With the multitude of masks (surgical and general public) with uneven qualities put on the market in recent months, the question of their reliability has become a fundamental criterion.
To strengthen confidence in these devices and particularly in surgical masks, LNE is creating a certification to provide guarantees on the effectiveness of the masks that are part of our daily lives.
Since the start of the health crisis, LNE has mobilized all its know-how to serve the health authorities to test the effectiveness of masks, drawing on its experience in medical device evaluation and aerosol metrology. LNE has been particularly active in helping health authorities (French Public Health, ARS, etc.) to provide masks to protect healthcare personnel: surgical masks, FFP2 masks.
In order to continue in this direction, and in view of the lack of certification by an independent third-party body, LNE is today launching "Protective masks" certification.
To obtain this certification, manufacturers must ensure that their products meet several quality and safety requirements:
In order to check that the masks comply with these requirements, tests are carried out in LNE laboratories at two sites in the Ile-de-France region, using validated methods in the fields of aerosols, materials characterization and consumer product safety. LNE has dedicated testing facilities to be reactive in order to issue analytical results.
As a Class I device, surgical masks are not subject to assessment by a Notified Body to obtain CE marking. The manufacturer is responsible for the evaluation and must make a declaration to the ANSM to be authorized to place its products on the market. LNE's "Protective masks" certification thus provides buyers and users with guarantees on the quality and performance of these masks.
Alexandre Papin - 01 40 43 38 92 - firstname.lastname@example.org - Valérie Mulot - 01 40 43 40 93