IEC 62304:2015 Medical Device Software Lifecycle Processes
Clause 5: software development process – IEC 62304:2015 Medical Device Software Lifecycle Processes

IEC 62304:2015 Medical Device Software Lifecycle Processes 5.7.5: 5.7.5 Software system test record contents

To support repeatability, the system test record documents a reference to the test case procedures with actions and expected results, the test result with anomalies, the version of software tested, the relevant hardware and software configurations, the test tools, the date, and the identity of the person who executed the test and recorded the results. Applies to classes A, B and C.

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