Labeling Symbols for EU - E.g. EN980 - Dimension, color, font, etc.



Need input from people who have hands on experience with making labeling for EU. Please respond to the following:

If you need to include any symbol from EN980, how do you accomplish the requirement? Do you create the symbol and confirm it is matching the standard or you copy the symbol from the standard and past it as a bitmap or equivalent in your labeling?

From reading EN980, I get the impression that it does not impose restriction or requirement for dimension, color, font, etc. Is this you understanding too?


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You can buy the symbols from ISO in various formats, alernatively I have just reproduced them and confirm my version matches.

From recollection EN980 does not set restrictions on dimensions, colour or font, but you may cover this in your risk assessment - a symbol that is 1mm in height doesn't really convey much of a warning and therefore isn't effective


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Hi - no restrictions on the symbols except of course the CE mark (no less than 5mm).

I have used ISO 15223 along with EN 980. The engineering group creates the serial labels in an excel spreadsheet (very cumbersome) and I have seen them copy them from the web (images) and from other documents and paste them in using paint. Given that I do the labeling reviews, I am seeing a lot of inconsistencies re: size.

Sure would be nice to have a labeling software program. Any symbols on labels, should be defined within IFUs (when I arrived at company, I found that there was one IFU for Domestic and another IFU (which included english and all languages) for global/interntional. Have worked very hard to obsolete the domestic and have one IFU for global use.

More info. than you needed, sorry - I am passionate about labeling :)


Buy them here if you want

Medical Equipment Symbols & Safety Signs Clip Art Collection
More than 640 symbols and safety signs for medical equipment are included in this clip art collection from AAMI. Features all of the ISO 15223 and IEC 60878 symbols in high-resolution, scalable graphics in several file formats. Just copy and paste into your packing or product information materials!
AAMI Member:
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Starting to get Involved
Related question: for CLP pictograms is it permissible to use colours other than Black on White with red border? The red border adds another colour to the print process which would be advantageous to omit.
We received an answer (from HSE) stating "Where a CLP compliant label is required, the hazard pictograms have to have a black symbol on a white background with a red frame (CLP Article 19). However, the CLP Regulation does not state the colours that should be used on the CLP label. It does however, state that the label elements as referred to in CLP Article 17(1) should be clearly and indelibly marked, should stand out clearly from the background and be of such a size and spacing as to be easily read (CLP Article 31(3)). Therefore, the colours used for the label elements (in Article 17(1)) are left to the discretion of the supplier."

Discretion or not?
My original interpretation is that "... does not state colours..." means that the colours are not specified (e.g. as a pantone colour) but that 'Red' would be a suitable shade of red; not a different colour.

Any feedback appreciated!


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Article 31 directs you to annex I 1.2.1 which states

1.2.1. Labelling General rules for the application of labels required by Article 31 Hazard pictograms shall be in the shape of a square set at a point. Hazard pictograms as laid down in Annex V shall have a black symbol on a white background with a red frame sufficiently wide to be clearly visible.
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