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Filtering masks FFP2-FFP3: practical guide on the acronyms

The filtering masks became parts of our everyday life, in spite of ourselves, due to Covid-16 emergency. These include masks, which are classified as personal protective equipment.

These devices are not medical devices according to the Directive 93/42/EEC, differently from the surgical masks, but they are regulated by Regulation (EU) 2016/425. These products were created with the aim of protecting the user, hence they are called personal protective equipment (PPE); for filtering masks, the aim is the protection of the respiratory tract.

Before the pandemic, they were usually used by professionals, for example people working with paints or in dusty environments. These products must be compliant to both the above-mentioned European Regulation and the specific technical standards.

In particular, the filtering masks, or “filtering facepieces” (acronym: FFP) to be more specific, must meet the requirements of the standard EN 149:2001 “Respiratory protective devices – Filtering half masks to protect against particles”, including the revision A1 dated 2009. This standard was made available for free on the UNI website (in Italian language) and on the CEN website in order to promote the fight against the pandemic.

The compliance with all the requirements defined in the European Regulation, together with the technical standards, is diplayed on these devices and on their packaging by means of written information, codes and acronyms, and it is not uncommon to find also further information with international meaning.

The above often creates confusion in users, even when done with the best intentions.

In this article we will try to clarify the most common acronyms, symbols and marks for this type of PPEs, without neglecting any regulatory aspects, especially concerning the FFP2 and FFP3 masks, considered nowadays as the most appropriate to fight the Covid-19 pandemic.

The CE mark

Perhaps this is the symbol on which it is more important to linger and which must meet specific sizes.

The presence of the CE mark gives a well-defined information to the user: this product meets the requirement of the relevant European Directive (or Regulation).

It does not, however, represent an evidence for the product goodness or quality, as people often think.

Moreover, the CE mark is not displayed on all the products on the market, but only the products ruled by the directives of the so called “new approach” can bear it, as specified in this webpage of the European Commission.

The CE mark must be combined with an identification number, in the case of FFP2 and FFP3 masks:

This number is necessary because these products are PPEs of category III, therefore they must undergo a process of evaluation of conformity with the intervention of a Notified Body. In particular, the identification number refers to the Body, which carried out the evaluation in accordance with either Annex VII or Annex VIII of the Regulation (EU) 2016/425.

FFP1, FFP2 or FFP3

One of these acronyms must be present on the device when compliant to the EN 149:2001+A1:2009. The standard classifies the filtering facepieces according to their filtering efficiency and their maximum total inward leakage. In general, the FFP3 masks meet the strictest requirements.

R o NR

Another acronym from European standard EN 149:2001+A1:2009. It states whether the filtering facepieces can be re-used for more than one work shift (R) or not (NR).

D

The mask passed the clogging test, performed with dolomite according to EN 149:2001+A1:2009.

This acronym is mandatory in case of re-usable half masks.

EN 149:2001+ A1:2009

The reference to the technical standard and its publication year must be reported on the smallest commercially available package and on the PPE itself.

Foto di Wilfried Pohnke da Pixabay

GB 2626-2006

Reference to the Chinese national technical standard, published by the Standardization Administration of China (SAC). The requirements defined in this standard are comparable to the ones required by the European EN 149:2001+A1:2009. However, a mask shall be CE marked to be sold in the European market.

KN 95 o KN100

Acronyms referring to the classification defined in the GB 2626-2006. They are present on masks similar to the FFP2 and FFP3 respectively in terms of filtering efficiency.

Foto di viarami da Pixabay

N95

Acronym referring to the classification defined by the NIOSH (National Institute for Occupational Safety and Health), which indicates that the filtering mask has 95% filtering efficiency at the minimum and that it is not resistant to oils (N). The performance is similar to the FFP2 masks in terms of filtration, but the NIOSH marking alone does not allow marketing the product in Europe.

Scritto da: Riccardo Del Signore

Foto di Bellahu123 da Pixabay