What does the conformity assessment procedure according to Category I Module A involve?
The documentation prepared by the manufacturer shall enable the conformity of the pressure equipment with the applicable requirements to be assessed and shall include an appropriate risk analysis and assessment. The technical documentation shall specify the applicable requirements and, as far as necessary for the assessment, cover the design, manufacture and operation of the pressure equipment. The technical documentation shall include at least the following elements, as appropriate:
- a general descriptionof the pressure equipment,
- conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits,etc.,
- descriptions and explanations necessary for an understanding of those drawings and diagrams and the operation of the pressure equipment,
- a list of which harmonized standards have been applied in full or in part and a description of the solutions adopted to meet the essential safety requirements of this Directive where those harmonized standards have not been applied; in the case of partially applied harmonized standards, those parts shall be indicated in the technical file,
- results of design calculations made, examinations carried out, etc.,
- test reports.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured pressure equipment with the technical documentation and with the requirements of the relevant directive.
CE marking and EU declaration of conformity:
- The manufacturer shall affix the CE marking to each item of pressure equipment that satisfies the applicable requirements of the relevant directive.
- The manufacturer shall draw up a written EU declaration of conformity for one model of the pressure equipment and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration of conformity must clearly identify the pressure equipment for which it was issued.