IEC 62304 Amd 1 2015 - Figure 3 – Assigning Software Safety Classification

[kreid]

How do people interpret Figure 3 in Section 4.3 Software safety classification?

I find the middle decision box particularly confusing:
'Does the failure of the software result in unacceptable risk?'

Surely every risk management report concludes that there are no unacceptable risks?
If so, why would there ever be a Yes answer to the middle desicion box in the flow diagram, and hence, when would anyone classify there software as anything other than Class A?

 

[Marcelo]

First, the initial definition shall of the safety class be performed without risk control measure applied.

Then, you can perform an evaluation again after risk control measures have been implemented (for example, in hardware), and then change the safety classification.

This is explained in the text:

"For a SOFTWARE SYSTEM initially classified as software safety class B or C, the MANUFACTURER may implement additional RISK CONTROL measures external to the SOFTWARE SYSTEM (including revising the system architecture containing the SOFTWARE SYSTEM) and subsequently assign a new software safety classification to the SOFTWARE SYSTEM."

 

[mikezv]

I would venture further and ask what does "failure of the software" mean. Does this mean that if the CPU overheated causing the software to crash, that this is a failure of the software? Does it mean that there was a software bug? I think we all need clarification of the term "failure of the software".

 

[rothlis]

kreid,
I found myself asking a similar question after looking at the amendment, but I then realized that there are two important items to take note of:
1) Only external (i.e., independent) risk controls can be accounted for in the determination of 'acceptable risk', and
2) The safety classification is based on whether the software can contribute to a hazardous situation - this includes software as both cause and control (per clause 7.2.2b).

Once these two elements are taken into account I think we can see how a classification in a medical device can easily rise above Class A.

mikezv,
I have always understood a "failure of the software" to only include those faults which can occur with normally operating hardware - which would exclude processor overheating but would include those rare memory bit corruptions that are inherent to RAM (and are less rare than previously thought).

 

[glork98]

1) Only external (i.e., independent) risk controls can be accounted for in the determination of 'acceptable risk'

I don't quite understand what you're getting at here.

Once these two elements are taken into account I think we can see how a classification in a medical device can easily rise above Class A.

I've found it to be the other way: if the device poses any risks, it's hard to avoid having software that is not Class A.

 

[rothlis]

glork98,
My first statement was just highlighting the guidance in the standard which says that only external controls can be considered. So if you are doing the evaluation to determine whether the software has any unacceptable risks, you can't account for risk reductions due to any risk controls that are implemented in the same software that is the source of the risk (though the definition of "same software" is subject to your interpretation and partition definitions).

By "rise above Class A" I meant "Class B or Class C". The OP was asking how you would ever not have Class A software (due to an unacceptable risk) if risk evaluations always show that everything is acceptable in the end. I was pointing out how the classification is not just drawing from the final evaluation.

 

[MediKit]

I am actually still confused with Figure 3. How can you possibly go from Class C to Class B based on the flow chart? Example:

Harm - Burn

1) Can a hazardous situation arise from a failure of the software?
Yes, software controls heater and failure can cause burn - serious injury

2) Evaluate effectiveness of risk control external to SW
- Thermal Cutout

3) Does failure of the SW result in unacceptable risk?
Now two possibilities:
a) if we treat Thermal Cutout as extremely reliable and has 1 in 1000000 failure rate, then the answer is No, so according to Figure 3, our software is class A
b) if we treat Thermal Cutout to be reasonable reliable e.g. 1 in 1000 failure rate, then the answer is Yes so go to 4)

4) What severity of injury is possible? So now we go back to 1) which is burn - serious injury, and software class remains class C

So how can we possibly get a class B software when the default is class C? The only possible way is if we treat Thermal Cutout as a reduction in severity of harm to non-serious injury, but that sounds wrong to me. Now, I am confused about whether a risk control reduces severity vs probability...

Am I missing something?

 

[glork98]

You could get a "B" if, for example, the mitigation was a physical guard that allowed contact with a 75C surface instead of a 500C surface.

Perhaps the example is flawed but consider a mitigation that reduces the severity and not just the likelihood.

 

[MediKit]

You could get a "B" if, for example, the mitigation was a physical guard that allowed contact with a 75C surface instead of a 500C surface.

Perhaps the example is flawed but consider a mitigation that reduces the severity and not just the likelihood.

Hi glork98,

Yes, but that doesn't sound right as it implies that only risk control that reduce severity is effective to protect against software failure.

Furthermore, in my opinion, only inherently safe design can reduce severity - e.g. use a lower power heater so it can only heat up to 75C instead of 150C, replace a sharp corner with a rounded one etc. Any protection measures such as guard can be viewed as reducing probability, as there is always a possibility that the protective measure can fail.

 

[rothlis]

MediKit,
Your response to glork98 is forgetting the "Does the failure of the software result in unacceptable RISK?" decision point in Figure 3. If you reduce the probability enough, then that kicks in and you go to Class A. But I think it is correct to observe that the only way for risk controls to move you from Class C to Class B is by reducing severity.