Eurofins offers testing for hygienic and community masks, surgical and medical masks to meet the standards required in Europe and the US.
Hygenic/Community Masks
Hygienic masks intended to be distributed to the general public should meet the safety and performance benchmarks outlined in the standards
of the country in which they are sold. Hygienic masks are not subject to specific regulation in Europe and the US, but certain countries have recommended use of such masks in light of the coronavirus outbreak. As a result, Spain, France and Mexico have published some
relevant standards with certain basic requirements (UNE 0065, UNE 0064-1, UNE 0064-2, AFNOR-SPEC-S76, breathability, particle filtration, etc.).
French DGE Approved Laboratory.
Eurofins has been nominated by the French DGE (Direction Générale des Entreprises) as an approved laboratory to perform the mandatory tests to sell community masks (for non-sanitary usages) in France.
More information - French DGE Approved Laboratory
Surgical/Medical Masks
Surgical/medical masks are designed to cover the mouth and nose providing a barrier to minimise the direct transmission of infective agents between the wearer and a person close to them, or vice versa. There are three different types of surgical masks: Type I, Type II and Type IIR (in Europe according to Directive 93/42/EEC to be replaced by Regulation (EU) 2017/7451) and Level 1, Level 2 and Level 3 (in US according to FDA requirements). Surgical and medical masks are classified as medical devices.
Eurofins can support manufacturers in ensuring the functionality and safety of these products.
Testing Services
Eurofins provides high standard quality assurance and control services throughout the supply chain.
Manufacturers are responsible for ensuring that masks which are put on the market and supplied to healthcareworkers comply with safety and
effectiveness requirements and the standards which are required in the country in which they are sold.
For more information about Mask Testing and our [email protected] Solutions , please email [email protected]
Eurofins has been nominated by the French DGE (Direction Générale des Entreprises) as an approved laboratory to perform the mandatory tests to sell community masks (for non-sanitary usages) in France.
Background
Starting from 11th May 2020, it has become mandatory to wear face masks in France in some public areas, such as transport. To cope with the high demand on non-sanitary usages masks, the French government has issued the cross-ministry information note on April 26th 2020 to provide a clear framework on how to use and test this new category of fabric masks (community masks) for the French market.
Selling Community Masks in France
It is mandatory for any seller, importer or manufacturer that sells community masks in France to observe below three requirements laid out by French DGE:
(1) Testing requirement
Sellers are required to conduct two performance tests on the products, namely filtration (against EN 13274-7:2019) and breathability (against ISO 9237:1995 or EN 13274-3:2019) at a laboratory approved by French DGE.
(2) Logo display
With reference to the test results, sellers should display corresponding logo on the products or on the packaging to well inform the consumers. The logos below indicate how many washing cycles the community masks are expected to live up to, ranging from zero wash to 50 washes.
(3) Notice of use
The sellers are required to provide a notice of use to the consumers.
Upon random surveillance check in the market, sellers will be required by the French authorities to provide document proof including test reports on the community masks they sell.
Our Services
Eurofins has been nominated by French DGE to perform the necessary tests on community masks outlined above.
Apart from requirement by French DGE, our tests are also in compliance with the technical recommendations by the Belgian government.
For more information about Mask Testing and our [email protected] Solutions , please email [email protected]