Dielectric Test for HF Surgical Equipment (IEC 60601-2-2 clause 201.8.5.1.2)

I

indorewalep

#1
Hello,

I have HF surgical Medical equipments in which have peak working voltage of 3kV, as per Table 6 of IEC 60601-1 3rd Edition we have to give 10 kV isolation.

Where as IEC 60601-2-2 clause 201.8.5.1.2 * MEANS OF PATIENT PROTECTION (MOPP): It writes that

" For HF SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES, separation between the HF APPLIED PARTS and the ENCLOSURE including SIGNAL INPUT PARTS and SIGNAL OUTPUT PARTS and between different HF PATIENT CIRCUITS need not be subjected to the dielectric strength test of 201.8.8.3"

This is supported by Subclause 201.8.5.1.2 – MEANS OF PATIENT PROTECTION (MOPP), which says:

"These reduced requirements are considered to be adequate because the "voltages stressing the insulation..." are of HIGH FREQUENCY and therefore, if insulation fails between the HF APPLIED PARTS and the ENCLOSURE, the RISK is much lower than at lower frequencies".

So my query is - Seeing both the clauses my interpretation is that we can avoid the insulation of 10kV for HF surgical equipment which is suggested in general standard. Is this the correct interpretation?

Regards,
indorewalep
 
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Peter Selvey

Staff member
Super Moderator
#2
This looks to be a major change from IEC 60601-2-2:2006 and IEC 60601-2-2:2009. The previous edition required the tests in the general standard, which could result in very high test values.

However, I would suggest it either poorly written or a mistake.

It makes sense to reduce the dielectric strength or replace it with a special test, given that peak voltages like 3kV are only short time and less dangerous (being HF). A test voltage per Table 6 (1.4 x U + 5000) in rms is far too high and would require special components which are difficult to source.

However, it does not make sense to eliminate the test altogether. For one point, it is required that HF equipment is Type BF or CF, so the output circuit should have at least 1.5kVrms (for 230Vrms equipment). The standard appears to delete this test as well, which is clearly wrong.

Also, although HF is less dangerous, it is still dangerous and breakdown of the barrier will cause an increase HF leakage currents with a corresponding increase in the risk of serious burns. Therefore the insulation should be confirmed to be adequate at a voltage above the peak working voltage. A test voltage with a peak of 1kV above rating is reasonable, and this is already specified for active accessories. For example, for a rating of 3kVp, a test voltage of 4kVp, or 2.83kVrms is still well below a point at which there are many parts available (e.g. optocouplers etc).

Good question!
 
Last edited:
#3
Dear Peter Sir,
We test the HF Surgical Unit . If suppose working voltage is 890Vrms Between live and applied part then as per the table 6 of 60601-1 we have applied test voltage 2 x (√2U+ 1 500) (approx : 6.3 KV). But EUT is not pass on 6.3 KV , so as per the particular standard 201.8.8.3
lf, during dielectric strength testing of solid insulation forming MOPP, a breakdown or flashover occurs at the Creepage Distance specified in
8.9 of the general standard and 201.8.5.1.2 of this standard, then the test shall be carried out on the components which provide MOPP, such as
transformers, relays, optocouplers or Creepage Distance on printed circuit boards.
So can we test on transformers, relays, optocouplers components? And how much KV we have applied.
 
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