What it takes for N95 respirator manufacturers to become NIOSH-certified

It is recommended that all PPE Kit and N95 respirator buyers check if the product is complied with by NIOSH certification. There are valid reasons behind it. When NIOSH certifies a company that is trading in N95 Respirators, there will be no doubt about its effectiveness. Which is 3M so popular among the thousand other companies who sell N95 masks? First, the company is in the industry producing this same mask for a long time because of the different purposes of N95 other than medical use. Second, the company is certified by NIOSH. To prevent COVID-19 infection from spreading among the community and to keep yourself healthy and fit in this pandemic, it is important to choose a mask carefully by checking its certification from the NIOSH. 

Now, if a company is interested in trading in N95 masks and wants to get it started properly, where will it get the certification from NIOSH? Well, there is a lengthy procedure as it is about the medical sector we are talking about, and it is going to be used in this pandemic to stop a deadly virus that is around us. Safety precaution needs to be checked thoroughly before the approval. Here, in this blog, we will take a look at the process of approval by NIOSH for N95 respirators and masks. 

To get NIOSH certified, the respirator manufacturer needs a lot of effort and planning. Any company that produces NIOSH-approved respirators has done a great deal of work to improve their respirators, obtain NIOSH approval, create and sell these respirators, and maintain their quality continues to remain NIOSH-approved. Code of Federal Regulations 42 part 84, commonly known as 42 CFR 84, is the specific code manufacturers comply with for NIOSH authorization.

The company will have to plan a comprehensive NIOSH package if the manufacturer has finished all the design and development work and is ready to apply for NIOSH approval. It covers numerous sketches, performance checks, a product quality plan, packaging and labels copies, comprehensive user instructions, and a manual for its manufacturing facility for quality control.

Suppose a manufacturer needs to have NIOSH approval on an N95 respirator that is developed to filter non-oil-based elements. In that case, filter efficiency tests with sodium chloride aerosol must be performed. The manufacturer must also perform quality checks on mask resistance and valve leakage. Additionally, the manufacturer plans an in-depth quality control plan for its manufacturing facility, which addresses inspection of raw materials and components, ensuring that they meet specified requirements, complying with test protocols, and providing transparent information about where the respirators are sold.

This kind of NIOSH approval training isn't limited to N95 respirators. Whatever level of approval the supplier applies for, be it N, R, or P with an efficiency of 95% or 99%,  the company must carry out quality checks and develop different application packages for that approval.

All information is collected and sent to NIOSH along with respirator’s samples in a formal, approved submission package. NIOSH not only verifies the data but also performs its own testing to validate the findings of the manufacturer. If all goes by and the sketches and QC plans follow the requirements, a check and certification number will be issued to the supplier, which will be noted on the product label of the supplier. Usually, this process takes about three months, from submission to acceptance. If NIOSH has any questions to the manufacturers, they can allow a reasonable amount of time for its answers.

When approval is received from the supplier, the respirator may get into marketing. Changes to the manufacturing process cannot be made, which would improve the respirator's output in some way from the original form. Each supplier is subject to NIOSH tests on-site and in the field. NIOSH buys respirators in the area during a field audit and checks them in their government laboratory. When NIOSH discovers any anomalies on-site or in the field, they can request a correction from the supplier, stop selling the product, and recall the current product from the ground.


How is N95 Tested?

N95 masks need to undergo specific challenges to comply with NIOSH standards. Here are the tests which you can consider as precertification tests:


Sodium Chloride Aerosol Test

Sodium Chloride Aerosol test is to determine the filtration efficiency of the masks and if it goes up to 99.999% or not. 


Dioctyl Phthalate (DOP) Test

The DOP test is an acceptable way to evaluate the penetration of particles and airflow along with the resistance power for various filtration elements.


Tests for Exhalation, Inhalation and Valve Leak 

Mask manufacturers need to undergo the tests for exhalation, inhalation, and valve leak and comply with NIOSH standards.

Each of these laws and standards is intended to ensure public health when using respiratory products. Nevertheless, employers and end-users must also take responsibility by ensuring that the respirators are used in compliance with OSHA requirements and guidelines from the manufacturer, that they function correctly, and that they are not misused. 

Therefore, check the information on the product to ensure whether those are compliant with NIOSH standards or not. You are going to use that to protect yourself, your family, or kids from germs or anything infectious and contagious, so you need to be sure of the quality, no matter how great online deal you are getting to buy them. Be aware, be safe. 

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