The CE mark is a mandatory European marking for certain product groups to indicate conformity with the essential health and safety requirements set out in European Directives. The letters 'CE' are an abbreviation of Conformité Européenne, French word for European conformity. The CE mark must be affixed to a product if it falls under the scope of 'New Approach' Directives of European union. Without the CE marking, and thus without complying with the provisions of the Directives, the product may not be placed in the market or put into service in the fifteen member states of the European Union and Norway, Iceland and Liechtenstein. However, if the product meets the provisions of the applicable European Directives, and the CE mark is affixed to a product, these countries may not prohibit, restrict or impede the placing in the market or putting into service of the product. The CE Mark is compulsory within the context of the application of EC New Approach Directives. Thus, CE marking can, be regarded as the product’s ‘trade passport’ for Europe. Notified bodies are recognized organizations within Member States, which can certify conformity assessment on the basis of the New Approach Directives. KEY DIRECTIVES Machinery Safety - 98/37/EEC All Machines in the European Economic Area (EEA) from January 1st 1995 must comply with the Machinery Directive and be safe. Also all components which are supplied separately to fulfill a safety function when in use and the failure or malfunctioning of which endangers the safety or health of exposed persons. EMC - 2004/108/EC The EMC Directive applies to apparatus liable to cause electromagnetic disturbance or the performance of which is liable to be affected by such disturbance. Low Voltage Equipment – 2006/95/EC The Low Voltage Directive applies to all electrical equipment designed for use with a voltage rating between 50 and 1,000v for alternating current and between 75V and 1,500V for direct current. These voltage criteria define the scope of the directive rather than the limit at which you start applying the regulations (e.g. hazards in 12Vdc circuits of a 240Vac supplied computer are covered under the LVD). Pressure Equipment – 97/23/EC This directive covers equipments which affects equipment operating at a pressure greater than 0.5 bars, entered into force and is mandatory from May 2002. Medical Devices General - 93/42/EEC All medical products marketed in European Union must carry the CE Marking under Medical Device directive. There are essential requirements in the MDD (such as safety, efficacy and EMC), and products must meet all applicable requirements. Construction Products Directive – 89/106/EEC Construction Product means any products, which is produced for incorporation in a permanent manner in construction works, including both building and civil engineering works.
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