Term and Legal Framework: Pressure Equipment
Definition of Pressure Equipment
According to European and German law, pressure equipment refers to technical products intended to be used under internal pressure. The term covers vessels, piping, safety devices, as well as pressure-retaining accessories. The excess pressure can be caused by liquids, gases, or vapors. The regulations concerning the handling, placing on the market, and use of pressure equipment serve to protect health, safety, and the environment.
European Legal Foundations
Directive 2014/68/EU (Pressure Equipment Directive – PED)
The applicable European legal basis is Directive 2014/68/EU on the harmonization of the laws of the Member States regarding the making available of pressure equipment on the market, known as the Pressure Equipment Directive (PED). It regulates requirements for design, manufacture, testing, conformity assessment, commissioning, and marking of pressure equipment and assemblies with a maximum allowable pressure greater than 0.5 bar. The PED aims to harmonize national laws and ensure safety in the movement of pressure equipment within the European Economic Area.
Scope and Exemptions
The scope of the PED is comprehensive. It affects not only traditional boilers and vessels but also heat exchangers, steam lines, pressure piping, compressors, and pressure equipment in facilities such as chemical plants or power stations. Exemptions include, among others, aerosol dispensers, equipment under pressure related to road traffic (e.g., tire pressure), as well as certain transport containers regulated by other directives such as the Directive on Transportable Pressure Equipment (Directive 2010/35/EU).
Implementation in German Law
Product Safety Act and 14th ProdSV
In Germany, the PED is implemented through the Product Safety Act (ProdSG) and the Pressure Equipment Ordinance (14th Product Safety Ordinance – 14. ProdSV). The 14. ProdSV contains specific provisions regarding the requirements for placing on the market, conformity assessment procedures, CE marking, and the handling of pressure equipment within Germany.
Ordinance on Industrial Safety and Health (BetrSichV)
In addition to market access, the Ordinance on Industrial Safety and Health regulates the use and safe operation of pressure equipment in the workplace. The BetrSichV defines operator obligations, including regular inspections (initial, periodic, extraordinary), documentation requirements, risk assessments, maintenance, and measures management in case of malfunctions or incidents.
Duties and Responsibilities
Manufacturer Obligations
Manufacturers of pressure equipment must ensure that their products meet the essential safety requirements. This includes:
- Conducting a risk assessment
- Selection and application of an appropriate conformity assessment procedure
- Provision of an EC Declaration of Conformity
- Affixing the CE marking
- Preparation of operating instructions and technical documentation in the respective official language
Assignment to specific categories is based on parameters such as type of medium, capacity, maximum allowable pressure, and hazard potential.
Obligations of Operators
Persons responsible for operation are required to operate pressure equipment safely, observing the BetrSichV and technical rules (e.g., TRBS 1201: “Inspection of Work Equipment and Installations Requiring Supervision”). Key duties include:
- Carrying out and documenting regular inspections by Notified Inspection Bodies
- Preparation and implementation of a risk assessment
- Observance of safe operating limits
- Training and instruction of employees
Inspection Obligations and Intervals
The inspection intervals depend on the type, category, and hazard potential of the pressure equipment as well as its operational conditions. The recurring inspections include internal and external inspections and, where applicable, strength testing.
Conformity Assessment and CE Marking
Pressure equipment is subject to graded conformity assessment procedures. These range from the manufacturer’s own responsibility (Module A) to the involvement of a notified body (Modules B, C, D, E, F, G). After successful conformity assessment, the CE marking must be affixed and the equipment may freely circulate in the European internal market.
Sanctions and Measures in Case of Violations
Violations of regulations relating to the manufacture, placing on the market, or use of pressure equipment can result in official measures, such as:
- Withdrawal or recall of unsafe products
- Decommissioning of unsafe pressure equipment
- Fines and, in case of imminent danger, criminal sanctions
The market surveillance authorities of the federal states are responsible for monitoring compliance with the requirements and enforcing measures.
Technical Standards and Harmonized Norms
Compliance with harmonized European standards such as DIN EN 13445 (Unfired Pressure Vessels), DIN EN 12952/12953 (Steam Boilers), as well as additional specific standards, simplifies proof of compliance with the essential safety requirements.
Environmental and Occupational Safety
Safe operation of pressure equipment involves not only aspects of operational safety but also those of occupational and environmental protection. Escaping pressurized substances can cause considerable hazards, which is why legislation also aims to limit such risks.
Summary
Pressure equipment is subject to a comprehensive and detailed legal framework. The key provisions include the European Pressure Equipment Directive, the implementing Pressure Equipment Ordinance, and, in addition, the Ordinance on Industrial Safety and Health. Manufacturers and operators are bound by strict obligations to exclude hazards to people and the environment. Compliance with the regulations is monitored by market surveillance authorities and notified inspection bodies. Therefore, the legal framework for pressure equipment is a central building block of technical safety law in Europe and Germany.
Frequently Asked Questions
What legal foundations apply to the placing on the market of pressure equipment in the European Union?
The placing on the market of pressure equipment in the European Union is subject to strict legal requirements, primarily governed by Directive 2014/68/EU on pressure equipment (Pressure Equipment Directive, PED). This directive stipulates that pressure equipment and assemblies with a maximum allowable pressure of more than 0.5 bar may only be placed on the market if they meet certain essential safety requirements described in the PED. These requirements include, among others, the preparation of comprehensive technical documentation, the conduct of a conformity assessment by a notified body depending on the category of equipment, the affixing of the CE marking, and the issuance of an EU Declaration of Conformity. Additionally, national laws and regulations such as the Pressure Equipment Ordinance (14th ProdSV) in Germany must be observed, which ensures the implementation of European requirements into national law. Violations of these legal provisions can lead to sales bans, recalls, or fines.
What obligations do manufacturers have regarding the CE marking of pressure equipment?
Manufacturers are obliged to ensure that their pressure equipment is affixed with the CE marking before being placed on the market, provided it falls within the scope of the Pressure Equipment Directive. In order to obtain the CE marking, a conformity assessment must be performed to demonstrate that the product meets all applicable EU requirements. Depending on the category of pressure equipment, the assessment is carried out by means of internal production control or with the involvement of a notified body, for example, through type examination or quality management system assessment. Moreover, the manufacturer must keep technical documentation and issue and provide an EU Declaration of Conformity. Violations, such as affixing an unauthorized CE marking or lacking the required documentation, constitute administrative offenses and can result in legal action by market surveillance authorities.
What legal consequences are threatened in case of non-compliance with the Pressure Equipment Directive?
If the requirements of the Pressure Equipment Directive or its national implementing provisions are not met, severe legal consequences can ensue. These include, in particular, official measures such as sales bans, product recalls, orders to retrofit or even destroy non-compliant equipment. In addition, substantial fines are provided for manufacturers, importers, and distributors in many countries. In certain situations, criminal consequences may also arise, such as when defective pressure equipment causes injury or endangers persons. Furthermore, manufacturers and, where applicable, other economic operators are civilly liable for damages caused, which can result in high claims for compensation.
What role do notified bodies play in the legal context of pressure equipment?
Notified bodies are independent organizations that have been designated and officially recognized by EU Member States to perform conformity assessment procedures under the Pressure Equipment Directive. They verify whether pressure equipment meets the essential safety requirements and issue the corresponding test certificates and attestations. The involvement of a notified body is mandatory for certain categories of pressure equipment, especially where higher hazard potential exists (e.g., at higher pressures or with hazardous media). The results of inspections and issued certificates are legally binding. Circumventing a required assessment by a notified body constitutes a legal violation and can lead to the sanctions mentioned above.
What special requirements apply to the placing on the market of used pressure equipment?
The placing on the market of used pressure equipment within the EU is subject to the same basic legal requirements as new equipment. In particular, this includes compliance with the applicable safety requirements, a conformity assessment if the equipment has not yet been assessed under the current directive, as well as the retention of technical documentation and ensuring the CE marking. It is also prohibited to place used pressure equipment on the market that was originally intended for markets outside the EU and does not comply with European requirements. For used equipment already placed on the EU market, it must be ensured that no significant changes have been made that would trigger a new assessment. Otherwise, the equipment must be treated as new.
What legal obligations do operators of pressure equipment have?
Operators are required to operate their pressure equipment safely in accordance with national legal provisions, such as the Ordinance on Industrial Safety and Health (BetrSichV) in Germany. This includes regular inspections by competent persons or notified inspection bodies, proper maintenance and servicing, as well as maintaining a correct operating logbook. The operator is also responsible for personnel training, conducting risk assessments, and implementing precautionary measures. If an operator fails to meet these obligations and this results in accidents or damage, he may be liable under criminal and civil law, and authorities may prohibit further operation and impose fines.
