N95 mask refers to the mask that passed the US NIOSH standard, but do you know how to pass it?
1. What is American NIOSH?
The National Institute of Occupational Safety and Health (NIOSH) works at the Centers for Disease Control and Prevention (CDC), a federal agency that specializes in generating new knowledge in the field of occupational safety and health and turning that knowledge into practice to improve workers.
Because personal protective equipment (PPE) plays an important role in keeping many workers in various industries safe during their duties, the National Personal Protection Technology Laboratory (NPPTL) was established as a department of NIOSH to prevent disease.
To accomplish this mission, NPPTL conducts scientific research, develops guidance and authoritative recommendations, disseminates information, and responds to the requirements of workplace health hazard assessment.
Under the authorization of the Occupational Safety and Health Act of 1970, the National Institute of Occupational Safety and Health (NIOSH) provides a test, approval, and certification program to ensure that the respirator used in the workplace meets the standards of 42 CFR Part 84.
Since 1994 NIOSH has maintained a searchable online version of the list of certified equipment.
NPPTL was established in 2001 at the request of Congress. The laboratory was created to meet the recognized need to improve personal protective equipment (PPE) and focus on personal protection technology (PPT).
According to the NIOSH guidelines, the enterprise needs to send samples to the NIOSH laboratory for testing, and submit technical information (including some quality system information) to the NIOSH document review. Only after the document review and test pass, NIOSH will issue the approval.
NIOSH classifies its certified anti-particulate masks into 9 categories, and specific tests are performed by NPPTL (National Personal Protective Technology Laboratory) laboratory under NIOSH.
The main test indicators include exhalation resistance test, exhalation valve leakage test, inhalation resistance test, and filtration efficiency test.
3. N95 face mask NIOSH certification standard:
National Institute of Occupational Safety and Health (NIOSH) New Standard for Dust Respiratory Protection 42CFR84
4. Introduction of FDA mask certification
N95 face mask
The N95 face mask that has been approved by NIOSH can be directly registered by the FDA.
According to updated data from the US Food and Drug Administration (FDA), as of April 13th, masks produced by 62 manufacturing plants in China have obtained FDA emergency use authorization (EUA), including such as KN95, ZK601 meets the Chinese national standards for a class of masks with particulate filtering efficiency.
Some industry sources said that obtaining the FDA’s emergency use authorization only represents that the mask is allowed to enter the United States, and American hospitals still recognize the masks that have obtained NIOSH certification.
Class II (special control) of surgical gowns and surgical masks. If the N95 surgical face mask or N95 filter face mask respirator is designed to prevent specific diseases or infections, or is marked or otherwise expressed as filtering surgical smoke or fumes, filtering a specific amount of viruses or bacteria, reducing the following diseases Quantity and/or killing viruses, bacteria or fungi, or affecting allergenicity, or including coating techniques not related to filtration (eg, reducing and/or killing microorganisms).
Surgical N95 respirators and N95 filter-mask respirators are not subject to the premarket notification procedures in Section E of Section 807 of this chapter, but subject to the following conditions of 878.9:
(i) It must be demonstrated that the components of the user’s contact with the device are biocompatible.
(ii) Analytical and non-clinical tests must:
(A) It is flammable and proved to be suitable for the intended use environment;
(B) Demonstrate the ability of the device to resist the penetration of fluids (such as blood and body fluids) at a rate consistent with the intended use of the device.
(iii) NIOSH is approved according to its regulations.
(2) Class I (conventional control) of surgical apparel other than surgical gowns and surgical masks.
5. U.S. entry requirements for masks and other anti-epidemic products:
Masks: The United States also manages medical masks and protective masks separately. Medical masks are managed by the US Food and Drug Administration (FDA), and personal protective masks are managed by the National Institute of Occupational Safety and Health (NIOSH).
Medical masks: Medical masks need to be registered with FDA, and companies apply directly to FDA and submit relevant materials.
There are two alternative ways:
1. N95 masks that have obtained NIOSH registration can be exempted from product registration (510K) when the product biological test, flame retardant test and blood penetration test pass, and directly carry out FDA factory registration and medical device listing.
2. If authorized by a manufacturer holding 510K, it can use its 510K approval number as its foundry for enterprise registration and device listing.
Personal protective masks: protective masks need to be registered with NIOSH, and companies apply directly at NIOSH.
6. N95 NIOSH-approved masks
The N95 face mask is one of 9 anti-particulate masks certified by NIOSH (National Institute of Occupational Safety and Health).
“N” means not suitable for oily particles (oil fumes produced by cooking are oily particles, and the droplets generated by people talking or coughing are not oily);
“95” means that the filtration efficiency reaches 95% under the test conditions specified in the NIOSH standard. N95 is not a specific product name. As long as it conforms to the N95 standard and has passed the NIOSH review, it can be called the “N95 face mask”.
Masks are divided into 9 categories. The specific certification is operated by the NPPTL (National Personal Protective Technology Laboratory) laboratory under NIOSH.
According to the filtering characteristics of the middle filter of the mask, it is divided into the following three types:
N series: N stands for Not resistant to oil and can be used to protect non-oily suspended particles.
R series: R stands for Resistant to oil and can be used to protect non-oily and oily suspended particles.
P series: P stands for oil Proof and can be used to protect non-oily and oily suspended particles.
According to the low filtration efficiency of the filter material, the mask can be divided into the following three levels:
95 grade: indicates that the low filtration efficiency is 95%.
99 grade: indicates a low filtration efficiency of 99%.
100 grade: indicates a low filtration efficiency of 99.97%.
