PPEs testing, certification and inspection
GÉPTESZT Ltd, the organization notified under number 2233, performs conformity assessment of respiratory and fall protection devices.
The requirements for the design and manufacture of personal protective equipment for placing on the market in the European Union and the rules for the free movement of personal protective equipment within the Union are laid down in EU Regulation 425/2016.
The Regulation defines three categories, such as I, II and III. The conformity assessment modules applicable to the products shall be selected according to these categories.
Masks covered by standard EN 149 as well as various fall protection devices shall be considered as a III. category product as described in the regulation. The certification process for products in this category is as follows:
Step 1. EU-Type-Examination. Module B, EU-type examination certificate
The manufacturer must draw up the technical documentation, which contains all the details of the product characteristics.
The manufacturer shall submit an application for certification with a notified body, together with the technical documentation and product samples.
The notified body shall issue an EU-type Examination Certificate after approval of the technical documentation and successful completion of the EU-type examination. The certificate is valid for 5 years.
Step 2. Production Control. Module C2 or Module D certificate
The EU type-examination certificate does not in itself guarantee the right to affix the CE marking to the product. For category III. protective equipment, the homogeneity of production must be demonstrated by a notified body in addition to the type-examination certificate. The manufacturer can decide which module to do this.
Selection of Module C2
Conformity to type based on internal production control plus random product inspections at random intervals.
The notified body shall carry out product inspections in order to check the conformity of production and the conformity of the personal protective equipment with the type as described in the EU-type examination certificate and with the essential health and safety requirements concerned.
Product inspections shall be carried out at least once a year, at random intervals specified by the notified body. The first product inspections shall be carried out within one year of the date of issue of the EU-type examination certificate.
Selection of Module D
Conformity to type based on production quality assurance.
The manufacturer must operate an approved quality system for production, final product inspection and testing of the protective equipment. The notified body shall carry out an inspection of the quality management system in place at the manufacturing plant and shall publish the certificate after a positive inspection. The system is reviewed annually, but the notified body may pay unexpected visits at the manufacturer’s plant.
Step 3. EU Declaration of Conformity
The manufacturer must draft an EU declaration of conformity for each model of personal protective equipment.
The EU declaration of conformity (category III.) must refer to the notified body that carries out the EU-type examination and supervises the production (module C2 or D).
Step 4. CE marking
The manufacturer must affix the CE marking to each PPE and affix the identification number of the notified body (category III.).