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- 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
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The certification process for compliance with Directive 2014/34/EU involves assessing the safety and suitability of equipment and protective systems for use in potentially explosive atmospheres, documenting compliance with essential requirements, and affixing the CE marking to indicate conformity with EU regulations. Compliance with the ATEX Directive is essential for manufacturers seeking to market their products in the European Union.
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 or protective system falls within the scope of the ATEX Directive. The directive applies to a wide range of products used in potentially explosive atmospheres, including electrical and mechanical equipment, protective systems, and components.
Classification of Equipment
Manufacturers must classify their equipment or protective systems into categories defined by the ATEX Directive based on the likelihood of ignition sources and the level of protection required. Categories include equipment for use in zones with gas and/or dust explosion hazards, as well as categories for equipment intended for use in mining applications.
Identification of Essential Requirements
Manufacturers must identify the essential health and safety requirements set out in Annex II of Directive 2014/34/EU that are applicable to their products. These requirements address factors such as design, construction, testing, and marking of equipment and protective systems intended for use in potentially explosive atmospheres.
Risk Assessment
Manufacturers must conduct a risk assessment to identify and evaluate potential ignition sources and explosion risks associated with their products. This includes assessing factors such as material properties, electrical and mechanical design, and operating conditions in hazardous environments.
Design and Manufacturing Compliance
Manufacturers are responsible for designing and manufacturing equipment and protective systems in accordance with the essential requirements of the ATEX Directive. 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 2014/34/EU. This documentation should include information about the design, construction, testing, and performance of the equipment or protective system, as well as risk assessments and instructions for use.
Conformity Assessment
The ATEX 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 2014/34/EU has been demonstrated, the manufacturer must affix the CE marking to the equipment or protective system. The CE marking indicates that the product meets the essential requirements of all applicable EU directives, including the ATEX Directive.
Declaration of Conformity
Manufacturers or their authorized representatives must draw up a Declaration of Conformity stating that the equipment or protective system complies with the requirements of Directive 2014/34/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 equipment and protective systems placed on the market comply with the requirements of the ATEX Directive. 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.
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