CPU BIST IEC 62304 - Embedded code has CPU instruction tests

W

WeightOnWheels

#1
Hello all, my first post but I've been poking around for a while. Great spot for excellent information.

I've been performing IV&V within different safety critical industries for a few years now. I have a new medical device project and I noticed that the embedded code has CPU instruction tests that are executed every time the system is powered up. My question is, Is this completely necessary? I ask because this is a class C device and I'm wondering if this can just get removed by the developers, or if it is in fact needed, will we have to perform complete tests (unit tests, integration..) on these instruction tests?

I've never seen these types of tests done at every startup. I've seen ram tests but not built in opcode testing.

Please advise.
 
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yodon

Leader
Super Moderator
#2
Re: CPU BIST IEC62304

Anything implemented should tie back to a requirement (which could be a risk control). I'd get the developers to walk it back to requirements. Since it's class C, there should be a pretty good trail back up through detailed design & architecture.
 
W

WeightOnWheels

#3
Re: CPU BIST IEC62304

Thanks yodon!
Since this is a really big job, I just wanted to make sure it was completely necessary. Or if I could just yank it out. The code for these tests create an incredible amount of code that now has to be verified down to the unit test level.

Thanks again!
 
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