What should mouth masks comply with?

It was gloomy news for the Netherlands when 600,000 mouth masks had to be recalled because they did not meet European safety requirements. And that while we so desperately need this personal protective equipment (PPE) in these times!

To avoid future recalls of urgently needed personal protective equipment, we would like to help you clarify the ambiguity about different types of mouth masks and the corresponding European obligations.

The distinction between mouth masks

There are many different types of mouth masks but basically they can be divided into two groups: Surgical Masks and Respiratory Protection Masks.

Surgical mask

This group of masks are not personal protective equipment because they protect the wearer's environment but not the wearer themselves. Surgical masks are designed to block fluid or residue released during speech or exhalation. These types of masks are classified as medical devices and must meet the requirements of Regulation (EU) 2017/745 on Medical Devices. There are 3 different types of surgical mouth masks: Type I, Type II and Type IIR (non-moisture permeable).

Respiratory protection masks

This group of masks are designed to protect the wearer from inhaling unwanted substances from the environment. Because of this, the respiratory protection mask does fall under personal protective equipment.

There are three differences classes of respiratory protection masks, FFP1, FFP2 and FFP3. FFP stands for "Filtering Facepiece Particals."

FFP1 masks offer the least protection and are not recommended as masks against Corona virus. However, FFP2 and FFP3 types of masks are recommended because they have efficiencies of 94% and 99%.

Legal obligations

Personal protective equipment must comply with the requirements set out in Regulation EU 2016/425. More detailed information on personal protective equipment and the conformity assessment procedure can be found on our expertise page.

Respiratory protection masks fall under risk category III personal protective equipment and must meet the requirements according to European standard EN 149:2001+A1:2009. Products in this category also require EU type approval before these items can be offered on the European market.

An EU type inspection may only be carried out by a European Notified Body. An EU type examination checks that the technical documentation is complete and required tests have been carried out. If a presumption of conformity with the regulation is demonstrated, an EU type examination certificate is issued.

Respiratory protection masks must bear the following product markings:

• CE mark;
• Number of the Notified Body which carried out the EU type examination;
• Mention of the European Standard EN 149:2001+A1:2009;
• Indication of mask type (FFP1,2 or 3);
• Possibility of reusing the mask (NR or R);
o NR staat voor eenmalig gebruik.
o R staat voor meervoudig gebruik.

Need advice or support?

Do you need advice on mouth masks? Précon Quality Services is happy to advise and support you in identifying and meeting your obligations under Regulation EU 2016/425 Personal Protective Equipment.

Please feel free to contact us at +31 (0)30 - 65 66 010 or info@precongroup.com