IEC 60601-2-18 Endoscopic Medical Electronic Equipment question

Roland chung

Trusted Information Resource
#1
The Annex J out of IEC 60601-2-18 gives an insulation example for endoscopic equipment. In the example 2, the number "12" (separation between SIP/SOP and secondary/endoscopic circuit) requires 2 MOOP @MAINS VOLTAGE. Is this reasonable?

Thanks,
Roland
 

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#3
I think the reason is that in Endoscopic ME the SIP/SOP includes INTERFACE CONDITION where the existence of mains voltage is mostly probable. Therefore, the existence of MAINS VOLTAGE at SIP/SOP is not considered as SINGLE FAULT CONDITION and, hence, should be protected by 2 MOOP rather than 1 MOOP.

Confirmation welcomed.
 

Peter Selvey

Staff member
Moderator
#4
I'd be inclined to think it is a mistake. It's an informative annex so not checked as closely as the main text.

Under Clause 16.5 of the general standard, if a separation device is used as a solution for SIP/SOPs, then only 1 MOP is required. But there are many other solutions possible for Clause 16, it's just an option.

From a F-Type perspective, it could require 1 MOPP but it depends on the design of the patient interface area.

I find that even some of the diagrams in Annex J of the general standard don't make sense. But again it's just informative.
 
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