ISO 15223-1 (Medical Device Label Symbols) - Revisions, EU commission?

[eyalhend]

Hello all,
Would appreciate your insights trying to understand if ISO 15223-1 is applicable for the European Commission. I still can't find it along the list of harmonized standards.

Moreover, can someone tell what are the main differences between 2012 and 2016 revisions?
I found in ISO website that 2012 was replaced by 2016 rev.

THanks ahead!
EH

 

[Marcelo]

You can apply any standard (or any solution, for that matter) to comply with essential requirements for CE marking. However, if you don't use a harmonized standard, you don't gain "presumption of conformity". This means that you would need to evaluate your solution (usually using risk management) to show why your solution gives a level of safety as good as a solution from a harmonized standard.

The 2016 version is a minor revision. It includes some new text on some symbols, and removes some text from other symbols. For example, one comment is related to how to use the symbol of "consult instructions for use" in the case of electronic instructions for use. The new revision does not include any new symbol.