Does IEC 62304 require documenting unresolved anomalies for all safety classes?

[snoopy2017]

Hi everyone,

Does IEC 62304 require documenting unresolved anomalies for all safety classes?

 

[yodon]

The standard only requires, for software release, documenting known residual anomalies for class B and C.

To me, though, it seems only logical to document known anomalies so you can tell your customers what issues there are. That won't stop them from (re-)reporting them.

 

[TomaszPuk]

When looking at the new IEC 62304:2018 standard version (still in draft) it states that anomalies shall be recorded in the following cases:

5.6.7 Integration test record contents (anomalies) - Class B, C
5.7.5 Software SYSTEM test record contents (anomalies) - Class A, B, C
5.8.2 Document known residual anomalies - Class A, B, C
5.8.3 Evaluate known residual anomalies - Class B, C
7.1.3 Evaluate published SOUP Anomaly list - Class B, C
9.8 Test documentation contents (anomalies) - Class A, B, C

Thus, I would argue to document anomalies for any software safety classification. but evaluate them for at least Classes B and C.
Personally, I would suggest to document them all

 

[MrTetris]

The standard only requires, for software release, documenting known residual anomalies for class B and C.

To me, though, it seems only logical to document known anomalies so you can tell your customers what issues there are. That won't stop them from (re-)reporting them.

Really? In the CEI 62304 COMPIL:2015 class A was added in 5.8.2 (document all known residual anomalies)...

 

[yodon]

Ah... good point. I was only looking at the :2006 version. Thanks for correcting.