IEC60601 3rd Edition Insulation Thickness for electrosurgical devices

K

Krisp

#1
Hi All,

We are developing an electrosurgical (High frequency surgical equipment) accessory that is to be used inside an off the shelf endoscope. The accessory will be connected to an off the shelf high frequency surgical equipment already sold on the market. This accessory that we are developing has a metal outer shaft that may come into contact to the patient/ operator. The metal shaft is used over plastic due to mechanical reasons.

1) The active "hot tip" of the accessory is insulated from this outer shaft.
2) The wire that carries the electrical energy to the tip of the accessory at the distal end only has 0.2 mm of insulation. This wire can come into contact with the metal outer shaft.
3) A small section outer metal shaft may touch the patient as it exists the endoscope at the distal end.

I have 2 questions:

a) Since our accessory is a type BF applied part, the internal wire insulation must have at least 1 MOPP (8.5.2.1 of IEC standard). Do you think I am right on this, or do I need two MOPP for the wire insulator?

b) If that is the case, then the wire insulator would be considered as BASIC INSULATION if designed for 1 MOPP and section 8.8.2 will not apply to the wire insulator. Is this correct ? I hope 8.8.2 does not apply as we are currently struggling to find a way to meet it.

Thank you !!

Christopher :bigwave:
 
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