BS EN980 and Latex symbol

C

cochranemurray

#1
The updated standard indicates a new symbol to identify the presence of Latex.
Currently we are using the word Latex in a circle with a line through it to indicate a product is Latex free. I see this as an incorrect use of this symbol (the circle with the line through it) as I understand it to mean "do not" rather than "does not". ie a circle with a 2 in it and a line through it indicates do not reuse.
My question is, should we use the new symbol with a line through it to mean Latex free (as we do just now) or write the words "Latex Free" or not make any mention at all if there is no Latex present?
I already see product with the new symbol and a line through it to indicate "Latex free" which I think is an incorrect usage.
Any thoughts?
 
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Ajit Basrur

Staff member
Admin
#2
Good question :)

Since the new version requires the Latex symbol only if it contains any Latex compunds, I would go for it and not use the earlier symbol of "Latex Free" to indicate the absence.

Therefore, if your product does not contain Latex, would suggest stop usage of the earlier symbol. :2cents:
 
M

MIREGMGR

#3
The FDA recognizes only a subset of the symbols defined in
ISO 15223 and EN 980, for use on labels of regulated medical devices. All other information that is required to be included on such labels is required to be stated in English text. Symbols and/or other text languages may additionally be used if they do not decrease the communicative effectiveness of the label. The FDA is not harmonized with EU MDD and Asian requirements in this regard.

The FDA's current stance on symbols is stated in "
Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use" (http://www.fda.gov/cdrh/ocd/guidance/4444.pdf). While this document clearly states its applicability to IVDs, we have been told by the FDA that it is applicable to medical devices as well.

When the FDA imposed controls on natural rubber latex in medical devices in 1997 (http://www.fda.gov/cdrh/dsma/fr93097.html), they banned the prior common usage of text statements on labels, not backed with comprehensive biocompatibility testing, that a product was "hypoallergenic" as a way of communicating that the product did not contain natural rubber latex. It was at that point that companies selling devices in the US market began to use the "latex-in-a-circle-with-the-cross-bar" symbol to communicate the "does not contain natural rubber latex" message.

Currently, that symbol is broadly used on device labels for professional usage in the US market.
 
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