Hazard analysis for our medical device - Hazards seem to overlap

D

dcjass2

#1
Hi Experts,

I have a question that I believe one of you can help me with. We are working on hazard analysis for our medical device.

While drafting the Hazard analysis for the medical device, the listed hazards and causes seem to overlap. How can I avoid this? Or is it acceptable? Kindly advise.

Here is an example:
Hazard-01: Flammability
One of the causes: Overheating due to overcharging of battery

Hazard-02: Overheating
One of the causes: Overcharging of battery
 
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yodon

Staff member
Super Moderator
#2
Those specific examples are definitely unique. Yes, both can cause burns but you may well have situations where the temperature could rise above an acceptable level (I think 60601 says 43) but not result in fire.

It's been my experience that there can be 'overlap' in the analysis. I don't see it as an issue; to me it shows proper due diligence.
 
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