- Home
- About
- Certification
- Product Certifications
- CE Mark Certification
- Medical Devices & IVDS
- Other Directive & Regulations
- LVD – Low Voltage Directive LVD2014/35/EU
- MCD | Directive Machinery_2006/42/CE
- DLS – Directive Lifts and Safety Components for Lifts_2014/33/UE
- EMC | Directive 2014/30/UE Electromagnetic Compatibility
- RED | Directive 2014/53/UE Radio Equipment Directive
- NOISE | Directive 2000/14/CE Noise
- PED – Directive 2014/68/UE
- ATEX – Directive 2014/34/UE
- Toys – Directive 2009/48/CE
- PPE – Regulation (EU) 2016/425
- GAR – EU Regulation 2016/426
- PED – Directive 2014/68/UE
- CE Mark Certification
- Inspection
- Public Documents
- Contact
The certification process for compliance with Directive 2014/68/EU involves assessing the safety and integrity of pressure equipment and assemblies, documenting compliance with essential requirements, and affixing the CE marking to indicate conformity with EU regulations. Compliance with the Pressure Equipment Directive is essential for manufacturers seeking to market their products in the European Union.
Directive 2014/68/EU, also known as the Pressure Equipment Directive (PED), is a European Union directive that sets out requirements for the design, manufacture, testing, and conformity assessment of pressure equipment and assemblies. The directive aims to ensure a high level of safety for pressure equipment and to facilitate the free movement of such equipment within the European Economic Area (EEA).
Here's an overview of the certification process for compliance with Directive 2014/68/EU:
Directive 2014/34/EU, commonly referred to as the ATEX Directive, is a European Union directive that sets out requirements for equipment and protective systems intended for use in potentially explosive atmospheres. The directive aims to ensure a high level of protection for workers and the public by preventing explosions and minimizing the risks associated with hazardous environments.
Here's an overview of the certification process for compliance with Directive 2014/34/EU:
Scope Determination
The first step is to determine whether the equipment falls within the scope of the Pressure Equipment Directive. The directive applies to a wide range of pressure equipment, including vessels, piping, safety accessories, and assemblies with a maximum allowable pressure greater than 0.5 bar.
Classification of Equipment
Manufacturers must classify their pressure equipment into categories defined by the PED based on the degree of hazard and the level of protection required. Categories include equipment in Categories I to IV, with increasing levels of conformity assessment and documentation requirements.
Identification of Essential Requirements
Manufacturers must identify the essential safety requirements set out in Annex I of Directive 2014/68/EU that are applicable to their products. These requirements address factors such as design, materials, manufacturing, testing, and marking of pressure equipment and assemblies.
Risk Assessment
Manufacturers must conduct a risk assessment to identify potential hazards associated with their pressure equipment and to determine appropriate measures to mitigate those risks. This includes assessing factors such as pressure, temperature, fluid properties, and potential failure modes.
Design and Manufacturing Compliance
Manufacturers are responsible for designing and manufacturing pressure equipment in accordance with the essential requirements of the PED. This may involve adopting harmonized standards, technical specifications, or other recognized methods of compliance.
Technical Documentation
Manufacturers are required to compile technical documentation demonstrating compliance with Directive 2014/68/EU. This documentation should include information about the design, construction, materials, testing, and performance of the pressure equipment, as well as risk assessments and instructions for use.
Conformity Assessment
The Pressure Equipment Directive allows manufacturers to choose from several conformity assessment procedures to demonstrate compliance with the directive. These procedures may include self-assessment based on internal production control, involvement of a notified body for assessment of full quality assurance, or type examination of individual products.
CE Marking
Once compliance with Directive 2014/68/EU has been demonstrated, the manufacturer must affix the CE marking to the pressure equipment or assembly. The CE marking indicates that the product meets the essential requirements of all applicable EU directives, including the Pressure Equipment Directive.
Declaration of Conformity
Manufacturers or their authorized representatives must draw up a Declaration of Conformity stating that the pressure equipment or assembly complies with the requirements of Directive 2014/68/EU. The Declaration of Conformity should be kept on file and made available to authorities upon request.
Market Surveillance
Competent authorities in EU member states are responsible for market surveillance activities to ensure that pressure equipment and assemblies placed on the market comply with the requirements of the PED. This may include inspections, testing, and enforcement actions to address non-compliant products.
PRNS would serve CE mark certification services of Medical Devices, IVDs and other directive and regulations through Collaboration/Partnership Agreement with a European Notified Body.
Contact
We will be happy to give you more information about our quality solutions. Please fill in this form to contact us, we will respond as soon as possible.
