Surgical Mask Tests
Surgical face masks or medical face masks are protective equipment manufactured to provide the highest quality protection for hospital staff and patients. It provides protection of the mouth and nose area against splashes, infection prevention, lets or sprays during operations. Employees in hospitals, medical centers or health boards are required to wear face masks to prevent the spread of disease. Masks, which help people prevent the spread of infectious microbes in the air, have become an equipment that everyone needs today, as they are used in these areas. Thousands of microorganisms are released into the air when coughing, talking or sneezing. Face masks are part of the infection control strategy to prevent cross contamination. But the truth is that wearing masks in crowded and public places, public transport, shopping malls is a great need, especially during epidemics. Many people unknowingly transmit germs by coughing, touching, or having close contact. Masks act as a physical barrier to protect both the wearer and those around them from viral and bacterial particles.
The said standard includes masks that prevent the transmission of infectious substances from personnel to patients, especially during a surgical procedure, and surgical mask testing methods that meet design, production and performance requirements. EN 14683, a European standard, describes the requirements and test methods for masks. This standard has been published by the Turkish Standards Institute (TSE) in our country. Published in: TS EN 14683 + AC Medical Face Masks – Requirements and test methods. These surgical mask tests, carried out in mask testing laboratories, mainly regulate the bacteria filtering efficiency of masks. It is mentioned that the bacterial filtration efficiency and the permeability of a respiratory material, bacteria and microorganisms are measured by surgical mask tests. This test is performed on filtering materials designed to protect against biological aerosols, such as face masks, surgical gowns, headgear, and air filters. The presence of infectious microorganisms during surgeries and other medical interventions is a threat. The main contamination points are the mouths and noses of employees who can deal with more than one person at the same time. In order to minimize the risk of infection, especially in epidemic situations, everyone, not just healthcare workers, should use a medical mask.
Medical Face Masks Requirements
Medical surgical masks are examined in two groups according to their bacterial filtering performance in the surgical mask test.
• Type I masks are generally used in epidemic situations to minimize the risk of transmission of infection to patients and other people. These masks are not intended for use by healthcare professionals. Such medical masks are used in epidemic or epidemic situations to prevent the spread of infections among people.
• Type II masks are designed for use by physicians and healthcare professionals. This type of masks are also examined in two groups, Type II and Type IIR, in terms of splash and let resistance.
Surgical mask permeability tests are applied to finished products or parts taken from the product according to EN 14683 standard. In this case, the surgical mask tests applied to the raw material of the mask do not guarantee whether it meets the requirements of the standard.
EN 14683 standard surgical mask tests order:
• In vitro evaluation of bacterial filtration efficiency
Air permeability (differential pressure) test
• Microbial cleanliness test
Splash resistance test within the framework of ISO 22609 standard (test applied for Type IIR masks)
• Biocompatibility tests
In order for masks to be called medical or surgical masks, the filtering performance applied in the surgical mask test must be at least 95 percent. For masks providing medium or high protection, this ratio should yield results above 98 percent.
The filtering efficiency and protective power of the face mask pose a danger in cases such as tearing, getting wet or coming out of the mask. In other words, according to the mask permeability test, the higher the protection value of a mask, the longer the filtering performance. However, the effective wearing time of the mask depends on the humidity level, respiratory rate, nasal discharge or speaking rate.
Basic requirements for masks according to the surgical mask test:
• Particle filtration efficiency
• Bacterial filtration efficiency
• Delta P (pressure difference)
• Spread fever
• Compliance with ISO 10993 – 5 standard
One of the most important points during the conformity assessment of medical masks according to the surgical mask test is the conditions under which the mask will be used. Afterwards, it is evaluated by considering the performance values ??according to the surgical mask test. There are more than one special test standard for surgical masks and test criteria depending on these standards. Due to the recent epidemic, the demand for masks has increased at a high rate. It has gained great importance to provide masks that can provide adequate protection for those in need and are also suitable for the surgical mask test. Surgical mask tests are essential to ensure that the mask meets the basic requirements. Tests applied with certain steps are important in terms of reaching clear results. It is also important that the surgical mask test is performed by an accredited laboratory. Surgical mask testing is sensitive to errors that may occur more than once and is performed within certain controls. These surgical mask tests, which are made in line with the needs and requirements, try to give precise results.