A
Hi,
We currently have medical device that has been tested and approved to the FDA recognized standards.
My question is: Do I have to retest the EMC tests (60601-1-2) on every minor change in the hardware such as :Capacitors or resistors value or manufacturer.
is writting a rational enough in that case?
Do I have to involve my 3rd part laboratry with every change?
How do I know in which product change I must retest the EMC?
Is there any refernece about that issue in the standard?
Thanks
We currently have medical device that has been tested and approved to the FDA recognized standards.
My question is: Do I have to retest the EMC tests (60601-1-2) on every minor change in the hardware such as :Capacitors or resistors value or manufacturer.
is writting a rational enough in that case?
Do I have to involve my 3rd part laboratry with every change?
How do I know in which product change I must retest the EMC?
Is there any refernece about that issue in the standard?
Thanks