Electrosurgical Testing - Is there a specific standard for Electrosurgical Testing?

N

nikolaos

#1
Hello All,
I plan to test a medical autotransfusion medical device for immunity against electrosurgical. Is there a specific standard for this? Can someone advice me how to perform this test?
Thank you
 
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S

SteveK

#2
Re: Electrosurgical testing - Is there a specific standard for this?

There are an awful lot of standards based around EN (or IEC) 60601. Maybe EN 60601-2-24 "Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion pumps and contollers" might meet your requirements. Not read it, got the list of Harmonized Standards from: http://ec.europa.en/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html.

There is the overall standard EN 60601-1 "Medical electrical equipment; Part 1: General requirements for basic safety and essential performance".:2cents:
 
N

nikolaos

#3
Re: Electrosurgical testing - Is there a specific standard for this?

Thank you, I haven't find any specific standard till now. Immunity tests according the EMC standard 60601-1-2 are simulated in the EMC Labs to rappresent the real world. What I am searching for is how to do the immunity test with an electrosurgical device a verify the immunity of the medical device. To my knowledge there ie no test the simulate the radiated electrosurgical emissions, so a real electrosurgical device must be used.
 

Marcelo

Inactive Registered Visitor
#4
Re: Electrosurgical testing - Is there a specific standard for this?

There´s no standard for this.

Anyway, you´re right in using a real electrosurgical device. Some standards in the IEC 60601-1 even requires this, that is, that you use a real electrosurgical unit (i just cannot remember exactly which ones right now).

AAMI has a document, "Guidance on electromagnetic compatibility (EMC) of medical devices to assist clinical engineers and other biomedical personnel in evaluation of the radiated frequency (RF) electromagnetic environment in health care facilities", which might have some info, but i´ve never seen it, so i´m not sure it can help.
 
N

nikolaos

#5
Re: Electrosurgical Testing - Is there a specific standard for Electrosurgical Testin

Thank you for the link. I found a preview copy of the AAMI TIR18:1997 but ther is no mention to an electrosurgical generator in the index. Anyway I performed the test and the result was positive, no interference. I used a 400W generator with a frequncy of 475Khz with an electrosurgical analyzer where I connected the electrodes to simulate the patient. I tested 5 times with 30sec of duration and checked for the essential performance of the medical device that was functioning in normal operation. The mediacal device was about 30cm from the electrosurgical electrodes. What do you think? Can this test be realistic?
 

Peter Selvey

Staff member
Super Moderator
#6
Re: Electrosurgical Testing - Is there a specific standard for Electrosurgical Testin

There are some of particular standards that specify testing for immunity against electrosurgical units (ESUs).

An example is IEC 60601-2-27:2005 (ECG, monitoring), Clause 36.202.101. That standard specifies a 300W cut and 100W coag mode (both with 400kHz +/- 10% fundamentals).

A critical point is that they specify that an arc is drawn between the active electrode and a metal block which simulates real world (ESU are typically used in this way, with an arc).

It is the high frequency content of the arc (well above 400kHz) that is likely to cause the most disturbance. It is a bit unpredictable, which is why the standard requires to repeat the test 5 times cut mode + 5 times in the coag mode.

The ESU should be tested with a special high power non-inductive test load (e.g. 200-500 ohms, 300W thick film resistors), since just shorting the electrodes will probably trigger the ESUs short circuit protection so that nothing is coming out.

And finally you need to simulate electrical connection between the ESU and your infusion device (assuming we are talking here about ESU operation on the same patient that is being infused), and the return path. Note that this is not expected to be a radiated issue, but rather conducted problem through the fluid circuit. IEC 60601-2-27 includes a circuit for this appropriate for ECGs, and this could be adapted for an infusion circuit. I would go for saline fluid with the minimum length of tubing, with the patient simulated by an electrode in the fluid at the end of the tubing. This electrode would connect to one pole of the ESU test load. IEC 60601-2-27 then specifies a 47nF capacitor (should be a HV type) which should also connected between the other pole and earth. I cannot see any reason why you would not use the same value.

Having written all the above, it also seems clear that this might be difficult to set up without some hands on experience with ESUs. On the other hand, better to do it properly, especially if you are going to claim ESU immunity as part of your intended purpose or advertising material.
 
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