Mask CE Certificate


Masks with CE mark are called CE Certified Masks. The presence of a CE mark on a mask indicates that the circulation and sale of that mask in the European Economic Area (EEA) is possible. Surgical masks must meet the requirements of the EN 14683 Standard in addition to the CE mark for circulation and sale in the EEA. The EN 14683 Standard can be explained as the requirements and test Methods for Medical Face Masks. According to the Medical Devices Regulation, Surgical Intervention Masks are considered Class I. Surgical masks are suitable for use by healthcare professionals.

Manufacturer companies must attach the CE mark to their masks for the masks they manufacture. It shows that the masks with the CE mark on them are placed on the market in accordance with the relevant regulations and standards. Products without CE marking are products that do not meet legal requirements and are not allowed to be sold. The manufacturer must affix the CE mark to its products. The CE marking attached masks show that they comply with European norms. When the usage areas and types of masks are examined; Respirators must be produced in accordance with EN 136, EN 140, EN 143, EN 149, EN 14378, EN 12941, EN 12942, EN 1835, EN 14683 standards. In addition, masks produced according to the N95 standard, which is another international standard set by other countries other than the basic standards of the European Union, can be found.

According to the relevant EN 14683 standard, the following tests are performed according to the ed mask type:

* Bacteria Filtration
* Differential Pressure
* Synthetic Blood Penetration Test
* Microbiological Cleaning

Masks, which are one of the measures taken to prevent virus diseases, must be produced in accordance with CE standards and placed on the market according to these conditions.

The mask classification for which CE Certificate can be obtained is as follows:

* Surgical Mask CE Certificate
* Personal Protective Mask CE Certificate
* Medical Mask CE Certificate
* Medical Mask CE Certificate
* Face Mask CE Certificate
* Textile Face Mask CE Certificate

Is It Legal to Sell Non-CE Certified Masks?

Mask manufacturers CE certification or declaration in the work of their products if they do not submit to the European market and sales in Turkey. In addition, they may be subject to criminal proceedings arising from these deficiencies detected when they are subject to inspection by the relevant authorities. For this, manufacturers and assembly companies must obtain CE certificates or publish self-declaration statements in order to put CE mark on the products they produce.

EKOL Certification

Laboratory tests, technical file audits and CE Certification processes for mask manufacturers within the scope of the relevant standards within the framework of EKOL Certification, 2016/425 / EU Personal Protective Equipment Regulation and 93/42 / EEC Medical Device Regulation (MDR-2017/745 / EC Medical Device Regulation) provides professional services for. You can contact us to benefit from these services and have detailed information.

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