shimonv
Trusted Information Resource
Hi Guys,
If a medical electrical equipment includes a set of visual error messages on the screen to indicate some sort of error that could mean an hazardous situation does that mean it must comply with 60601-1-8? if so, most all ME equipment with a GUI must comply with this standard. Can someone please clarify?
Moreover, I looked at the standard and it's not clear to me if auditory ALARM is an imperative part of the alarm system. I'd appreciate input on that as well.
Perhaps another way to phrase the question would be: when does an error message becomes an alarm signal, and if so do you have to add auditory element to it?
Thanks!
Shimon
If a medical electrical equipment includes a set of visual error messages on the screen to indicate some sort of error that could mean an hazardous situation does that mean it must comply with 60601-1-8? if so, most all ME equipment with a GUI must comply with this standard. Can someone please clarify?
Moreover, I looked at the standard and it's not clear to me if auditory ALARM is an imperative part of the alarm system. I'd appreciate input on that as well.
Perhaps another way to phrase the question would be: when does an error message becomes an alarm signal, and if so do you have to add auditory element to it?
Thanks!
Shimon
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