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Shanghai Shengbaiou CE Certification Agency
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NIOSH N95 US certification



The N95 mask is one of nine anti-particulate masks certified by NIOSH (National Institute of Occupational Safety and Health). "N" means unsuitable for oily particles (the soot produced by cooking is oily particles, and the droplets produced by people speaking or coughing are not oily); "95" means the filtering efficiency under the detection conditions specified by the NIOSH standard Reached 95%. N95 is not a specific product name. As long as it meets the N95 standard and passes the NIOSH review, the product can be called "N95 mask".
Classification of NIOSH and 9 kinds of anti-particulate masks
NIOSH: National Institute for Occupational Safety and Health, the United States National Institute for Occupational Safety and Health, is an internationally renowned and important research institute for occupational safety and health. It is mainly engaged in scientific research on occupational safety and health, and advises on the prevention of work-related injuries and diseases. . The institute is affiliated with the Centers for Disease Control and Prevention of the United States Department of Health and Human Services.
According to the "42 CFR Part 84" of the Department of Health and Human Services (HHS) regulation, NIOSH has classified its certified anti-particulate masks into 9 categories. 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, which can be used to protect non-oily and oily suspended particles.
P series: P stands for oil Proof, which can be used to protect non-oily and oily suspended particles.
According to the minimum filtering efficiency of the filter material, the masks can be divided into the following three levels:
Level 95: The minimum filtration efficiency is 95%.
Grade 99: The minimum filtration efficiency is 99%.
100 level: The minimum filtration efficiency is 99.97%.
The combination is N100, N99, N95, R100, R99, R95, P100, P99, P95. There are 9 types. In the actual testing process, NPPTL based on different types of test materials (A, B, C) and test time, and then determines whether the application mask meets the criteria for its classification.
N95 application process
For manufacturers applying for N95 for the first time, the application is divided into two stages:
The first stage. Submit a questionnaire (to NPPTL) and photos (enterprise factory appearance, product production line, etc.) to NPPTL assessment. After NPPTL assessment is qualified, the manufacturer will be given an enterprise code and other relevant information. The first stage ends. It takes about 3 weeks to a month to complete the first phase from the submission of information.
second stage. After completing the first stage and receiving the documents from the NPPTL, prepare detailed application materials. In addition to filling in the standard forms, the company also needs to provide the following materials that meet the standards:
Pre-test data,
Drawings,
Assembly Matrix,
Draft approval labels,
QA manual,
Process Quality Control Plan,
Service Life Plan,
User's Instructions,
Test samples and Hardware.
Pay the test fee in advance when you submit the information. If the submission is unqualified, NPPTL will request rectification and re-submission. Everything went smoothly. The second phase took about 3-4 months from the submission of the information.
After the manufacturer obtains N95 certification, NIOSH conducts random checks on certified products sold by manufacturers on the market every year to determine whether the company has always met the N95 requirements.
N95 application precautions
1. The N95 certificate will only be issued to entities capable of controlling product design. Only manufacturers and designers (manufactured by others) can apply. The importer or any distributor cannot be the beneficiary of the N95 certificate, which means that the N95 certificate will not be issued to them, whether it is a second conversion or they re-apply (to the manufacturer's product). Manufacturers can apply for N95 by themselves or entrust a professional consulting company to handle it on their behalf.
2. N95 certification is charged according to the model. The more models, the more expensive. The specific classification is determined by NPPTL evaluation. That is to say, if the manufacturer provides a series of models when applying, there are also several small models below. NPPTL may require Manufacturers have refined the model division, increasing costs.
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