulators task

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6.3 6.3.1 6.3.2 see 5.3 see 5.4 see 5.5 see 5.6 see 5.7 see 5.8 7 7.1 7.1.1 7.1.2 7.1.3 7.1.4 7.1.5 7.2 7.2.1 7.2.2 7.3 7.3.1 7.3.2 7.3.3 7.4 7.4.1 7.4.2 7.4.3 8 8.1 8.1.1 8.1.2 8.1.3 8.2 8.2.1 8.2.2 8.2.3 8.2.4 8.3 8.3.1

Modification Implementation Activity Use established PROCESS to implement modification task Re-release modified SOFTWARE SYSTEM task Architectural Design Activity Detailed Design Activity Software Coding Activity Integration and Testing Activity System Testing Activity Release Activity

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SUPPORTING PROCESSES
SOFTWARE RISK MANAGEMENT Process (referenced ISO 14971) Analysis of software contributing to hazardous situations Activity Identify SOFTWARE ITEMS that could contribute to a hazardous situation task Identify potential causes of contribution to a hazardous situation task Review published SOUP anomaly lists task Document potential causes task Document sequences of events task RISK CONTROL measures Activity Define RISK CONTROL measures task RISK CONTROL measures implemented in software task VERIFICATION of RISK CONTROL measures Activity Verify RISK CONTROL measures task Document any new sequences of events task Document TRACEABILITY task RISK MANAGEMENT of software changes Activity Analyze changes TO MEDICAL DEVICE SOFTWARE with respect to safety task Analyze impact software changes on existing RISK CONTROL measures task Perform RISK MANAGEMENT ACTIVITIES based on analyses task SOFTWARE CONFIGURATION MANAGEMENT Process Configuration identification Activity Establish means to identify CONFIGURATION ITEMS task Identify SOUP task Identify SYSTEM configuration documentation task Change control Activity Approve Change requests task Implement changes task Verify changes task Provide means for TRACEABILITY of change task Configuration status accounting Activity Configuration status accounting task X X X X X X X X X X X X X X X X X X X X X X X X X X X

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9 9.1 9.2 9.3 9.4 9.5 9.6 9.7 9.8

SOFTWARE PROBLEM RESOLUTION Process Prepare problem reports activity Investigate the problem activity Advise relevant parties activity Use change control process activity Maintain records activity Analyze problems for trends activity Verify software problem resolution activity Test documentation contents task

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Section