Copyright for label symbols (from ISO 15233-1)

[MarRz]

Hello,
We are preparing a label and IFU for our medical device that will include relevant symbols with meaning as presented in the ISO 15233-1 standard, such as caution, consult IFU, temperature limit, etc.

Are the symbols copyright-protected, and should they be purchased on the ISO platform?

https://www.iso.org/obp/ui/#iso:grs:7000:0632

Or can we use some examples we find on the internet, and just copy those on the label?

 

[Cloud808]

MDR Annex I, Chapter III, 23.1(h) - Where appropriate, the information supplied by the manufacturer shall take the form of internationally recognised symbols. Any symbol or identification colour used shall conform to the harmonised standards or CS. In areas for which no harmonised standards or CS exist, the symbols and colours shall be described in the documentation supplied with the device.

Given EN ISO 15223-1 is harmonized, I would consider purchasing the EN version of the standard. I do not believe referencing an internet resource would hold up for certain auditors.

 

[Al_Z1]

According to p. 4.2 of ISO 15223-1:
b) The manufacturer should determine the appropriate size for the symbol to be legible for its
intended function.
NOTE This document does not specify colours or minimum size for the symbols in Table 1, nor does it specify the
relative size of symbols and that of indicated information.

So, theoretically speaking, it is not necessary to buy symbols, or collections of symbols...
But I second @Cloud808 about purchasing ISO 15223-1. Also ISO 20417 could possibly be additional source of information, as there are many references to it in ISO 15223.

 

[Jean_B]

MDR Annex I, Chapter III, 23.1(h) - Where appropriate, the information supplied by the manufacturer shall take the form of internationally recognised symbols. Any symbol or identification colour used shall conform to the harmonised standards or CS. In areas for which no harmonised standards or CS exist, the symbols and colours shall be described in the documentation supplied with the device.

Given EN ISO 15223-1 is harmonized, I would consider purchasing the EN version of the standard. I do not believe referencing an internet resource would hold up for certain auditors.

Auditors will compare against the requirement, but copyright is not in their specific scope. Insofar I know, copyright does not apply to those symbols; but it does to the additional information the ISO standard gives.
It is likely that auditors will use the ISO OBP for comparison (each symbol has a further unique reference beyond the standard); or know the characteristics of the specific ones they're looking for by heart.

Colours from harmonized standards are indirectly present in EN ISO 15223, but actually specified in the ISO 3864 series (not harmonized). That standard includes other legibility aspects as well, such as the minimum height of the safety sign/symbol.
ISO 80416-3 might also be of interest as it stipulates what can reasonably be modified in a harmonized symbol to fit styling.
Use ISO 9186-1 to structure comprehension testing of symbols that are not harmonized.

 

[ChrisM]

The symbols cannot be copyrighted, since if you buy them as self-adhesive stickers to apply, there is no copyright symbol or text present.
The idea of the Standard is that it defines the symbols that must be used

 

[Jean_B]

The symbols cannot be copyrighted, since if you buy them as self-adhesive stickers to apply, there is no copyright symbol or text present.
The idea of the Standard is that it defines the symbols that must be used

I think the presence of a copyright symbol or statement (ISO 16016) is not a requirement for copyright to be applicable. Not a lawyer, but dealt with it enough to give up on detail, and think in generics.

 

[Raisin picker]

Jean is right. A (c)-symbol or a copyright statement is not required for copyright to apply (at least for the jurisdictions I know, and we're here in EU ;-).

The symbols are (at least most) so basic that they do not fall under copyright laws. Some might be so old that any copyright has expired.

 

[MarRz]

Thank you everyone for the replies. I have bought ISO 15233-1, and the graphic designer will be glad to hear that the company does not need to buy all the symbols we need.

 

[dgrainger]

ISO - Terms and conditions - Licence Agreement

www.iso.org

6. Codes and Graphical Symbols (and their Collections)​

You may use codes (such as language, currency, and country) and graphical symbols for the implementation of their respective ISO standard(s). For example, this means using the symbol in accordance with its meaning as a graphical symbol, e.g., the “No smoking” symbol to designate a non-smokers’ area. However, you may not post or resell these on the Internet. If you would like to use the codes or symbols differently, please contact us or your ISO Member.