Colour of symbols on Medical Device labelling and packaging

TechnicalGuy

Research and Development
#1
Hello all,

We claim compliance to ISO 15223-1:2016 for the symbols we apply to our device labels and packaging. Do these symbols always have to be black (or black outlined as required by some)? Or can these be, for example, blue or yellow? I cannot see anywhere where it states the colour just as long as it is clear and recognisable.

Thanks
 
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craiglab

Involved In Discussions
#2
This is because there is no requirement for the base (article) color and the standard assumes a white base color. You should be in a good position to justify the use of something other than black on white if you apply human factors (contrast ratio) and risk analysis.
 
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