OR

I'm looking for in the

[COVID-19] Masks: testing, marketing

LNE informs you

Protective masks are classified into different categories according to their use. They are subject to different regulations depending on their category. Whatever the emergency situation, a mask must comply with the regulatory requirements applicable to its intended use and to the claims defined by the manufacturer and/or importer, like any product placed on the European Union market. LNE carries out a number of tests and trials on behalf of its customers, authorities and manufacturers. This file presents mask categories and the process for placing them on the market, and the evolving list of tests proposed by LNE.

This page will be updated regularly according to the latest news and information in our possession. (last updated on 11/05/2020)

Placing on the market of protective masks

Medical device masks (including surgical masks)

Masks for medical applications, including surgical masks, are Class 1 medical devices which must comply with Directive 93/42/EEC, or Regulation 2017/745. Standard NF EN 14683 "Masks for medical use, Requirements and test methods" defines a series of tests to demonstrate the performance of bacterial filtration efficiency, breathability, splash resistance and microbial cleanliness.

According to their filtration efficiency, the standard classifies masks into three categories:

  • Type I filters a minimum of 95% of bacteria
  • Type II filters more than 98% of bacteria
  • Type II « R » filters more than 98% of bacteria and is splash resistant.

These masks do not protect the wearer from possible contamination, but they allow the wearer to avoid contaminating those around him. They are for medical use only for contagious patients and caregivers.

Certification process

Like any medical device (MD), surgical masks must be certified. As a Class I device, they are not subject to assessment by a Notified Body under the MD Directive or Regulation to obtain the CE marking of the device. The manufacturer is responsible for the assessment and must make a declaration to the ANSM to be allowed to place his products on the market.

Sterile masks derogate from this rule and are classified as Class IS devices. They therefore require the intervention of a notified body such as GMED to obtain a CE marking certificate before being placed on the market.

In the context of the COVID-19 health crisis, EU Commission Recommendation 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures allows the production of surgical masks without CE marking, under several conditions.

Consult the recommendation (in french)

FFP2 type masks

The FFP2 masks fall into the category of Personal Protective Equipment (PPE). EU Regulation 2016/425 defines the health and safety requirements for respiratory protective masks of which FFP2 masks are one category. The European standard EN149+A1(2009) "Respiratory protective devices - Filtering half masks against particles - Requirements, testing, marking" defines the performance that masks must meet in terms of total inward leakage, penetration of the filter material, skin compatibility, flammability, etc.

The standard classifies masks into three categories, from FFP1 to FFP3, according to their filtration efficiency and total inward leakage.

Rules for placing on the market (in french only)

In order to place masks of type FFP2 on the market, manufacturers must demonstrate compliance with the applicable essential health and safety requirements. FFP2 masks shall be subject to a combination of the conformity assessment procedures described in Annexes V, VII and VIII of Regulation 2016/425. The intervention of a third party conformity assessment body (Notified Body) is necessary before the CE marking can be affixed.

If the mask manufacturer claims a medical use of his masks, they are no longer considered as PPE.

In the context of the COVID-19 health crisis, the EU Commission Recommendation 2020/403 of 13 March 2020 on conformity assessment procedures and market surveillance allows the production of FFP2 masks without CE marking, under several conditions.

See the Commission recommendation


Masks for the general public or  « barriers »

With the shortage of masks due to the COVID-19 health crisis, a new category of masks was introduced : masks for the general public. These masks meet the needs of the health emergency and the level of performance requirements is lower than for surgical and FFP2 masks. These masks can be made in a craft or industrial way and with different types of filtering materials.

Reserved for use by non-health professionals, they are manufactured in compliance with demanding specifications* drawn up by the National Agency for the Safety of Medicines and Health Products (ANSM) in conjunction with the National Agency for Food, Environmental and Occupational Health Safety (ANSES), and are designed to prevent the projection of droplets and their consequences. Before being placed on the market, these masks must be tested, under the responsibility of their manufacturer or importer, by competent laboratories, such as the LNE laboratory, in order to demonstrate their filtration and breathing capacities.

ANSM classifies these masks into two categories, the requirements of which are set out in two notices :

  • Individual masks for use by professionals in contact with the public, they filter out at least 90% three-micron particles**,
  • To protect an entire group wearing these masks, they filter out at least 70% of the three-micron particles**.

** the filtration corresponds to the filtering material, and does not presume that the mask is airtight on the face.

These masks do not protect the wearer from possible contamination, but they do allow the wearer to avoid contaminating those around him.

* * Refer to the requirements in the ANSM notices of March 24, 2020 and March 25, 2020 (revised April 21).

Marketing rules and performance requirements

Placing on the market

Consult the interministerial note which defines the categories of masks, their prescription for use, their conditions of marketing and the recognized competent third parties.

Please note: these masks are not concerned by the CE marking because they are not regulated at the European level.  

Interministerial note (updated on 26 April 2020, in french only)

Performance requirements

LNE experts took part in drafting the SPEC S76-001 document published by AFNOR, which defines the performance requirements for so-called "barrier" masks.

Consult the AFNOR specifications (updated on 28 April 2020, in french only)

See also the DGE's "Masks and Protective Equipment" file.

Producers and tests (in french only)

Further information

Importation of masks

The ministerial instruction DGT/DGS/DGCCRF/DGDDI/2020/55 of 31 March 2020, sets out a series of measures relating to the import and conformity of masks:

  • Masks bearing the CE marking can be freely imported, regardless of the requisition mechanism (decree n°2020-293 of 23 March 2020, article 12).
  • Authorisation until 31 May 2020 for the import of surgical masks in accordance with US and Chinese standards, as well as FFP2 masks in accordance with US, Chinese, Australian, New Zealand, Korean and Japanese standards.

Read the press release (in french only)

Refer to the Ministerial Instruction (in french only) 

Rehabilitation of masks

The Directorate General of Labour published a note on 27 March 2020, indicating that FFP2 type masks that had expired less than 24 months previously could be rehabilitated if the following checks had been carried out beforehand:

  • Visual inspection of the integrity of the packaging
  • Visual appearance check (original colour)
  • Checking the strength of the elastic band and the nasal support bar
  • Performing a fit test

Consult the news on the Ministry of Labour's website (in french only)

Tests carried out at LNE

Note on the lead time for testing.

Since the beginning of the health crisis, LNE as a public establishment, has been giving priority of its capacities to the health authorities. As such, since mid-March LNE has been testing mainly surgical and FFP2 masks distributed to medical staff. As the number of laboratories capable of carrying out these tests, which are crucial for crisis management, is very limited and the volume is high, almost all of LNE's filtration testing capacity is dedicated to this priority mission.

As a result, the turnaround time for other players (manufacturers, importers, etc.) to carry out filtration tests is currently several weeks. The lead times for all other tests, and for all categories of masks (visual inspections, breathability, permeability, maintenance cycle for "general public" masks, set of straps, performance of elastics and the nasal bar, flammability, performance in use, etc.) are not affected by these limits.

Aware of the need for additional resources to meet the major needs of manufacturers and importers, LNE is currently developing new test benches to increase its filtration test capacities and dedicate part of them to "consumer" masks.

Thank you for your understanding.

Medical device masks

Tests according to NF EN 14683 standard

    §5.2 Visual inspections

    §5.2.2 - Bacterial filtration efficiency (EFB) :

        As LNE does not handle bacteria, colloidal suspensions with similar particle sizes will be used for the tests. The potentially biocidal nature of the materials will therefore not be tested.

    §5.2.3 - Breathability (differential pressure)

    §5.2.5 Microbial cleanliness test

Quality check of the elastic bands and nose bridge on request.

FFP2 type masks

Tests according to EN 149

    §8.2 - Visual inspection

    §8.4 - Practical performance test

    §8.6 - Flammability

    §8.11 - Penetration of the filtering material. Method according to NF EN 13274-7:2019

Quality check of the elastic bands and nose bridge on request.

Tests under development :

    §8.9 - Respiratory resistance

Masks for the general public or "barriers"

Tests on masks for the general public can be carried out at LNE.

The interdepartmental note includes the following tests:

  • Filtration tests with an aerosol of micron particles
  • Breathability testing
  • Maintenance cycles (washing, drying, ironing), if applicable

Testing according to SPEC S76-001 specifications is possible.

    §6.2.1 - Visual inspection

    §6.2.2 - Penetration of the monolayer or multilayer composite, according to the 3 methods

    §6.2.3 - Flange clearance resistance

    §6.2.4 - Respiratory resistance

 

Quality check of the elastic bands and nose bridge on request.

Note: for the masks concerned, LNE can carry out tests before and after washing.

>> Make an online price estimate and request a quote for consumer mask testing (in french only)

Technical assistance

LNE is also able to provide you with regulatory technical assistance and help you to understand these different standards and directives.

Resources

Standards available free of charge :

European standards for protective and medical devices (in french only)

EU Guide :

Conformity assessment procedures for protective equipmenty (pdf) 

Frequently Asked Questions :

FAQ on the different types of masks (pdf available on the DGE website, in french only) 

Contact us

For your trial requests on

  • masks for the general public / barrier masks, you can make a price estimate online and then request a quote.

Make an online price estimate/ get a quote

  • FFP2 masks or medical masks, please contact us via our Contact form.
×
En poursuivant votre navigation sur ce site, vous acceptez l’utilisation de cookies conformément à notre politique de données personnelles. En savoir plus.