*Directive 2014/68/EC was adopted in May 2014. It applies to pressure-operated equipment and assembly units that are being placed on the EU market for the first time. This refers to both new products manufactured in the EU and new or used products imported from third countries.
Scope of application
The Directive applies to equipment and assembly units with a maximum allowable pressure of more than 0.5 bar. Its effect extends to their design, production and conformity assessment. An exception is the assembly of equipment on site and under the control of a user who is not the manufacturer, as well as in the case of an industrial installation.
Equipment operating under pressure is vessels, pipelines, protective devices and related devices that also work under pressure. These may include elements connected to sealing parts. These are flanges, nozzles, couplings, supports, lifting brackets, etc.
Related devices are devices with a working function, the body of which is under pressure.
Assembly units are several pieces of equipment. The manufacturer intends them to create a single and functional whole. Assembly units can be simple (autoclaves) and complex (water-tube boilers). The directive applies to an assembly unit if the manufacturer puts it on the market as a whole, and not in the form of composite disassembled elements.
However, there are a large number of types of equipment that are not included in the scope of the Directive.
The Directive does not apply to:
– Equipment with a pressure of less than 0.5 bar, which does not pose a significant danger
– Equipment that is subject to other EU Directives, in particular Directive 2008/68/EC and Directive 2010/35/EC
Certain types of equipment operating under a pressure of more than 0.5 bar, which, due to the pressure force, do not pose a significant danger
– Equipment with a maximum permissible pressure of more than 0.5 bar, which poses a significant danger, but for which free handling and a certain level of safety are guaranteed
Conformity assessment
Conformity assessment is the responsibility of the manufacturer, since he has comprehensive information in the field of the design and production process. The manufacturer must draw up an EU declaration of conformity for its equipment. This way he ensures that the products fully comply with the Directive and other requirements.
The equipment is classified into four categories according to the increasing level of danger (the order of its classification is set out in Annex II to the Directive). Each category has its own conformity assessment procedures. At the same time, the manufacturer has the right to choose between procedures of the same rigor.
Modules (combinations) of procedures are established by Decision 768/2008/EC. Each module includes less and more rigorous procedures. The elements that are added to them are determined by the nature of the verification that is required for equipment of this category.
Conformity assessment procedures
Equipment category Possible evaluation procedures
I = Module A
II = Modules A2, D1, E1
III = Modules B (standard design sample)+ D, B (standard design sample)+ F, B (standard production sample)+ E, B (standard production sample)+ C2, H
IV = Modules B (standard production sample) + D, B (standard production sample) + F, G, H1
Important: All modules (with the exception of module A) contain conformity assessment procedures that are carried out only with the participation of the certification body.
1) Modules A2 and C2. The certification body conducts a final assessment of the equipment. It confirms the quality of internal inspections of equipment, taking into account its technological complexity and production volume. Experts study the accompanying documentation, select product samples and conduct their tests.
2) Modules D1, E, E1, H, D. The certification body evaluates the manufacturer’s quality system. It includes periodic audits to confirm that the manufacturer ensures the functioning of the quality system and applies it properly. Periodic inspections are carried out with such frequency that a full re-evaluation takes place every three years.
Based on the results of the inspections, the certification body draws up a report. It can also carry out unscheduled inspections and, if necessary, carry out product tests to assess how the quality system functions. In this case, the manufacturer is handed an inspection report and a test report.
3) Module B1 will include an EU type examination. The examination consists of two stages. The certification body first examines the technical design of the equipment and confirms that it meets the requirements of the Directive. Then he conducts research on a sample of complete equipment. Additionally, the certification body evaluates the materials used for the manufacture of the sample.
If the standard sample meets the requirements of the Directive, the certification body issues the manufacturer an EU type examination certificate. It contains the name and address of the manufacturer, conclusions based on the test results, conditions (if any) its validity and the necessary information for the identification of the approved standard sample. The certificate is valid for 10 years (with the right to renew).
4) Module F. The certification body evaluates whether the equipment complies with the approved standard model specified in the EU type examination certificate and the requirements of the Directive. To do this, he conducts the necessary checks and tests, and each product passes them. In addition, the certification body verifies the certificate issued by the manufacturer of the material.
Based on the results of the inspections and tests carried out, the certification body issues a certificate of conformity. He also puts an identification number on each unit of approved equipment.
5) Module G. The certification body participates in the verification of the equipment. It carries out inspections and tests provided for by the relevant standard(s) and/or equivalent tests in order to verify the compliance of the equipment with the requirements of the Directive. In the absence of a standard(s), the certification body determines which tests are required to be carried out when applying other technical specializations.
Based on the results of the inspections and tests carried out, the certification body issues a certificate of conformity and applies an identification number to the approved equipment.
6) Module H1. The certification body verifies the manufacturer’s quality system and evaluates the quality of the project of each piece of equipment.
If the project meets the requirements of the Directive, the certification body issues to the manufacturer a certificate of the EU examination of the project. The certificate indicates the name and address of the manufacturer, conclusions based on the results of the inspection, conditions (if any) its validity and the data necessary to identify the approved project.
The certificate and its appendices contain all the essential information that allows you to assess the conformity of finished products to the approved project and, if necessary, provides for operational control.