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Level of V&V in Class II Medical Device (Dialysis Machine)
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Level of V&V in Class II Medical Device (Dialysis Machine)
Level of V&V in Class II Medical Device (Dialysis Machine)
Level of V&V in Class II Medical Device (Dialysis Machine)
Level of V&V in Class II Medical Device (Dialysis Machine)
Level of V&V in Class II Medical Device (Dialysis Machine)
Level of V&V in Class II Medical Device (Dialysis Machine)
Level of V&V in Class II Medical Device (Dialysis Machine)
Level of V&V in Class II Medical Device (Dialysis Machine)
Level of V&V in Class II Medical Device (Dialysis Machine)
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Some Related Topic Tags
class ii medical device, validation (general), verification (general)
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  Post Number #9  
Old 3rd August 2017, 05:46 PM
WeightOnWheels

 
 
Total Posts: 6
Re: Level of V&V in Class II Medical Device (Dialysis Machine)

Thanks again Peter.
I have another related V&V question.
The legacy code we're looking at has built in start up tests that include, memory test, CRC test and many many instruction tests.
I've never seen and/or heard of any CPU instructions ever failing. Do you see actual value added in having the CPU instruction tests? I understand the memory test, just not the instruction tests. I only ask because it's a lot of code that would require documentation and tests (previous owner of the code did not have proper documentation/tests for this startup tests).

I appreciate your experience on this subject.
Thanks!

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  Post Number #10  
Old 3rd August 2017, 06:22 PM
Peter Selvey

 
 
Total Posts: 860
Re: Level of V&V in Class II Medical Device (Dialysis Machine)

This sounds like the "functional safety" which I was taught when I worked in TUV SUD.

Personally I don't subscribe to this as it is virtually impossible to test a CPU's core ALU and the tests that TUV accepted were more of a token just to be able to write "Pass" in a test report.

The real story is as you say the core CPU is super reliable, probability of failure is in the region of 10^-9/year or less. It's the nature of CPUs that they have to be super-reliable to be practical.

It's possible to write it up as a "high integrity component" in the risk management file which then allows it to be excluded from any fault analysis.

But, if third party testing is involved, it might be best to retain it just to allow them to write "Pass" for their functional safety tests. And then just keep some simple records for V&V.

Memory is a different story and I have seen flash memory corruption over long term even in my own products (albeit likely cause being power supply brown out events).
Thanks to Peter Selvey for your informative Post and/or Attachment!
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  Post Number #11  
Old 6th August 2017, 09:58 AM
Roland chung

 
 
Total Posts: 451
Re: Level of V&V in Class II Medical Device (Dialysis Machine)

If you look at the IEC 61508 series, even for the low diagnostic coverage (60%), "Stuck-at" fault should be taken into account for CPU.
Thanks to Roland chung for your informative Post and/or Attachment!
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