Surgical face masks: What does tested to EN 14683:2019 mean?

Since 2019, face masks have become a day-to-day item for all of us. Especially in crowded environments we want the best protection available. In some other European countries, it is even compulsory to wear a surgical face mask on public transport.

As customers and staff alike rely on the responsibility of businesses, it is paramount to understand the difference between different types of face masks. Every business wants to offer the best protection for everyone involved, but even the UK Government has shown how easy it is to order PPE that is not offering the standards required. For a business this would either mean a loss, as the substandard supplies can’t be used, or it will offer a substandard protection to customers and employees – something no reputable business will do willingly.

What is a surgical face mask?

A surgical face mask (also known as medical or procedure mask) is a device covering the mouth, nose and chin ensuring a barrier which limits the transition of an infective agent (like viruses) in hospitals and other environments. They are used to prevent large respiratory droplets and splashes from reaching the mouth and the nose of the wearer and help reduce and/or control at the source. Surgical face masks comply with the requirements defined in European Standard EN 14683:2019+AC:2019.

What are the performance requirements for surgical face masks according to EN 14683:2019+AC:2019?

Surgical face masks have to meet the following requirements to conform with EN 14683:2019+AC:2019

CharacteristicsType IªType IIType IIR
Bacterial filtration efficiency (BFE), %>95>98>98
Differential pressure, Pa/cm2<40<40<60
Splash resistance (kPa)Not requiredNot required>16.0
Microbial cleanliness (cfu/g)<30<30<30

 What do these characteristics mean?

What does BFE mean for surgical face masks?

BFE is the abbreviation for Bacterial Filtration Efficiency.

The Bacterial Filtration Efficiency test determines the filtration efficiency by comparing the bacterial control counts to test article effluent counts. The test is conducted using staphylococcus aureus as the challenge organism. After the filtration media is preconditioned, a liquid suspension of S. aureus is aerosolized and delivered to the filtration media at a constant flow rate of 28.3 litres per minute (LPM) or 1 cubic foot per minute (CFM).

According to EN 14683:2019+AC:2019 the filtration efficiency for surgical face masks type IIR has to be above 98%. This is the highest standard for this kind of masks and this is the standard Home Shield Products type IIR face masks are tested and certified for.

What does the differential pressure mean for face masks?

The Differential Pressure test, often shortened to DP, measures how easily air is passed from one side of the mask to the other. This indicates how easily the wearer can breathe through the mask, which is indicated by Delta P (the pressure difference). The higher Delta P results in better filtration, while still providing comfortable breathing for the wearer.

What is the splash resistance for Type IIR face masks?

The splash resistance is the resistance of the medical face mask to penetration of splashes of liquid and it has to conform to the minimum value of 16 kilopascal for Type IIR. The property of splash resistance is only tested for the highest standard of surgical face masks, Type IIR.

What is microbial cleanliness and what does it mean for face masks?

The Microbial Cleanliness is a measurement to identify the total number of viable micro-organisms on a face mask using an extraction method. The total viable aerobic microbial and fungal load is determined. The test indicates the total bioburden per individual mask and based on the mask weight, the total bioburden per gram.

Highest quality type IIR face masks for your business

There a lot of reasons why you should look for a responsible supplier for face masks for your business. Your staff and your customers rely on you to provide the best protection to keep them safe.

If you have any question about our products, want to visit our manufacturing site in Nottingham or have a price inquiry, please contact us.

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