2. Certification procedures for respiratory protective devices

To be placed on the European market, respiratory protective equipment must first be certified by a third party, the result of which enables the CE mark to be affixed.

Verification of equipment performance is carried out on the basis of harmonized European standards, where these exist, giving a presumption of conformity with the essential requirements of the directive. If no standard exists for the equipment concerned, the examination is carried out directly by reference to the essential requirements and the protection characteristics claimed by the manufacturer. In this case, the notified body will propose a series of tests to verify the device's performance.

Since respiratory protective equipment is "category 3" PPE, the manufacturer is required to comply with one of the quality control procedures for the final product described in Articles...