Ultimate Guide to Pressure Equipment Directive Compliance (2014/68/EU)
23/6/2019 Law & Legislation
1. What is the Pressure Equipment Directive?
The Pressure Equipment Directive 2014/68/EU (formerly 97/23/EC) outlines the standards to which pressure equipment within the EU must conform - it includes equipment such as pressure vessels, boilers, piping, and safety valves
The purpose of the Pressure Equipment Directive is to ensure the free flow of stationary pressure equipment within the European Union. At the same time it is to ensure that all pressure equipment passes a high degree of safety.
According to the Community Regime of the Directive, when pressure equipment and assemblies fall above a specified pressure and volume threshold they must adhere to these requirements:
- They must be safe
- They must meet essential safety requirements covering design, manufacture and testing
- They must satisfy suitable conformity assessment procedures
- They must carry the CE marking
When pressure equipment and assemblies fall below a specified pressure and volume threshold:
- They must be safe
- They must be in accordance with sound engineering practices of a member state
- They must bear specified markings (not necessarily the CE marking).
2. Directive Name
Pressure Equipment Directive
3. Directive Number & Download Link to Legal Directive
Directive 2014/68/EU to be downloaded from the following link:
4. Notified Body (aka, Independent Assessment) Required?
Before a manufacturer can start with the required procedure to assess their product, it is important that they determine whether said product requires self-assessment or whether a Notified Body needs to be involved.
Pressure equipment in the viewpoint of the Directive, are classified according to different categories. These range from I to IV. This is in accordance with levels of hazard arranged in ascending order, stipulated in Annex II of the Directive.
Of utmost importance is the following stipulation:
A Notified Body must be involved in the assessment of equipment of category II or higher.
5. Products Covered
Pressure equipment and assemblies covered in this Directive are those that adhere to the design, manufacturing as well as the conformity assessment with a maximum allowable pressure PS greater than 0.5 bar.
The equipment outlined in the Directive are used in the process industry:
- Especially in the plastics and rubber, food and beverage, chemical, pharmaceutical as well as the oil & gas process industry.
- Apart from these industries pressure equipment are also used in the high temperature process industry like in the processing of glass, paper and board.
- Included as well is the energy production industry and the supply of air conditioning, gas storage, transportation, heating and the supply of utilities.
6. Examples of Products Covered
The type of products covered under the pressure equipment Directive, include the following:
- Plant vessels
- Pressurized storage containers
- Industrial pipework
- Heat Exchangers
- Shell and water tube boilers
- Steam generators
- Safety devices and pressure accessories
7. Examples of Products NOT Covered
The Pressure Equipment Directive is only applicable to components and sub assemblies. It is not applicable to the assembling of pressure equipment on-site while under the supervision and responsibility of the user, as in industrial installations.
Other exclusions include equipment of military use, and equipment used in transportation. Also excluded is equipment portraying a very low potential of danger from pressurization but which falls within the range of another CE mark directive, like the Machinery Directive.
More exclusions in the pressure equipment directive are containers used in transporting fluids by road, air, sea or rail. They belong to another directive called the Transportable Pressure Equipment Directive (TPED). This directive has different verification and marking requirements, called the “pi-mark”.
Simple pressure vessels are also not included as they belong to a different directive.
8. Enforcement & Penalties
Each EU member state is required to lay down rules on penalties for not complying with the Pressure Equipment Directive. Below you can find the penalties for member states Germany and the UK as an example. For penalties relevant to other specific EU member states, please consult that state's local legislation on product safety.
- Germany - violation of the "Produktsicherheitsgesetz" (product safety legislation) can result in fines of €3,000 - €30,000 (§ 19) and imprisonment of up to 1 year (§ 20).
- In the UK, directive violations are are covered under Section 33 HSWA offenses and can result in an unlimited fine and up to two years imprisonment.
9. How to Comply: Requirements & Process
Higher categories with greater danger have more rigorous conformity assessment modules.
As an example, equipment in Category I are subject to the manufacturer’s own production control, whereas those in Category II, III and IV require involvement of Notified Bodies.
Declaration of Conformity (contents)
The basic layout and content of a Declaration is common for all directives, but may differ slightly per each directive.
The following is required by most of the directives:
- Name and full business address of the manufacturer or the representative authorized to issue the Declaration;
- An identification number of some sort. This number could easily refer to the serial number, product number, model or type.
- A Declaration statement, stating that the Declaration is issued under the manufacturer.
- The name, address and identification number of the Notified Body which carried out the conformity assessment procedure;
- The relevant legislation complied with; standards used, with dates and amendments specified.
- Identity and signature of an authorized person
- The date the Declaration was issue
Directive 2014/68/EU requires technical documentation to be established by the manufacturer. The technical document is instrumental in the assessment of the conformity of the said appliance with the Directive’s requirements.
The technical document must contain the following elements:
- description of the pressure equipment
- abstract design, manufacturing drawings, diagrams of components, sub-assemblies, circuits, etc.,
- descriptions, explanations which are necessary to understand the drawings and diagrams as well as the operation of the pressure equipment
- list of the harmonised standards
- results of design calculations and examinations
- as well as test reports
Affix CE Mark
After all necessary steps were taken to complete conformity, the CE mark should be affixed to the product. This marking should be placed on the product in a visible and legible manner and should consist of the initials “CE”.
10. Free Template Download
For a free Declaration of Conformity template for the Pressure Equipment directive, please refer to the downloads section of the page below:
11. Related Directives
No related directives.
12. Useful Links (testing Labs, further information)
Links you might find useful in gaining more information regarding the Pressure Equipment Directive.