What is a PPE mask?
A PPE (Personal Protective Equipment) mask allows its wearer to be protected against the risk of airborne contamination. The wearer of this type of mask must therefore be protected in the face of a real or presumed danger.
What should be checked on the packaging of a PPE mask?
A PPE (Personal Protective Equipment) mask in Europe must be CE marked to comply with quality and safety requirements. The CE marking is attributed by a notified body (private company) which verifies a set of documentary, administrative and technical documents.
What types of requirements does this PPE mask meet?
In order to recognize a mask with the CE marking, the notified body must ensure that the performance criteria for this mask are met. The performance criteria for PPE masks are defined in standard EN 149: 2001 + A1: 2009.
Are there different performance levels between PPE masks?
Yes, the EN 149 standard distinguishes 3 levels of classification of PPE masks according to their level of penetration of the filtering membrane and the respiratory resistance of the mask:
Table 1 – Filter Material Penetration
| Classification | Pénétration maximum des aérosols d’essai | |
| Essai au chlorure de sodium 95l/min % max | Essai à l’huile de paraffine 95l/min % max | |
| FFP1 | 20 | 20 |
| FFP2 | 6 | 6 |
| FFP3 | 1 | 1 |
Table 2 – Breathing resistance
| Classification | Résistance maximale permise (mbar) | ||
| Inspiration | Expiration | ||
| 30 l/min | 95 l/min | 160 l/min | |
| FFP1 | 0.6 | 2.1 | 3.0 |
| FFP2 | 0.7 | 2.4 | 3.0 |
| FFP3 | 1 | 3 | 3.0 |
Is there an equivalence with non-European and therefore non-EN 149 masks?
Yes, the GB2626 standard in China, which specifies the performance level of KN type masks (e.g. KN95 could be assimilated to a FFP2 mask according to EN 149). Quant à la référence américaine NIOSH, le N95 pourrait être assimilé également à un masque FFP2.
Does HeX perform the tests according to EN 149?
Yes, HeX performs its testing of PPE masks according to the requirements of EN 149. However, in order for a notified body to be able to verify performance, all the requirements of EN 149 must be verified. HeX performs only part of the tests of EN 149.
What are the EN 149 tests offered by HeX?
HeX directs:
- the penetration test of the filtering material according to §8.11 on the whole (half)mask on the two aerosols NaCl and kerosene oil.
- and the breathing resistance test (inspiratory) according to §8.9.3.
Table summarizing the tests proposed by HeX and compared to the requirements of EN 149
| Type of test or mask test | Paragraphs of the standard | Number of samples | Conditioning | Realized or not by HeX |
| Penetration of the filter material | 7.9.2 & 8.11 | 3 for NaCl aerosol | E.R. (State of reception) |  |
| Penetration of the filter material | 7.9.2 & 8.11 | 3 for NaCl aerosol | C.T. (Conditions in temperature only a without R.M. Mechanical resistance) | |
| Penetration of the filter material | 7.9.2 & 8.11 | 3 for NaCl aerosol | P.S. (Simulated Port Processing) | |
| Penetration of the filter material | 7.9.2 & 8.11 | 3 for the aerosol Paraffin oil | E.R. (State of reception) | |
| Penetration of the filter material | 7.9.2 & 8.11 | 3 for the aerosol Paraffin oil | C.T. (Conditions in temperature only a without R.M. Mechanical resistance) | |
| Penetration of the filter material | 7.9.2 & 8.11 | 3 for the aerosol Paraffin oil | P.S. (Simulated Port Processing) | |
| Inspiratory breathing resistance (without valve) | 7.16 & 8.9.3 (et pas 8.9.2) | 3 | E.R. (State of reception) | |
| Inspiratory breathing resistance (without valve) | 7.16 & 8.9.3 (et pas 8.9.2) | 3 | C.T. (Conditions in temperature only a) | |
| Inspiratory breathing resistance (without valve) | 7.16 & 8.9.3 (et pas 8.9.2) | 3 | P.S. (Simulated Port Processing) |
HeX also performs Fit Tests on your site to verify that your masks match the faces of your staff.
How does HeX ensure the quality of these test results?
Like most of the tests offered by HeX (more than 40) to its customers in the pharmaceutical and hospital industries, HeX performs these tests in accordance with the requirements of the ISO 17025 standard expected for testing, calibration and analysis laboratories.
What are the tests proposed for the COVID-19 pandemic?
HeX offers you a simplified test protocol based on the European Commission’s recommendation (EU) 2020/403. In order to check the quality of PPE masks efficiently and quickly, HeX proposes to check the penetration of the filtering material on both aerosols (NaCl and kerosene oil) and the inspiratory breathing resistance, both in the receiving state (E.R.) only.
Table summarizing the proposed simplified COVID-19 tests by HeX and compared to the requirements of EN 149
| Type of test or mask test | Paragraphs of the standard | Number of samples | Conditioning | Realized or not by HeX |
| Penetration of the filter material | 7.9.2 & 8.11 | 3 for NaCl aerosol | E.R. (State of reception) | |
| Penetration of the filter material | 7.9.2 & 8.11 | 3 for the aerosol Paraffin oil | E.R. (State of reception) | |
| Inspiratory breathing resistance (without valve) | 7.16 & 8.9.3 (et pas 8.9.2) | 3 | E.R. (State of reception) | |
In Belgium, HeX decided on June 17, via its press release to withdraw from the list of reference laboratories for the ATP protocol of the FPS ECONOMY. Indeed, according to HeX, the Fit Testing and the PortaCount particle penetration tests lead to erroneous results and therefore to erroneous interpretations.
#HeXGroup denounces the test protocol set up by the FPS Economy
In the context of the COVID-19 pandemic, as a hospital manager, I am allowed to reuse PPE masks after treatment (disinfection or sterilization). Can HeX assist me in this process?
Yes, HeX has set up a test protocol to measure the level of degradation of PPE masks according to the maintenance cycles undergone by these masks. The protocol verifies several parameters in order to provide the pharmacist in charge of a hospital, for example, with all the necessary guarantees to conduct his strategy for reusing this type of mask in complete safety. Many hospital sites have already benefited from HeX expertise in this field.
