Mask certifications in Italy
Why is it important for masks to be EC marked?
When an object is EC marked (European Certification) it means that it has passed specific conformity tests according to Regulation (EC) No. 765/2008, and that it can be freely marketed in the European market. Once these tests have been passed, the tested item does not affect the health and safety of the user.
For this reason, it is important that masks are also CE marked on the packaging or on the device itself, depending on whether they are PPE or Medical Device.
What is the difference between masks certified as a Medical Device and masks which are PPE?
Masks certified as Medical Device and those certified as PPE have different characteristics.
Specifically, Medical Devices, to be considered as such, must be registered with the Ministry of Health, or authorized by the ISS ("Istituto Superiore di Sanità", the Italian Institute of Health) only during the coronavirus emergency. The main characteristic of surgical masks, which fall into this category, is that they do not protect the person wearing them, but the person next to them. Finally, surgical masks are regulated by EN 14683:2019.
The masks registered as PPE are FFP1, FFP2 and FFP3, usually regulated by EN 149:2001. These devices must be subjected to specific tests that approve their conformity according to the standard, and must be certified by a specific body (during the Covid-19 emergency it is the Italian INAIL that places them on the market by derogation). FFP masks without valve protect both the person wearing them and the person next to them.