What is a PPE mask?

A PPE (Personal Protective Equipment) mask protects the wearer against the risk of airborne contamination. The wearer of this kind of mask therefore needs protection from a real or presumed danger.

What do you need to check on the packaging of a PPE mask?

In Europe, a PPE (Personal Protective Equipment) mask needs to be marked with the letters CE to ensure compliance with quality and safety requirements. The CE marking is attributed by a notified body (a private company) that has to check a number of documentary, administrative and technical elements.

What kind of requirements does this PPE mask fulfil?

In order to label a mask with the CE marking, the notified body needs to make sure that the performance criteria connected to this mark are respected. The performance criteria for PPE masks are defined by the EN 149: 2001 + A1: 2009 standard.

Are there different levels of performance for PPE masks?

Yes, the EN 149 standard distinguishes between 3 levels of classification for PPE masks, including in particular in relation to the penetration level of the filter layer and the breathing resistance of the mask:

Tabel1 – Penetration of the filter material

Classification Maximum penetration of test aerosols
Sodium chloride test 95l / min% max Paraffin oil test 95l / min% max
FFP1 20 20
FFP2 6 6
FFP3 1 1
Extract §7.9.2 of standard EN 149: 2001 + A1: 2009

Tabel 2-breathing resistance

ClassificationMaximum allowable resistance (mbar)
InhaleExhale
30 l/min95 l/min160 l/min
FFP10.62.13.0
FFP20.72.43.0
FFP3133.0
Extract §7.16 of standard EN 149: 2001 + A1: 2009

Is there an equivalent for non-European masks, so not the EN 149 standard?

Yes, the GB2626 standard in China, which specifies the performance of KN masks (for example KN95 could be equivalent to a FFP2 mask according to EN 149).

As for the American reference NIOSH, the N95 could also be regarded as equivalent to an FFP2 mask.

Does HeX carry out its tests in accordance with EN 149?

Yes, HeX carries out its tests on PPE masks in accordance with the requirements of EN 149. However, in order for a notified body to be able to check performance, it is a good idea if all of the requirements of the EN 149 standard can be verified. HeX only carries out some of the tests covered by the EN 149 standard.

What EN 149 tests does HeX offer?

HeX carries out:

  • the penetration test for the filter material according to §8.11 on the full (half) mask with two aerosols, NaCl and paraffin oil.
  • the breathing resistance test (inhalation) according to §8.9.3.

Tabel summarising the tests offered by HeX and compared with the requirements of the EN 149 standard

TypeParagraphs of the standardNumber of samplesConditioningOffered by HeX or not
Penetration of the filter material7.9.2 & 8.113 for NaCl aerosolA.R. (As received)
Penetration of the filter material7.9.2 & 8.113 for NaCl aerosolT.C. (Temperature Conditioning only, without M.S. Mechanical Strenght)
Penetration of the filter material7.9.2 & 8.113 for NaCl aerosolS.W (Simulated Wear)
Penetration of the filter material7.9.2 & 8.113 for Paraffin Oil aerosolA.R. (As received)
Penetration of the filter material7.9.2 & 8.113 for Paraffin Oil aerosolT.C. (Temperature Conditioning only, without M.S. Mechanical Strenght)
Penetration of the filter material7.9.2 & 8.113 for Paraffin Oil aerosolS.W (Simulated Wear)
Breathing resistance, inhalation (valveless)7.16 & 8.9.3 (not 8.9.2)3A.R. (As received)
Breathing resistance, inhalation (valveless)7.16 & 8.9.3 (not 8.9.2)3T.C. (Temperature Conditioning only, without M.S. Mechanical Strenght)
Breathing resistance, inhalation (valveless)7.16 & 8.9.3 (not 8.9.2)3S.W (Simulated Wear)

HeX can also carry out Fit Tests on your premises to make sure your masks are suitable for your staff.

How can HeX guarantee the quality of the results of these tests?

Like most of the (over 40) tests that HeX offers its clients in the pharmaceutical and hospital industries, HeX carries out these tests in accordance with the requirements of the ISO 17025 standard expected of testing, calibration and analysis laboratories. LOGO COMPLIANT TEST ISO 17025

What tests are available within the context of the COVID-19 pandemic?

HeX offers a simplified testing protocol based on the European Commission’s recommendation (EU) 2020/403. In order to verify the quality of PPE masks quickly and effectively, HeX can check the penetration of the filter material with two aerosols (NaCl and paraffin oil) and the breathing resistance (inhalation), both in “As Received” (A.R.) condition only.

Tabel summarising the simplified COVID-19 tests offered by HeX and compared with the requirements of the EN 149 standard

Type of test on the maskParagraphs of the standardNumber of samplesConditioningOffered by HeX or not
Penetration of the filter material7.9.2 & 8.113 for NaCl aerosolA.R. (As received)
Penetration of the filter material7.9.2 & 8.113 for Paraffin Oil aerosolA.R. (As received)
Breathing resistance, inhalation (valveless)7.16 & 8.9.3 (not 8.9.2)3A.R. (As received)

In Belgium, on 17 June via a press release HeX made the decision to withdraw from the list of reference laboratories for the SPF ECONOMIE’s ATP protocol. In fact, in HeX’s opinion, the Fit Tests and particle penetration assessment tests using the PortaCount lead to incorrect results and therefore interpretations.

#HeXGroup dénonce le protocole de test mis en place par le SPF Economie

En savoir + sur les tests des masques EPI

Within the context of the COVID-19 pandemic, as a manager in a hospital, I am allowed to reuse PPE masks after they have been treated (disinfected or sterilised). Can HeX help me with this?

Yes, HeX has introduced a testing protocol that can measure the level of deterioration in PPE masks depending on the cleaning cycles that these masks have undergone. The protocol checks a number of parameters so that the head pharmacist in a hospital, for example, has all the guarantees they need to manage their strategy for reusing this kind of mask safely. Many hospitals have already benefited from HeX’s expertise in this area.

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