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.
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.
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:
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
(as required by IEC 62304:2006->5.6.4).
(as required by IEC 62304:2006->5.6.7c/9.8g).
Relevant test tool(s) used
(as required by IEC 62304:2006->9.8e).
Test parameters to ensure repeatability
(as required by IEC 62304:2006->5.6.7b NOTE /9.8d ).
The following custom fields must be filled out before verification/evaluation can be finshed and the work item can be closed:
Person(s) to perform, performing or have performed a review.
Short summary of the review. Attachments should be used for additional information.
Last review date
Hidden field automatically set when review has been finshed. Intended to be used for sorting and statistical analysis.
The following checklist must be filled out before evaluation can be finshed and the work item can be closed:
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 ).
(as required by IEC 62304:2006->5.6.7a ).
The following table shows the possible resolution values when the work item is closed:
The integration test has been executed and successfully evaluated.
The integration test has become obsolete and is no longer needed.
The work item entry has been discarded. No further attention is needed.