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EMC testing for a system that is provided with a computer

#1
Hi,
I am working on a medical device system that includes using a computer and monitor (provided by the medical device manufacturer, but the computer is off the shelf). I would like to know if in order to do EMC testing according to IEC 60601-1-2, do I need to test the computer and monitor as well? Particularly the ESD testing. I doubt if the computer will handle the ESD testing. Can someone provide some insight on this? Thanks!

Regards,
FC
 
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Al Rosen

Staff member
Super Moderator
#2
Hi,
I am working on a medical device system that includes using a computer and monitor (provided by the medical device manufacturer, but the computer is off the shelf). I would like to know if in order to do EMC testing according to IEC 60601-1-2, do I need to test the computer and monitor as well? Particularly the ESD testing. I doubt if the computer will handle the ESD testing. Can someone provide some insight on this? Thanks!

Regards,
FC
The computer and monitor may have already been tested. Check the documents supplied with them. We buy off the shelf computers and monitors and haven't had an issue. You can contact the manufacturer to request a declaration of conformity.
 
#3
Hi Al,
Thanks! I will check that. But, what if they are not? Also, does the FDA require EMC testing on an off the shelf computer and monitor?
When you say you have bought off the shelf computers, did you do the EMC testing on those? including ESD? Thanks!

Regards,
FC
 

Al Rosen

Staff member
Super Moderator
#4
Hi Al,
Thanks! I will check that. But, what if they are not? Also, does the FDA require EMC testing on an off the shelf computer and monitor?
When you say you have bought off the shelf computers, did you do the EMC testing on those? including ESD? Thanks!

Regards,
FC
We have a recognized lab perform the testing according to the standard. The system is complex and they test the access points. The computer is in a console so they apply the test to the mouse, keyboard and monitor as well as other points that might be subject to an ESD discharge in use. They do all the EMC testing as well for the entire product.
 

Jaydub

Involved In Discussions
#6
Look at IEC 60601-1-2:2014, 4.2

If EMI to the non-medical equipment could result in loss of basic safety or essential performance, it needs to comply with IEC 60601-1-2. Otherwise it just needs to comply with standards that applicable to that type of equipment.
 

Mark Meer

Trusted Information Resource
#7
...If EMI to the non-medical equipment could result in loss of basic safety or essential performance, it needs to comply with IEC 60601-1-2. Otherwise it just needs to comply with standards that applicable to that type of equipment.
This is the route we went. Initially, we had the off-the-shelf computer tested to 60601-1-2, however it quickly became apparent that this strategy was not sustainable - the obsolescence cycle for OTS computers is just too short, necessitating a new round of testing every few months! So instead, we justified - based on our risk assessment - that it is sufficient that we receive safety test reports or declarations of conformity from the vendor to EN/IEC standards to demonstrate consumer safety. We made this a purchasing requirement for the computer.
 
#9
Look at IEC 60601-1-2:2014, 4.2

If EMI to the non-medical equipment could result in loss of basic safety or essential performance, it needs to comply with IEC 60601-1-2. Otherwise it just needs to comply with standards that applicable to that type of equipment.
Thanks!
 
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