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 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