3.1.1 CE certification
The CE marking is a mandatory European marking for certain product groups which indicates conformity with the essential health and safety requirements set out in a number of EU directives (e.g. machinery -2006/42/EC [9], low voltage -2006/95/EC [10], gas appliances -90/396/EEC [11], ATEX equipment directive 94/9/EC [12]).
CE conformity marking concerns the design, manufacture, placing on the market and entry into service of a product. The CE marking must be affixed by the manufacturer or his agent established in the EC.
Depending on the directive concerned, certification is either through self-declaration or through examination and assessment by a notified body.
The manufacturer bears the ultimate responsibility for the conformity of the product. He has to issue a Declaration of Conformity which includes his identity, a list of EU directives he declares compliance with, a list of standards the product complies with, and a legally binding signature.
The basis of the conformity assessment is the Technical Construction File (also referred to in some directives as the technical file or the technical demonstration) which is a compilation of documents containing the product design and security measures that make it safe.
Prototype and demonstration units are not required to have CE marking.
A number of ‘Agreement of Mutual Recognition of Conformity Assessment’ between the EC and third countries (USA, Canada, Australia, Japan, New Zealand, and Israel) allows industries based in those countries to use local certification organisations accredited for the specific directive.
To assist fuel cell components manufacturers, relevant directives are listed in Table 2 below and a check list which can be used when seeking EC certification, together with further details as to the CE mark The Technical Construction File and the EC Declaration of Conformity have been included in Appendix A4.
Table 2 Relevant directives requiring compulsory CE marking
Directive | Applicable to.. | Comments |
90/396/EEC - Gas appliance directive [11] | Appliances burning gaseous fuels used for cooking, heating, hot water production, refrigeration, lighting or washing and having, where applicable, a normal water temperature not exceeding 105oC | Strictly only applicable to fuel cells where the primary function is heating, However, some principles on general health and safety considerations may still be useful. |
94/9/EC - ATEX equipment directive [12] | Equipment and protective systems intended for use in potentially explosive atmospheres | Hazardous area classification must be carried out to assess potential locations and likelihoods of an explosive atmosphere being present to ensure that any equipment cannot act as a source of ignition |
97/23/EC - Pressure Equipment Directive [13] | This directive applies to the design, manufacture and conformity assessment of pressure equipment with a maximum allowable pressure greater than 0,5 bar above atmospheric pressure for the maximum/minimum temperatures for which the equipment is designed for gases, liquids and vapours | The certification process by the Pressure Equipment Directive, both certification by the manufacturer and by a notified body, depends on a number of parameters fully described in the directive. These parameters include the hazards posed by the pressurised gas/liquid, the characteristics and dimensions of the equipment and its intended use |
2004/108/CE - Electromagnetic Compatibility Directive [14] | Equipment or combinations thereof made commercially available as a single functional unit, intended for the end user and liable to generate electromagnetic disturbance, or the performance of which is liable to be affected by such disturbance | The manufacturer shall perform an electromagnetic compatibility assessment of the apparatus, on the basis of the relevant phenomena, with a view to meeting the protection requirements set out in 3.1.5. The correct application of all the relevant harmonised standards whose references have been published in the Official Journal of the European Union shall be equivalent to the carrying out of the electromagnetic compatibility assessment |
2006/95/EC - Low Voltage Directive [10] | Electrical equipment designed for use with a voltage rating of between 50 and 1,000 V for alternating current and between 75 and 1,500 V for direct current | The electrical equipment should be so designed and manufactured as to ensure that protection against the hazards set out in 3.1.5 is assured, providing that the equipment is used in applications for which it was made and is adequately maintained |
2006/42/EC - Machinery Directive [9] | Machinery, interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, removable mechanical transmission devices, partly completed machinery | The manufacturer or his authorised representative should also ensure that a risk assessment is carried out for the machinery which he wishes to place on the market. For this purpose, he should determine which are the essential health and safety requirements applicable to his machinery and in respect of which he must take measures |
A list of useful standards associated with the various parts of a fuel cell system is given in Appendix A2.