Medical Device Warning Lights Colors

W

wally4u

#1
Hi All,

I'm looking into implementing some LED warning lights on one of our new products. However I'm a bit confused about the warning colors of the LED.
I've seen devices with Yellow/Orange/Red and even Green warning LEDs.

I've been reading up and couldn't really find an normative list.

in the IEC 60601-1-6 CCC.4 they say:
Controversial mapping – This is any mapping that contradicts an established convention. An obvious example would be the use of the colour green as a warning indicator. Another would be the flow control on a gas machine requiring a clockwise turn of the knob to increase flow.
[edit]
Seems that the 60601-1 7.8.1 also has something to say about indicator lights
Red Warning – immediate response by the OPERATOR is required
Yellow Caution – prompt response by the OPERATORis required
Green Ready for use
Any other colour Meaning other than that of red, yellow or green
[edit]

So green is obviously out.

I also found an advisory from the FDA advisory, basically stating for lasers they just need to visible with safety glasses on.

Any ideas on this?
 
Last edited by a moderator:
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Mark Meer

Trusted Information Resource
#2
My feeling is to just follow the 60601-1 conventions, as these are pretty standard.

Also, depending on the number of states you want to represent, you always have the options of having LEDs flash, strobe or blink...

The critical things are:
  1. You have done some sort of risk analysis on the events the LED would indicating. This would provide justification for when the LED should be red (immediate response) as opposed to yellow.
  2. You have clearly documented all states and meanings in the instructions for use.
 

Peter Selvey

Leader
Super Moderator
#3
In the second edition (IEC 60601-1:1988/A2:1995), the color red was restricted to warning / urgent action, while other colors (green / yellow) were "recommended" only.

In the 3rd edition (IEC 60601-1:2005), the green / yellow meanings also became a "shall" requirement. So this is an issue under transition, a device you saw may have not yet been evaluated for the 3rd edition.

Also test labs may also take time to adjust. The only way to check the requirement properly is to systematically list every indicator, the color(s) and the meaning. However I expect that most test labs will just eyeball the product and as a result they will miss a lot of indicators.
 
W

wally4u

#4
Hi Peter,
we're working with the 3rd edition, so I think that Yellow would be best suitable for our implementation.
Thanks for replying
 
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