Atex guidelines

-41-13. HARMONISED EUROPEAN STANDARDSDirective 94/9/EC provides manufacturers with the option of complying with its requirements bydesigning and manufacturing directly in accordance with the Essential Health and SafetyRequirements, or to harmonised standards which are developed specifically to allow a presumption ofconformity with those requirements. In other words, in the case of a challenge, the responsiblenational authorities will have to prove that the equipment is not in conformity with the EssentialHealth and Safety Requirements of the directive.The presumption of conformity is conferred, in regulatory terms, only by the use of the nationalstandards transposing a harmonised standard the reference of which is published in the OJEC. Wherethe relevant national standardisation body has not transposed the standard, use of the originalharmonised standard or of a transposed standard in another Member of the EU confers the samepresumption of conformity. However, such transposition must have taken place into the nationalstandards collection of at least one of the Member States of the European Community.Industry and many Notified Bodies are involved in the development of these standards and it is likelythat these standards will be the preferred option for demonstrating compliance once they becomeavailable.In the absence of harmonised standards, manufacturers may decide to use existing European, nationaland other technical standards and specifications regarded as important or relevant to cover therelevant essential requirements, together with additional controls addressing those other requirementsnot already covered. In view of the ongoing work still being carried out and the current availability ofstandards under directives 79/196/EEC and 82/130/EEC as amended it is recognised that this is also auseful route towards a presumption of conformity in the short-term.The Notified Bodies have internally agreed to consider the following documents when assessing theconformity of a product to the Essential Health and Safety Requirements. The order of preference isfrom 1 down to 10 (the highest ranking is 1!):1. Applicable harmonised standards2. CENELEC/CEN published 2nd edition3. Applicable EN standards 1st edition4. Final EN projects ex : EN 50014 pr A15. EN projects6. Applicable National standards (UK,D,Fr,It,..)7. Interface documents CLC/CEN (if any)8. Applicable ISO/IEC documents9. Local testing procedure from a NB10. Other available standards or part of standards (USA, Japan,...)13.1 Standards published in the Official JournalBy way of information, Annex 5 contains a reference list of Harmonised European Standards that areto be published in the EC's Official Journal.European standards are available from:- CEN, rue de Stassart, 36, 1050 Bruxelles;- CENELEC, rue de Stassart, 35, 1050 Brussels.