Hi Peter, actually, how does the checks you mentioned and other software techniques fit into IEC62304? And how does class C compliance fit into single fault / safety evaluation? If I understand correctly, IEC62304 is about process without specific requirement on software implementation, but it mentions that by using process control it is possible to treat software as high integrity. Let's say I am designing a high risk device e.g. infant incubator, and I decide to use software as risk control for patient burn and the development process for the whole software complies to class C. Does it mean the software is now treated as high integrity and considered single fault safe?
It does not make sense and I would have thought a standard that specify certain characteristics of the software would be more useful. Such as the checks you mentioned, certain scheduling schemes, identification of critical code and data and ensure protection, clear redundancy in software etc. But currently the IEC62304 does not seem to enforce any of these and even segregation is not compulsory if whole software is treated as class C. What are your thoughts?
Thanks.
It does not make sense and I would have thought a standard that specify certain characteristics of the software would be more useful. Such as the checks you mentioned, certain scheduling schemes, identification of critical code and data and ensure protection, clear redundancy in software etc. But currently the IEC62304 does not seem to enforce any of these and even segregation is not compulsory if whole software is treated as class C. What are your thoughts?
Thanks.