Emergency Switch - Mandatory for Medical Device?

J

jayanthi

#1
Hi all,
We are Class IIA medical device according to MDD, currently using push button switch as E- stop. This device has a pump that will rotate in clockwise & anti-clockwise direction, a tube rolled over the pump is connected to the patient.

Do we need a separate E-stop switch as per the IEC 60601-1? or push button switch sufficient(simply stops pumping)?

we are in process of going for IEC testing as well as UL.
Pl clarify...
 
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Stijloor

Staff member
Super Moderator
#2
Hi all,
We are Class IIA medical device according to MDD, currently using push button switch as E- stop. This device has a pump that will rotate in clockwise & anti-clockwise direction, a tube rolled over the pump is connected to the patient.

Do we need a separate E-stop switch as per the IEC 60601-1? or push button switch sufficient(simply stops pumping)?

we are in process of going for IEC testing as well as UL.
Pl clarify...
Can a medical device expert help?

Thank you.

Stijloor.
 
V

Vincnet

#3
Hello jayanthi,

I came accross this one not long ago.

What we had was a portable classIIb Device and the request to put an Emergy Stop Red Mushroom was not a good option even safety wise.

So after discussing/negociating it with our 60601 testing lab we addressed the issue in our Risk Management. The result of the analysis being that the function of the emergency push button was provided even if the button itself was not there.

The testing lab was very happy with that. You've got to remember that it is the purpose that is important so the method to comply can always be adapted if one finds a senible way to do so.

Hope this helps.

Vincent
 
J

jayanthi

#4
Thanks Vincent,

Now I got an idea on this and will talk to my testing lab also.

In your device, whether you provided any switch for this purpose or function of E.stop is embedded in our device?

Regards

jaya
 
Last edited by a moderator:
J

jmalm

#5
Emergency stops are usually required for mechanical hazards. It's not obvious if your pump presents a mechanical hazard to the patient or operator in normal use.

In terms of the pump not turning off, you will need to analyze the risks if the pump does not deactivate when required. If the risk is acceptable, you may not require the redundancy of an ESTOP.

If the mechanical hazard is obvious, behind a protective barrier, or not accessible except during repair when suitable lockout can be performed, warning signs and directions in the IFU may be adequate.
 
V

Vincnet

#6
In our case no mechanical hasard it's a laser but emergency stop is required by specific 60601 sub standard.
And yes jayanthi there is no proper red Mushroom E-Stop but the standard on/off switch acts the same way by physical and not electronically cutting the power from the power supply which was not the case in the first design we had.

So we fullfill the requirement but by a different route justifying the option in the risk analysis which is what the standard allows for in a way.
in fact everything as often is linked to good communication with both Testing Lab and Notified Body
 

Peter Selvey

Staff member
Super Moderator
#7
Sorry for slow reply:

If it is a laser, you need to check IEC 60601-2-22 for specific requirements on the emergency stop.

The 1995 edition allows a red push button (not necessarily a mushroom), but some Class 3B lasers are exempt.

The 2007 edition is the same but allows risk management as part of the decision to include such a button.
 
S

sankui

#8
The equipment mentioned by the poster is similar to heart-lung machine. The E-stop switch is not necessary for such machine. Generally, extracorporeal circulation equipment incorporates pump cover with magnet switch (such as, hall sensor) to protection against the mechanical hazards caused by the rotor. That is to say, if the pump cover opened, alarm will be generated and cause the machine to stop.

In addition, a functional switch (neither is mains switch nor is E-stop) used to STOP the pump normally employed.

In the view of functional safety study, start up self-test should consider the pump cover.
 
Last edited by a moderator:
A

Athir

#10
Sorry for slow reply:

If it is a laser, you need to check IEC 60601-2-22 for specific requirements on the emergency stop.

The 1995 edition allows a red push button (not necessarily a mushroom), but some Class 3B lasers are exempt.

The 2007 edition is the same but allows risk management as part of the decision to include such a button.
Hi, do you know any suppliers providing this type of buttons. I could'nt find them.

Thanks
 
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