Do N95 masks meet FFP standards?

N95 masks are the example of personal protection equipment (PPE), used to prevent contamination by airborne viruses or bacteria. These are tight-fitting, disposable devices that create a physical barrier between the mouth and nose of the wearer and the contaminations in the immediate environment. They are nowadays very popular and in-demand due to the increasing rate of Coronavirus (COVID-19) pandemic. The Centers for Disease Control and Prevention (CDCs) also regulate N95 respirators and encourage their usage for protection against airborne diseases.


What are FFP standards?
FFP standards are certain standards applied to the respirators by the European Union, CDC, or the FDA in the US. The FFP standard filters help to eliminate the threats of contamination by particulates such as aerosols, dust particles, small viruses, and bacteria. FFP filters are viewed as practically equal to certain other global standards, for example, N95 standards of the US, or KN95 standards of China.


EN 149 standards:
The EN 149 European standards classify the minimum characteristics of respiratory protection equipment and are necessary for the qualification of FFP standard respirators. It consists of certain lab tests, field tests, and requirements to ensure the conformity of the filters. It analyzes the packaging, resistance to manipulation, practical performance test, and total leakage inward or penetration risk of the filter. EN 149 describes the efficiency of filters by dividing them into three categories- FFP1, FFP2, and FFP3 masks.


FFP1 mask:
FFP1 masks are the least filtering mask of the three, with a minimum 80% aerosol filtration percentage, with an internal leaking rate of a maximum of 22%. It is mainly used as a dust mask, protecting against dust-induced lung diseases such as silicosis, asbestosis, and so on.


FFP2 mask:
FFP2 masks filter at least 95% of the dust particles and have internal leakage of a maximum of 8%. This mask offers protection in industries such as glass, cement, pharmaceutical and agricultural industry, filtering the powdered chemicals. It can serve as a protection against severe acute respiratory syndrome associated with coronavirus (SARS) and is closely similar to the N95 mask.


FFP3 masks:
FFP3 masks have an aerosol filtration percentage of 98% and have a maximum 2% internal leakage rate. It is the most filtering of all the FFP masks and protects against fine particles like asbestos and ceramic. However, it does not protect against fine gases, in particular nitrogen oxide.


Difference between certified FFP filter and a surgical mask.
The FFP standard respirators are designed to reduce the wearer’s exposure to the airborne particles around him. However, the surgical N95 masks help prevent the expulsion of biological particles such as bacteria and viruses by the wearer. Surgical N95 masks are not designed to tightly seal the face, so air might leak from the sides. Some approved respirators have the characteristics of both the respirator and a surgical N95 mask and can be utilized for either purpose. In the US, surgical N95 respirators are both approved by NIOSH and FDA for their use in surgery.


What does 95% efficiency mean?
All the respirators are used to help reduce, not eliminate the risk of contamination by the airborne particles and biological entities. According to the testing criteria of NIOSH, the N95 masks have a filtration efficiency of at least 95%, against the non-oily particles. However, the filtration is not only dependent upon the filtration rate of penetration of hazards from the environment. Some other key external factors that affect the filtration are fit and wear time.


N95 masks in Industrial and Medical settings:
Most N95 masks are manufactured to be used in industrial settings, to be used by the workers to help prevent exposure to industrial waste and chemicals. These are usually approved by the National Personal Protective Technology Laboratory (NPPTL) under the Center for Disease Control (CDC). However, some N95 masks are intended to be used under the medical care setting, for the sake of the safety of both the patient and the doctor. These are disposable, single-use protective devices used by health care professionals to prevent the exchange of microorganisms and body fluids with the patients.
The surgical N95 masks are class II devices, approved by the FDA, CDC, and NIOSH, intended to prevent certain diseases and infections. The respirators used have the filtration technology used to flush out the microorganisms, such as viruses and bacteria. They also filter out the smoke and plumes, eliminating the risk of allergies or respiratory infections or problems. The FDA has a Memorandum of Understanding (MOU) with the CDC that outlines the framework of collaboration between them for the regulation of N95 masks.


N95 and FFP standards:
With the increasing rate of coronavirus (COVID-19) pandemic, especially in the US, the demand for N95 masks has increased a fold. They are not only being used by the professionals but are also very famous for domestic use. Although according to CDC, surgical masks are also very effective in protection against COVID-19, people prefer N95 or KN95 masks for their safety. Although they do not provide 100% protection, they are relatively safer to use and easily accessible to the public.
N95 masks meet the US National Institute for Occupational Safety and Health (NIOSH) N95 standards and are also considered equivalent to the standards of the European Union’s FFP2 masks and China’s KN95 masks. Hence, N95 masks are comparatively better than surgical or cloth masks, but they cannot be completely relied upon for safety against COVID-19.

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