IEC 60601-2-2 - EMC Requirements - Surgical instrument manufacturer

[JamesWong]

Hi All,

We are surgical instrument manufacturer and would like to ensure our instrument is meeting EMC Directive. Our instrument is work together with electrosurgical unit(ESU) which is not our product. In order to compliance to The EMC Requirement , do we need to perform IEC 60601-1-2 EMC Test sufficient or we need to perform both IEC 60601-1-2 EMC Test and IEC 60601-2-2 Annex BB ? On top of that, I was adviced that when performing IEC 60601-1-2 EMC Test , the sytem should be in idle mode and the ESU unit should not generate energy, is it Correct ? Thanks for your value input.

James

 

[isolytical]

The EMC testing is performed by an independent testing house not by the manufacturer. Once contracted, the testing house will help with all questions.

 

[JamesWong]

Thanks for your reply. In our case, we intend to perform testing ourself. Is there a requirement that Medical testing must be performed by independant test provider ? Thanks.

 

[isolytical]

There is an internal path for meeting the EMC directive. A company can self-certify for the requirements of the EMC Directive. The EMC Directive indicates that a product must meet emissions and immunity requirements but it does not say what the limits or values of those requirements are. The European standards give the specific values for emissions and immunity for certain products which the directive does not give.
For me, not knowing the product it is difficult to say which direction the company should take for meeting the EMC directive. The EMC directive is a certification. If you do not know how to perform the certification, or do not have the calibrated equipment to perform it, how can you perform that certification?
Perhaps professional consulting help is needed?

 

[Pads38]

Assuming that your product is a medical device, then talking of the EMC directive is perhaps misleading.

The accepted route to show EMC compliance for a medical device is to show that the requirements of 60601-1-2 are met, for both emissions and immunity.

It is possible to do this work 'in house' - as it is possible to test to the base 60601-1 standard. However, setting up and calibrating equipment and installations for the EMC tests is enormously complicated and expensive. For this reason the use of an external EMC test house tends to make a lot of sense.

A nice 'Certificate' from a reputable EMC test house, particularly one with ISO17025 certification, can enhance confidence in your customers and regulators.

There are many parts of 60601-1-2 that can be done as 'pre-compliance' tests. We often do this to try and eliminate potential difficulties before the large expense of the formal tests. For this we often rent the specialist equipment needed.

As for 60601-2-2 - I am not familiar with that standard. But I can see that your device would need to be tested to prove that concurrent use does not cause a problem. This would have to be part of your Risk Management process. There may be tests in that Particular standard that you could use to show satisfactory concurrent use.

 

[raworld]

Hi guys,
Could you please help me to answer below mentioned query?
When there is swagged needle attached to suture and whole combination is supplied as finished product, should we consider needle as an instrument or not? And whether ISO:16061 is applicable or not?

I tried finding New Thread but I could not get it.

Thanks and regards,
RA World

 

[isolytical]

What part of the swagged suture is electrical? - none based on my knowledge. What IEC 60601 test do you think applies? To obtain FDA marketing clearance the evidence of 'substantially equivalent to a predicate device(s) under the FFDC Act' is required, and the device(s) chosen for that comparison should at least help with requirements. Perhaps some external consulting help is needed to identify the quickest route to market.