IEC 62304 | ||||
Reference | Software Lifecycle Process | Applicable for | ||
Class | Class | Class | ||
| PRIMARY LIFECYCLE PROCESESS |
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5 | SOFTWARE DEVELOPMENT Process |
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5.1 | Development Planning Activity |
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5.1.1 | Software development plan task | X | X | X |
5.1.2 | Software development plan reference to SYSTEM requirements task | X | X | X |
5.1.3 | SOUP management planning task |
| X | X |
5.1.4 | Software development measures planning task |
| X | X |
5.1.5 | Software integration and integration testing planning task |
| X | X |
5.1.6 | Software VERIFICATION planning task | X | X | X |
5.1.7 | Software VERIFICATION requirements coverage planning task |
| X | X |
5.1.8 | Software RISK MANAGEMENT planning task | X | X | X |
5.1.9 | Documentation planning task | X | X | X |
5.1.10 | Software configuration management planning task | X | X | X |
5.1.11 | Software configuration control planning task |
| X | X |
5.1.12 | Software problem resolution planning task |
|
| X |
5.2 | Requirements Analysis Activity |
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5.2.1 | Define software requirements from SYSTEM requirements task | X | X | X |
5.2.2 | Establish software requirements task | X | X | X |
5.2.3 | Software requirements content task | X | X | X |
5.2.4 | Include RISK CONTROL measures in software requirements task |
| X | X |
5.2.5 | Update RISK ANALYSIS task | X | X | X |
5.2.6 | Ensure compliance with SYSTEM requirements task | X | X | X |
5.2.7 | Uniquely identify software requirements task | X | X | X |
5.2.8 | Update SYSTEM requirements task | X | X | X |
5.2.9 | Verify software requirements task | X | X | X |
5.2.10 | Document software requirements VERIFICATION task | X | X | X |
5.3 | Architectural Design Activity |
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5.3.1 | Transform software requirements into an ARCHITECTURE task | X | X | X |
5.3.2 | Document software ARCHITECTURE task | X | X | X |
5.3.3 | Document software safety classification of each SOFTWARE ITEM task | X | X | X |
5.3.4 | Develop an ARCHITECTURE for the interfaces of SOFTWARE ITEMS task |
| X | X |
5.3.5 | Specify SYSTEM hardware and software required by SOUP item task |
| X | X |
5.3.6 | Specify functional and performance requirements of SOUP item task |
| X | X |
5.3.7 | Identify segregation necessary for SAFETY task |
| X | X |
5.3.8 | Verify software ARCHITECTURE task |
| X | X |
5.3.9 | Verify appropriateness of software development plan task |
| X | X |
5.3.10 | Document results of software ARCHITECTURE VERIFICATION task |
| X | X |
5.4 | Detailed Design Activity |
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5.4.1 | Refine SOFTWARE ITEMS into SOFTWARE UNITS task |
| X | X |
5.4.2 | Inheritance of software safety classification task |
| X | X |
5.4.3 | Develop detailed design for each SOFTWARE UNIT task |
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| X |
5.4.4 | Develop detailed design for interfaces task |
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| X |
5.4.5 | Verify detailed design task |
| X | X |
5.4.6 | Additional detailed design VERIFICATION task |
|
| X |
5.4.7 | Document results of design VERIFICATION task |
| X | X |
5.5 | Software Coding Activity |
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5.5.1 | Implement each SOFTWARE UNIT task |
| X | X |
5.5.2 | Establish SOFTWARE UNIT VERIFICATION PROCESS task |
| X | X |
5.5.3 | Verify software code task |
| X | X |
5.5.4 | Additional software code VERIFICATION task |
| X | X |
5.5.5 | Document the results of software code VERIFICATION task |
| X | X |
5.6 | Integration and Testing Activity |
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5.6.1 | Integrate SOFTWARE UNITS task |
| X | X |
5.6.2 | Verify software integration task |
| X | X |
5.6.3 | Document the results of software integration task |
| X | X |
5.5.4 | Additional software code VERIFICATION task |
| X | X |
5.6.5 | Integration testing content task |
| X | X |
5.6.6 | Include integration testing for non-normal cases task |
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| X |
5.6.7 | Conduct regression tests task |
| X | X |
5.6.8 | Document results of software integration tests task |
| X | X |
5.6.9 | Integration test documentation contents task |
| X | X |
5.6.10 | Use formal software problem resolution PROCESS task |
| X | X |
5.7 | System Testing Activity |
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5.7.1 | Establish tests for each software requirement task |
| X | X |
5.7.2 | Use formal software problem resolution PROCESS task |
| X | X |
5.7.3 | Repeat tests and conduct regression tests task |
| X | X |
5.7.4 | Verify SOFTWARE SYSTEM testing task |
| X | X |
5.7.5 | Record data for each test task |
| X | X |
5.8 | Release Activity |
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5.8.1 | Ensure software VERIFICATION is complete |
| X | X |
5.8.2 | Ensure documentation is complete |
| X | X |
5.8.3 | Document known residual anomalies |
| X | X |
5.8.4 | Evaluate known residual anomalies |
| X | X |
5.8.5 | Document released VERSIONS |
| X | X |
5.8.6 | Document how released software was created |
| X | X |
5.8.7 | Archive master copies |
| X | X |
5.8.8 | Use established procedures for software release |
| X | X |
6 | SOFTWARE MAINTENANCE Process |
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6.1 | Establish software maintenance plan Activity |
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6.1.1 | Establish software maintenance plan task | X | X | X |
6.2 | Problem and Modification Analysis Activity |
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6.2.1 | Record and evaluate feedback task | X | X | X |
6.2.2 | Use software problem resolution PROCESS task | X | X | X |
6.2.3 | Analyse modification requests task | X | X | X |
6.2.4 | Conduct analysis of changes implied by modification request task | X | X | X |
6.2.5 | Document new, modified and deleted item task | X | X | X |
6.2.6 | Review and approve modification task | X | X | X |
6.2.7 | Document modification task |
| X | X |
6.3 | Modification Implementation Activity |
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6.3.1 | Use established PROCESS to implement modification task | X | X | X |
6.3.2 | Define criteria for testing modifications task |
| X | X |
6.3.3 | Verify modifications task |
| X | X |
6.3.4 | Conduct regression testing task |
| X | X |
6.3.5 | Demonstrate software RISK CONTROL measures remain effective task |
| X | X |
6.3.6 | Document the test results task |
| X | X |
see 5.3 | Architectural Design Activity |
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see 5.4 | Detailed Design Activity |
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see 5.5 | Software Coding Activity |
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see 5.6 | Integration and Testing Activity |
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see 5.7 | System Testing Activity |
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see 5.8 | Release Activity |
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| SUPPORTING PROCESSES |
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7 | SOFTWARE RISK MANAGEMENT Process (referenced ISO 14971) |
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7.1 | Analysis of software contributing to HAZARDS Activity |
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7.1.1 | Identify SOFTWARE ITEMS that could contribute to a HAZARD task |
| X | X |
7.1.2 | Identify potential causes of contribution to a HAZARD task |
| X | X |
7.1.3 | Consider specific potential causes task |
| X | X |
7.1.4 | Review published SOUP anomaly lists task |
| X | X |
7.1.5 | Document potential causes task |
| X | X |
7.1.6 | Document sequences of events task |
| X | X |
7.2 | RISK CONTROL measures Activity |
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7.2.1 | Define RISK CONTROL measures task |
| X | X |
7.2.2 | RISK CONTROL measures implemented in software task |
| X | X |
7.3 | VERIFICATION of RISK CONTROL measures Activity |
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7.3.1 | Verify RISK CONTROL measures task |
| X | X |
7.3.2 | Document any new sequences of events task |
| X | X |
7.3.3 | Document TRACEABILITY task |
| X | X |
7.4 | RISK MANAGEMENT of software changes Activity |
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7.4.1 | Analyse changes TO MEDICAL DEVICE SOFTWARE with respect to safety task | X | X | X |
7.4.2 | Analyse impact software changes on existing RISK CONTROL measures task |
| X | X |
7.4.3 | Perform RISK MANAGEMENT ACTIVITIES based on analyses task |
| X | X |
8 | SOFTWARE CONFIGURATION MANAGEMENT Process |
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8.1 | Configuration identification Activity |
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8.1.1 | Establish means to identify CONFIGURATION ITEMS task | X | X | X |
8.1.2 | Identify SOUP task | X | X | X |
8.1.3 | Document SOUP designator task | X | X | X |
8.1.4 | Identify SYSTEM configuration documentation task | X | X | X |
8.2 | Configuration control Activity |
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8.2.1 | Identify and record change requests task | X | X | X |
8.2.2 | Approve requests prior to implementation task | X | X | X |
8.2.3 | Implement changes task | X | X | X |
8.2.4 | Provide means for TRACEABILITY of change task | X | X | X |
8.3 | Configuration status accounting Activity |
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8.3.1 | Configuration status accounting task | X | X | X |
9 | SOFTWARE PROBLEM RESOLUTION Process |
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| SOFTWARE PROBLEM RESOLUTION Activity |
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9.1.1 | Prepare problem reports task | X | X | X |
9.1.2 | Advise relevant parties task | X | X | X |
9.1.3 | Investigate the problem task | X | X | X |
9.1.4 | Evaluate the problem's relevance to safety task | X | X | X |
9.1.5 | Track and report status task | X | X | X |
9.1.6 | Resolve the problem task | X | X | X |
9.1.7 | Maintain a record of the problem task | X | X | X |
9.1.8 | Analyse problems for trends task | X | X | X |
9.1.9 | Verify task | X | X | X |
IEC_62304_CheckList
最新推荐文章于 2021-03-01 22:48:42 发布