How Do You Know Your Face Mask is Fit For Purpose?
Ever since the coronavirus pandemic started to take hold, there have been a lot of stories in the news around PPE and other protective equipment failing to meet the standard that it’s supposed to. You might have heard about the 700,000 face masks that were detained at East Midlands Airport after being suspected of being fake. So, what are the standards required for a surgical face mask and how do you know if what you’ve bought meets those standards?
The European standard for surgical masks is EN 14683:2019. In order to get their certification, mask samples must be sent to an accredited testing lab where they will be subject to four different tests. Here, we’re going to look into each of those four tests as well as how to tell whether your masks are genuine.
Test 1: Splash Resistance
The main difference between a Type II mask and a Type IIR mask is whether it is splash resistant or not. A Type II mask is not splash resistant so, in order to gain that extra certification, Type IIR masks have to pass a series of splash tests to ensure that fluid will not pass through and touch the user.
These tests involve spraying water at the mask several times at different speeds. The results are a simple yes or no – a pass or fail – for this certification. This stage tests the outer, hydrophobic layer of the mask and makes sure that whatever it has been treated with is sufficient to stop fluids from coming through.
Test 2: Breathability
Next, masks need to have a breathability rating below 60 kilopascals. On some imported masks, the breathability rating is proving to be much higher, meaning they would be quite hard to breathe through after an extended period of time.
This is another difference between the standards for a Type II and a Type IIR mask. For Type II masks, the breathability rating needs to be even better i.e. below 40 kilopascals. What this means on a practical level is that we are seeing many NHS trusts issuing Type IIR masks to their staff and Type II masks to their patients. This is because a better breathability rating will make masks easier to wear for longer periods of time if you don’t require the splash resistance of Type IIR masks.
We are proud to say that our OBISK Type IIR masks have a low enough breathability rating to meet Type II standards. So, they are no less comfortable for medical professionals even with the additional splash resistance.
Test 3: Bacterial Filtration Efficiency
The third test concentrates on the Meltblown layer of the mask. The Meltblown fabric is a very finely bonded fabric and these fine fibres filter out small particles and bacteria.
This layer also has an electro-static charge to it which plays a big part in achieving the necessary Bacterial Filtration Efficiency (BFE). To meet EN14683 standards, masks need to have a BFE of equal to or greater than 98%. This charge is also one of the key factors in establishing a mask’s expiry date because without that charge, the masks will not be as efficient.
Test 4: Bio-Burden Test
The final test is a bio-burden test. This test is to ensure that the masks are clean and aren’t carrying any contaminating bacteria. The score needs to be lower than 30 and is really about the environment that the masks have been produced in. Manufacturers will need to build specialised clean room environments in order to produce their masks to meet this standard.
How Can You Check Your Mask’s Certification?
With so many masks coming into the UK from overseas, there’s a large amount of retesting going on. This is unfortunately causing a lot of pressure on the limited number of testing labs in the UK. Some of the common problems have involved fake test certificates or certificates that don’t actually relate to the product being sold.
Many testing labs and notifiable bodies are providing guidance on their sites around how to check whether their certificates are genuine. So if you haven’t received one already, you should ask for a EU type examination certificate from the face mask manufacturer. This certificate should have the identification number of the notified body who provided the certification. You can go to that notified body’s site and check their guidance on verifying documents, or you can use portals like the BSI Certificate Directory to check its authenticity.
As the only manufacturers of Type IIR masks within the UK, we can offer you unparalleled reliability in your supply chain. Get a guaranteed monthly delivery with fixed pricing using our subscription service.