Regulations for respirator face masks

Unlike surgical face masks, respirator masks are regulated as PPE. In Europe, the masks are split into three filtering face piece (FFP) protection categories: FFP1, FFP2 and FFP3, with the latter conforming to the highest standards.

The category awarded depends on how much protection from outside substances is provided. 

Most respirator masks used by healthcare professional are ranked at either FFP2 or FFP3. 

Menut explains: “The reason why these masks are considered PPE equipment is the shape of the mask — it covers a person’s face really well and is supposed to be sealed all around the nose and mouth.” 

For a respirator mask to be approved, it has to go through what is often called the seal test.

This involves one person wearing the mask, while someone else sprays it, with the amount of ingress being measured.

Respirator masks are commonly referred to as N95 — named as such because they block at least 95% of small micron test particles. 

Alongside healthcare, these masks are used in construction, painting and mining sectors.  

In the US, all such masks must be approved by the National Institute for Occupational Safety and Health (NIOSH). 

Alison Casey, a medical devices analyst at market research company GlobalData, adds: “A subset of N95 masks are also approved by the FDA — and these are used by healthcare institutions. 

“This second approval process has got less to do with the resource because all of them have a certain grade of filtration — it looks more at how tightly it fits to someone’s face.”

In the wake of the pandemic, the FDA has introduced an emergency use authorisation, which means all NIOSH-approved N95 respirators can be used by healthcare institutions. 

The regulator has also said masks with approval in other countries, such as China’s KN95, can be imported and used by healthcare workers in the US.