Question about IEC 60601-2-10 - Which waveform should I measure?

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raymond02302

#1
Hello folks,
I have one qution about the IEC 60601-2-10. It is a very old standard, when i handled project against IEC 60601-2-10, i faced a question as follow. To make it esay to understand, please see find the attached illustration.
In the standard, Cl 51.103 required a indication of output if energe exceed 10mJ per pulse. As shown in the illustration which waveform should i measure ?
My opinion is the burst (sum of a,b and c for case 1;sum of e,f,g and g for case 2), it represent one cycle delivering into patient.
Another opinion is that the energy shoud be measure in a, b or c separately for case 1 and e,f,g or h for case 2.
For the latter opinion, i think it is rare that one pulse can exeed 10mJ for stimulator, for instance, for a pluse (rectangular waveform) with duration of 200 µs (long enough), the amplitude of the waveform shoud be 223V.It is really very high for stimulator.therefore, it make this requirement meaningless.

Any one has idea about it?

thanks in advance.

Raymond
 

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Elsmar Forum Sponsor
#2
Re: Question about IEC 60601-2-10

Hullo Raymond,

Yes 60601-2-10 is quite old (dated 2000 as an EN but is largely a 1988 standard). It is currently being updated by IEC.

A problem with it that you have identified is that it really only works for stimulators that give out a single pulse at a time; more complex waveforms require some interpretation.

There is no definition of "pulse" in the existing standard, although pulse duration is defined (duration between 50% amplitudes). I have seen a draft of the new standard with pulse being defined as the waveform between two zero crossings. This would suggest that, from your illustration, a b and c are individual pulses and the energy in each pulse should be considered against the 10mJ indicator requirement. This is consistent with how I have considered it as well.

The same requirement applies to outputs above 10mA rms or 10V rms, averaged over 5sec. So this is where you would consider your pulse repitition frequency / bipolar stimulation / duration of stimulation etc.
 
R

raymond02302

#3
Re: Question about IEC 60601-2-10

Thanks for your input.
Commonly, we consider one individual pluse against this requirement. But, it does't stand for actual case. The stimualtor outputs one combined waveform to patient at a time. If the energy of the combinded waveform is too large, there also is unacceptable risk.
Besides, If this requirement is for individual pulse, did you ever see a stimulator with a single pulse more than 10 mJ ? 10 mJ is a very large value for individual pulse whis used in stimualtor.
About the new standard, do you konw when will it be published ? There are many obscurities in the current edition.

Thanks a lot.

Raymond
 
#4
Re: Question about IEC 60601-2-10

Thanks for your input.
About the new standard, do you konw when will it be published ? There are many obscurities in the current edition.
From the IEC SC62D committee page it is forecast to be available at the beginning of next year, but it looks to be at Committee Draft Vote stage at the moment so still more stages to go. (There still has to be a FDIS stage). At a guess it will be towards the middle of next year.

I did provide some comments to our national committee at an earlier stage but I have no idea whether they have been taken up. One comment I made was on the definition of a pulse and the need to consider more than the simplest of waveforms.
 
R

raymond02302

#5
Re: Question about IEC 60601-2-10

Thanks.
The "pulse" is the key word in this standards,there should be a clear definition for it.
I hope the NC have taken up your comments which will make us work smoothly.
Your effort is appreciated very much.
 
R

raymond02302

#6
This question is clear in IEC 60601-2-10 ed 2.0. The amplitude is defied as rms value over 1s, whick I believe is originated from IEC/TS 60479-2 (1 s is corresponding to cycle of heart beat (60s/70bpm). there is no cumulative effect to heart for single phase pulse ).

I compared IEC 60601-2-10 ed 1.1 and ed 2.0 and the comparison table (some comments included)was uploaded
 

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M

maracu

#7
I have been trying to find if the new (ed 2) 60601-2-10 has been harmonized and when it will be mandatory but with no success. Does anyone have any information on the date yet?
:thanx:
 
#8
IEC 60601-2-10 was published in June 2012.

The latest Official Journal (in which a listing indicates that a standard is now harmonised) was published in August 2012, which is a bit too quick for a new version to make it in. There should be a new OJ within the next couple of months.

There will probably be a period of 3 years before the old (EN -2-10:2000) version is withdrawn.
 
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