Key takeaways:
The article describes the objectives, scope, and legal basis of PED, as well as how pressure equipment is classified into risk categories and the associated conformity assessment modules.
- Directive 2014/68/EU (PED) harmonizes the requirements for pressure equipment, supporting safety and the free movement of goods within the EU.
- The scope covers equipment with PS > 0.5 bar: vessels, piping, safety accessories, and assemblies.
- The exclusions indicated in the text include, among others, simple pressure vessels, aerosol dispensers, and equipment for controlling wells.
- Conformity assessment depends on the risk category determined, among other things, by PS, V, DN, and the fluid group (group 1: hazardous; group 2: other fluids).
- Conformity assessment modules include, among others, A, A2, D1, and combinations with module B (EU-type examination); once the requirements are met, the manufacturer affixes the CE marking
Pressure Equipment Directive: Conformity assessment of pressure equipment under Directive 2014/68/EU: A guide for manufacturers
Directive 2014/68/EU on pressure equipment (PED – Pressure Equipment Directive) is a key piece of EU legislation aimed at harmonising rules for pressure equipment. It enables such equipment to move freely between Member States while meeting high safety standards. This article explains the conformity assessment process under the Directive, as well as the risk categories and the corresponding conformity assessment modules.
Purpose of the Directive
Directive 2014/68/EU on pressure equipment was introduced to ensure uniform safety standards for pressure equipment across the European Union. Its main purpose is to protect the health and safety of users and to facilitate the free movement of this equipment within the EU internal market.
Scope of the Directive
The Pressure Equipment Directive applies to pressure equipment with a maximum allowable pressure (PS) greater than 0.5 bar, including both new equipment manufactured in the EU and equipment imported from third countries. This includes vessels, piping, safety accessories and assemblies of pressure equipment. Exclusions include, among others, simple pressure vessels, aerosol dispensers and well-control equipment.
History and legal background
Previous regulations
The first regulation covering pressure equipment was Directive 97/23/EC, introduced on 29 May 1997, with the aim of harmonising legislation in this area. Over time, it became clear that it needed updating to reflect technological progress and new safety standards.
Need for change
The new Pressure Equipment Directive 2014/68/EU was introduced to provide greater clarity and consistency in the rules, aligning them with other EU legal acts, such as Regulation (EC) No 765/2008, which lays down rules for the accreditation of conformity assessment bodies, and Decision No 768/2008/EC, which establishes a common framework for various industrial sectors.
Key provisions of the Directive
Scope of application
The Directive covers a broad range of pressure equipment and assemblies. This equipment must meet specified safety requirements before it can be placed on the EU market. Equipment with a maximum allowable pressure greater than 0.5 bar falls within the scope of the Directive, while certain equipment, such as transmission pipelines or water networks, is excluded.
Technical requirements and conformity assessment
The Pressure Equipment Directive sets out detailed technical requirements that pressure equipment must meet. These requirements cover materials, design, testing and inspection of the equipment. The conformity assessment process is tailored to the level of risk associated with the equipment:
Pressure Equipment Directive: Risk categories for pressure equipment and the corresponding conformity assessment modules
Directive 2014/68/EU classifies pressure equipment according to its level of risk, determined on the basis of maximum allowable pressure (PS), volume (V), nominal diameter (DN), and the type of fluid (group 1 or 2).
Categories of pressure equipment
Fluid groups:
- Group 1: Hazardous fluids (explosive, flammable, toxic, oxidising).
- Group 2: Fluids other than those in group 1.
Category I (Lower risk)
Equipment:
- Pressure vessels and piping with lower PS and V values.
Criteria:
- Capacity of pressure vessels for group 2 liquids: PS x V ≤ 200 bar x L.
- Nominal diameter of piping: DN ≤ 25 for group 1 fluids, DN ≤ 32 for group 2 fluids.
Conformity assessment modules:
- Module A (Internal production control).
Category II (Medium risk)
Equipment:
- Vessels and piping with moderate PS and V values.
Criteria:
- Capacity of pressure vessels for group 1 gases: 50 < PS x V ≤ 200 bar x L.
- Nominal diameter of piping: 25 < DN ≤ 100 for group 1 fluids, 32 < DN ≤ 350 for group 2 fluids.
Conformity assessment modules:
- Module A2 (Internal production control plus supervised pressure equipment checks at random intervals).
- Module D1 (Production process quality assurance).
Category III (Higher risk)
Equipment:
- Vessels and piping with higher PS and V values, used for more hazardous fluids.
Criteria:
- Capacity of pressure vessels for group 1 liquids: PS x V > 200 bar x L.
- Nominal diameter of piping: DN > 100 for group 1 fluids, DN > 350 for group 2 fluids.
Conformity assessment modules:
- Module B (EU-type examination) + Module D (Quality assurance of the production process).
- Module B (EU-type examination) + Module E (Product quality assurance).
- Module B (EU-type examination) + Module C2 (Internal production control plus supervised final assessment).
Category IV (Highest risk)
Equipment:
- Vessels and piping with the highest PS and V values, used for the most hazardous fluids.
Criteria:
- Capacity of pressure vessels for group 1 gases: PS > 200 bar.
- Nominal diameter of piping: DN > 350 for group 1 and 2 fluids.
Conformity assessment modules:
- Module B (EU-type examination) + Module D (Quality assurance of the production process).
- Module B (EU-type examination) + Module F (Product verification).
- Module H (Full quality assurance).
Pressure Equipment Directive: Conformity Assessment Modules
Module A (Internal production control)
Description:
- The manufacturer carries out the conformity assessment independently.
- It is responsible for preparing the technical documentation and the EU declaration of conformity.
- The CE marking is affixed by the manufacturer once the requirements have been met.
Application:
- Low-risk pressure equipment (Category I).
Module B (EU-type examination)
Description:
- A notified body performs the type examination of the pressure equipment.
- Assessment of the technical documentation and performance of tests.
- Issue of the EU-type examination certificate.
Application:
- Medium- and higher-risk equipment (Categories II, III, IV).
Module C (Conformity to type based on internal production control)
Description:
- The manufacturer assesses the conformity of the equipment in accordance with the EU-type examination certificate (obtained under Module B).
- Preparation of the EU declaration of conformity and affixing of the CE marking.
Application:
- Medium-risk equipment (Categories II, III).
Module D (Conformity to type based on quality assurance of the production process)
Description:
- The manufacturer applies an approved quality management system covering the production process, assessed by a notified body.
- The quality system must ensure that products conform to the approved type.
Application:
- Higher-risk equipment (Categories III, IV).
Module E (Conformity to type based on product quality assurance)
Description:
- The manufacturer applies a quality management system covering final inspection and testing of products, approved by a notified body.
- The quality system must ensure that products conform to the approved type.
Application:
- Higher-risk equipment (Categories III, IV).
| Category | Description | Conformity assessment modules |
|---|---|---|
| Category I | Low-risk pressure equipment | Module A (Internal production control) |
| Module A2 (Internal production control plus supervised final assessment) | ||
| Category II | Medium-risk pressure equipment | Module D1 (Quality assurance of the production process) |
| Category III | Higher-risk pressure equipment | Module B (EU-type examination) + Module D (Quality assurance of the production process) |
| Module B (EU-type examination) + Module E (Product quality assurance) | ||
| Module B (EU-type examination) + Module C2 (Internal production control plus supervised final assessment) | ||
| Category IV | Highest-risk pressure equipment | Module B (EU-type examination) + Module D (Quality assurance of the production process) |
| Module B (EU-type examination) + Module F (Product verification) | ||
| Module H (Full quality assurance) |
Pressure Equipment Directive: Designing pressure vessels in accordance with Directive 2014/68/EU
Designing pressure vessels in accordance with Directive 2014/68/EU requires compliance with a range of technical and safety requirements. Key design considerations include selecting suitable materials, ensuring adequate structural strength, and carrying out detailed strength analyses, including finite element analysis (FEA).
Technical requirements
- Materials: Materials used in the construction of pressure vessels must comply with the relevant standards and have appropriate mechanical and chemical properties. They should be resistant to corrosion, fatigue, and other degradation mechanisms.
- Structural design: The vessel must be designed to withstand the maximum allowable pressure (PS) and other expected loads, such as dynamic pressure, thermal loads, and mechanical loads. The design should also incorporate appropriate safety factors.
- Welds and joints: Welds and joints in a pressure vessel must be properly designed and manufactured in accordance with applicable standards to ensure structural integrity and strength. Appropriate non-destructive testing (NDT) should also be carried out to detect any defects.
- Strength analysis: Before a pressure vessel is placed on the market, detailed strength analyses must be performed, including finite element analysis (FEA), to confirm that the design meets all safety requirements.
Finite element analysis (FEA)
FEA is a key tool in the pressure vessel design process. It enables accurate analysis of structural strength under various loads. This process includes:
- Geometric modelling: Creating an accurate geometric model of the vessel in FEA software, taking into account all relevant design details.
- Defining material properties: Entering the material properties of the materials used to build the vessel, such as Young’s modulus, yield strength, Poisson’s ratio, and other material parameters.
- Defining boundary conditions and loads: Specifying boundary conditions, such as supports and fixings, and applying the relevant loads, including internal pressure, thermal loads, and mechanical loads.
- Finite element mesh: Generating a finite element mesh that divides the geometric model into smaller elements, enabling more accurate analysis of stress and strain distribution.
- Simulation and results analysis: Running the FEA simulation and analysing the results, including identifying stress concentration areas, potential damage zones, and assessing the overall structural strength.
- Verification and optimisation: Based on the FEA results, designers can make the necessary design changes and optimisations to ensure that all safety requirements are met.
The role of the design office and engineering outsourcing
In the design and analysis of pressure vessels, design offices play a key role. They have the specialist expertise and tools, such as software for FEA calculations, needed to carry out accurate strength analyses. Through engineering outsourcing, manufacturers can draw on the experience and skills of experts in pressure equipment design, improving the quality and safety of the structures being developed.
Engineering outsourcing allows companies to manage engineering resources flexibly and focus on project management, which is essential for the effective delivery of complex projects. External design offices can also provide support in meeting the requirements of Directive 2014/68/EU, including during the CE marking process.
CE marking and project management
For a pressure vessel to be placed on the EU market, it must obtain CE marking. This process includes:
- Conformity assessment: Carrying out the appropriate conformity assessment procedures in accordance with the requirements of Directive 2014/68/EU.
- Technical documentation: Preparing complete technical documentation confirming that the product meets the requirements of the directive.
- EU declaration of conformity: Issuing an EU declaration of conformity by the manufacturer, as the formal statement that the product complies with the applicable requirements.
- CE marking: Affixing the CE mark to the pressure vessel, confirming its compliance with EU requirements.
Project management in the context of pressure vessel design includes coordinating all of the above activities, ensuring tasks are completed on time, and maintaining a high level of quality and regulatory compliance. Effective project management enables even the most complex projects to be delivered efficiently while ensuring compliance with standards and directive requirements.
Pressure Equipment Directive: Implementation and enforcement
Role of the Member States
Member States are responsible for transposing the directive into national law and overseeing its enforcement. They must adopt appropriate legal and administrative measures to ensure that pressure equipment meets the requirements of the directive.
Penalties for non-compliance
Where national provisions adopted under the directive are breached, Member States must apply effective, proportionate and dissuasive penalties. These may include financial penalties, withdrawal of non-compliant products from the market, and other measures to ensure compliance.
European Commission implementing powers
The European Commission has implementing powers to monitor how Member States apply the directive. It may carry out audits, inspections, and initiate infringement procedures in cases of non-compliance.
Pressure Equipment Directive: Benefits and challenges
Benefits
The directive brings a number of benefits, including harmonised rules across the EU market, improved safety of pressure equipment, and easier free movement of goods. Thanks to CE marking, consumers can be confident that the equipment meets high standards of quality and safety.
Challenges
Implementing the directive may involve challenges, such as the need for manufacturers to adapt to new requirements and for Member States to ensure effective market surveillance. Differences in how the rules are interpreted may lead to inconsistencies in the application of the directive.
European Union directives on pressure equipment and related areas
The European Union has introduced a number of directives aimed at ensuring high standards of safety and health protection, while also facilitating the free movement of goods within the internal market. Below is an overview of the key directives relating to pressure equipment and associated areas.
1. Directive 2014/68/EU (PED – Pressure Equipment Directive)
Purpose: Harmonisation of the rules for pressure equipment to ensure safety and facilitate trade within the EU market.
Scope: Pressure equipment with PS > 0.5 bar.
Categories: I-IV (from lower-risk to highest-risk).
2. Directive 2014/29/EU (SPVD – Simple Pressure Vessels Directive)
Purpose: Harmonisation of the rules for simple pressure vessels.
Scope: Simple welded pressure vessels intended to contain air or nitrogen, with PS ≤ 30 bar and the product PS x V ≤ 10 000 bar x litres.
3. Directive 2014/34/EU (ATEX – Equipment for Explosive Atmospheres)
Purpose: Ensuring the safety of equipment and protective systems intended for use in potentially explosive atmospheres.
Scope: Electrical and mechanical equipment, as well as protective systems, intended for use in hazardous areas. See also the related ATEX Directive 2014/34/EU.
4. Directive 2014/35/EU (LVD – Low Voltage Directive)
Purpose: Ensuring the safety of electrical equipment designed for use within specified voltage limits.
Scope: Electrical equipment with a rated voltage between 50 V and 1000 V for alternating current and between 75 V and 1500 V for direct current.
5. Directive 2014/30/EU (EMC – Electromagnetic Compatibility Directive)
Purpose: Ensuring that electrical and electronic equipment operates correctly in its electromagnetic environment without causing electromagnetic disturbance. See also the EMC Directive.
Scope: Electrical and electronic equipment, as well as fixed installations.
6. Directive 2006/42/EC (MD – Machinery Directive)
Purpose: To harmonize legislation relating to machinery, ensuring a high level of health and safety protection while facilitating the free movement of machinery within the EU.
Scope: Machinery, spare parts, safety components, lifting equipment.
7. Directive 2009/105/EC (SPV – Simple Pressure Vessels Directive) [replaced by 2014/29/EU]
Purpose: Similar to 2014/29/EU, concerning simple pressure vessels.
8. Directive 2013/29/EU (Pyrotechnic Articles Directive)
Purpose: To harmonize legislation on pyrotechnic articles in order to ensure a high level of health and safety protection.
Scope: Pyrotechnic articles, including fireworks, theatrical pyrotechnics, and pyrotechnic articles for vehicles.
9. Directive 2011/65/EU (RoHS – Restriction of Hazardous Substances Directive)
Purpose: To restrict the use of hazardous substances in electrical and electronic equipment.
Scope: A broad range of electrical and electronic equipment, including household appliances, IT equipment, and telecommunications equipment.
10. Directive 2000/14/EC (Noise Emission in the Environment by Equipment for Use Outdoors Directive)
Purpose: To reduce outdoor noise emissions from equipment intended for outdoor use.
Scope: Various types of equipment intended for outdoor use, including construction machinery and gardening equipment.
The Pressure Equipment Directive 2014/68/EU is a key legal act that ensures the safety of pressure equipment on the EU market. The manufacturer must carry out a conformity assessment of the equipment, selecting the appropriate module depending on the risk category. This process may involve the manufacturer’s own conformity assessment for lower-risk equipment or more stringent procedures involving a notified body for higher-risk equipment. In this way, the directive ensures that pressure equipment meets high safety standards, which is essential for protecting the health and safety of users and for the smooth functioning of the EU internal market.
Link to the directive on the European Union website:
https://eur-lex.europa.eu/legal-content/PL/TXT/PDF/?uri=CELEX:32014L0068
Pressure Equipment Directive 2014/68/EU (PED)
The aim is to harmonize safety requirements for pressure equipment in the EU. The Directive is intended to protect the health and safety of users and to facilitate the free movement of this equipment within the internal market.
It covers pressure equipment with a maximum allowable pressure (PS) exceeding 0.5 bar, including vessels, piping, safety accessories, and assemblies. It applies to equipment manufactured in the EU as well as imported equipment.
The text mentions, among other things, simple pressure vessels, aerosol dispensers, and well-control equipment. It also refers to exclusions such as transmission pipelines and water supply networks.
Classification depends on PS, volume (V), nominal diameter (DN), and the type of fluid (group 1 or 2). Group 1 includes hazardous fluids, and group 2 all others.
For Category I, Module A (internal production control) is specified. For higher categories, Module A2, D1 and combinations involving Module B (EU-type examination), such as B+D, B+E and B+C2, as well as Module F and Module H, are used.