IEC 60601-2-43 - Clause 203.6.103 - Physical button?

BargeSim

Starting to get Involved
#1
Hi,

Standard IEC 60601-2-43: 2010 requires to have an "IRRADIATION DISABLING SWITCH" @clause: 203.6.103.

"A switch shall be provided to disable/enable the LOADING STATE without affecting any other functions of the INTERVENTIONAL X-RAY EQUIPMENT. The operation of this switch shall not, in itself, be capable of initiating the LOADING STATE. The state of the IRRADIATION disabling switch shall be displayed at the working position of the OPERATOR. The switch should be configured to minimize the likelihood of accidental operation."


Does this mean a "physical button" or could it be a software setting/ button?


Thank you for your help
 
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Benjamin Weber

Trusted Information Resource
#2
I would say, a physical button is not explicitely required. The standars says "a switch" and this is not explained/defined in detail.

So I think, yes, it could be a software button. But be aware, that software as a means of protection (MOP) has to be treated in the risk management process and the soultion shall be dafe in single fault condition. And implementing MOP via software can be very tricky!
 
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