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Tuesday, April 20, 2010

CE Marking FAQs

FAQs - CE marking

BSI - helping you through the CE marking process

CE marking

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Does Your Product Require CE Marking?

CE Marking is required if your customers are in located in certain countries and if they purchase certain types of products from you.

  1. Are your current or future customers in the following countries?
    1. Austria
    2. Belgium
    3. Denmark
    4. Finland
    5. France
    6. Germany
    7. Greece
    8. Ireland
    9. Italy
    10. Luxemburg
    11. Netherlands
    12. Portugal
    13. Spain
    14. Sweden
    15. United Kingdom (Great Britain)
    16. Malta
    17. Cyprus
    18. Iceland
    19. Liechtenstein
    20. Norway
    21. Estonia
    22. Latvia
    23. Lithuania
    24. Poland
    25. Czech Republic
    26. Slovakia
    27. Hungary
    28. Slovenia
    29. Bulgaria
    30. Romania
  2. Do you now, or will you in the future, ship to these customers the following types of products?
    • Toys-A "toy" shall mean any product or material designed or clearly intended for use in play by children of less than 14 years of age.
    • Construction Products-The "construction product" means any product which is produced for incorporation in a permanent manner in construction works, including both buildings and civil engineering works
    • Pressure Vessels-The "simple pressure vessel" means any welded vessel subjected to an internal gauge pressure greater than 0,5 bar which is intended to contain air or nitrogen and which is not intended to be fired.
    • Telecommunications
    • Medical Devices-A "Medical Device" is defined in Directive (93/42/EEC) as: any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to be used for human beings for the purpose of :

      • Diagnosis, prevention, monitoring, treatment or alleviation of a disease, an injury or a handicap
      • Investigation, replacement or modification of the anatomy or of a physiological process
      • Control of Conception
    • Machinery-The "Machinery" Means:

      • An assembly of linked parts or components, at least one of which moves, with the appropriate actuators, control and power circuits, etc., joined together for a specific application, in particular for the processing, treatment, moving or packaging of a material
      • An assembly of machines which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole
      • interchangeable equipment modifying the function of a machine, which is placed on the market for the purpose of being assembled with a machine or a series of different machines or with a tractor by the operator himself in so far as this equipment is not a spare part or a tool
    • Personal Protective Equipment-The "personal protective equipment" means any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards.
    • Satellite Station Equipment
    • Gas Appliances
    • Pressure Equipment-The "Pressure Equipment" means vessels, piping, safety accessories and pressure accessories.

      Where applicable, pressure equipment includes elements attached to pressurized parts, such as flanges, nozzles, couplings, supports, lifting lugs, etc.

      'Vessel` means a housing designed and built to contain fluids under pressure including its direct attachments up to the coupling point connecting it to other equipment. A vessel may be composed of more than one chamber.

      'Piping` means piping components intended for the transport of fluids, when connected together for integration into a pressure system. Piping includes in particular a pipe or system of pipes, tubing, fittings, expansion joints, hoses, or other pressure-bearing components as appropriate. Heat exchangers consisting of pipes for the purpose of cooling or heating air shall be considered as piping.

      'Safety accessories` means devices designed to protect pressure equipment against the allowable limits being exceeded. Such devices include:

      • Devices for direct pressure limitation, such as safety valves, bursting disc safety devices, buckling rods, controlled safety pressure relief systems (CSPRS)
      • Limiting devices, which either activate the means for correction or provide for shutdown or shutdown and lockout, such as pressure switches or temperature switches or fluid level switches and 'safety related measurement control and regulation (SRMCR)devices
      'Pressure accessories` means devices with an operational function and having pressure-bearing housings.

      'Assemblies` means several pieces of pressure equipment assembled by a manufacturer to constitute an integrated and functional whole
    • Appliances (other than gas)
    • Non-automatic weighing instruments
    • Recreational Craft-The "Recreational craft" means any boat of any type, regardless of the means of propulsion, from 2,5 to 24 m hull length, measured according to the appropriate harmonized standards intended for sports and leisure purposes.
    • Lift Machinery-The "lift" here means an appliance serving specific levels, having a car moving along guides which are rigid and inclined at an angle of more than 15 degrees to the horizontal and intended for the transport of:

      • Persons
      • Persons and Goods
      • Goods alone if the car is accessible, that is to say, a person may enter it without difficulty, and fitted with controls situated inside the car or within reach of a person inside
    • Equipment and Protective systems for explosive atmospheres-
      • Equipment means machines, apparatus, fixed or mobile devices, control components and instrumentation thereof and detection or prevention systems which, separately or jointly, are intended for the generation, transfer, storage, measurement, control and conversion of energy for the processing of material and which are capable of causing an explosion through their own potential sources of ignition
      • Protective systems means design units which are intended to halt incipient explosions immediately and/or to limit the effective range of explosion flames and explosion pressures. Protective systems may be integrated into equipment or separately placed on the market for use as autonomous systems
      • Components means any item essential to the safe functioning of equipment and protective systems but with no autonomous function. Explosive atmospheres Mixture with air, under atmospheric conditions, of flammable substances in the form of gases, vapours, mists or dusts in which, after ignition has occurred, combustion spreads to the entire unburned mixture
    • Non-Automatic Weighing equipment-
      • A "Weighing Instrument" is defined as a measuring instrument serving to determine the mass of a body by using the action of gravity on that body. A weighing instrument may also serve to determine other mass-related magnitudes, quantities, parameters or characteristics
      • A "non-automatic weighing instrument" is defined as a weighing instrument requiring the intervention of an operator during weighing
    • Measuring Instruments
    • In-Vitro Diagnostic Medical Devices-The "in vitro diagnostic medical device" means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information.
    • Marine Equipment-The "Marine Equipment" here means items listed in Directive 96/98/ec Annexes A.1 and A.2 which must be placed on board a ship for use in order to comply with international instruments or are voluntarily placed on board for use, and for which the approval of the flag State administration is required according to international instruments
    • Electrical products

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