Do HF accessories require EMC testing according to IEC 60601-1-2?

A

ascherp

#1
Hello,

It is not clear to us whether EMC testing according to IEC 60601-1-2 is appropriate for HF accessories. The specific device in question are insulated handle-shaft-insert modular instruments (laparoscopic forceps and dissectors) for electrosurgical coagulation.

According to European regulations, an HF accessory such as this is considered to be passive with regard to electromagnetic emissions. It is argued that the ESU generates the emissions, not the coagulation accessory. Testing according to IEC 60601-1-2 is not required for these instruments and none of approximately 10 manufacturers of HF accessories that I work with perform this type of testing.

Actually, Tables BB.1 and BB.2 of HF standard IEC 60601-2-2 indicate that, with all other factors (HF accessories, test set-up and protocol) being equal, there is a marked difference in the emmissions created by two different types of ESU. This seems to justify the standpoint that testing according to IEC 60601-1-2 would be appropriate for the ESU, not the accessory.

The FDA, on the other hand, is not clear about this issue. We have submitted three 510(k)s for different HF coagulation accessories over the last 15 months. The reviewers of two of those 510(k)s did not request EMC testing, the most recent one has.

So, as far as electrical safety is concerned (as opposed to the regulatory bodies' marketing authorization requirements), does it make sense to test HF accessories according to IEC 60601-1-2? And why (or why not)?

Thank you and kind regards.
 
Elsmar Forum Sponsor
#4
I'll try to give an answer although I am not familiar with the particular standard 60601-2-2.

I do not think it sensible to EMC test an accessory. When testing the device (the electro-surgical unit) it would be configured in a normal or worst case use scenario, which would include having the instruments plugged in with the connecting cable laid out in a repeatable manner (perhaps a 'serpentine' board).

One would then argue that any design differences between different instruments would be highly unlikely to influence either the emissions or the immunity of the ESU. If significant differences in design are present (perhaps one instrument is much bigger, or has a connecting cable much longer) then it may be necesary to do some extra testing to cover these differences.

Hope this helps.
 

Peter Selvey

Leader
Super Moderator
#6
As Pads38 said, the impact on the EMC profile of full system (HF generator with accessory) would negligible.

Furthermore, the EMC profile depends primarily on the generator, not the accessory. Since the manufacturer of the accessory has no controls over the design and manufacturer of the generator, it would be a meaningless test in the regulatory context.

So, I think your FDA reviewer is just following a script without thinking.
 
A

ascherp

#7
Just an update to this thread, in case someone faces the same problem: In the meantime this FDA requirement has become official. EMC testing is mentioned as one of the basic performance tests that "may" be required for 510(k) clearance in the draft guidance document Evaluating Substantial Equivalence in Premarket Notifications (510(k) ) published by FDA on Dec. 27, 2011. I checked with 510(k) review staff and it was confirmed: EMC testing according to IEC 60601-1-2 is definitely being requested for both monopolar and bipolar accessories.
 
Y

yinonsha

#9
Thanks fot the valuable information ascherp!

It would really help me if you knew which testing is applicable in the 60601-1-2 standard regarding the accessory alone (HF surgical/laparoscopic accessory).

To refine my question, do you mean that now the FDA expects that all testing applicable to manufacturers of ESUs (generators) should also be performed for a laparoscopic accessory?
 
A

ascherp

#10
Hello,

IEC 60601-1-2 doesn't apply to accessories alone, only to electrical equipment or systems. The testing requirement we faced was based on the clauses that basically state that when an accessory is to be used with an ESU, a cable etc., the whole setup has to be tested for EMC together, as a system.

Since EMC testing requirements don't apply to electrosurgical equipment when in active use (according to IEC 60601-2-2), the emissions must be measured with the ESU in stand-by mode. The objective is to test whether a specific accessory (HF surgical/laparoscopic accessory) will cause an unacceptable surge in emissions.

We tested both the 510(k) subject device and a cleared predicate (also HF surgical/laparoscopic accessory of the same type and with the same indications for use) with two different FDA-cleared ESUs.

Hope this helps.
 
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