FOS (Factor of Safety) Medical Device

Charlotte Percy

Starting to get Involved
#1
Hello All,

I am looking for a published general recommendation for mechanical factor of safety for medical devices. Does anyone have a standard textbook reference?

Thanks,
Charlotte
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hi,

I'm not aware of one, such all-encompassing figure.

I doubt that you will find one - "medical devices" is a very broad and diverse field. Almost everything related to medical devices design is risk-based today, so it comes down to what the device is, what it is intended to do and what it can (unintentionally) do, and what the risk is.

Sorry, and I'll be happy if someone will prove me wrong...
Ronen.
 

Ajit Basrur

Staff member
Admin
#3
Hello All,

I am looking for a published general recommendation for mechanical factor of safety for medical devices. Does anyone have a standard textbook reference?

Thanks,
Charlotte
Most of the regulations, namely the ones below, state "with an appropriate factor of safety"

Sec. 890.3110 Electric positioning chair.
Sec. 890.3930 Wheelchair elevator
Sec. 890.5150 Powered patient transport

Looks there it will be dependent on design criteria.

Sorry, not able to help but there should be ASTM standards on the related topics.

Please let us know once you get some information. Thanks !
 

Charlotte Percy

Starting to get Involved
#4
Thanks Guys,
My Mechanics of Materials professor in college gave us a general rule of thumb of 4 for medical devices. I haven't been able to find any specific number called out anywhere. I guess others don't either.;)
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Thanks Guys,
My Mechanics of Materials professor in college gave us a general rule of thumb of 4 for medical devices. I haven't been able to find any specific number called out anywhere. I guess others don't either.;)
Could have given you 17, 7 or 2.43 just as well, for that matter. Any rationale for 4?
 
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