HazLoc Essential Guides: Intertek Deeside Lane, Chester, CH1 6DD UK hazloc@intertek.com 01244 882590 www.intertek-hazloc.com
Introduction This white paper aims to clarify ATEX Technical Files. As a Notified Body, Intertek deals with the technical and legal aspects of the ATEX Directive on a day to day basis. Thanks to the experiences we ve had with our clients and by means of responding to their most frequently asked questions we have written this white paper and hope the following will help you to prepare your documents in a way that is clear, concise and as legally correct as possible. ATEX Directive, DoC and the Technical File ATEX Directive 94/9/EC The ATEX Directive applies to electrical and mechanical equipment and protective systems intended for use in potentially explosive atmospheres. It was adopted by the European Parliament and the Council in 1994 and came into force in Europe in 1996. The aim of directive 94/9/EC is to allow the free trade of ATEX equipment and protective systems within the EU by removing the need for separate testing and documentation for each member state It is mandatory for organisations in the EU to follow the directive to protect employees from explosion risk in areas with an explosive atmosphere. Equipment must meet three preconditions (to be certified): 1. Have its own effective source of ignition 2. Be intended for use in a potentially explosive atmosphere 3. Be used under normal atmospheric conditions The Directive applies to all equipment intended for use in explosive atmospheres, whether electrical or mechanical, including protective systems. Declaration of Conformity (DoC) The Declaration of Conformity (DoC) is self declared by the manufacturer. The DoC, accompanies the product during its placing on the market. Signing this document, the manufacturer declares to be the sole and ultimate person responsible for: The design and manufacture of the product in accordance with the Essential Health and Safety Requirements (EHSR) listed in the Directive www.intertek.com 1
Carrying out conformity assessment in accordance with the procedures described in the Directive The aim of the Technical File is enable conformity with the requirements of the Directive and supports DoC. The Technical File The Technical File contains documentation which meets specified criteria in accordance with the ATEX Directive. It contains the evidence that the equipment meets the requirements of the Directive and supports the DoC. A technical file is required for: A single piece of equipment A series of equipment An assembly Equipment is defined as, machines, apparatus, fixed or mobile devices, control components and instrumentation. The Technical File should give a full and correct specification of the explosion safety aspects of the equipment including any relevant test results. It should show the requirements of the relevant European Standards for the types of ignition protection concerned have been observed for the design and construction of the equipment together with Essential Health and Safety Requirements (EHSR s) of the Directive. A Technical File should include: Bill of Materials (material certificates necessary) General Assembly (GA) drawings (design and manufacturing drawings) A Key for drawings (all descriptions and explanations necessary for the understanding of drawings) Label drawing (name plate) Test results (test reports) All relevant assessment reports Ignition hazard assessment (BS EN 1127-1:2011) Description of the equipment Declaration of Conformity (DoC) Any certificates of previously certified components (assemblies) Installation, Operation and Maintenance manual (IOM) www.intertek.com 2
Extract from Clause 9.2 Information for use BS EN 134631:2009 All equipment shall be accompanied by instructions including at least the following particulars: a) A recapitulation of the information with which the equipment is marked, except for the serial number, together with any appropriate additional information to facilitate maintenance (e.g. address of the importer, repairer, etc.) b) Description of the intended use of the equipment c) A summary of the hazards identified and the preventive and/or protective measures used d) Instructions for safe use: I. All parts of the instructions relevant for explosion protection including for example procedures to be carried out before start up and during lifetime use to ensure the safe use of the equipment II. Putting into service III. Use IV. Assembling and dismantling V. Maintenance (Servicing and emergency repair) VI. Installation VII. Adjustment e) Where necessary, an indication of any special hazard arising from the use of the equipment e.g. danger areas in front of pressure-relief devices f) Where necessary training instructions g) Details which allow a decision to be taken beyond any doubt as to whether an item of equipment in a specific category can be used safely in the intended are under the expected operating conditions Note: This information is generated as a consequence of carrying out the ignition hazard assessment. Sometimes a manufacturer will be aware of ignition risks that come from the process, which cannot be controlled by the design of the equipment. In this case the manufacturer should inform the user that additional precautions will be needed. h) Pressure parameters, maximum surface temperatures and other limit values i) Where necessary, special conditions of use, including particulars of possible misuse which experience has shown might occur j) Where necessary, the essential characteristics of accessories which may be fitted to the equipment The instructions shall contain text, drawings and diagrams necessary for the putting into service, maintenance, inspection, checking of correct operation and, www.intertek.com 3
where appropriate, repair of the equipment, together with all useful instructions, in particular with regard to safety. The Technical File should be prepared by the manufacture; however, Intertek can assist where necessary. Requirements A Technical File should be prepared for all Categories of equipment. The Technical File can be used to support an application for an EC Type Examination Certificate or to support manufacturing internal processes. Technical Files for Category 2 non-electrical equipment needs to be submitted to a Notified Body for their storage for a period of 10 years after the piece of equipment is manufactured. (Chapter II, Article 8, Section 1. (b) (ii) of Directive 94/9/EC) Intertek operates an archive system for the storage of technical files whereby a manufacturer may lodge a technical file with the Notified body on remittance of a standard fee. An archive file number will be assigned to the technical file and it will be held at the disposal of the national authorities. No evaluation or inspection of the technical file will be undertaken unless specifically requested. www.intertek.com 4
The Technical File will be opened and a cursory check made to confirm that it contains an ATEX Technical File. No technical review will be carried out at this stage unless requested by the manufacturer. This is not a Notified Body activity. It is up to the manufacturer to decide on whether they want their technical file reviewed prior to storage. A benefit of having the Technical File reviewed is that the manufacturer can have confidence that the file contains sufficient information to support their DoC. Deficiencies where noted can be corrected before storage. How Intertek can help Intertek offers a Review and Lodge Service of the Technical File. This includes providing a GAP analysis report against the technical file and issuing a Certificate of Assessment and Lodging acknowledgment letter. Intertek offers market leading services from our knowledgeable team of hazardous locations testing engineers located in facilities around the world. Our experienced, global teams provide comprehensive services required in today s competitive market. Our service levels range from EC Type Examination (required only for Category 1, 2 electrical and internal combustion engines & M1) to storing your Technical Documentation (minimum requirement for Category 3 equipment). Intertek can offer manufacturers of Category 2 and Category 3 non-electrical equipment a service level appropriate to their needs, as a minimum we can provide; Ignition Hazard Assessment Technical File Storage Technical File Gap Analysis Testing to applicable standards Certification Body Services To understand our full capabilities and services for ATEX compliance reducing your costs and improving speed to market, please contact us. For more information on specific testing and certification information, please contact Intertek at +44 (0)1244 882590, emailhazloc@intertek.com or visit our website at www.intertek-hazloc.com. This publication is copyright Intertek and may not be reproduced or transmitted in any form in whole or in part without the prior written permission of Intertek. While due care has been taken during the preparation of this document, Intertek cannot be held responsible for the accuracy of the information herein or for any consequence arising from it. Clients are encouraged to seek Intertek s current advice on their specific needs before acting upon any of the content. www.intertek.com 5