What are the regulations for surgical face masks?

  • By:Connexions
  • Date:2020/06/17

In the EU, medical devices are split into one of four classes — I, IIa, IIb and III — with Class III devices being the most stringently assessed. 

For sales on the European market, all products are required to hold a CE mark. 

Although surgical face masks are considered a Class I medical device, they still have to undertake several tests to be certified. 

These include how efficiently the masks filter out bacteria — with the devices also needing to be breathable, splash-resistant and complete a microbial cleanliness test. 

Similar examinations are carried out by the FDA for businesses looking to sell surgical face masks in the US — with the authority also looking at a device’s particle filtration efficiency, alongside conducting a fire test. 

Explaining the regulations for surgical face masks, Menut says: “It’s about finding the right balance between the highest filtration for the bacteria, and in the meantime, the comfort of breathing through it all day long.

“So you need to find the right balance between comfort and performance.”

To provide the most efficient filtration of bacteria, most face mask developers use either celluloid or polypropylene plastic fabrics.

Due to the simplicity of the design, surgical masks are simple to upscale and mass produce, although it takes a long time to certify a design. 

Traditional surgical face mask manufacturers, such as 3M and Medline, have significantly upscaled their production of the device.

Businesses in the fashion and automotive industries are also helping by developing surgical face masks.

The FDA still recommends healthcare professionals use FDA-cleared products, although products that don’t have its device marketing authorisation can be used. 

Alongside this, the WHO says surgical face masks are not required for members of the general public without respiratory symptoms, because there’s no evidence on its usefulness to protect those without the virus.  

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