CE
CE Marking Certification & EU Compliance
Concept: CE Marking is the manufacturer's indication that the product has undergone the applicable conformity assessment and meets the requirements of the EU legislation that applies to it.
Procedure: Define the product and intended use → identify applicable EU Directives/Regulations → identify applicable standards → perform risk assessment → design and verify the product → prepare technical documentation → carry out testing/assessment where required → complete the applicable conformity assessment procedure → prepare and sign the EU Declaration of Conformity → affix the CE marking and maintain required records.
Marking & documents: CE marking must be applied in accordance with the applicable rules. The technical file normally includes product description, drawings, calculations, risk assessment, standards used, test evidence, instructions and declarations, as applicable. Where a notified body is required, its identification number may accompany the CE marking as required by the applicable legislation.
Important concept: CE is not a single universal certificate. The applicable legislation and conformity assessment route determine what evidence and third-party involvement are required.
EX
ATEX Certification & Ex Equipment
Concept: ATEX 2014/34/EU concerns equipment and protective systems intended for use in potentially explosive atmospheres. The assessment focuses on preventing ignition hazards associated with the equipment and its intended operating conditions.
Procedure: Define product and intended use → identify hazardous-area conditions and applicable equipment group/category → identify ignition hazards and protection concept → select applicable EN/IEC 60079 standards → review design and materials → prepare drawings, calculations and technical documentation → perform required testing → assess conformity using the applicable ATEX procedure → prepare documentation and declarations → apply the required Ex and ATEX marking.
Marking: Depending on the product and protection concept, Ex marking communicates information such as equipment group/category or EPL, protection type, gas/dust designation, temperature class or maximum surface temperature, and other applicable information. Exact marking depends on the certified design and applicable standard.
Important concept: Hazardous-zone classification is used by the user/operator to select suitable equipment; the equipment certification route and marking must correspond to the product's intended use and protection characteristics.
PE
PED 2014/68/EU Compliance
Concept: PED 2014/68/EU applies to pressure equipment and assemblies within its scope. Classification determines the applicable conformity assessment requirements.
Procedure: Identify equipment type → determine maximum allowable pressure (PS), volume (V) or nominal size (DN), and temperature limits → identify the fluid and fluid group → determine the applicable PED category → select the applicable conformity assessment module → review design, materials, manufacturing, welding, inspection and testing → complete the required conformity assessment → prepare technical documentation and Declaration of Conformity → apply required marking.
Marking & documents: Pressure equipment marking and documentation depend on the PED route. Typical technical records may include drawings, design calculations, material certificates, welding qualifications, inspection/test reports, safety information, nameplate details and conformity documentation.
Important concept: PED classification is not based on pressure alone. Equipment type, fluid, pressure, volume or DN and fluid group are key inputs to determining the category and assessment route.
EA
EAC Certification & EAEU Market Access
Concept: EAC conformity assessment is associated with applicable Eurasian Economic Union (EAEU) Technical Regulations and is used for products entering the relevant EAEU markets.
Procedure: Identify the destination EAEU market and product → determine applicable Technical Regulations → identify whether certification or declaration is required → determine applicable standards/testing → prepare technical documentation → perform required testing and conformity assessment → issue the applicable certificate or declaration → complete EAC marking and other required market-access information.
Marking: The EAC mark identifies products that have completed the applicable EAEU conformity assessment requirements. The mark, documentation and accompanying information must follow the applicable Technical Regulation and conformity route.
Important concept: EAC is not one single regulation. The applicable EAEU Technical Regulation depends on the product and its characteristics, so the first step is always to establish the correct regulatory scope.
IX
IECEx Certification & Explosion Protection
Concept: IECEx is an international conformity assessment system for equipment, services and personnel associated with explosive atmospheres, using applicable IEC standards and scheme rules.
Procedure: Define equipment and intended Ex application → identify applicable IEC standards and protection concept → review design and technical documentation → conduct required testing → prepare the ExTR where applicable → assess the manufacturer's quality system/processes through the applicable IECEx route → issue the relevant IECEx certification documentation.
Marking & documents: Ex marking communicates the protection characteristics of the certified equipment. IECEx documentation can include an ExTR for test results and a QAR relating to the quality assessment requirements, depending on the certification route.
Important concept: IECEx certification and ATEX certification are related to explosion protection but are different conformity assessment systems. The applicable market and certification scheme determine which route is appropriate.
TD
Technical Documentation for Product Certification
Concept: Technical documentation is the evidence package demonstrating how a product has been designed, assessed and verified against the applicable regulatory and technical requirements.
Procedure: Define product scope → identify applicable legislation and standards → collect product specifications and drawings → document materials and components → perform risk assessment → prepare design calculations where applicable → compile test reports and certificates → prepare instructions and marking information → prepare declarations and other conformity records → maintain the technical documentation throughout the required retention period.
Typical contents: Product description, GA/engineering drawings, schematics, BOM, specifications, risk assessment, calculations, material certificates, component certificates, test reports, inspection records, user manual, nameplate/marking details, Declaration of Conformity and conformity assessment records, as applicable.
Important concept: There is no single universal technical-file format for every product. The required contents depend on the applicable legislation, standards, product type, conformity assessment procedure and certification scope.