What is NIOSH certification? NIOSH certification evaluation

Company Introduction

The Occupational Safety and Health Act of 1970 established NIOSH as a research agency focused on studying worker safety and health and empowering employers and workers to create safe and healthy workplaces. NIOSH is part of the U.S. Centers for Disease Control and Prevention within the U.S. Department of Health and Human Services. Its mission is to ensure "safe and healthful working conditions for every man and woman in the nation and to protect our human resources." NIOSH has more than 1,300 employees from a variety of fields, including epidemiology, medicine, nursing, industrial hygiene, safety, psychology, chemistry, statistics, economics, and many branches of engineering.

Review Process

It must be implemented in accordance with the guidelines of NIOSH. Enterprises must send samples to the NIOSH laboratory for testing and submit technical information (including some quality system information) to NIOSH for review. Only after the review and test are passed, NIOSH will issue the approval. NIOSH divides its certified anti-particle masks into 9 categories, and the specific tests are performed by the 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.

About N95

About N95 masks

N95 masks are one of the nine types of anti-particle masks certified by NIOSH (National Institute for Occupational Safety and Health). "N" means that it is not suitable for oily particles (the fumes produced by cooking are oily particles, while the droplets produced by people talking or coughing are not oily); "95" means that under the test conditions specified by the NIOSH standard, the filtration efficiency reaches 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 an "N95 mask."

Mask grade

According to the filtering characteristics of the middle filter of the mask, it can be divided into the following three types:

N series: N stands for Not resistant to oil, which can be used to protect against 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 against non-oily and oily suspended particles.

According to the filtration efficiency of the filter material, masks can be divided into the following three levels:

95 grade: indicates that the filtration efficiency is 95%.

99 grade: indicates the filtration efficiency is 99%.

100 grade: indicates a filtration efficiency of 99.97%.

The combination is N100, N99, N95, R100, R99, R95, P100, P99, P95. A total of 9 types. In the actual testing process, NPPTL determines whether the applied mask meets the standards of the applied classification based on different types of test materials (A, B, C) and test time.

N95 Application Process

For manufacturers applying for N95 for the first time, the application is divided into two stages:

Phase 1. Submit a questionnaire (given by NPPTL) and photos (factory appearance, product production line, etc.) to NPPTL for evaluation. After passing the NPPTL evaluation, the manufacturer will be given a company code and other relevant information, and the phase ends. Starting from the submission of information, the phase takes about 3 weeks to one month to complete.

Phase 2. After the phase is over and the documents sent by NPPTL are received, prepare detailed application materials. In addition to filling in the standard form, the company must also provide the following information that meets the standard requirements:

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 testing fee in advance when submitting the materials. If the submitted materials are unqualified, NPPTL will require rectification and re-submission. If everything goes well, starting from the submission of materials, the second stage will take about 3-4 months.

After a manufacturer obtains N95 certification, NIOSH will conduct spot checks on the certified products sold on the market by the manufacturer every year to determine whether the company always meets the N95 requirements.

N95 Application Notes

1. N95 certificates are only issued to entities that can control product design. Only manufacturers and designers (OEMs) can apply. Importers or any distributors cannot be beneficiaries of N95 certificates, which means that N95 certificates will not be issued to them, whether they are secondary conversions or they re-apply (with the manufacturer's products). Manufacturers can apply for N95 by themselves, or entrust professional consulting companies to handle it on their behalf.

2. N95 certification is charged by model. The more models there are, the more expensive it is. The specific classification is determined by the NPPTL evaluation. That is to say, if the manufacturer provides a series model when applying, which also contains several small models, NPPTL may require the manufacturer to divide the model into smaller models, thereby increasing the cost.

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