Valved filtering half masks to protect against gases or gases and particles (EN 405)
Certification of valved filtering half masks to protect against gases or gases and particles is a process in which the manufacturer is required to involve a third independent party (notified body) to assess the product’s compliance with the harmonized standard EN 405 according to module B (type examination) and C2 or D (production control). After obtaining the Module B and C2 or D certificates, the manufacturer is entitled to use the CE mark.
The technical requirements for for half masks and quarter masks are confirmed by testing in accordance with the harmonized standard EN 405.
ACCREDITATION DOCUMENTS
LOTRIČ Metrology is accredited by Slovenian Accreditation with accreditation number CP-016 in the field of certification of products, processes and services (ISO/IEC 17065).
All activities of the certification (notified) body are carried out in accordance with:
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
- TestingEN 405
- EU type-examination certificateRegulation (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.
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 C2: Certification of internal production control system
- EU type-examination certificateRegulation (EU) 2016/425 on personal protective equipment, Annex VII
- Module D: Certification of approval of the quality system
- EU type-examination certificateRegulation (EU) 2016/425 on personal protective equipment, Annex VIII