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What is FDA certification, CE certification and NIOSH certification?

Issuing time:2020-05-01 16:49

FDA certification

The food and Drug Administration (FDA) is one of the executive agencies set up by the U.S. government in the Department of health and human services (DHHS) and the Department of public health (PHS). As a scientific regulatory agency, FDA is responsible for ensuring the safety of food, cosmetics, drugs, biological agents, medical equipment and radiation products produced or imported in the United States. It is one of the federal agencies with the main function of protecting consumers.

That is to say, it belongs to the category of food, cosmetics, drugs, biological agents, medical equipment and radiation products. The products exported to the United States need to be FDA certified, and the products that do not belong to this category cannot be FDA certified.

For example: the export of mobile phones to the United States requires FCC certification and UL certification, not FDA certification.

Kn95 respirator belongs to the category of labor protection products and medical devices in China, so it does not belong to FDA or need FDA certification.

Disposable medical masks and disposable surgical masks belong to medical devices in China and medical devices in the United States. They are under the management of FDA, so they need to be FDA certified.

 NIOSH certification

FDA approved mask

The National Institute for occupational safety and health (NIOSH) was established in 1971 by the U.S. Department of health, education and welfare under the U.S. Occupational Safety Act. Its purpose is to revise and formulate new occupational safety and health standards, and train occupational safety and health professionals.

The scope of nisoh research is: toxic and harmful substances; dust; industrial products; Biology (animals and plants); noise and vibration, hearing; ionizing radiation; ultraviolet, visible and infrared radiation, lighting; radio-frequency radiation; thermal environment; ventilation, air conditioning and process; electric machine; lifting, transportation and storage equipment, human transportation; various accidents; occupational pathology and labor physiology Science, ergonomics; labor conditions; theory and analysis of occupational hazard prevention; combined research of industry or special sectors of various industries.

N95 respirator is one of nine kinds of particle respirators certified by NIOSH (National Institute of occupational safety and health). "N" means the particles that are not suitable for oil (the oil smoke produced by cooking is the oil particles, while the droplets produced by people's talking or coughing are not oil particles); "95" means that under the detection conditions specified in NIOSH standard, the filtration efficiency reaches 95%. N95 is not a specific product name. As long as the product meets the N95 standard and passes the NIOSH review, it can be called "N95 mask".

NIOSH classifies its certified particulate respirators into 9 categories according to Department of health and human services (HHS) Regulation 42 CFR Part 84. The specific certification is operated by npptl (National Personal Protective Technology Laboratory) under NIOSH.

FDA approved mask


According to the filtering characteristics of the middle filter screen 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 non oily suspension particles.

R Series: R stands for resistant to oil, which can be used to protect non oily and oily suspension particles.

P Series: P stands for oil proof, which can be used to protect non oil and oily suspended particles.

According to the low filtering efficiency of the filter material, the masks can be divided into the following three grades:

Grade 95: indicates 95% low filtration efficiency.

Level 99: indicates that the low filtering efficiency is 99%.

Grade 100: low filtration efficiency is 99.97%.

In combination, there are nine kinds of products, N100, n99, N95, R100, R99, R95, P100, p99, p95. In the actual test process, npptl determines whether the mask meets the standard of the applied classification according to different types of test materials (a, B, c) and test time.

CE certification

CE certification refers to the basic safety requirements for products that do not endanger the safety of human beings, animals and goods, rather than the general quality requirements. The coordination instructions only stipulate the main requirements, and the general instruction requirements are the standard tasks. Therefore, the exact meaning is: CE mark is a safety conformity mark rather than a quality conformity mark. It is the "main requirement" that constitutes the core of the European directive.

The "CE" mark is a safety certification mark, which is regarded as a passport for manufacturers to open and enter the European market. CE stands for the European Union.

The "CE" mark in the EU market is a compulsory certification mark. No matter the products produced by enterprises within the EU or by other countries, if they want to circulate freely in the EU market, they must affix the "CE" mark to show that the products meet the basic requirements of the EU Directive on New methods of technical coordination and standardization. This is a compulsory requirement of EU law for products.

FDA approved mask

Conclusion: CE certification is the access certificate for the circulation of goods in EU countries. During the emergency period, some European countries will also certify Chinese goods. If the bacterial filtration rate of respirator is above 95, they will accept it. If there is no CE, they will also accept it.

FDA is the pass for medical masks to circulate in the United States. It makes civil masks, such as kn95 protective masks. It belongs to labor protection products and does not belong to FDA, so it can be exported to the United States without FDA certification.

Noish certified masks are mainly gas and dust-proof civil masks. The common ones are N90, N95, N100, etc. The filtration rate of N95 was 95%.

No matter what the certification, it is important that the qualification of the manufacturer is complete, and the treatment of the product should ensure that the bacterial filtration rate is more than 95%. The national standards of respirators are attached.

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