Pictogram

Pictograms are a simple and effective way of communicating information about medical devices, so that it can be understood in any languages.

It requires though that these pictograms have a single meaning shared by all. When such a definition is established, the pictograms are harmonized and can be used without further definition:

According to the revised European Medical Device Directive(2007/47/EEC), medical devices containing phthalates must be labelled as such, if:

1. The device contains phthalates as an integral part of the medical device material formulation (i.e. not including contaminants or residues) AND
2. These phthalates are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I of Directive 67/548/EEC AND
3. The device is intended to administer and/or remove medicines, body liquids or other substances to or from the body or devices intended for transport and storage of such body fluids or substances AND
4. The phthalates are present in that part of the device that is intended to administer and/or remove medicines, body fluids or other substances to or from the body or devices intended for transport and storage of such body fluids or substances.

 Only three phthalates are currently classified as carcinogenic, mutagenic or toxic to reproduction:

• DEHP [Di (2-ethylhexyl) phthalate] also known as DOP (DiOctyl Phthalate)
• DBP (Di-n-butyl phthalat )
• BBP (Butyl Benzyl phthalate ) also called BBzP

 There are at the time being no harmonized pictograms for such a labelling.

LiNA Medical has chosen to use the following

Adding the chemical description of the concern phthalates on the side of the pictogram: