RPE must comply with Personal Protective Equipment Regulation (EU( 2016/425). RPE are classified as category III PPE. The manufacturer must ensure that PPE complies with the relevant health and safety requirements. Respiratory protective equipment sold in Finland must include:
An EU type-examination certificate (the type examination process is described in detailed on the Tukes website and in the PPE Regulation)
EU declaration of conformity, in Finnish and Swedish (template in Annex IX of the PPE Regulation)
user instructions in Finnish and Swedish
CE marking and identification number of the relevant notified body on the PPE
manufacturer and product identifier on the PPE.
technical documentation drawn up by the manufacturer (see Annex III of the PPE Regulation for more information). The manufacturer draws up technical documentation for the type examination.