IEC 60601-1-2 ESD: Lower Compliance Level for ESD Immunity

N

nbarabino

#1
Hi

According to IEC 60601-1-2 it can be specified a lower compliance level for ESD immunity if the appropriate environment for use is specified.

The question is, how to know which is the appropriate environment (i.e., relative humidity, surface material, etc.) for a certain compliance level, e.g. 4kV/4kV air/contact discharges instead of 8kV/6kV.

Thank you

Regards
 
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Marcelo

Inactive Registered Visitor
#2
Re: IEC 60601-1-2 ESD: Lower compliance level

You are doing things backward.

First you need to define the environment of use of your device. If it?s intended environment can be expected to have lower ESDproblems, then you define the levels based on the environment.
 
#3
Re: IEC 60601-1-2 ESD: Lower compliance level

The rationale for that clause (6.2.2.1) states that 4kV would be satisfactory for both air and contact if the materials were wood, concrete or ceramic (tiles). But most clinical areas typically use vinyl flooring for it's ease of cleaning. So that then requires the 8/6KV levels.

If you look at clause 6.2.1.1 - Immunity Test Levels - it only allows lower levels when "justified by significant physical, technological or physiological limitations". I would not expect that justification to be possible unless it was part of a "particular" standard. (60601-2-xx). For instance, 60601-2-26 (EEG) allows equipment to show a "temporary degradation" for up to 10 seconds. But does not allow a lower test level.

To claim that the expected environment is not prone to ESD build up would have to mean that the equipment would only ever be used in a very restricted environment. The obvious one would be a device for use during surgery. But then the device is more likely to be critical (failure would represent a significant hazard). Which would suggest the need for robust equipment.

So, unless you can prove that your device is only for use during hydrotherapy sessions [ ;-) ] I think you are stuck with the 8/6kV levels.
 
N

nbarabino

#4
Thank you Marcelo and Pads38.

The intended environment of use is the patient's home environment. Also the device is not critical, and a failure due to ESD will not represent a hazard. Do you think it is possible to claim compliance with 4kV/4kV under this conditions?

Regards
 
Last edited by a moderator:
#5
Thank you Marcelo and Pads38.

The intended environment of use is the patient's home environment. .................. Do you think it is possible to claim compliance with 4kV/4kV under this conditions?

Regards
In my opinion - no. Sorry.

A home environment is less well controlled than a clinical environment so could be expected to be more challenging. Also note that in 60601-1-11 (requirements for equipment for a home healthcare environment) the possibility of excluding certian connectors from discharge (by labeling) is removed. Discharge is to any point where the test finger can reach.

Remember also that equipment that relies on an earth connection is not suitable for home environments.

If you really cannot meet the requirements then you might have to argue that the device does not provide "essential performance" (see 6.2.1.10). But notified bodies, or other regulators, do not like seeing that so you would need rock-solid justification.
 
N

nbarabino

#6
Ok, thank you.

Earth connection is not a problem as the device is internally powered.

Regarding the ESD protection, anyone here has experience with ESD shielding techniques?
 
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