IEC 62304 Items by Class

SectionTitleClass AClass BClass C
4General requirementsYYY
4.1Quality management systemYYY
4.2Risk managementYYY
4.3Software safety classificationYYY
4.4Legacy software (not applicable unless you have legacy software)YYY
4.4.2Risk management activitiesYYY
4.4.3Gap analysisYYY
4.4.4Gap closure activitiesYYY
4.4.5Rational for use of legacy softwareYYY
5Software development process
5.1Software development planning
5.1.4Software development standards, methods and tool planningY
5.1.5Software integration and integration test planningYY
5.1.10Supporting items to be controlledYY
5.1.11Software configuration item control before verificationYY
5.1.12Identification and avoidance of common software defectsYY
5.2Software requirements analysis
5.2.3Include risk control measures in software requirementsYY
5.3Software architectural design
5.3.1Transform software requirements into an architectureYY
5.3.2Develop an architecture for the interfaces of software itemsYY
5.3.3Specify functional and performance requirements of SOUP itemYY
5.3.4Specify system hardware and software required by SOUP itemYY
5.3.5Identify segregation necessary for risk controlY
5.3.6Verify software architectureYY
5.4Software detailed design
5.4.1Subdivide software into software unitsYY
5.4.2Develop detailed design for each software unitY
5.4.3Develop detailed design for interfacesY
5.4.4Verify detailed designY
5.5Software unit implementation
5.5.2Establish software unit verification processYY
5.5.3Software unit acceptance criteriaYY
5.5.4Additional software unit acceptance criteriaY
5.5.5Software unit verificationYY
5.6Software integration and integration testing
5.6.1Integrate software unitsYY
5.6.2Verify software integrationYY
5.6.3Software integration testingYY
5.6.4Software integration testing contentYY
5.6.5Evaluate software integration test proceduresYY
5.6.6Conduct regression testsYY
5.6.7Integration test record contentsYY
5.6.8Use software problem resolution processYY
5.7Software system testing
5.8Software release for utilization at a system level
5.8.3Evaluate known residual anomaliesYY
5.8.5Document how released software was createdYY
5.8.6Ensure activities and tasks are completeYY
6Software maintenance process
6.2Problem and modification analysis
6.2.1Document and evaluate feedback
6.3Modification implementation
7Software risk management process
7.1Analysis of software contributing to hazardous situations
7.1.1Identify software items that could contribute to a hazardous situationYY
7.1.2Identify potential causes of contribution to a hazardous situationYY
7.1.3Evaluate published SOUP anomaly listsYY
7.1.4Document potential causesYY
7.2Risk control measures
7.2.1Define risk control measuresYY
7.2.2Risk control measures implemented in softwareYY
7.3Verification of risk control measures
7.3.1Verify risk control measuresYY
7.3.2(Not used)
7.3.3Document traceabilityYY
7.4Risk management of software changes
7.4.2Analyse impact of software changes on existing risk control measuresYY
7.4.3Perform risk management activities based on analysesYY
8Software configuration management process
8.1Configuration identification
8.2Change control
9Software problem resolution process
5.1.1Software development planYYY
5.1.2Keep software development plan updateYYY
5.1.3Software development plan reference to system design and developmentYYY
5.1.6Software verification planningYYY
5.1.7Software risk management planningYYY
5.1.8Documentation planningYYY
5.1.9Software configuration management planningYYY
5.2.1Define and document software requirements from system requirementsYYY
5.2.2Software requirements contentYYY
5.2.4Re-evaluate medical device risk analysisYYY
5.2.5Update requirementsYYY
5.2.6Verify software requirementsYYY
5.5.1Implement each software unitYYY
5.7.1Establish tests for software requirementsYYY
5.7.2Use software problem resolution processYYY
5.7.3Retest after changesYYY
5.7.4Evaluate software system testingYYY
5.7.5Software system test record contentsYYY
5.8.1Ensure software verification is completeYYY
5.8.2Document known residual anomaliesYYY
5.8.4Document released versionsYYY
5.8.7Archive softwareYYY
5.8.8Assure reliable delivery of released softwareYYY
6.1Establish a software maintenance planYYY feedbackYYY and evaluate feedbackYYY problem report’s effects on safetyYYY
6.2.2Use software problem resolution processYYY
6.2.3Analyse change requestsYYY
6.2.4Change request approvalYYY
6.2.5Communicate to users and regulatorsYYY
6.3.1Use established process to implement modificationYYY
6.3.2Re-release modified software systemYYY
7.4.1Analyse changes to medical device software with respect to safetyYYY
8.1.1Establish means to identify configuration itemsYYY
8.1.2Identify SOUPYYY
8.1.3Identify system configuration documentationYYY
8.2.1Approve change requestsYYY
8.2.2Implement changesYYY
8.2.3Verify changesYYY
8.2.4Provide means for traceability of changeYYY
8.3Configuration status accountingYYY
9.1Prepare problem reportsYYY
9.2Investigate the problemYYY
9.3Advise relevant partiesYYY
9.4Use change control processYYY
9.5Maintain recordsYYY
9.6Analyse problems for trendsYYY
9.7Verify software problem resolutionYYY