Conformity assessment and certification of pressure equipment in accordance with Directive 2014/68/EU

Scope of application

The Directive applies to pressure equipment and assemblies with a maximum allowable pressure exceeding 0.5 bar. Its scope covers the design, manufacture and conformity assessment of such equipment.

The directive does not apply to the on-site assembly of equipment by a user (other than the manufacturer) and controlled as an industrial installation.

Types of pressure equipment covered by the Directive:

• Tanks (vessels): A body designed and constructed to be pressurized by working fluids or gases (including elements attached up to the first connection point: flanges, nozzles, joints, supports, lifting brackets, etc.).
• Pipelines: Piping systems and components designed to transport flowing substances (liquids, gases, vapors) when connected in a single pressure system.
• Shut-off and safety devices: Devices designed to protect pressure equipment against exceeding permissible limit values (safety valves, diaphragms, limiters), as well as devices with a working function whose housing is exposed to pressure (control valves, measuring instruments).

Assembly units (complexes):

Several pieces of pressure equipment which have been combined by the manufacturer to form a single and functional whole. The assemblies may be simple (e.g. autoclaves) or complex (e.g. water-tube boilers). The Directive applies to an assembly if the manufacturer places it on the market as a single unit.

The Directive does not apply to:

• For equipment with a maximum permissible pressure not exceeding 0.5 bar, as they do not pose a specific danger due to pressure.
• For equipment subject to other EU directives and transport regulations (e.g. Directive 2008/68/EC and Directive 2010/35/EU on transportable pressure equipment).
• For specific types of equipment that do not pose an increased hazard even at pressures above 0.5 bar due to design features.

Principles of conformity assessment

The manufacturer is responsible for the conformity assessment, as he has comprehensive information about the design and production process. The manufacturer is obliged to draw up an EU declaration of conformity, by which he declares and assumes responsibility that the product fully complies with the requirements of Directive 2014/68/EU and other applicable legislation.

Pressure equipment is divided into four categories (I, II, III, IV) according to increasing hazard level. The classification is based on:

1. Type of equipment (tank, pipeline or steam boiler);
2. Group of fluid substances (Group 1 – hazardous gases/liquids; Group 2 – all other fluid substances);
3. The maximum permissible pressure and volume or nominal size, in accordance with the diagrams in Annex II to the Directive.

Specific conformity assessment procedures (modules) are provided for each hazard level (category), and the manufacturer has the right to choose between procedures of the same stringency.

Conformity assessment modules (procedures)

Important: In all modules, except Module A, conformity assessment procedures are carried out only with the participation of a notified (certification) body.

• Modules A2 and C2: The certification body carries out the final assessment and surveillance of pressure equipment with random inspections to confirm the quality of the internal checks. Experts examine the accompanying documents and may carry out product sample tests.
• Modules D, D1, E, E1, H: The certification body assesses and monitors the manufacturer’s quality assurance system (production, product testing or full quality assurance). This includes periodic audits to verify that the manufacturer maintains and correctly applies the approved system.
• Module B (EU-type examination): The certification body checks and certifies that the technical design (design model) or the actual production model of the pressure equipment meets the requirements of the Directive. After successful examination and testing, an EU-type examination certificate is issued with a validity period of 10 years.
• Module F: The certification body checks each individual product or batch to ensure compliance with the EU-type examination certificate and the requirements of the Directive, and issues a certificate of conformity.
• Module G (Conformity based on unit verification): Designed for the certification of unique, one-off pressure equipment. The certification body examines each piece of equipment individually (design, manufacture, tests) and issues a certificate of conformity for the specific unit.
• Module H1 (Full quality assurance with design examination): In addition to the quality system audit (as in Module H), the Certification Body carries out a design examination of each equipment and issues an EU design examination certificate.

Rules for the certification process and status management

The certification body ensures transparent, objective and standardized management of certification statuses at all stages of cooperation.

1. Granting of the certificate

The certificate is granted if the results of the application, technical documentation evaluation and audit/testing (depending on the selected module) are positive. The certification body makes a decision and issues the manufacturer with an EU certificate (or certificate supplement) for the relevant module. If the customer does not eliminate the identified non-conformities by the specified deadline, the certification body makes a decision to reject (deny) the certification .

2. Maintenance and monitoring of certification

In modules related to the certification of the manufacturer’s quality system (D, D1, E, E1, H, H1), maintenance is ensured by regular surveillance audits (usually every 12 months). A full reassessment of the quality system and renewal of the certificate is carried out every 3 years. The certification body reserves the right to make unannounced or short-notice visits to the manufacturer to carry out additional inspections or product control tests and to verify the effectiveness of the system.

3. Change in scope of certification (Extension or Restriction)

• Scope extension: If the customer wishes to add new pressure equipment types, models or additional modules to the certificate, a new extension application is submitted. The certification body evaluates only the additional aspects applied for and, in case of a successful outcome, issues an updated version of the certificate.
• Scope limitation: If it is determined during a surveillance audit that the manufacturer is no longer able to ensure compliance with any of the approved product groups, or if the client requests it in writing, the Certification Body shall reduce the scope of the certificate and issue a new version of the certificate with a limited scope.

4. Suspension and revocation of the certificate

• Suspension: The certification body may temporarily (up to 6 months) suspend the certificate if:
  • The client does not allow supervisory audits to be conducted within the specified deadlines;
  • The audit has identified critical non-conformities that cannot be resolved immediately;
  • The customer misuses certification marks or references to certification;
  • Financial obligations are not being met.
  • During the suspension, the manufacturer is prohibited from placing pressure equipment on the market with reference to this certificate.
• Cancellation (revocation): The certificate is completely cancelled if the customer has not eliminated the reasons that were the basis for the suspension within the suspension period, if the customer completely ceases production of the relevant equipment, or if blatant violations, fraud and deliberate labeling and placing on the market of non-compliant equipment are discovered. The customer is notified in writing about the cancellation of the certificate, as well as the responsible market surveillance authorities and other notified bodies are informed in accordance with the procedure specified in regulatory enactments.