Tests used to certify your N95 mask

As a consequence of the COVID-19 pandemic, one of the most critical and crucial items needed for protection is the N95 mask. They’re used mainly in healthcare setting where exposure to the coronavirus is much more prominent. However, the high demand for these items has made them become scarce, and medical centers are finding it hard to buy them in bulk and wholesale. Regular people can’t buy them easily, as they’re not found for sale regularly, even in online stores.

Even though the biggest and smallest American companies have been working all year to increase the production of these items, their production is surpassed by the gigantic demand for these items. Experts on the matter attribute this to many factors, including the high complexity and expense that comes with the manufacturing process, as well as the scarcity of the raw materials used.

This situation has led to large medical centers and even state authorities falling for scams and illegal schemes involving this mask. A lot of counterfeit N95 masks are circulating right now, which don’t have the proper certifications and regulations that ensure they’re offering the protection an N95 mask does. Some of the most targeted brands are the 3M N95 masks, including the 3M 8210, 3M 1860, and 3M 8511 models.

In this article, we’ll give you an explanation of what constitutes an N95 mask, how they’re regulated, and which tests are used for their certification.

What are N95 masks?

N95 masks have been considered throughout the pandemic as the best type of face mask for virus protection. While surgical masks, which are the most popular face mask used in the healthcare field, are not considered to have the proper antiviral filtration capacity for situations of high risk of exposure, N95 masks are. This is why they’ve been a crucial item for healthcare workers during the pandemic.

The name of these masks is established by a federal agency, the National Institute for Occupational Safety and Health, known by their acronym, NIOSH. This institution was created as a part of the Centers for Disease Control and Prevention (CDC) to help work settings in the United States be safe for their workers, avoiding occupational illnesses or injuries.

One of the things this organization does to achieve this is regulate respirators, and their classification and naming system for these masks is considered the standard in the USA. This classification is based on two characteristics to name respirators:

  • According to their oil resistance, they’re assigned a letter. N means there’s no resistance, N means there’s some resistance, and P means the respirator is oil-proof.
  • Based on their filtration efficacy, which is represented by the percentage of minimum particulate filtration efficacy, the respirator can have a 95, 99, or 100 in their name. This is the percentage of airborne particles, which are those with a size as small as 0.3 microns, they can filter out.

Based on this classification, N95 masks refers to any respirator without oil resistance and with a filtration rate of 95%. This allows them to filter out particles such as dust, smoke, pollen, and even bioaerosols like the flu virus or even the new coronavirus, which are not oil-based and are airborne. For this reason, N95 respirators can have many different uses in work settings other than the healthcare one.

NIOSH has the responsibility to test out every face mask manufactured with the intention to be sold as an N95 mask. They perform several tests to ensure the mask performs as an N95 one, and only with their approval can manufacturers distribute them as an N95 mask. Additionally, when these masks are going to be used as medical equipment, the Food and Drug Administration (FDA) has to approve them as well, since they are in charge of regulating medical equipment.

Tests used to certify N95 masks

To ensure the effectiveness of N95 masks, a set of tests need to be performed to evaluate different aspects of the respirator. All the details of this process are available on the CDC website for you to read, but in general, this is how N95 masks are tested for certification.

The first thing to be done is to condition the masks for 24 hours before the test begin. This is done by keeping the masks in an environment with a temperature of 38 degrees Celsius and a humidity level of 85%. First, let’s talk about the tests NIOSH performs.

Since NIOSH only cares if the respirator can both filter out the number of particles it’s supposed to and be safe and comfortable, the three main tests they perform on N95 masks are:

  • Particle penetration (to make sure particles are being filtered).
  • Saturation with particles (to see at which point the filters become saturated with particles).
  • Breathing resistance (to ensure the mask will hold its shape during breathing).

For their use in the healthcare field, the FDA has to do some additional tests to ensure the mask will be safe in medical environments. These tests are:

  • Biocompatibility
  • Fluid resistance (this is done because medical and surgical procedures often involve the release of fluids at a high pressure, and the mask needs to resist this)
  • Particulate filtration
  • Flammability (this is because in the operating room there are many things that can start a fire and it’s important for these masks to not be flammable)

More information can be found on this link.


We want to finish this informative article by encouraging our readers to not use medical equipment, including face shields, KN95 masks, and surgical masks as well as N95 masks. Reusable cloth masks are the preferred item for protection in the general public, including kids above the age of 2, in combination with social distancing.

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