The EU type examination step by step
EU TYPE-EXAMINATION. STEP BY STEP
Before place on the market the PPE the manufacturer or his authorized representative established in the Community shall assemble the technical documentation referred to in Annex III of Regulation (EU) 2016/425 so that this can, if necessary, be submitted to the competent authorities.
The technical documentation shall include at least the following elements:
(a) a complete description of the PPE and of its intended use;
(b) an assessment of the risks against which the PPE is intended to protect;
(c) a list of the essential health and safety requirements that are applicable to the PPE;
(d) design and manufacturing drawings and schemes of the PPE and of its components, sub-assemblies and circuits;
(e) the descriptions and explanations necessary for the understanding of the drawings and schemes referred to in point (d) and of the operation of the PPE;
(f) the references of the harmonised standards referred to in Article 14 that have been applied for the design and manufacture of the PPE. In the event of partial application of harmonised standards, the documentation shall specify the parts which have been applied;
(g) where harmonised standards have not been applied or have been only partially applied, descriptions of the other technical specifications that have been applied in order to satisfy the applicable essential health and safety requirements;
(h) the results of the design calculations, inspections and examinations carried out to verify the conformity of the PPE with the applicable essential health and safety requirements;
(i) reports on the tests carried out to verify the conformity of the PPE with the applicable essential health and safety requirements and, where appropriate, to establish the relevant protection class;
(j) a description of the means used by the manufacturer during the production of the PPE to ensure the conformity of the PPE produced with the design specifications;
(k) a copy of the manufacturer's instructions and information set out in point 1.4 of Annex II;
(l) for PPE produced as a single unit to fit an individual user, all the necessary instructions for manufacturing such PPE on the basis of the approved basic model;
(m) for PPE produced in series where each item is adapted to fit an individual user, a description of the measures to be taken by the manufacturer during the fitting and production process to ensure that each item of PPE complies with the approved type and with the applicable essential health and safety requirements.
Before apply for the EU type examination you should clearly identify the product (determine name, type, model), identify product purpose, clearly define the hazards against with the PPE product is supposed to protect against, determine harmonized standards used for the EU type examination, identify the raw materials used during the manufacturing process, gather confirmation of meeting corresponding requirements (in practice – test reports) and carried out the risk assessment.
The basic elements of the process of certification are:
- submission of an application for certification with documentation and standard product EU type-examination Download>>>,
- formal assessment of the completeness,
- registration of the application,
- testing of the product,
- assessment (evaluation of test reports, evaluation of conformity of the product with the essential requirements, evaluation of product labelling),
- issuance of a certificate.
EU type-examination certificates are valid for 5 years.
Conformity to type based on internal production control plus supervised product checks at random intervals of personal protective equipment, category III, consist of:
- testing of samples taken at the place of production of a personal protective equipment, in order to verify compliance with the essential requirements and the type of product as described in the EU type-examination certificate,
- assessing the stability of the conditions of production, including the final inspection and testing manufactured PPE.
Forms can be found in the section EU type-examination - Download>>>,