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Certification of protective masks is a process where the manufacturer has an obligation to involve an independent third party (notified body) to assess the conformity of the product with modules B and C2 or D. After obtaining the certificates from modules B and C2 or D, the manufacturer then obtains the CE mark.

The technical requirements for protective masks are confirmed by testing in accordance with the harmonized standard EN 149: 2001 + A1: 2009.


EU type-examination is the part of the conformity assessment procedure in which the notified body examines the technical design of the PPE, and verifies and attests that the technical design of the PPE meets the requirements of the Regulations that apply to it.

Module B: EU type-examination certificate
Testing EN 149:2001+A1:2009
EU type-examination certificate Regulation (EU) 2016/425 on personal protective equipment, Annex V

Provided the initial assessment procedure is successfully completed, a certificate of approval of the internal production control system and controlled testing of products at random intervals shall be issued. This is valid for three years from the beginning of the assessment process, if all the conditions satisfy the requirements of the Regulation (EU) 2016/425.

Module C2: Certification of internal production control system
EU type-examination certificate Regulation (EU) 2016/425 on personal protective equipment, Annex VII

If the initial assessment is successfully completed, the certificate of approval of the quality system is issued. It is valid for three years from the beginning of the assessment process, if all the conditions satisfy the requirements of the Regulation (EU) 2016/425.

Module D: Certification of approval of the quality system
EU type-examination certificate Regulation (EU) 2016/425 on personal protective equipment, Annex VIII

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