Can a surgical mask be used as respiratory protection?
To answer this question, we need to look at the design of the masks.
Surgical masks or medical face masks usually consist of a two-layer non-woven fabric with a filter in the form of a cloth. They are often referred to as 3-ply. A tight seal between the face and the mask cannot be guaranteed with this type of construction, because part of the air you breathe reaches the airways from the side without passing through the mask.
Medical face masks, or surgical masks, are designed to protect patients from contamination by the wearer. Surgical masks are mainly used in operating theatres to prevent surgeons’ aerosols from reaching the patient or on the operating table. So they serve to protect the patient and not to protect the person who wears them.
Even a surgical mask certified according to EN 14683 complies with the Medical Devices Act, but does not meet the requirements of the EU directive for personal protective equipment.
Respirator masks on the other hand, are usually made entirely of filter material. They are usually preformed or composed of several parts. As a result, the respirators enclose the mouth and nose so that the air you breathe has to flow through the filter.
Respirator masks were designed to protect the wearer from aerosols, germs and viruses. They belong exclusively to category 3 of personal protective equipment (PPE). According to Directive 89/686 / EEC for personal protective equipment, respirator masks may only be placed on the market if they have been subjected to a type test (here EN149) and additional production monitoring by a designated test centre. Users can recognise this by a CE symbol with a four-digit code number and the specification of the standard applied on the product.
There is an abundance of different products on the market that differ significantly not just in terms of price but also in properties. Unfortunately, medical face masks are wrongly offered as cheap respiratory protection. It is often suggested to the user that some surgical masks meet the stricter requirements of EN 149. However, the corresponding markings are completely missing.
However, specially designed surgical masks that are certified according to EN 149 are also available to protect the wearer. These surgical masks were built to actually enclose the mouth and nose. These correspond to category 3 of the directive for personal protective equipment. A type examination by a named test centre is therefore required. An EC-type examination certificate must be available. The applied standard and protection class as well as the CE mark with the four-digit code number must be attached to the product. If this is not the case, this product must not be offered as a respirator.
Conclusion: Surgical masks or FFP (mouth and nose protection) in the form of a cloth are not respiratory protection in the sense of personal protective equipment (Directive 89/686 / EEC).
If the manufacturer claims this, he must prove it with an EC type-examination certificate and mark the product in accordance with EN 149.