Face Mask and Respirator CE standards/labelling

Respirators (FFP2, FFP3) and medical face masks (Type I, II & IIR) correspond to 2 different EU standards and regulations:

1.Medical Face Masks Type I, II & IIR fall under the Medical Device Directive/Regulation (MDD/MDR)

A medical face mask is used to protect the patient from micro-organisms in the wearer's (healthcare professional's) breath.

Surgical face masks of Type IIR also protect the wearer against liquid splashes> 120mmHg (average systolic arterial blood pressure i.e.: possible strength of a blood splash in case of rupture in small arteries).

Medical face masks should be marked with a CE-mark showing that it conforms with the requirements of the Medical Device Directive 93/42 (MDR as from end May 2020) as Class 1 medical device.

The CE mark must only be displayed on the packaging (it is not accompanied by the registration number of a Notified Body).

EN 14683 is the European standard setting the construction and performance requirements, and test methods for medical and surgical masks.

Main performance requirements according to standard:

•      Bacterial Filtration Efficiency

Determines the filtration efficiency of the face mask: the higher the BFE %, the better the protection.

Classification:

•        TYPE I  = ≥ 95 %

•        TYPE II = ≥ 98 %

•      Breathing Resistance

Determines the airflow resistance of the surgical mask: the lower the differential pressure, the higher the breathing comfort.

Classification:

•        TYPE I & II (non splash resistant) = < 29.4 Pa/cm2

•        TYPE IR & IIR (splash resistant) = < 49.0 Pa/cm2

•      Splash Resistance

Determines the resistance of the mask to potentially contaminated fluid splashes.

Classification:

•        TYPE I & TYPE II: not applicable

•        TYPE IR & TYPE IIR: >120 mmHg*

2.FFP respirators are falling under the Personal Protective Equipment (PPE) Regulation:

FFP3 stands for:

·         FF = filtering facepiece (filtering half mask)

·         P = particles

·         3 = class (where 3 is the class that has the highest protection effect)

A respirator is intended to protect the wearer (healthcare personnel) against airborne particles (e.g.: fine dust particles, but also possibly virus particles).

All personal protective equipment, such as respiratory protection, must be clearly marked on the product according to the regulations in force.

In the new European regulation 2016/425 on Personal Protective Equipment, respiratory protection “Category III covers exclusively risks that can lead to very serious consequences, such as death or permanent health damage, e.g. with regard to hazardous substances and mixtures ”, which is the strictest category.

EN 149 + A1: 2009 is a European standard for respiratory protection, filtering half masks for protection against particles. The standard sets requirements for both the product and the manufacturer.

Requirements according to standard

·         Labeling of product according to standard

Tests to be performed according to the standard are:

·         Total leakage

·         Filter penetration

·         Leakage around the face

·         Leakage in the valve

·         Flame safety

·         Respiratory resistance

·         Exposure test = extended loading; a lab test to ensure that the filter material does not start to leak

·         Clogging test (= clogging test); a voluntary test of disposable breathing protection. Marked with "D" (D = Dolomite dust, which is the substance used in the test)

Respiratory protection is divided into three different classes; FFP1, FFP2, FFP3 according to:

·         Efficiency (E%)

·         Total leakage (P%)

·         Protection factor

The respirators should be marked with;

·         Manufacturer name and item number (e.g.: 3M 1883+)

·         Which standard and class it meets (e.g.: EN 149 + A1: 2009, FFP3: 2001)

·         CE-Mark followed by 4 digits (e.g.: CE0086) showing that it is approved by a notified body as  conform with the requirements of the strictest PPE category III.

The CE marking must be clearly marked on each individual product and the instruction manual must be in local language (local market).

Some products may be dual labelled both as Medical Face Mask (Type IIR) AND FFP3 Respirator. But they are quite rare (most respirators are sold as dust masks PPE).

In any case, it is still worth to consider that product even if single labelled (either as medical face mask or as protective respirator) will still provide some level of protection for both the user and the patient (or people around them).