Certifications

Certottica evaluates essential safety standards, while also issuing detailed test reports to further support the technical documentation and declaration of conformity. Within its laboratories, thanks to the specialized expertise of its technicians, the Institute tests and certifies that every personal protective equipment for eyes and face complies with the legal requirements of the sector.

CERTIFICATIONS

To initiate the product certification process, the manufacturer must:

Submit a duly completed EU type-examination application and a technical file in compliance with the requirements of Annex III of Regulation (EU) 2016/425, related to the product intended for certification, in the case of certifying a new product under Module B of Regulation (EU) 2016/425. The technical file must include the test reports used for the product’s technical validation.

For category III personal protective equipment only, provide:
•An application for Module C2, possibly accompanied by the EU type-examination certificate and the technical file if the certificate was not issued by Dolomiticert, for the conformity assessment of the production process along with product testing under official control, carried out at random intervals, in accordance with Module C2 of Regulation (EU) 2016/425;
•An application for Module D along with the necessary system documentation for the assessment, to evaluate the conformity of the production process quality system according to Module D of Regulation (EU) 2016/425.

CERTIFICATIONS

EU Type-Examination Application (for Module B certifications)

Form to be completed for submitting the examination application

M.16.108.2.001-Domanda-di-esame-UE-del-tipo-Rev.3-del-06.11.2020

Instructions for completing the examination application

PQ 16.108.002 Domanda di esame UE del tipo (Rev.2 del 06.11.2020)

CERTIFICATIONS

Technical documentation

Along with the EU Type-Examination Application, the product’s Technical Documentation must be submitted, including all the information outlined in the procedure below, in compliance with Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016:

Technical Documentation

PQ 16.108.003 Documentazione Tecnica (Rev.1 del 15.05.2020)

CERTIFICATIONS

Inspection according to Module C2 and Module D

Dolomiticert conducts inspections according to:

Module C2 (product testing under official control carried out at random intervals) for category III Personal Protective Equipment (PPE), in compliance with Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016.

Modulo C2

M.16.108.2.004 Domanda di prove (Modulo C 2) (Rev.2 del 06.11.2020)

Module D: Activities for verifying the Quality Assurance System of the production process for category III Personal Protective Equipment (PPE) in accordance with Regulation (EU) 425/2016 of the European Parliament and of the Council of 9 March 2016.​⬤

Modulo D

M.16.108.2.003 Domanda di Sorveglianza (Modulo D) (Rev. 2 del 06.11.2020)

CERTIFICATIONS

Regolamento di certificazione

Anyone interested in the certification services provided by Dolomiticert can review the adopted procedures by downloading the following regulation, related to Type Certification in accordance with Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016:

Certification Regulation

PQ 16.101.004 Regolamento per la certificazione dei dispositivi di protezione individuale (Rev.6 del 30.11.2020)

Accreditations