What information is required for CE certification of masks?

Our company's name is UNIVERSAL, and we are a Notified Body with European Commission registration number 2163, which specializes in providing CE marking services for personal protective products that want to enter the European market. For the export of masks to Europe, it is necessary to apply for CE certification in accordance with the EPE personal protection directive EN 149, for example, for the export of protective clothing to Europe, it is necessary to apply for CE certification in accordance with the EPE personal protection directive EN 14126, for the export of goggle products to Europe, it is necessary to apply for CE certification in accordance with the PPE personal protection directive EN 166, and for the export of safety footwear products to Europe, it is necessary to apply for CE certification in accordance with the PPE personal protection directive 20345 apply for CE certification;

<> In addition, our company is also a system certification body authorized by the Certification and Accreditation Administration of the People's Republic of China, record number: CNCA-R-2019-534 (Shanghai European Testing Certification Service****), our company can also issue ISO 9001, ISO 14001, ISO 45001 and other system certification certificates;

If your company's products need to be CE certified for export, your company can contact me 15021904723, if you are disturbed, please understand!

It is not too complicated to apply for CE certification for masks: 1. Test samples 2. Fill in the application** 3. Product description information;

The others are all organizations to help you complete the process of obtaining CE certification. Hope it helps.

Generally speaking, you need certification application form, product samples, samples, etc., you can consult Foshan Nino Testing for details, and I handled it there.

Particle filtering half masks have a certain filtering effect on the air entering the lungs, and wearing a mask has a very good effect when respiratory infections are prevalent and when working in a polluted environment such as dust.

Masks can generally be broadly divided into air filter masks and air supply masks.

The working principle of the air filter mask, referred to as the filter mask, is to make the air containing harmful substances filter and evolve through the filter material of the mask before being inhaled.

The air supply mask refers to a clean air source isolated from harmful substances, which is delivered to the person's face through a pipe and mask through a power force such as a compressor or compressed gas cylinder device for people to breathe.

CE applicable standard for dust masks: EN 149:2001+A1:2009

The CE certification of a mask means that the mask has passed the corresponding conformity assessment procedure or the manufacturer's declaration of conformity, complies with the relevant EU directives, and is allowed to enter the European Community as the product.

Marketplace sales passes. If a mask does not bear the CE mark, it is not allowed to be sold on the EU market.

Novel coronavirus.

It is not only in China, but also in all countries of the world. The most important thing to prevent the new coronavirus is to wash your hands frequently and wear a mask. Masks were not enough in China before, but now masks are needed all over the world.

The epidemic in our country has been controlled, but the masks in our country need CE certification to be exported abroad. And most of us don't know what the CE certification of masks is?

CE marking. It is a mark on behalf of the product that has complied with a series of European standards and directives such as safety, health, environmental protection, and hygiene, and all products sold in the EU must be mandatory to be marked with the CE mark to find Beston for testing. Therefore, masks are no exception and also require CE certification.

In fact, whether it is a product produced by an enterprise within the EU or a product produced in other countries, if it wants to circulate freely in the EU market, it must be affixed with the CE mark to show that the product meets the basic requirements of the EU "New Methods of Technical Cooperation and Standardization" directive. If there is no CE mark, it shall not be put on the market, and the products that have been affixed to the CE mark to enter the market, and if it is found that it does not meet the safety requirements, it shall be ordered to withdraw from the market, and if it continues to violate the provisions of the directive on CE marking, it will be restricted or prohibited from entering the EU market or forced to withdraw from the market.

There are two modes of CE certification for masks, the first is to send samples to the mask laboratory in Europe for testing every year and submit a complete quality system.

Technical documentation as well as drawings, factory test reports.

and other documents. If the documentation is complete, EU agency personnel may not conduct an on-site audit of your factory system. The second is to send samples to the European laboratory for testing every year, plus factory audits twice a year.

Most multi-agency applications will only be accepted for the second option, as the certification body for the second option is more reassuring.

CE certification, that is, limited to the basic safety requirements of the product without endangering humans, animals and goods, rather than the general quality requirements, the harmonised directive only stipulates the main requirements, and the general directive requirements are standard tasks. Therefore, the precise meaning is: the CE mark is a safety mark and not a quality mark.

are the "main requirements" that form the core of the European Directive.

CE certification, i.e. limited to the basic safety requirements in terms of products that do not endanger the safety of humans, animals and goods, rather than general quality requirements, the Harmonized Directive only stipulates the main requirements, and the general directive requirements are standard tasks. Therefore, the precise meaning is: the CE mark is a safety mark and not a quality mark.

It is the "main balance and lead demand" that forms the core of the European directive.

1. There will be a letter print in the upper right corner of the mask for CE certification, or the packaging bag of the mask will also have a CE certification icon.

2. CE certification for masks is one of the most popular product certifications recently, and it is a mandatory Kaihe certification for exporting to countries in the European Union. In Europe, masks are classified as Category 3 products under the Personal Protection Directive (very high safety level) according to the European standard EN149.

3. There are two modes of certification: (1) send samples to the mask laboratory in Europe for testing every year, and submit complete quality system technical documents and drawings, factory test reports and other documents. (2) Send samples to the European laboratory for testing every year, plus factory audits twice a year, many institutions only accept the application of the second way, because the certification body of the second way is more assured.

4. There is also a possibility that if your company's mask is used in a hospital, it does not belong to the scope of personal protection, and belongs to Fan Xiaoliangwei, a medical device, and it is necessary to make MDD instructions. The process is: sample testing, factory audit, and mandatory ISO13485 system certification is required.