IEC_62304_CheckList

IEC 62304

Reference

Software Lifecycle Process

Applicable for

Class
A

Class
B

Class
C

　  

PRIMARY LIFECYCLE PROCESESS

　  

　  

　  

5

SOFTWARE DEVELOPMENT Process

　  

　  

　  

5.1

Development Planning Activity

　  

　  

　  

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

　  

　  

　  

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

　  

　  

　  

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

　  

　  

　  

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

　  

　  

X

5.4.4

Develop detailed design for interfaces task

　  

　  

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

　  

　  

　  

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

　  

　  

　  

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

　  

　  

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

　  

　  

　  

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

　  

　  

　  

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

　  

　  

　  

6.1

Establish software maintenance plan Activity

　  

　  

　  

6.1.1

Establish software maintenance plan task

X

X

X

6.2

Problem and Modification Analysis Activity

　  

　  

　  

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

　  

　  

　  

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

　  

　  

　  

see 5.4

Detailed Design Activity

　  

　  

　  

see 5.5

Software Coding Activity

　  

　  

　  

see 5.6

Integration and Testing Activity

　  

　  

　  

see 5.7

System Testing Activity

　  

　  

　  

see 5.8

Release Activity

　  

　  

　  

　  

SUPPORTING PROCESSES

　  

　  

　  

7

SOFTWARE RISK MANAGEMENT Process (referenced ISO 14971)

　  

　  

　  

7.1

Analysis of software contributing to HAZARDS Activity

　  

　  

　  

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

　  

　  

　  

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

　  

　  

　  

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

　  

　  

　  

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

　  

　  

　  

8.1

Configuration identification Activity

　  

　  

　  

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

　  

　  

　  

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

　  

　  

　  

8.3.1

Configuration status accounting task

X

X

X

9

SOFTWARE PROBLEM RESOLUTION Process

　  

　  

　  

　  

SOFTWARE PROBLEM RESOLUTION Activity

　  

　  

　  

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
posted @ 2016-01-02 12:10  peapon  阅读(251)  评论(0)  编辑  收藏  举报