Electrosurgery interference equipment requirements

A

Ana792

#1
Hi all,

We want to test the electrosurgery interference according to the standard 60601-2-27 section 202.6.2.101. According to the test a HF surgical equipment with working frequency of 400 kHz ± 10% is required. However, the HF surgical equipment we have available has a working frequency of 300 kHz. What is the reason behind the frequency requirement in the standard?

Thanks!
 
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#2
Hi Ana,

If you check the rationale for that clause (in the informative annex AA) it states -
There is no ideal test method to generate electrosurgical interference in a test laboratory but the ones given...has been shown to give similar results to ...surgical practice and to be reproducible.
(I only have the outdated 2006 version - so this may have been altered).

The specifications given are there to try and create a reproducible test - always a significant issue in EMC testing, especially so for elctrosurgical interference.

So can you use a 300kHz generator instead of a 400kHz unit?
I think that this depends on what you hope to achieve by your testing.

If you are doing "pre-compliance" testing as part of your development work, then I would suggest the 300kHz unit could be used and could give strong confidence (90% +) that your device copes with the interference. Then, when you do the full compliance tests with a 400kHz unit you are unlikely to have any 'nasty surprises'.

If you are doing an in-house test programme to prove compliance I might suggest that a 'strong positive' test result form the 300kHz unit would be sufficient, but with the deviation of test equipment clearly noted in your test results.

However, if you are hoping to get full certification by one of the internationally recognised test houses, and use their test mark, then I would expect that they would only accept test results using a 400kHz test unit.

Welcome to the forums!
 
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