Assessment and conformity procedure are different for each category, in which the equipment is classified (Art.14):
||Conformity assessment route (Annex III):
• Module A: Internal production control
• Module A2: Internal production control plus supervised checks at random interval
• Module B: EU-Type examination certificate
• Module C2: Conformity to type based one internal production control plus supervised pressure equipment checks at random intervals
• Module D: Conformity to type based on quality assurance of production process
• Module D1: Quality assurance of the production process
• Module E: Conformity to type based on pressure equipment quality assurance
• Module E1: Quality assurance of final pressure equipment inspection and testing
• Module F: Conformity to type based on pressure equipment verification
• Module G: Conformity based on unit verification
• Module H: Conformity based on full quality assurance
||• Module A2
• Module D1
• Module E1
||• Module B+D
• Module B+F
• Module B+E
• Module B+C2
• Module H
||• Module B+D
• Module B+F
• Module G
• Module H1
Essential Safety Requirements
The Annex I of the Directive defines certain safety requirements about the design and performance of pressure equipment, such as:
– equipment must be designed for adequate strength taking into account internal/external pressure, ambient and operational temperatures, static pressure and mass of contents in operating and test conditions, traffic, wind, earthquake loading, corrosion and erosion, fatigue, decomposition of unstable fluids;
- it must be ensured safe handling and operation of examination;
- adequate means shall be provided for the draining and venting of equipment;
– equipment must be provided with protection against exceeding the allowable limits of pressure;
– where necessary, pressure equipment must be designed and fitted with suitable accessories to meet damage-limitation requirements in the event of external fire;
Specific requirements are defined for materials used for the manufacturer of pressure equipment.
Pressure equipment or assemblies, which are in conformity with harmonized standards or parts thereof, which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the essential safety requirements covered by those standards or parts thereof, referred to in Annex I.
The materials used for the manufacture of pressure equipment or assemblies which are in conformity with European approvals for materials, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the applicable essential safety requirements set out in Annex I.
There is a special category of pressure equipment and assemblies – below or equal to the limits set out in all the other categories – which must be designed and manufactured in accordance with the Sound Engineering Practice (SEP) of a Member State to ensure safe use.
The Essential Safety Requirements of the Directive do not apply to product falls in the SEP category but can be a good guidance in absence of other instructions. A derogation it is also made for the CE marking of SEP, since Article 4 paragraph 3 explicitly prohibits CE marking of SEP pressure equipment.
The manufacturer shall draw up the technical documentation referred to in Annex III of the Directive.
The non-compliance with the Directive’s requirements will result in the removal of the equipment from the market and the revoking of the CE marking affixed on it.