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

Description

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.

Attributes

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:
http://extensions.polarion.com/extensions/31-polarion-alm-medpack-iec-62304I hope you liked this article and you will visit our Blog again when there is another Morris Medical Monday article.

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