ISO 14971 Risk Analysis - Effects of component failure on the patient

D

DuttonT

#1
When doing an ISO 14971 risk analysis as a manufacturer - Do we take into account what might happen to a patient if a component fails?

Example: a light does not go on that should and causes an extended procedure.


Should we have documented that a light not going may cause a problem?


Thanks in advance.
 

Al Rosen

Staff member
Super Moderator
#2
When doing a 14971 risk analysis as a manufacturer - Do we take into account what might happen to a patient if a component fails?

Example: a light does not go on that should and causes an extended procedure.


Should we have documented that a light not going may cause a problem?


Thanks in advance.
Yes, the risk analysis should take into consideration the risk of normal use as well as failure modes.
 
D

DuttonT

#6
If the equipment failed during an operation - and the failure caused the operation to take longer. That would be an extended procedure.
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#7
And this warning light would be a visual sign of an alarm which is a means of risk control for a particular hazard? Look, it´s really difficult to give a technical answer if you do not use the correct technical terminology.

Usualy "warning lights" are used in that way.

If the "warning light" is used in that way on the device, yes you have to document it because it´s a risk control measure, meaning, it warns the operator that a fault condition exists.

Anyway, you have to tak into account the failureof ANY component of the device which could lead into a hazard, not just a warning light.
 

Top Bottom