Respiratory mask standards: what is tested and how?

July 2022
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Because not all types of breathing masks are required to provide the same kind of protection, they must meet strict standards prescribed by the health authorities. What is tested, and how? We asked Catherine Guillou, Research and Development Manager at Klap.

I bought a box of disposable masks. How do I know if they are compliant?

Catherine Guillou: First of all, the packaging or the mask itself must bear the CE mark. This indicates that the manufacturer has assessed the conformity of its product (manufactured or imported into Europe) with the safety, health and environmental requirements of the European Union.

Surgical masks are medical devices, qualified according to EN 14683+AC: 2019. FFP2 masks, on the other hand, are personal protective equipment (PPE) and must comply with the EN 149:2001 +A1:2009 standard for the safety of occupational equipment.

What do you test on an FFP2 mask to see if it is effective?

C.G.: To ensure that disposable respirator masks are a good health protection solution, their performance is tested on three criteria for surgical masks and four for FFP2 masks:

  • filtration,
  • breathability,
  • safety
  • + face sealing for FFP2 masks

For filtration, the mask is put in contact with two types of aerosols (the most demanding process): one with solid particles (with sodium chloride, i.e. salt) and the other is a liquid aerosol: paraffin oil. The test consists of measuring the filtration efficiency of the mask in the worst case, i.e. in the presence of the most penetrating particles.

For breathability, the device passes air through the mask at different flow rates (in litres per minute) and measures the pressure differential between the two sides of the mask. With these variable flow rates, breathability thresholds can be tested for both inhalation and exhalation, and under different conditions of physical activity.

At Klap, we are constantly looking for the best compromise between filtration and breathability.

Does KLAP test its own masks?

C.G.: Yes, at KLAP, we are keen to guarantee our customers total control over the conformity, quality and traceability of our products. Moreover, we produce our own filtering media in the heart of the masks, the meltblown.

We have test benches to check the filtration and breathability performance of our surgical and FFP2 masks. We are also very demanding on their solidity by systematically testing the resistance of the elastics.
For the mask safety criterion, we carefully select our suppliers to work with perfectly biocompatible raw materials. They must also comply with the European REACH regulation which aims to protect the environment and human health against the effects of certain chemical substances (mercury, cadmium, lead, etc.).

So we control the whole production line, from raw materials to finished products, and even to their recycling and revalorization, but that’s another story, which we will take the time to explain in a future article.

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