Assemblies, Skids and Machinery European Conformity Assessment Requirements under the ATEX 94/9/EC & Machinery 2006/42/EC Directives
Intertek Deeside Lane, Chester, CH1 6DD UK
[email protected] 01244 882590 www.intertek-hazloc.com
Assemblies, Skids and Machinery European Conformity Assessment
Introduction Manufacturers and assemblers of machinery, skid packaged units, complex electromechanical assemblies and similar are often requested by end-users to supply “certified” apparatus. This misnomer may lead to contractual and legal difficulties in the execution of the order and delivery, leaving the supplier out of pocket due to unforeseen expenses. This paper intends to give a lead in to the actual legal requirements under the ATEX and Machinery Directives for such equipment, thus giving the supplier a stronger position at the specification stage of such contracts. This paper also gives guidance on the technical aspects of the conformity assessment process and what to look out for in the assessment process.
Approved? Certified? Compliant with the Directive? When a client asks for Certified Equipment, what do they actually mean? •
An ‘Approved’ product is usually a product that is being produced in quantity that has been fully and successfully tested against the Product Standards that govern that product type, the factory where it is made has been checked and is regularly re-checked and the Approving Body who also conduct product surveillance to check the product being made at anytime during the run is the same as the product that was originally tested. This type of product usually carries an Approval Mark.
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A ‘Certified product, typically has been the subject of one or more successful type tests, but may not necessarily comply with ever aspect of the Standard that governs that product type. There is no product surveillance or factory inspection carried out and the product does not typically carry any type of Marking. – this is often used for small production runs and custom made equipment.
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A product compliant with the Directive isn’t necessarily even certified against all or part of a Standard. It can be said to be compliant as long as it meets all of the requirements of the Directive, but typically manufacturers demonstrate compliance with a Directive through testing and certification. As Rigs, Skids and Assemblies are usually created on an individual basis, compliance with the Directives that relate to them is primarily met with review and analysis and sometimes with specific testing.
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Assemblies, Skids and Machinery European Conformity Assessment
What is an assembly under the ATEX Directive? From the term 'jointly' in the definition of equipment in the Directive it follows that an assembly, formed by combining two or more pieces of equipment, together with components if necessary, has to be considered as a product falling under the scope of Directive 94/9/EC (see footnote 1, Notes), provided that this assembly is placed on the market and/or put into service by a responsible person (who will then be the manufacturer of that assembly) as a single functional unit. (3. General concepts [1] 3.7.5)
What is an assembly under the Machinery Directive? An assembly is equipment, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application. (Article 2 Definitions (a))
For the ATEX Directive what is the conformity assessment process? All assemblies and all parts of it shall be subjected to a documented hazard analysis. This assessment shall be made to determine which possible ignition sources arise in the assembly under consideration, and are therefore equipment related ignition sources and whether these may be potential ignition sources. The assessment shall also list the measures to be applied to prevent potential ignition sources becoming effective. All ignition sources identified in EN1127 are to be considered. Please refer to the following documents: • EN 1127-1: Explosive Atmospheres – Basic concepts & protection • EN1127 Clause 5 (Elements of risk assessment) states: “This risk assessment shall always be carried out for each individual situation in accordance with EN ISO 14121” Note: EN ISO 14121-1: Safety of Machinery Risk Assessment has now been replaced by ISO 12100:2010 Safety of Machinery
For the Machinery Directive what is the conformity assessment process? The manufacturer of machinery or his authorised representative must ensure that a risk assessment is carried out in order to determine the health and safety requirements which apply to the machinery. The machinery must then be designed and constructed taking into account the results of the risk assessment. ISO 12100:2010 specifies basic terminology, principles and a methodology for achieving safety in the design of machinery. It specifies principles of risk assessment and risk reduction to help designers in achieving this objective. These www.intertek.com
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Assemblies, Skids and Machinery European Conformity Assessment
principles are based on knowledge and experience of the design, use, incidents, accidents and risks associated with machinery.
ISO 12100:2010 Safety of Machinery Process Flow:
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Assemblies, Skids and Machinery European Conformity Assessment
Conformity Assessment hazard examples: •
ATEX Hot Surface - If an explosive atmosphere comes into contact with a heated surface, ignition can occur. The capability of a heated surface to cause ignition depends on the type and concentration of the particular substance in the mixture with air. (EN 1127-1-2007 Determining the presence of effective ignition sources 5.3.2)
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Machinery Hot Surface - Steps must be taken to eliminate any risk of injury arising from contact with or proximity to machinery parts or materials at high or very low temperatures. The necessary steps must also be taken to avoid or protect against the risk of hot or very cold material being ejected. (1.5 Risks Due to Other Hazards, 1.5.5)
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ATEX Flames & Hot Gases – Flames are associated with combustion reactions at temperatures of more 1000°C. Hot gases are produced as a reaction product and, in the case of dusty and/or sooty flames, glowing solid particles are also produced. (EN 1127-1-2007 Determining the presence of effective ignition sources 5.3.3)
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Machinery Flames & Hot Gases – Machinery must be designed and constructed in such a way as to avoid any risk of fire or overheating posed by the machinery itself or by gases, liquids, dust, vapours or other substances produced or used by the machinery. (1.5 Risks Due to Other Hazards, 1.5.6)
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ATEX Mechanical Sparks - As a result of friction, impact or abrasion processes such as grinding, particles can become separated from solid materials and become hot owing to the energy used in the separation process. (EN 1127-1-2007 Determining the presence of effective ignition sources 5.3.4)
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Machinery Mechanical Sparks - Machinery must be designed and constructed in such a way that risks of inhalation, ingestion, contact with the skin, eyes and mucous membranes and penetration through the skin of hazardous materials and substances which it produces can be avoided. (1.5 Risks Due to Other Hazards, 1.5.1.3)
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ATEX Electrical Apparatus - In the case of electrical apparatus, electric sparks and hot surfaces can occur as sources of ignition. Electric sparks can be generated when electric circuits are opened and closed, loose connections & stray currents. (EN 1127-1-2007 Determining the presence of effective ignition sources 5.3.5)
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Assemblies, Skids and Machinery European Conformity Assessment
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Machinery Electrical Apparatus - Where machinery has an electricity supply, it must be designed, constructed and equipped in such a way that all hazards of an electrical nature are or can be prevented. (1.5 Risks Due to Other Hazards, 1.5.)
Declaration of Conformity Do I need to issue a Declaration of Conformity for assemblies? The Declaration of Conformity and translations thereof must be drawn up under the same conditions as the instructions (see Annex I, section 1.7.4.1(a) and (b)), and must be typewritten or else handwritten in capital letters. The Declaration of Conformity relates exclusively to the machinery in the state in which it was placed on the market, and excludes components which are added and/or operations carried out subsequently by the final user.
Who should sign-off the Declaration of Conformity for assemblies? The signatory must be empowered to enter into commitments on behalf of the manufacturer or his authorised representative established within the Community. In making a Declaration of Conformity, the signatory makes himself personally liable for the conformity of the product and as such is subject to any legal penalties that’s are issued if it is found to be non-compliant – or even dangerous – including fines and even imprisonment.
Can I get help with ensuring my rigs, skids and assemblies are compliant? Yes, your partner test and certification body will be able to provide you with advice and guidance as to what is required for individual systems, and typically will be able to conduct Risk/Hazard Assessments for you.
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Assemblies, Skids and Machinery European Conformity Assessment
Conclusion The conformity assessment process should be followed in all cases as advised in the relevant EU Directive and should include the appropriate risk/hazard analysis using the applying the right terminology, principles and a methodology and a Declaration of Conformity. With reference to the Machinery and ATEX Directives the conformity assessment process can be conducted in parallel the advantages of this are: • • • •
Early identification of hazards improving machine safety Significant reduction in time, resulting in reduced certification costs Greater acceptance within the market place by end users Easily implemented into users risk assessments.
Speak to your partner test and certification body for assistance with dual assessment for multiple product Directives.
How Intertek can help? This paper is not intended as an exhaustive guide on conformity assessment for rigs, skids, assemblies and machines under the ATEX and Machinery Directives, but rather as an aide to understanding the process better - to arm the manufacturer/assembler with useful, practical knowledge that may lead to further study to conduct such assessments, or to be suitably informed with the right documents, data and information should the task seem too cumbersome for the manufacturer to conduct. Intertek is a Notified Body under the ATEX, Machinery, EMC, RTTE, LVD and other such Directives and offer compliance services for entry to global markets with respected marks such as ETL, ASTA, BEAB. Our team have particular experience in assessing products for industrial and potentially explosive environments and a wide portfolio of System Certification Accreditations, which we can leverage to help your products comply with the ATEX and Machinery Directives. Should you require assistance to conduct conformity assessment work, or need help to gain new market access, then please contact Intertek, who will gladly help to find a way past any barriers to market access.
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Assemblies, Skids and Machinery European Conformity Assessment
Contacts Technical
Sales
Roger D Jones
[email protected]
Asif Akbar
[email protected]
Intertek, Deeside Lane, Chester, Flintshire, CH1 6DD, UK Telephone: +44 (0)1244 882590
For more information on specific testing and certification information, please contact Intertek at 1-800-WORLDLAB, email
[email protected], 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.
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