Objective:
Scope:
Requirements:
Essential Safety Requirements (ESRs):
Conformity Assessment:
CE Marking:
Documentation:
Responsibilities:
Manufacturers:
Authorized Representatives:
Notified Bodies:
Market Surveillance:
Detailed Technical Information: Provide a thorough description of the product or technology, including its specifications, components, design principles, and functionalities. This should cover all essential aspects necessary for understanding its operation and application.
Safety and Compliance Data: Include information regarding safety considerations, compliance with relevant standards, regulations, and any certifications obtained. This is crucial for demonstrating that the product meets all necessary legal and safety requirements.
Testing and Validation: Present results from testing and validation processes that confirm the product's performance, reliability, and durability. This helps in substantiating claims about the product's efficacy and suitability for its intended use.
Risk Assessment and Mitigation: Discuss any identified risks associated with the product and detail the measures taken to mitigate these risks. This may include design features, warnings, instructions for use, and other safety precautions.
Instructions and Documentation: Provide clear instructions for installation, operation, maintenance, and troubleshooting. Include comprehensive documentation that supports the product throughout its lifecycle.
Intellectual Property Considerations: Disclose information related to intellectual property rights associated with the product, such as patents, trademarks, or copyrights. This helps in understanding the proprietary aspects and potential licensing or usage rights.
Essential Safety Requirements (ESRs):
Technical Documentation:
Declaration of Conformity (DoC):
CE Marking:
Pressure Equipment Technical File:
. What is the Pressure Equipment Directive (PED)?
The Pressure Equipment Directive (PED) is a European Union directive (2014/68/EU) that sets standards for the design, manufacture, testing, and conformity assessment of pressure equipment intended for placement on the EU market.
What is considered pressure equipment under the PED?
Pressure equipment is defined as vessels, piping, safety accessories, and pressure accessories with a maximum allowable pressure greater than 0.5 bar (7.25 psi).
. Why is compliance with the PED important?
Compliance with the PED ensures a high level of safety for pressure equipment used within the EU. It facilitates the free movement of pressure equipment across EU member states by harmonizing safety requirements.
Who is responsible for compliance with the PED?
Manufacturers, authorized representatives within the EU, and importers are responsible for ensuring that pressure equipment complies with the PED requirements. Compliance may involve conformity assessment procedures and involvement of notified bodies.
What are essential safety requirements (ESRs) under the PED?
Essential safety requirements are specified in Annex I of the PED. They cover aspects such as design, materials, manufacturing, pressure testing, and safety measures to protect against risks such as rupture, explosion, and leakage.