IEC_62304_CheckList
IEC |
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Reference |
Software Lifecycle |
Applicable |
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Class |
Class |
Class |
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|
PRIMARY |
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5 |
SOFTWARE |
|
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5.1 |
Development Planning |
|
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|
5.1.1 |
Software |
X |
X |
X |
5.1.2 |
Software |
X |
X |
X |
5.1.3 |
SOUP management |
|
X |
X |
5.1.4 |
Software |
|
X |
X |
5.1.5 |
Software |
|
X |
X |
5.1.6 |
Software |
X |
X |
X |
5.1.7 |
Software |
|
X |
X |
5.1.8 |
Software RISK |
X |
X |
X |
5.1.9 |
Documentation |
X |
X |
X |
5.1.10 |
Software |
X |
X |
X |
5.1.11 |
Software |
|
X |
X |
5.1.12 |
Software problem |
|
|
X |
5.2 |
Requirements Analysis |
|
|
|
5.2.1 |
Define software |
X |
X |
X |
5.2.2 |
Establish |
X |
X |
X |
5.2.3 |
Software |
X |
X |
X |
5.2.4 |
Include RISK |
|
X |
X |
5.2.5 |
Update RISK |
X |
X |
X |
5.2.6 |
Ensure |
X |
X |
X |
5.2.7 |
Uniquely |
X |
X |
X |
5.2.8 |
Update SYSTEM |
X |
X |
X |
5.2.9 |
Verify software |
X |
X |
X |
5.2.10 |
Document |
X |
X |
X |
5.3 |
Architectural Design |
|
|
|
5.3.1 |
Transform |
X |
X |
X |
5.3.2 |
Document |
X |
X |
X |
5.3.3 |
Document |
X |
X |
X |
5.3.4 |
Develop an |
|
X |
X |
5.3.5 |
Specify SYSTEM |
|
X |
X |
5.3.6 |
Specify |
|
X |
X |
5.3.7 |
Identify |
|
X |
X |
5.3.8 |
Verify software |
|
X |
X |
5.3.9 |
Verify |
|
X |
X |
5.3.10 |
Document results |
|
X |
X |
5.4 |
Detailed |
|
|
|
5.4.1 |
Refine SOFTWARE |
|
X |
X |
5.4.2 |
Inheritance of |
|
X |
X |
5.4.3 |
Develop detailed |
|
|
X |
5.4.4 |
Develop detailed |
|
|
X |
5.4.5 |
Verify detailed |
|
X |
X |
5.4.6 |
Additional |
|
|
X |
5.4.7 |
Document results |
|
X |
X |
5.5 |
Software |
|
|
|
5.5.1 |
Implement each |
|
X |
X |
5.5.2 |
Establish |
|
X |
X |
5.5.3 |
Verify software |
|
X |
X |
5.5.4 |
Additional |
|
X |
X |
5.5.5 |
Document the |
|
X |
X |
5.6 |
Integration and Testing |
|
|
|
5.6.1 |
Integrate |
|
X |
X |
5.6.2 |
Verify software |
|
X |
X |
5.6.3 |
Document the |
|
X |
X |
5.5.4 |
Additional |
|
X |
X |
5.6.5 |
Integration |
|
X |
X |
5.6.6 |
Include |
|
|
X |
5.6.7 |
Conduct |
|
X |
X |
5.6.8 |
Document results |
|
X |
X |
5.6.9 |
Integration test |
|
X |
X |
5.6.10 |
Use formal |
|
X |
X |
5.7 |
System |
|
|
|
5.7.1 |
Establish tests |
|
X |
X |
5.7.2 |
Use formal |
|
X |
X |
5.7.3 |
Repeat tests and |
|
X |
X |
5.7.4 |
Verify SOFTWARE |
|
X |
X |
5.7.5 |
Record data for |
|
X |
X |
5.8 |
Release |
|
|
|
5.8.1 |
Ensure software |
|
X |
X |
5.8.2 |
Ensure |
|
X |
X |
5.8.3 |
Document known |
|
X |
X |
5.8.4 |
Evaluate known |
|
X |
X |
5.8.5 |
Document |
|
X |
X |
5.8.6 |
Document how |
|
X |
X |
5.8.7 |
Archive master |
|
X |
X |
5.8.8 |
Use established |
|
X |
X |
6 |
SOFTWARE |
|
|
|
6.1 |
Establish software |
|
|
|
6.1.1 |
Establish |
X |
X |
X |
6.2 |
Problem |
|
|
|
6.2.1 |
Record and |
X |
X |
X |
6.2.2 |
Use software |
X |
X |
X |
6.2.3 |
Analyse |
X |
X |
X |
6.2.4 |
Conduct analysis |
X |
X |
X |
6.2.5 |
Document new, |
X |
X |
X |
6.2.6 |
Review and |
X |
X |
X |
6.2.7 |
Document |
|
X |
X |
6.3 |
Modification |
|
|
|
6.3.1 |
Use established |
X |
X |
X |
6.3.2 |
Define criteria |
|
X |
X |
6.3.3 |
Verify |
|
X |
X |
6.3.4 |
Conduct |
|
X |
X |
6.3.5 |
Demonstrate |
|
X |
X |
6.3.6 |
Document the |
|
X |
X |
see |
Architectural Design |
|
|
|
see |
Detailed |
|
|
|
see |
Software |
|
|
|
see |
Integration and Testing |
|
|
|
see |
System |
|
|
|
see |
Release |
|
|
|
|
SUPPORTING |
|
|
|
7 |
SOFTWARE |
|
|
|
7.1 |
Analysis |
|
|
|
7.1.1 |
Identify |
|
X |
X |
7.1.2 |
Identify |
|
X |
X |
7.1.3 |
Consider |
|
X |
X |
7.1.4 |
Review published |
|
X |
X |
7.1.5 |
Document |
|
X |
X |
7.1.6 |
Document |
|
X |
X |
7.2 |
RISK |
|
|
|
7.2.1 |
Define RISK |
|
X |
X |
7.2.2 |
RISK CONTROL |
|
X |
X |
7.3 |
VERIFICATION of RISK |
|
|
|
7.3.1 |
Verify RISK |
|
X |
X |
7.3.2 |
Document any new |
|
X |
X |
7.3.3 |
Document |
|
X |
X |
7.4 |
RISK |
|
|
|
7.4.1 |
Analyse changes |
X |
X |
X |
7.4.2 |
Analyse impact |
|
X |
X |
7.4.3 |
Perform RISK |
|
X |
X |
8 |
SOFTWARE |
|
|
|
8.1 |
Configuration |
|
|
|
8.1.1 |
Establish means |
X |
X |
X |
8.1.2 |
Identify SOUP |
X |
X |
X |
8.1.3 |
Document SOUP |
X |
X |
X |
8.1.4 |
Identify SYSTEM |
X |
X |
X |
8.2 |
Configuration control |
|
|
|
8.2.1 |
Identify and |
X |
X |
X |
8.2.2 |
Approve requests |
X |
X |
X |
8.2.3 |
Implement |
X |
X |
X |
8.2.4 |
Provide means |
X |
X |
X |
8.3 |
Configuration status |
|
|
|
8.3.1 |
Configuration |
X |
X |
X |
9 |
SOFTWARE |
|
|
|
|
SOFTWARE |
|
|
|
9.1.1 |
Prepare problem |
X |
X |
X |
9.1.2 |
Advise relevant |
X |
X |
X |
9.1.3 |
Investigate the |
X |
X |
X |
9.1.4 |
Evaluate the |
X |
X |
X |
9.1.5 |
Track and report |
X |
X |
X |
9.1.6 |
Resolve the |
X |
X |
X |
9.1.7 |
Maintain a |
X |
X |
X |
9.1.8 |
Analyse problems |
X |
X |
X |
9.1.9 |
Verify |
X |
X |
X |
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