How much does the mask cost to make EU CE certificate
Dust mask is mainly used to protect all kinds of particles. The body of the mask is usually made of filter material to prevent particles. It is fixed on the head by means of head strap, ear strap, etc. through forming a space separated from the polluted air in the mouth and nose area of the person, and the polluted air can enter the respiratory tract only after being forced to pass through the filter material of the mask by inhalation. This kind of respirator usually has no parts to be replaced and needs to be discarded as a whole after failure. It is also called disposable respirator or or maintenance free respirator, which is one of half mask respirators.
At present, the main export products in China are filter type half masks that can protect particles. Other products have relatively high technical requirements or small market, and there are almost no certified factories in China. Haze is so severe in China that most factories focus on making relatively simple en 149 masks.
EU standards for respiratory products are as follows:
BS EN 140: 1999 half / quarter masks
BS EN 14387: 2006 gas filters & combined filters
BS EN 143: 2000 particle filters
BS EN 149: 2001 filtering half masks to protect against particles
BS EN 136: 1998 full face masks - class 1, 2, or 3
Respirators are personal protective equipment, which have been under the PPE Directive before. Recently, the EU upgraded the PPE directive, and a new regulation (EU) 2016 / 425 emerged. From 2019, the new regulation (EU) 2016 / 425 will be enforced to end the transition.
Personal protective equipment is divided into 1-3 categories. Masks belong to products with high risk coefficient, which are classified into three categories. Application for CE certification requires factory audit, and annual supervision audit or test after obtaining the certificate.
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