We provide a range of hazardous area services to help to comply with the appropriate equipment conformity assessment procedure based on Standards IEC EN 60079 / IEC ISO EN 80079 series and other EN harmonized standards listed under Union Legislation Framework known as ATEX 2014/34/EU Directive.
Our Services on equipment and installation explosion protection, that we call as “Engineering of Compliance”, include mainly assistance on pre-compliance auditing and consulting in the following area:
- ATEX 2014/34/EU Conformity Assessment Dossier, based on EHSR, as Pre-Compliance Product Assessment.
- Gap-analysis on update of EN standards for already approved Ex-product
- Risk Assessment based on ATEX Directive
- Compliance and Auditing Activities on design, selection, erection of Installation in Explosive Atmosphere
- Ex-Quality Management Systems
- IECEx Pre-Compliance Auditing according to the International Electrotechnical Commission Ex System of Certification.
Pre-Compliance Product Assessment
Technical assistance to the product conformity design to ensure it would comply with the ATEX 2014/34/EU Directive (EN Standards and IEC / ISO Standards). We have more than 40 years of experience in the product conformity assessment and design of equipment for explosive atmospheres, mainly Instrumentation, Luminaries, Installation equipment and components.
Our team of competencies guarantee the comprehension of the product characteristics, of the market/standards and user expectation, and help in developing a Conformity Plan by a detailed pre-compliance assessment against the Harmonised Standards and the Essential Health and Safety Requirements of the ATEX 2014/34/EU Directive. The Pre-Compliance Service is fundamental for the initial design stage of equipment and for the relative certification steps.
Gap-analysis
Has been establish by the ATEX Guidelines 1st Edition April 2016, that is the responsibility of the manufacturer, owner of the current EC-Type Examination, to determine whether or not changes in the “state of the art” reflected in revisions of harmonized standards apply to his equipment.
Perform a review of the significant changes of the EN IEC standards as to whether or not changes in the “state of the art” are relevant, has to be taken and we support the manufacturer in review these changes.
Such service is effective even in case of self-declaration of compliance to 2014/34/EU Directive, based on the Technical File (Documentation), when there is a change in the “state of the art”.
Risk Assessment (Ignition Hazard Assessment)
Manufacturers, either when they lodge an application for EU-type examination or they self-declare compliance to the 2014/34/EU Directive, they have to establish the technical documentation, which shall include an adequate analysis and assessment of the risk(s). We offer technical assistance to establish such technical documentation including the risk(s) assessment.
Compliance and Auditing activity on design, selection, erection of Installation in Explosive Atmosphere
Where is necessary to ensure that any installation complies with the relevant equipment certificate as well as with IEC EN 60079-14 standard and any other requirements specific to the plant on which the installation takes place, a verification dossier (as defined in clause 3.1.2 and 4.2 of IEC EN 60079-14) shall be prepared for every installation and shall be either kept on the premises or stored in another location, and proper Documentation relevant to the SITE, EQUIPMENT and INSTALLATION as well.
In order to compile and establish the verification dossier, Engineering & Compliance support customers and in performing the Initial Inspection, when on completion of the erection and prior to first use. Inspection of the equipment and installation shall be carried out based on the “detailed” grade of inspection (see IEC 60079-17).
Ex-Quality Management Systems
Support Organization in establishing, document, audit and maintain a QMS to manufacture Ex equipment (either electrical or non-electrical) based on ISO IEC EN 80079-34 (which supplement ISO 9001) as well as performing pre-compliance audits according the Annex IV, V, VI and VII of the ATEX Directive 2014/34/EU.
Pre-Compliance auditing based on International Electrotechnical Commission System of Certification IECEx
Support Organization to achieve compliance of Equipment (electrical and non electrical) to the IECEx System. Information related to the IECEx system are available at www.iecex.com. Objective of the IECEx System facilitate international trade for equipment, installation and services for use in explosive atmospheres.