M
Matthies
Dear all,
Our company sells computers to hospitals and our company wants to be ISO 13485 certified.
The design of the computers is done elsewhere in a factory with ISO 13485, but we only add/change hard drive or RAM memory or wifi modules, but opening the device is necessary to perform this task.
Our computer systems (touch screen panel PC or Tablet like systems) are used in hospitals for basic use, but some are used in surgery operationg room and display heart rate and blood pressure.
My questions are:
Is a computer that is used in a hospital a medical device and if so of which class?
How to perform Earth Leakage Test?
How to perform Insulation Resistance Test?
How to perform Ground Bound Test?
Please help and thanks in advance!
Our company sells computers to hospitals and our company wants to be ISO 13485 certified.
The design of the computers is done elsewhere in a factory with ISO 13485, but we only add/change hard drive or RAM memory or wifi modules, but opening the device is necessary to perform this task.
Our computer systems (touch screen panel PC or Tablet like systems) are used in hospitals for basic use, but some are used in surgery operationg room and display heart rate and blood pressure.
My questions are:
Is a computer that is used in a hospital a medical device and if so of which class?
How to perform Earth Leakage Test?
How to perform Insulation Resistance Test?
How to perform Ground Bound Test?
Please help and thanks in advance!