CE marking of pressure equipment

that are new to the EU market, whether new or used, manufactured in the EU or imported from a third country. For the purposes of this article, the term "manufacturer" includes agents and importers.

do not prohibit the provision or use of equipment, components or assemblies complying with this Directive under the conditions specified by the manufacturer for reasons of pressure hazards restrict or hinder.

nozzles, couplings, brackets or lifting eyes. Assemblies are defined as multiple pressure equipment assembled by a manufacturer into an integrated and functional whole. Products covered by the Directive include the following:

• storage tanks under pressure, industrial pipelines,
• heat exchangers,
• Jacket and water tube boilers
• boiler
• steam generators
• safety devices
• printing supplies

• pipelines or a piping system designed to transport fluids or substances to or from a plant (on land or at sea), starting with and including the last shut-off device within the plant including all associated equipment specifically designed for piping; this exclusion does not apply to standard pressure equipment found in pressure reduction or compressor stations
• networks for the supply, distribution and discharge of water, as well as the associated equipment and pressure lines such as pressure pipelines, pressure tunnels, pressure shafts for hydropower plants and the corresponding specific accessories
• simple pressure vessels covered by Directive 2014/29/EU
• aerosol dispensers covered by Council Directive 75/324/EEC (14)
• equipment intended for the operation of vehicles defined in the following acts:
  • Directive 2007/46/EC
  • Regulation (EU) No 167/2013
  • Regulation (EU) No 168/2013
• Devices that are not higher than category I of this Directive and fall under one of the following directives:
  • (i) Directive 2006/42/EC
  • (ii) Directive 2014/33/EU
  • (iii) Directive 2014/35/EU
  • (iv) Directive 93/42/EEC
  • (v) Directive 2009/142/EC
  • (vi) Directive 2014/34/EU
• devices covered by Article 346 paragraph 1 letter b TFEU
• Articles specially designed for use in the nuclear field and whose failure can lead to the release of radioactivity
• Borehole control equipment used in petroleum, natural gas or geothermal exploration and production, and underground storage, which is used to contain and/or control borehole pressure, including the drill head (Christmas Tree)blow-out devices (BOP), pipe distributors and all upstream equipment
• devices comprising housings or machines where the design, choice of material and manufacturing requirements are based primarily on the requirements for sufficient strength, rigidity and stability, in order to meet the static and dynamic operating conditions or other operating characteristics, and where pressure is not an essential design factor; these devices may include:
  • i. engines, including turbines and internal combustion engines
  • ii. Steam engines, gas/steam turbines, turbogenerators, compressors, pumps and actuators
• blast furnaces, including the furnace cooling system, hot-wind recuperators, dedusting plants and blast furnace exhaust scrubbers, and direct reduction cupola furnaces, including furnace cooling, gas converters and furnaces for melting, remelting, degassing and casting steel, iron and non-ferrous metals
• Enclosures for high voltage electrical equipment such as switchgear, control units, transformers and rotating machinery;
• Pressure pipes for enclosing transmission equipment, such as power and telephone cables
• ships, rockets, aircraft and mobile offshore units, as well as equipment specifically designed for installation on board or propulsion thereof
• pressure equipment consisting of a flexible sleeve, such as tires, air cushions, game balls, inflatable boats and other similar pressure equipment
• Exhaust and intake silencers
• bottles or cans for carbonated drinks for final consumption
• containers for the transport and distribution of beverages with a maximum PS-V of 500 bar and a maximum permissible pressure of not more than 7 bar
• equipment covered by Directive 2008/68/EC and Directive 2010/35/EU, and equipment covered by the International Code for the Carriage of Dangerous Goods by Seagoing Vessels or the Convention on International Civil Aviation
• radiators and pipes in hot water heating systems
• Container for holding liquids with a gas pressure above the liquid not exceeding 0,5 bar

• be sure
• meet the essential safety requirements for design, manufacture and testing
• comply with appropriate conformity assessment procedures
• bear the CE marking and any other information

Pressure equipment and assemblies below the specified pressure/volume thresholds must:

• be sure
• be designed and manufactured in accordance with the recognised technical rules of a Member State
• bear the required markings (but not the CE marking)

by the directives before it can be placed on the market. Benefit from the years of CE experience of our experts at easyCE and let us advise you intensively about your product. easyCE even takes care of creating central CE documents for you.

Pressure equipment that falls within the scope of the Directive and exceeds the above-mentioned thresholds must be CE-compliant, before it can be placed on the market in the EEA (EU, Iceland, Liechtenstein and Norway). You have already prepared the documents, but are not sure whether the conformity is sufficiently proven? easyCE also offers a review.

By Regulation (EC) No. 1272/2008, in order to implement the globally harmonised system for the classification and labelling of chemicals, new hazard classes and categories are introduced which only partially comply with the provisions of Directive 67/548/EEC. Directive 97/23/EC should therefore be based on Regulation (EC) No. 1272/2008 to be harmonised, maintaining the level of protection provided for in the Directive.

• Procedures for permanent joints (usually welding procedures), where approval is granted by the notified body
• Qualification of welders and NDT personnel; approval is granted by the notified body
• Materials: here the notified body evaluates - if applicable - the respective material evaluations
• Assessment of the quality management system of material manufacturers by the notified body
• Assessment of pressure equipment by the notified body, including design review, final evaluation and pressure testing

Pressure equipment shall be subject to the conformity assessment procedure selected by the manufacturer from the available procedures of the category in which they are classified. The manufacturer can also choose a process of a higher category if available. A product may require either a self-assessment or the involvement of a notified body.

and for the monitoring of notified bodies of recognised independent bodies and operator verifiers. The notifying authority shall identify and designate notified bodies to perform the necessary tasks for a manufacturer.

This shall be a notified body or a third organisation recognised by a Member State, at the discretion of the manufacturer. In order to issue those authorisations, the notified body or the third party shall have carried out investigations and tests in accordance with the relevant harmonised standards or equivalent investigations and tests.

The manufacturer must also maintain a complaint register and recall non-compliant devices. Additionally, the manufacturer should inform dealers of any irregularities."

and shall be accepted by the notified body responsible for the design conformity assessment module, if any. This programme shall lay down the test conditions and the criteria for acceptance or rejection. The actual values of the essential dimensions and characteristics of the materials of which the tested equipment consists shall be measured before the test. Where appropriate, the critical areas of the pressure equipment must be observed during the tests with appropriate instruments that detect strains and stresses with sufficient accuracy.

The manufacturer shall provide the notified body with access to the manufacturing, acceptance, testing and storage facilities and provide it with all the necessary documentation, including the quality assurance system, technical documentation and quality reports such as test reports, test data, calibration data, reports on the qualifications of employees in this area.

The notified body shall conduct regular audits to ensure that the manufacturer maintains and applies the quality assurance system and shall provide it with an audit report. The minimum frequency of periodic audits shall be a full reassessment every three years.

In addition, the notified body may make unannounced visits to the manufacturer. The need and frequency of additional visits shall be determined on the basis of a visit control system operated by the notified body. The visit control system should take into account in particular the following factors: the category of pressure equipment, the results of previous monitoring visits, the need to follow up on corrective actions, where appropriate, specific conditions relating to the approval of the system, as well as significant changes in the manufacturing organisation, policy or techniques. During these visits, the notified body may carry out product tests to verify the proper functioning of the quality assurance system. The notified body shall provide the manufacturer with a report of the visit and, if tests have been carried out, a test report.

• Define device type
• Determine gas or liquid
• Select the fluid group
• Select Conformity Assessment Chart
• Select hazard category from the table
• Determine the conformity assessment module

• Vessel: A housing designed and constructed to accommodate pressurized fluids, including its direct attachments to the junction with other equipment. A container can consist of more than one chamber.
• Steam generator, pressure cooker or other heated pressure equipment: Fired or otherwise heated pressure equipment designed to produce steam or superheated water at a temperature of more than 110°C and with a volume of more than two liters. This includes all pressure cookers.
• Piping: Piping components for transporting liquids when connected to a pressure system for integration. Pipelines include pipes or pipe systems, hoses, fittings, expansion joints, hoses or other pressure-bearing components. Heat exchangers, which consist of pipes for cooling or heating air, should also be considered pipelines.
• Safety accessories: These accessories include direct pressure relief devices, such as safety valves and rupture discs, as well as limiting devices. Limiting devices can either activate the means for correction or provide for a shutdown or shutdown and locking, such as pressure switches and temperature switches.
• Pressure accessories: devices with an operating function and a pressure-bearing housing, for example valves, pressure regulators, pressure gauges, filters.
• Assemblies: Assemblies are multiple pressure equipment that are assembled by a manufacturer into an integrated and functional whole. Examples of assemblies are distillation units, evaporation units and filter systems.

Safety accessories are classified in category IV. However, exceptionally, a safety accessory manufactured for a particular device can be classified in the same category as the device that protects it. A pressurized piece of equipment is classified either as a pipe (by its volume) or as a container (by its diameter). If the printing accessory has both specifications (volume and diameter), the category with the higher value shall be applied. Assemblies are classified according to the higher category of pressure equipment (excluding the equipment with safety function).

• Category I: Module A
• Category II: Modules A2, D1, E1,
• Category III: Modules B(D) + F, B(P) + C2, B(D) + D, B(P) + E, H
• Category IV: Modules G, B(P) + F, B(P) + D, H1

You can also choose a procedure of a higher category.

each product must be tested by an independent body. The notified body shall review the technical documentation and carry out the final assessment. Upon completion of the test, the notified body shall issue the certificate of conformity. This is the basis for the issuing of the declaration of conformity and for the CE marking by the manufacturer.

are based on the current requirements of the certification according to DIN EN ISO 9001, supplemented by product-specific requirements, which result from the provisions of Annexes I and III of the PED.

Such evidence should include all documents used when the relevant harmonised standards have not been fully applied. Where necessary, the additional evidence should include the results of tests carried out by the manufacturer's corresponding laboratory using other relevant technical specifications.

The manufacturer shall grant the notified body access to the manufacturing, acceptance, testing and storage facilities and shall provide it with all the necessary documentation.

All pressure equipment shall be individually tested, subject to appropriate tests as provided for in the relevant harmonised standards or equivalent tests, in order to ensure its conformity with the approved and in the EUtype-examination certificate of the type described and with the corresponding requirements of this Directive. In the absence of such a harmonised standard, the notified body shall decide on the appropriate tests to be carried out.

• the name and full business address of the manufacturer or of the representative authorized to issue the declaration;
• An identification number; this number may be the serial number, product or batch number, model or type;
• A statement stating that the exhibition is under the sole responsibility of the manufacturer;
• A description of the pressure equipment or assembly and the conformity assessment procedure applied; for assemblies, a description of the assembly and the conformity assessment procedures applied to it;
• A declaration that the declaration complies with the relevant harmonisation legislation;
• references to the relevant harmonised standards used in or referred to in the technical specifications;
• the name, address and identification number of the notified body that carried out the conformity assessment procedure;
• the identity and signature of the authorised person; and
• The date the declaration was made.

easyCE is happy to prepare a declaration of conformity for you. After all necessary steps have been taken to ensure conformity, the CE marking must be affixed to the product.

The CE marking must be clearly visible, legible and permanently affixed to the product or its type plate. If this is not possible or not guaranteed due to the nature of the product, it must be affixed to the packaging (if available) and accompanying documents.

The importer should indicate on the printing equipment or assembly his name, his registered trade name or his registered trade mark and his postal address where he can be reached

An importer should be available to the competent authorities if further information or documentation is needed. In addition, he must keep a copy of the EU declaration of conformity for 10 years from the time the product is placed on the market so that the authorities can verify it.

• fines ranging from €3,000 to €30,000 (full 19) and
• Imprisonment of up to 1 year (§ 20).