Pressure equipment (Directive 2014/68/EU) – Module A2

Technical Documentation

Technical documentation prepared by the manufacturer enables the assessment of the conformity of pressure equipment with applicable requirements and includes appropriate risk analysis and assessment. This documentation specifies the applicable requirements and, to the extent necessary for assessment, covers the design, production, and operation of the pressure equipment. Where applicable, the technical documentation includes at least the following elements:

• General description of the pressure equipment: A comprehensive overview of the device, detailing its purpose and use.

• Conceptual design, drawings, and diagrams: Detailed plans, including component, assembly, and circuit diagrams.

• Descriptions and explanations: Necessary information to understand the drawings and diagrams, as well as the operation of the pressure equipment.

• List of harmonized standards: A list of the standards that have been fully or partially applied, along with descriptions of solutions adopted to meet essential safety requirements when harmonized standards are not fully applied. The parts of the harmonized standards that have been applied should be indicated in the technical documentation.

• Results of design calculations, tests, etc.: Documentation of the design calculations, tests, and other evaluations conducted.

• Test reports: Reports detailing the results of the tests performed.

Production

The manufacturer takes all necessary measures to ensure that the manufacturing process and its monitoring ensure that the pressure equipment produced complies with the technical documentation and the requirements of the directive.

Final Assessment and Inspections of Pressure Equipment

The manufacturer conducts the final assessment of the pressure equipment, which is monitored through unannounced visits by the notified body selected by the manufacturer.

The notified body conducts or commissions tests on products at irregular intervals specified by them to check the quality of the internal tests of the pressure equipment. This includes considerations of the technical complexity of the equipment and the scale of production.

During these visits, the notified body:

• Ensures that the manufacturer carries out the final assessment in accordance with Annex I, point 3.2 of the PED.
• Takes samples of pressure equipment from production facilities or storage for control purposes. The notified body decides the number and, if necessary, conducts or commissions all or part of the final assessment test.

The purpose of this sampling procedure is to determine whether the production process of pressure equipment remains within acceptable limits to ensure conformity.

In case of non-compliance of one or more pieces of pressure equipment, the notified body takes appropriate measures.

The manufacturer, under the responsibility of the notified body, places their identification number during the production process.

CE Marking and EU Declaration of Conformity

• CE Marking: The manufacturer places the CE marking on each piece of pressure equipment that meets the applicable requirements of the directive.

• EU Declaration of Conformity: The manufacturer prepares a written EU declaration of conformity for a single model of pressure equipment and keeps it, along with the technical documentation, available to national authorities for 10 years after the equipment has been placed on the market. The EU declaration of conformity must clearly identify the pressure equipment for which it has been issued.

A copy of the EU declaration of conformity is made available to the relevant authorities upon request.