Transformers and Thermal Cutouts

D

dhughessr

#1
I have a question regarding transformers with thermal cutouts and IEC 60601-1 I hope someone can answer.

I’m getting conflicting information from vendors.

One vendor says “these cutouts cannot be used to cut off the transformer power as that is not allowed in this standard and once they are provided they must go to signal an audible alarm.”

I cannot find anything resembling that statement in 60601-1 3rd. Ed.

The only thing I see is in 15.4.2.1 a) THERMAL CUT-OUTS and OVER-CURRENT RELEASES with automatic resetting shall not be used in ME EQUIPMENT if their use could result in a HAZARDOUS SITUATION by such resetting.

Are thermal cutouts allowed/required?

Do they need to have an associated audible alarm?
 
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Stijloor

Staff member
Super Moderator
#2
I have a question regarding transformers with thermal cutouts and IEC 60601-1 I hope someone can answer.

I’m getting conflicting information from vendors.

One vendor says “these cutouts cannot be used to cut off the transformer power as that is not allowed in this standard and once they are provided they must go to signal an audible alarm.”

I cannot find anything resembling that statement in 60601-1 3rd. Ed.

The only thing I see is in 15.4.2.1 a) THERMAL CUT-OUTS and OVER-CURRENT RELEASES with automatic resetting shall not be used in ME EQUIPMENT if their use could result in a HAZARDOUS SITUATION by such resetting.

Are thermal cutouts allowed/required?

Do they need to have an associated audible alarm?
Can someone help?

Thank you very much!

Stijloor.
 

Peter Selvey

Staff member
Super Moderator
#3
Thermal cut outs are common in medical devices, there is no problem to use them.

For some higher risk equipment the loss of power is a potential hazardous situation (15.4.2.1 d), for example:
- patient monitoring equipment
- equipment with mechanical constraints on the patient, where loss of power means mechanical parts cannot be moved

In these cases, there are usually other safety features, e.g. a power fail alarm; a mechanical lever which can release the patient independent of power loss.

Many parts manufacturers have a disclaimer against using their part in medical equipment. But this is normally ignored. Just use normal safety principles.
 
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