Medical Device Embedded Software Classification

sl344

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#1
Hello,

We have this piece of firmware that is embedded inside the medical device. the device itself is classified as class III. Based on the software hazard analysis, this firmware could potentially cause minor pain (and/or bruising) on patient skin. Based on IEC 62304, class A software has to be 'no injury or damage to health is possible'. Given that, what class do you think this firmware should be? is minor pain(bruising) considered an injury??

thanks a lot!
 

sl344

Involved In Discussions
#3
thanks. I'm looking for software classification per IEC 62304. It could be class A, B or C.

the bottom line question is: How to determine software classification?

1) based on severity level prior to mitigation?
2) Based on analysis of level of concern?

thanks
 
Last edited by a moderator:

sagai

Quite Involved in Discussions
#4
The MANUFACTURER shall assign to each SOFTWARE SYSTEM a software safety class (A, B, or C) according to the possible effects on the patient, operator, or other people resulting from a HAZARD to which the SOFTWARE SYSTEM can contribute.

The software safety classes shall initially be assigned based on severity as follows:
Class A: No injury or damage to health is possible
Class B: Non-SERIOUS INJURY is possible
Class C: Death or SERIOUS INJURY is possible

If the HAZARD could arise from a failure of the SOFTWARE SYSTEM to behave as specified, the probability of such failure shall be assumed to be 100 percent.

If the RISK of death or SERIOUS INJURY arising from a software failure is subsequently reduced to an acceptable level (as defined by ISO 14971) by a hardware RISK CONTROL measure, either by reducing the consequences of the failure or by reducing the probability of death or SERIOUS INJURY arising from that failure, the software safety classification may be reduced from C to B; and if the RISK of non-SERIOUS INJURY arising from a software failure is similarly reduced to an acceptable level by a hardware RISK CONTROL measure, the software safety classification may be reduced from B to A.
So,
1) based on severity level prior to mitigation, BUT
you can reduce in case it was mitigated by reducing to the acceptable level of the Risk by severity reduction.

regards
Sz.
 
Last edited:

glork98

Involved In Discussions
#5
Sagai has the pertinent section with highlights.

Unless you've got total mitigation outside of the software, you won't get away from the B classification.
 

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