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Evaluation and certification of respiratory protection equipment



26th june

One of the most important risks facing an operative is contracting diseases caused by breathing contaminated air, or oxygen deficiency in the atmosphere during their work. As a preventive measure, an employer must provide respiratory protection equipment.

This type of risk, which can cause death or irreversible damage to the employee, classifies the respiratory protection equipment as category III PPE.

In order to select the best respiratory protection equipment for a specific professional activity, whether insulating or filtering equipment, numerous factors must be considered, such as the type and concentration of pollutants, the concentration of oxygen in the atmosphere, the duration and effort required of the tasks to be performed, working conditions, etc. Standard EN 529: 2005 on respiratory protection, “Recommendations for selection, use, care and maintenance guidelines”, a programme is described to protect workers from exposure to air-borne pollutants.

Respiratoy protection equipment testing laboratory

Following requests from manufacturers in the sector, AITEX has broadened its scope as a Notified Body to enable us to evaluate the compliance of a range of respiratory protection filtering equipment. The Institute has purchased equipment and commissioned various tests under different standards necessary to certify different respiratory protection equipment.

The harmonised standards for each of the different types of respiratory protection equipment establish a range of tests, as well as applicable mandatory or optional performance requirements.

EU type certification

For a respiratory protection device to be marketed in the European Union, it must comply with the essential health and safety requirements established in Regulation 2016/425, through the following conformity assessment procedure: EU Examination of Type (module B).

Through this procedure the Notified Body will not only evaluate the prototype PPE using the tests according to the harmonised standards; it will also evaluate the technical documentation, the informative brochure that will be provided to the user with the equipment and the labelling. As a result of the EU type examination, the Notified Body will issue an evaluation report and an EU type examination certificate, together with any of the following options:

  • Conformity of type based on the company’s internal QA plus a supervised product QA at random intervals (module C2).
  • Conformity of type based on production process QA (module D).

AITEX has recently been approved and notified to test, evaluate and certify respiratory protection equipment under module B for the corresponding emission of the EU type certificate. It has also been notified for evaluation as category III PPE (module C2); this will require AITEX to carry out product QA at least once a year, and at the latest one year after the date of issue of the certificate, to verify the homogeneity of the production process and the conformity of the PPE with the type described in the EU type examination certificate.

Artículo publicado en AITEX review nº59

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