What is the CE certificate on face masks?

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Masks become a symbol in every pandemic period. It is very important to wear a mask for a viral enemy that is not clear where it will come from and is not visible even if it is not hidden. Although people sometimes wear a scarf wrapped around the face or colorful home textiles covering the mouth and nose, it is better to wear masks or, more rarely, N95 masks for effective and healthy protection.

CE certificate for sanitary mask

In the current Covid-19 epidemic, it is vital that people who carry this virus, but are not even aware of it, use these masks to protect themselves, but not the people around them. On the other hand, people who wear these masks protect themselves from this epidemic in closed environments, public transport vehicles or crowded areas.


It is observed that conscious people are increasingly using these masks in our days when the process of normalization has accelerated worldwide.


How could the virus that causes Covid-19 spread?

After the virus infects a person, it tends to multiply rapidly. As they multiply, these new virus particles mix with body fluids in the lungs, mouth and nose. When an infected person coughs, small droplets (which cannot be seen with the naked eye), known as virus-filled aerosols, diffuse into the air. A single cough can produce about three thousand particles. So much so that the virus can even be spread by talking. According to research, it has been determined that a person who says "stay healthy" releases thousands of droplets into the air.


These airborne particles are quickly deposited on surrounding surfaces. The smaller ones are suspended in the air. It is suggested that the virus remains airborne for several hours under the right conditions and infects people if inhaled. However, in closed environments, the virus has a greater tendency to spread and remain airborne. Areas where spread is most common are homes, public transportation, restaurants, cafes, movie theaters and stores. In poorly ventilated areas, the virus spreads to people sitting nearby with aerosol particles in the air.


Therefore, experts argue that face masks help reduce contamination in the community, especially when used in public transportation and crowded areas. Studies are underway to examine the effectiveness of face masks in preventing the virus from spreading from infected people. In these studies, a standard surgical mask has been found to be sufficient to significantly reduce particles escaping from the breath of people infected with coronaviruses, influenza and other cold-causing viruses.


How long does the coronavirus remain on surfaces?

It is possible to take Covid-19 by touching contaminated surfaces. However, it is a matter of curiosity how long the virus remains alive in the air, on objects and tissues, i.e. outside the human body.


Research shows that Covid-19 spreads at an alarming size and speed. Consequently, virus DNA left on the metal arm of a hospital bed in an isolation ward spreads to nearly twenty surfaces in ten hours, including door handles, chairs, the playground, the waiting room and books. In short, a virus in liquid particles falling on a bed is distributed to the environment by people touching the surfaces. The main spread of the virus is that after touching the surface or object contaminated with the virus, the hands come into contact with the face.


In this regard, the main issue of concern is how long the virus that causes Covid-19 disease survives on various surfaces outside the human body. The virus survives for nine days on metal, glass and plastic surfaces that have not been properly disinfected. Some even live up to 28 days at low temperatures.


The virus lives in airborne droplets for up to three hours after coughing on contaminated people. It can only remain airborne for a few hours in still air.


According to the research results, the virus survives up to 24 hours on cardboard and 2-3 days on plastic and stainless steel surfaces. The findings show that the virus will survive just as long on door handles, plasticized or laminated countertops and other hard surfaces. Other research shows that the virus survives and spreads on smooth surfaces for up to seven days, such as glass, plastic, stainless steel, ceramic and latex gloves. Maximum four days on cotton clothing and five days on paper surfaces.


Is CE marking required for masks?

Surgical masks to be offered to users in European Union countries must comply with EN 14683, which describes the requirements and test methods for CE marking and medical face masks. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: 


TS EN 14683 Medical face masks - Requirements and test methods.

CE certificate for mask

CE certified masks (in spanish: mascarillas con certificación CE) are defined as medical equipment that covers the mouth, nose and chin of the user in accordance with the standard in question. The masks must act as a barrier between the hospital staff and the patient, limiting the passage of an infectious agent. Masks should be manufactured according to different requirements and should be tested with recommended methods to determine their performance.


The classification of masks is based primarily on the results of the following tests:


Bacterial filtration efficiency test.

Breathability test (delta P)

Splash resistance test (synthetic blood)

Microbial cleanliness test

Biocompatibility test

Surgical masks are considered first class medical devices and manufacturers must perform risk analysis and additional testing in accordance with the European Medical Devices Directive 2017/745.


Once these processes have been passed, the manufacturer can place the CE mark on the masks.


What is bacterial filtration efficiency testing?

As mentioned above, the test method described in European Standard EN 14683 is a test method to determine how effective surgical masks manufactured in Spain (mascarillas quirúrgicas fabricadas en España) are at capturing bacterial aerosol particles. Filtration efficiency depends mainly on the following factors:


  • Particle size.
  • Size of virus or bacteria
  • Air flow through the mask.
  • On the surface properties of the particles.


During the test, the mask sample is placed between an impactor and the chamber where the bacterial aerosol is produced. Staphylococcus aureus is generally used as the bacterial aerosol. Particles passing through the aerosol mask sample are collected in Petri dishes placed in the impactor. The filtration efficiency of the mask is expressed by the percentage of bacteria stopped by the mask sample compared to an experiment without a sample. Depending on the type of mask, the required filtration levels should be at least 95 percent or 98 percent.


For this reason, these surgical masks are referred to as N95. N95 masks work much better than ordinary masks to filter out airborne contaminants such as viruses, bacteria, smoke, dust and mist. These masks have high filtration efficiency and low air resistance that makes breathing easier.

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