Morris Medical Monday: Work Item Type "Integration Test"

By morrisd

Welcome back to Morris Medical Monday: a weekly series for medical device development companies (and companies who are related to such companies), providing some useful information about Polarion solutions and Polarion extensions.

Today we will continue on the subject of Polarion’s MedPack extension, and have a look into MedPack’s Integration Test Work Item type.

Integration Test


An integration test description according to clause 5.6.3 of the IEC 62304:2006. Any issue of this type either describes the test completely or links to test procedure descriptions or code to perform the test. It must be linked to the software item(s) and software unit(s) covered by the test. Integration tests must only be performed in case of a class B or class C project.

Workflow Steps

The Integration Test Work Item uses the standard Full Workflow.


Traceability & Impact

An Integration Test Work Item must be traceable to a Software System Work Item, a Software Item Work Item or a SOUP Work Item. It can also be traceable to a Software Unit Work Item. It has an impact on a Anomaly Work Item.
For more information on traceability and impacts, see the Traceability wiki page.


Work Item Attributes

The following custom fields must be filled out before verification can be requested:

Attribute Name Type Description
Test type/content Enum A Integration Test has to be classify in the the following Test type/content:
– Required functionality of the software
– Implementation of Risk Control measures
– Specific timing and other behaviour
– Specific functioning of internal and external interfaces
– Testing under abnormal conditions including foreseeable misuse
(as required by IEC 62304:2006->5.6.4 NOTE1).
Pass/Fail criteria according to test type Text (as required by IEC 62304:2006->5.6.4).
Tester String (as required by IEC 62304:2006->5.6.7c/9.8g).
Relevant test tool(s) used Text (as required by IEC 62304:2006->9.8e).
Test parameters to ensure repeatability Text (as required by IEC 62304:2006->5.6.7b NOTE /9.8d ).

Verification/Evaluation Attributes

The following custom fields must be filled out before verification/evaluation can be finshed and the work item can be closed:

Attribute Name Type Description
Reviewer Text Person(s) to perform, performing or have performed a review.
Review summary Text Short summary of the review. Attachments should be used for additional information.
Last review date Date Hidden field automatically set when review has been finshed. Intended to be used for sorting and statistical analysis.

Evaluation Checklist

The following checklist must be filled out before evaluation can be finshed and the work item can be closed:

Checklist entry Description
Integration has been performed in accordance with the integration plan (as required by IEC 62304:2006->5.6.1/5.6.2a ).
All items have been integrated into the system All hardware items, software items and support for manual operations of the system have been integrated into the system (as required by IEC 62304:2006->5.6.2b ).
Test passed (as required by IEC 62304:2006->5.6.7a ).

Possible Resolutions

The following table shows the possible resolution values when the work item is closed:

Resolution Name Description
Done The integration test has been executed and successfully evaluated.
Obsolete The integration test has become obsolete and is no longer needed.
Discarded The work item entry has been discarded. No further attention is needed.


For more information about Polarion’s MedPack visit our Extension Portal using following link: hope you liked this article and you will visit our Blog again when there is another Morris Medical Monday article.

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This article first appeared on the Siemens Digital Industries Software blog at