How the National Institute for Occupational Safety and Health tests and certifies n95 respirators

The COVID-19 pandemic has brought personal protective equipment (PPE) to the forefront of the discussion. We’ve been wearing face masks every day to go out in public for several months now, and PPE has been talked about in the news and online, N95 masks in particular.

N95 respirators need approval and certification by an institution called the National Institute for Occupational Safety and Health. In this article, we’ll talk about this institution, N95 masks, and how they test and regulate them so they can be distributed and sold as N95 respirators.

N95 masks

Considered to be the best disposable face mask for virus protection, N95 masks have the highest antiviral properties among the main face masks used today, including surgical, medical, and reusable cloth masks, with or without face shields. They’ve been prioritized for healthcare workers and other first responders on the frontlines since the pandemic began for that very reason. Some of the most purchased N95 masks are the 3M N95 masks, including the models 3M 8210 and 3M 8511.

The name ‘N95’ comes from a classification of respirators that is established by the National Institute for Occupational Safety and Health, also known as NIOSH. This institution regulates and tests every type of respirator before they’re used in workplaces in the United States, making sure they meet the criteria for each of the respirator types inside their classification.

Respirators are masks or mask-like devices widely used as PPE in many industries where respiratory hazards, particles that can be harmful to humans when inhaled, are present. They filter out the air that is inhaled by the user, trapping the dangerous particles, preventing them from entering the airways.

The NIOSH classification names respirator types according to two characteristics, with three different options for each one, leaving nine possible types of respirators by combining the possibilities of each characteristic. These are oil-resistance, indicated by the letter N, R, or P, meaning not resistant, resistant, or oil-proof, respectively, and filtration rate, indicated by the percentage of minimum particulate filtration efficacy, which can be either 95, 99, or 100%.

According to this, N95 respirators would be any type of respirator that doesn’t have oil-resistance and can filter out at least 95% of the airborne particles in the air, that is any particles with a diameter of 0.3 microns. For this reason, they’re the best option for non-oil based airborne particles, which includes dust, smoke, and viruses like the flu or the coronavirus. This is why they’ve been reserved for healthcare workers, since they are at higher risk of exposure to the virus, and they need the best protection they can get.

Any respirator manufactured and aiming to be distributed as an N95 respirator needs approval by NIOSH to be considered a legitimate N95 respirator. They test and certify that they do meet the criteria to be considered as such and that anyone who uses them is going to be protected from 95% of the non-oil based particles in the environment. To be used as medical PPE, they need approval by the Food and Drug Administration (FDA) too, but with the coronavirus pandemic, the FDA has granted Emergency Use Authorizations (EUA) to many mask models that weren’t previously approved by them.

KN95 masks are often confused with N95 masks, and they aren’t so different from each other. Even though the first has been considered interchangeable with the latter for the most part, it’s important to point out KN95 masks are manufactured under Chinese standards, and not the ones from the USA (NIOSH). There are minor differences between the two, but KN95 masks have been considered a good substitute for N95 respirators during the coronavirus emergency, with many of them obtaining EUAs by the FDA.

NIOSH and how they certify respirators

NIOSH is a federal agency inside the United States that conducts research and makes recommendations to effectively prevent occupational illnesses or injuries. They’re a part of the Centers for Disease Control and Prevention (CDC), and its current director is John Howard.

Created in the 70s under the Occupational Safety and Health Act along with the Occupational Safety and Health Administration (OSHA), their main goal is to ensure safe working conditions through information, education, research, and training. They provide leadership in terms of work-related illnesses, injuries, death, and disability through scientific research and translating this knowledge into products and services. NIOSH and OSHA are often confused with each other, but even though they were created under the same law, they have different but complementary responsibilities.

There are many different qualities NIOSH takes into consideration when testing and regulating N95 respirators. For filtration efficacy, they used the Standard Test Procedure TEB-APR-STP-0059pdf icon to confirm the filtering efficiency, which has to be 95% or more. The test can be done by entities with the proper test equipment, without the need for permission from NIOSH.

The results from this test alone don’t imply a NIOSH approval on their own, as we mentioned, many other requirements are needed to be considered an N95 mask. This test only provides information about the filtration efficiency of the respirator.

Many alternatives to N95 masks can be found for sale online, with options for kids in a smaller size, and available to buy in bulk and wholesale as well. Make sure to always stay protected when in public, to protect not only yourself but also those around you who are more vulnerable, like older people and those with pre-existing conditions.

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