I have a question regarding Endoscopic system. If my product is a routing system between camera control unit and surgical monitor. Do I need to comply with IEC60601-2-18? I was told there is always Fail-Safe connection between CCU and surgical monitor, so no need to comply with IEC60601-2-18 since our system is just an"optional" video system. in case IEC60601-2-18, there are three Essential Performances in the standard. are these mandatory EP for product? no matter what result of your risk analysis is?
However, This is very tricky. I cannot find any incident about endoscopic image issue based on those three EPs.
However, This is very tricky. I cannot find any incident about endoscopic image issue based on those three EPs.