EN ISO 15223-1:2012 Clarification or Examples on when to use Safety Symbols

katastic2908

Involved In Discussions
#1
Hello,

I am pulling my hair out trying to find some sort of clarification in regards to the Consult Instructions for Use Symbol and the Caution Symbol that are specified in 5.4.3 and 5.4.4 of EN ISO 15223-1:2012. When is it appropriate to use the Consult IFU symbol, and/or the Caution Symbol, and would using both be appropriate? I feel that most Medical Devices (not all) have precautions or safety warnings that can't otherwise fit on the label, so it would seem that the Caution Symbol would be used on most labels, so if you used that symbol, what would be the point of the other symbol? Please before you judge, its Friday, I have tried to scour the interwebs for an answer, my brain hurts. I appreciate any help you can give me.
 
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Jean_B

Trusted Information Resource
#3
The answer ironically enough can be deduced from IEC 60601-1, edition 3.1 (or 3.0, if you only care about the situation, and not the newest symbol). See clause 7.4.3 and annex D of that standard.

Paraphrased.
60601-1, ed3.1: Blue icon of man reading book: mandatory instruction to read IFU, use if mitigation from risk control. (ed 3.0: blue i-booklet)
The usual I-booklet is advising to read the IFU, and may or may not be warning related.
The triangle exclamation is to advise that there are warnings in the book that are not on (the label of) the ME itself.

As the I-booklet is not specifically warning related (anymore), I assume the distinction was made to separate referencing for general instructions from referencing safety related matters. But whether this is actually the case, i have but only my simple mind and no evidence for it.
 

yodon

Staff member
Super Moderator
#4
I had a case where I had to use both the 'blue man reading' icon and the standard 'i-booklet' icon.

We had a device that had to direct the user to read the manual so we had to put the 'i-booklet' icon on the device. We also provided a cart with the system. When we put it through the product safety testing, they found that if the cart was on an incline, the drawers were loaded and opened downhill, there was a chance the cart would tip. We couldn't exactly re-design the cart so we concluded that the likelihood was low and the lab agreed that we could add the 'blue man reading' icon to warn that there was, essentially, an unmitigated risk. (We couldn't use the 'i-booklet' icon here since it was related to a hazard).
 
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