IEC60601-2-18 - Endoscopic Surgical Monitor System Images

J

Jimpupu

Registered
#1
#1
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.
 
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P

Peter Selvey

Leader
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#2
#2
Assuming here that "routing system" just means signal connections external to the main medical device(s)?

If so it's possible that IEC 60601 series may not apply.

Your equipment may fall under medical device regulation (it depends on the stated intended purpose) but even so IEC 60950-1 may be the correct standard.
 
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