Respiratory protection mask FFP1 FFP2 standard NF EN 14683:2014

About FFP1 and FFP2 respiratory protection masks standard EN 14683:2014

The FFP (Filtering Facepiece Particles) protective mask, also known as a disposable particulate respirator. This mask is a protection against particles also against various transmissible diseases in the air. Half-mask type, that is to say covering the chin, nose and mouth, this type of mask is subject to compliance with certain standards as well as effectiveness tests. Efficacy is evaluated as a function of the filtration rate but also as a function of the inward leakage rate, the mask having to be correctly adjusted on the face. Standard EN 14683:2014 defines three classes of filtration efficiency for these masks, namely FFP1, FFP2 and FFP3. Sold by box of 50 masks.

Manufacturing conditions and standards in force for medical masks

Transmission of infectious agents during surgical procedures in operating theaters and for other medical procedures can occur in different ways. Sources of transmission are, for example, the nose and mouth of members of the surgical team. Masks for medical use are primarily intended to protect the patient against the transmission of infectious agents, and, in certain circumstances to protect the person wearing them against splashes of liquids likely to be contaminated and against certain active particles. Masks for medical use can also be worn by patients and others to reduce the risk of spreading infection, especially in the context of an epidemic or pandemic.

Performance requirements for medical masks EN 14683:2014

This European standard EN 14683: 2014 was adopted by CEN on February 4, 2014. It has been transcribed into NF standard since August 2014 Continuing from its first edition in 2005, the 2014 version incorporates the basic requirements regarding the performance of medical masks.
1- Bacterial filtration efficiency (EFB): 2 levels
2- Breathability (Delta P): 2 levels
3- Splash resistance: 1 level

And it completes the list with two additional requirements:

4- Microbial cleanliness (microbial load): 1 level
5- Biocompatibility: Evaluation according to ISO 10993-1

*The classification into 3 families of masks is distributed as follows:*
TRIAL	Type 1a	Type 2	Type 2R
Bacterial filtering efficiency (EFB) in%	≥95	≥98	≥98
Differential pressure (Pa / cm²)	<29,4	<29,9	<49
Spray resistance pressure	Non éxigé	Non éxigé	≥16,0
Microbial cleanliness (cfu / g)	≤30	≤30	≤30

Type Ia medical masks should only be used for patients and others to reduce the risk of spreading infection, especially in the context of an epidemic or pandemic. The type I mask is not intended for use by professional surgeons, in operating theaters, or in another room with similar requirements.

To go further than the requirements ...

For a better transparency, with its users, CA Diffusion, undertakes to carry out the tests of efficiency of bacterial filtration EFB and Breathability (ΔP), on the same mask. These tests are carried out by an independent laboratory: Laboratoires NELSON. To guarantee the quality of its masks, CA Diffusion, undertakes to carry out technical tests regularly, renewing their realization over a period of 3 years (EFB, DeltaP, Splash resistance). CA Diffusion guarantees the filtration level of these masks up to 5 hours of continuous use.The tests carried out on type II and type IIR masks, every hour, during a period of 6 hours of use show that the filtration (EFB) and breathability (Delta P) performances remain far beyond the requirements. The performances are maintained over time.

Manufacturing conditions

We Médi-Aube-Santé, participate in obtaining an essential guarantee of quality, it is about respecting non-pre-contamination. The production of medical masks is carried out in an ISO 7 qualified clean room, reserved for the manufacture of these products. At regular frequency, microbiological tests (search for total germs and yeast-molds) are carried out by an independent laboratory according to a validated method (requirement of standard EN 11737: 2006) which follows the protocol described in standard NF EN 14683:2014. Quarterly, tests are also carried out on the absence of germs: Staphilococcus, Escheria-coli, Anaerobic sulfito-reducers. This working environment makes it possible to constantly ensure respect for microbial cleanliness (otherwise called Bioburden) on all of the masks offered by Médi-Aube-Santé, by rushing to the manufacturing companies to ensure good compliance. standards in force.

Cerficat protective mask FFP1 and FFP2 standard EN 14683:2014

Respiratory protection mask FFP3 standard EN 149: A +: 2009

FFP3 mask with valve

Non-woven synthetic fiber filtering respirator FFP3. Nose adjustment bar. Integral foam face seal. High performance exhalation valve. Hygienic individual bag. Optional DOLOMITE test for prolonged breathing comfort.

Mask: non-woven synthetic. Straps: elastic.

use:

Biological chemical High performance exhalation valve

STANDARD certification:

PPE DIRECTIVE 89/686 / EEC

EN149: 2001 + A1: 2009 Filtering half-masks against particles

How is COVID-19 Coronavirus transmitted?

The outbreak of the Coronavirus called COVID-19 originated in the city of Wuhan in China and more specifically in a market (closed since January 1) where are sold animals, this is why the hypothesis of a zoonosis (disease transmitted by animals) is preferred. The risk of transmission is by close contact, that is to say when sharing the same place of life as a sick person when he presents symptoms or in direct contact, that is to say , if she coughed or sneezed within one meter of us without effective protection.

How to protect yourself?

The main recommendations, for the moment, mainly concern people who travel to areas affected by the COVID-19 virus. It is necessary:

Avoid contact with animals, living or dead
Avoid going to markets where live or dead animals are sold
Avoid close contact with people suffering from acute respiratory infection
Do not eat uncooked or undercooked meat
Wash your hands regularly with soapy water or alcohol-based solutions

Should we wear a FFP2 respiratory protection mask according to standard NF EN 14683:2014?

According to the Ministry of Health, wearing a surgical mask is recommended only for people who have symptoms of the disease to avoid spreading it by air, in case you have symptoms of COVID-19, a anti-contamination mask is necessary therefore a type 1 mask at least a FFP1 respiratory protection mask according to standards EN 149: 2009.

On the other hand, for people who are not sick, it is "not recommended and its effectiveness has not been demonstrated".

For caregivers wanting to protect themselves from a respiratory mask, then for these people, it is necessary to wear a respiratory protection mask of type 2R FFP2 to standards NF EN 14683: 2014.