FFP2 mask requirements| KENJOY

What are the requirements for FFP2 masks? What are its certification criteria? Today, mask supplier takes you to understand the ce certification standards for the export of masks.

FFP2 mask requirements standard

The European Union's unified CE certification standards for masks include BSEN140, BSEN14387, BSEN143, BSEN149 and BSEN136, among which BSEN149 is a filter semi-mask that can protect particulates. According to the test particle penetration rate is divided into P1(FFP1), P2(FFP2), P3(FFP3) three grades, FFP1 low filtration effect ≥80%, FFP2 low filtration effect ≥94%, FFP3 low filtration effect ≥97%.

FFP2 masks are very close to the filtering efficiency of medical protective masks, KN95 masks and N95 masks mentioned above. Medical masks must comply with BSEN14683 and can be classified into three grades: low standard Type, then Type and TypeR. The previous version was BSEN146832014 and has been replaced by the new version BSEN146832019. Set safety standards for various products, subdivided into different materials and production modes, etc. Since its establishment in 1985, it has become a symbol of high quality, high standards and strict law enforcement, and goods lacking it will not be allowed to enter the market.

Now CE mark has become a globally recognized quality mark, CE mark can prove that the batch of products made in the EU or imported to the EU member states meet the quality standards, meet the protection of consumer health, supply chain safety and environmental sustainable development requirements. If there is a big demand for something, I believe you all know it is masks and other protective equipment. There is also a large demand abroad, and many enterprises are exporting masks.

The European standard for personal protective masks is EN149, which is divided into FFP1/FFP2 and FFP3 categories. All masks for export must be CE certified. CE certification is a mandatory product safety certification system implemented by the European Union. The purpose is to protect the life and property safety of the people in the European Union.

The urgent advice contains several important points of information:

1. This product is mainly for the following products: personal protective equipment such as masks, protective suits, protective gloves, protective goggles, and medical equipment such as surgical masks, medical gloves, and medical isolation suits.

2. Relevant products must ensure that they meet the critical safety and health requirements of relevant regulations or directives.

3. Related products still need to be certified by the announcement agency, but they can be exported before completing the compliance assessment process (CE mark). It is necessary to ensure that the certification work will continue to be completed. Compliance assessment of epidemy-related products is a priority for notified agencies: PPE(personal protective equipment) products that do not adopt PPE regulatory harmonization standards as technical requirements can also be approved in an emergency manner. The original CE certification process can take months to obtain a certificate, pass safety and performance tests and apply for an MDR.

4. The relevant countries or authorized institutions of HUANmeng may purchase personal protective devices or medical devices without CF logo, provided that such products are only for the use of medical staff and shall not be sold through conventional sales channels.

5. The market supervision authorities of the relevant EU member states will focus on spot-checking non-CE marked epidemic prevention products and evaluate them to prevent serious risks caused by unqualified products. If it is found that personal protective equipment does not meet the requirements stipulated in this Regulation, it will be recalled and corrective measures will be taken to make it conform to the requirements.

The above is about FFP2 masks. If you want to know more about FFP2 masks, please contact us for mask wholesale.