What does the conformity assessment procedure according to Category I Module A include?
The conformity assessment procedure according to Category I, Module A requires manufacturers to create technical documentation that demonstrates the compliance of the pressure equipment with applicable safety requirements. The documentation must include, among other things, designs, calculations, and test reports, and must be kept for ten years.
Technical Documentation
The documents prepared by the manufacturer should allow for the evaluation of the compliance of the pressure equipment with the relevant requirements and must include a suitable risk analysis and assessment.
The technical documentation must list the applicable requirements and, as far as necessary for the evaluation, capture the design, manufacture, and operation of the pressure equipment. The technical documentation, if applicable, includes at least the following elements:
- a general description of the pressure equipment;
- designs, manufacturing drawings and plans of components, subassemblies, circuits, etc.;
- descriptions and explanations necessary for understanding these drawings and plans as well as the operation of the pressure equipment;
- a listing of the harmonized standards that have been applied fully or in part, and a description of the solutions with which the essential safety requirements of this directive have been met in the areas where these harmonized standards were not applied; in the case of partially applied harmonized standards, these parts are indicated in the technical documentation;
- the results of design calculations, tests, etc.;
- the test reports.
Manufacturing
The manufacturer must take all necessary measures to ensure that the manufacturing process and its monitoring guarantee that the manufactured pressure equipment complies with the technical documentation and the requirements of this directive.
CE marking and EU Declaration of Conformity:
- The manufacturer affixes the CE marking to each individual pressure equipment that complies with the applicable requirements of the respective directive.
- The manufacturer issues a written EU Declaration of Conformity for a model of the pressure equipment and keeps it together with the technical documentation available to national authorities for ten years after the pressure equipment has been placed on the market. The EU Declaration of Conformity must clearly indicate for which pressure equipment it was issued.
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