Search the Elsmar Cove!
**Search ALL of Elsmar.com** with DuckDuckGo including content not in the forum - Search results with No ads.

Safety Class A with no test?

#1
Hi

In a recent past, I was involved in the development of safety class B (62304) software medical devices but never for Class A.
I was surprised that there is no requirement for verification for Class A software medical devices.
Chapters 5.5 (SW Unit Implementation and verification), 5.6 (SW Integration & Integration Verification), and 5.7 (SW System Testing) are not requested by the IEC62304 because they only apply to class B and C.

Do you confirm that we do not need to provide evidences of testing for class A software medical devices?

Thank you very much for your help.
Best
 
Last edited:

primavesvera

Starting to get Involved
#2
Hi, check the year of the standard. In the IEC 62304:2006/A1:2015, section 5.7, which refers to the software system testing, states that it is applicable for class A, as well, whereas in the 2006 edition it was only for class B and C.
 
Top Bottom