Graphical symbols for use in the labeling of medical devices - EN 980:2008 (E) June -2008

Has anyone had a chance to look at it and what are the changes in the latest version?

Regards
Subbu
India

Hi there,

I do not have the chance to look at the standard yet but I got the information of the changes in this document.

The new changes in this document are exciting and will certainly have a
positive impact on medical device labeling. EN 980:2008 greatly increases
the number of symbols that are recognized in Europe that can be used without
further explanation.

The biggest change is that Clause 5 (Symbols in Use) has been greatly
expanded to include a total of 29 symbols, up from 12 previously. These 29
symbols can now be used "without explanation in the information supplied by
the manufacturer."

It will be more appreciate should there anyone can share the copy of standard!!

:tg:

Tiff

Graphical symbols for use in the labeling of medical devices - EN 980:2008 (E) June -2008

Has anyone had a chance to look at it and what are the changes in the latest version?

Regards
Subbu
India

You would probably get better response by posting under a current thread with the same title (EN 980:2008(E)-Graphical symbols for use in the labeling of medical devices (http://elsmar.com/Forums/showthread.php?t=28211)) instead of starting a new one.

By concentrating discussions and information in one thread and especially for information type of topics, you'll help future searches a lot.

Hi

There are a bunch of changes to the 2008 version:

The symbols that were previously under section 6 (and needing translation) and are now under section 5 and can be used without additional translations.

There are new symbols under section 6 for:

6.2 "Contains or Presence of Natural Rubber Latex";
6.3 "Do not use if package is damaged" and
6.4 "Sterile fluid path".
These need explanation or translation in the accompanying information.

There is an informative section stating that symbols containinga circle with a diagonal line are a prohibition symbol and indicate "Do Not" and not "Does not Contain".

It says "Does not.." should be in the form of a large "X" placed over a symbol. It then says you can't use this form with any of the symbols already in EN980.

Chris

............ It will be more appreciate should there anyone can share the copy of standard!! Tiff

Hi Tiff,

We do not allow sharing of copyrighted documents in this forum - so anyone interested can buy from BSI / Techstreet.