Mask CE Certificate

Why is it necessary to use a mask?

Face masks become a symbol in each pandemic period. It is very important to wear a mask for a viral enemy that is unclear where it will come from and is not visible even if it is not hidden. Although people sometimes use a scarf wrapped around their face or colorful homemade textiles that cover the mouth and nose, it is best to use masks or, more rarely, N95 masks for effective and healthy protection.

In the Covid-19 epidemic today, 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 wearing these masks protect themselves from this epidemic in closed environments, public transportation vehicles or crowded areas.

It is observed that conscious people are increasingly using these masks in our day when the normalization process has accelerated all over the world.

How Could the Virus Causing Covid-19 Spread?

After the virus infects a person, it tends to multiply rapidly. As they multiply, these new virus particles mix into the body fluids in the lungs, mouth and nose. When an infected person coughs, small droplets (not possible to see them by eye), known as virus-filled aerosols, diffuse into the air. A single cough can produce around three thousand particles. So much so that the virus can spread even by talking. According to the researches, it has been determined that a person who says “stay with health” releases thousands of droplets into the air.

These airborne particles quickly settle on the surrounding surfaces. The smaller ones are suspended in the air. It is suggested that the virus stays in the air for several hours under appropriate conditions and infects people if inhaled. However, in closed environments, the virus has a higher tendency to spread and stay in the air. The areas where the spread is most common are houses, public transportation, restaurants, cafes, cinemas and shops. In poorly ventilated areas, the virus spreads to people sitting in the immediate vicinity with aerosol particles in the air.

Therefore, experts argue that facial masks help reduce contamination in the community, especially when used in public transport and crowded areas. Studies are underway to examine the effectiveness of facial masks to prevent the virus from spreading from infected people. In these studies, it has been found that a standard surgical face mask is sufficient to significantly reduce particles that escape the breath of people infected by coronavirus, influenza and other viruses that cause colds.

How long does 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 fabrics, that is, outside the human body.

Research shows that Covid-19 spreads at an alarming size and speed. Accordingly, the virus DNA left in the metal arm of a hospital bed in an isolation room spreads to nearly twenty surfaces within ten hours, including door handles, chairs, playground, waiting area and books. Briefly, a virus in liquid particles falling on a bed is distributed to the environment by people who touch 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 worrying issue is how long the virus causing Covid-19 disease survives on various surfaces outside the human body. The virus survives 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 contaminated people. It can only stay in the air 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 so long on door handles, plastic-coated or laminated worktops and other hard surfaces. Other research shows that the virus survives and smears on smooth surfaces for up to seven days, such as glass, plastic, stainless steel, ceramic and latex gloves. Maximum four days in cotton clothes and five days on the paper surface.

Is CE Marking Required for Masks?

Surgical masks to be offered to users in the European Union countries must comply with the EN 14683 standard, which describes the requirements and test methods for carrying 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.

Surgical masks are defined as medical equipment covering the mouth, nose and chin of the user according to the standard in question. Masks should act as a barrier between hospital staff and the patient, limiting the passage of an infectious agent. Masks should be produced according to different requirements and should be tested with the recommended methods to determine their performance.

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

• Bacterial filtration efficiency test
• Breathability (delta P) test
• Splash resistance (synthetic blood) test
• Microbial cleaning test
• Biocompatibility test

Surgical masks are considered first-class medical equipment, and manufacturers must conduct risk analyzes and additional tests in accordance with the European Medical Device Directive 2017/745.

After these processes are passed, the manufacturer can put the CE mark on the masks.

What is Bacterial Filtration Efficiency Test?

As mentioned above, the test method described in the European standard EN 14683 is a test method to determine how effective a surgical mask is in capturing bacterial aerosol particles. Filtration efficiency mainly depends on the following factors:

• The size of the particles
• Virus or bacteria size
• Air flow through the mask
• On the surface properties of 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 a bacterial aerosol. Particles passing through the aerosol mask sample are collected on 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 face mask, the required filtering levels must be at least 95 percent or 98 percent.

This is why such surgical masks are called N95. N95 masks perform much better than ordinary masks in filtering airborne pollutants such as viruses, bacteria, smoke, dust and fog. These masks have high filtration efficiency as well as low air resistance that facilitates easy breathing.

What is Splash Resistance Test?

The mentioned EN 14683 standard is based on the ASTM F1862 standard published by the American Testing and Materials Organization (ASTM) (Standard test method for the resistance of medical face masks to penetration with synthetic blood).

This test method, which is applied to determine the resistance of the surgical face mask to the penetration of synthetic blood, is practically known as a splash resistance test. This test method is applied to determine the resistance of medical face masks to penetration by the effect of a small volume of high-speed synthetic blood flow. During the test, the effect rates and volumes of synthetic blood are selected to simulate different scenarios in the operating room.

Conclusion

Masks bearing the CE mark are approved for safety, health and environmental protection standards. After tests performed in advanced laboratories, masks are classified as N95, N99 and N100 according to their level of efficiency, and CE marking is put on it by rating it as FFP1, FFP2 or FFP3.

Our company also provides mask CE certification services to businesses within the scope of certification services.