IEC 60601-1 - Service life testing

david316

Involved In Discussions
#1
Hello,

I have posted this in another part of the forum but probably makes more sense to post it in this section so sorry for any duplication...

I have a question that I would be grateful for any input on. Do any regulations or standards require that a manufacturer prove that an electrical medical device performs as intended over it's service life. My understanding is 60601-1 requires a manufacturer to state the devices service life over which essential performance and basic safety is expected to be maintained. I would expect accelerated life testing to prove it. But as far as I know there is no requirement to prove a medical device operates as per it's specs (.g. performance stated in the device manual) with accelerated life testing or that it even needs to be justified to maintain performance over the service life. I also note that the functional performance limits (e.g. spec stated in manual) may be tighter than the essential performance requirements. You need to conduct risk management as per 14971 and identify any risks associated with the device which would include the device falling to operate within its spec and make the risks acceptable. But as I understand it there is no mandate that testing must be conducted to prove a device performs as intended over it's life.

So, is it acceptable to prove as per 60601-1 that a medical device maintains essential performance and basic safety over it's service life as well as conducting risk management as per 14971 or are there regulations or expectations from regulatory bodies that additional testing be conducted?

Thanks
 
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Marc

Hunkered Down for the Duration
Staff member
Admin
#4
Just go to the existing discussion thread. Use the "Report" link on the first post in the discussion. Give the reason as Request this discussion be moved to <what ever forum you want>.
 

yodon

Staff member
Super Moderator
#5
We've never had to prove a system operates over the expected service life. Expected service life could include maintenance so it would not be feasible to test.

(Realize that shelf life; e.g., for sterilized product is completely different and you do have to prove shelf life.)

Of course, as part of your risk management activities, you should be considering component failure and such to help define service life and maintenance periods (and maybe warnings and such).
 

david316

Involved In Discussions
#6
We've never had to prove a system operates over the expected service life. Expected service life could include maintenance so it would not be feasible to test.

(Realize that shelf life; e.g., for sterilized product is completely different and you do have to prove shelf life.)

Of course, as part of your risk management activities, you should be considering component failure and such to help define service life and maintenance periods (and maybe warnings and such).
I understand shelf-life is different and there are specific requirements around shelf-life but I am interested in service life. For the products I work with, our company has chosen not to service/repair/maintain said products. We have a 1 year warranty and a 5 year service life. If the device is deemed faulty within 1 year the customer gets a replacement. If its faulty after 1 year but within its service life we typically provide a discount on a new product.

As part of design controls, we "prove" essential performance and basic safety is maintained over the service life. We do not prove the device functions as per its specifications but address risks (component failures, etc) through risk management and ensure all risk are acceptable. It sounds like this is acceptable and I assume that not making our units serviceable does not change this?
 

david316

Involved In Discussions
#7
As a follow up question, does testing need to be conducted to prove risk controls, EP and basic safety are maintained across it's service life or is an assessment in risk management adequate?
 

yodon

Staff member
Super Moderator
#8
As a follow up question, does testing need to be conducted to prove risk controls, EP and basic safety are maintained across it's service life or is an assessment in risk management adequate?
In short, risk controls need to be verified and/or validated. I would expect that if you demonstrate that you have controls in place to maintain EP & basic safety in the event of component failure, that should be sufficient.
 

Jaydub

Involved In Discussions
#9
Hello,

I have posted this in another part of the forum but probably makes more sense to post it in this section so sorry for any duplication...

I have a question that I would be grateful for any input on. Do any regulations or standards require that a manufacturer prove that an electrical medical device performs as intended over it's service life. My understanding is 60601-1 requires a manufacturer to state the devices service life over which essential performance and basic safety is expected to be maintained. I would expect accelerated life testing to prove it. But as far as I know there is no requirement to prove a medical device operates as per it's specs (.g. performance stated in the device manual) with accelerated life testing or that it even needs to be justified to maintain performance over the service life. I also note that the functional performance limits (e.g. spec stated in manual) may be tighter than the essential performance requirements. You need to conduct risk management as per 14971 and identify any risks associated with the device which would include the device falling to operate within its spec and make the risks acceptable. But as I understand it there is no mandate that testing must be conducted to prove a device performs as intended over it's life.

So, is it acceptable to prove as per 60601-1 that a medical device maintains essential performance and basic safety over it's service life as well as conducting risk management as per 14971 or are there regulations or expectations from regulatory bodies that additional testing be conducted?

Thanks
I don't have a definative answer to your question, but at my previous employer our notified body was saying that we needed a better justification for our stated product life. We had simply stated a 5 year life based on previous similar products. I couldn't find anything that said we needed to prove it. The company folded before the issue was resolved.
 
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