udir
Newbie level 5
Hello All,
I have a question to address this forum.
I am the service manager in a medical device company which manufactures and sells medical equipment.
As part of the obligations, each and every device manufactured has to undergo a few tests including safety test such as dialectic strength,i.e hi-pot.
My question is:
Should a device is malfunctioned on the field, and i replaced a component on the board, or replace the complete board, am I obliged to preform again hi-pot test after each repair?
To me it sounds un reasonable as not all Tech labs who service machine has this tool , moreover if i understand correctly, applying this test various times on the same board may damage it.
Can someone direct me to the law/guidance dealing with such cases?
Thanks a lot
Udi
I have a question to address this forum.
I am the service manager in a medical device company which manufactures and sells medical equipment.
As part of the obligations, each and every device manufactured has to undergo a few tests including safety test such as dialectic strength,i.e hi-pot.
My question is:
Should a device is malfunctioned on the field, and i replaced a component on the board, or replace the complete board, am I obliged to preform again hi-pot test after each repair?
To me it sounds un reasonable as not all Tech labs who service machine has this tool , moreover if i understand correctly, applying this test various times on the same board may damage it.
Can someone direct me to the law/guidance dealing with such cases?
Thanks a lot
Udi