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Tuesday, April 20, 2010

CE Marking FAQs

CE Marking and notification

CE marking is a declaration by the manufacturer that the product is in conformity with all applicable EEA legislation and that all appropriate conformity assessment procedures have been completed. Consequently, Member States are not allowed to restrict the placing on the market and putting into service of CE marked products, unless there is evidence that CE marking has been erroneously or abusively affixed on these products.

CE marking can therefore be regarded as a sort of passport for Europe, although it should be noted that it also applies to products manufactured in and for Europe.

CE marking is not the same as certification, because it does not always involve a third party (Notified Body).

CE marking is also not a proof of conformity with European standards; it is a presumption of conformity with the European Directive(s).

Notification, when related to CE marking and European Directives, is when a country informs the European Commission and the other countries in Europe that a conformity assessment body (certification body, testing laboratory or inspection body) has been designated by them to carry out conformity assessment according to a specific Directive. Thus, notification is the responsibility of a country and not a responsibility of the European Commission or CEN.

Notification can be given for one or more Directives.

To find out which conformity assessment bodies have been notified (Notified Bodies) and for which Directive, visit the NANDO web site.

When a Directive provides for CE marking, the manufacturer is obliged to affix it on the product. When there is no Directive, CE marking is not allowed. So CE marking is not a voluntary option; either it is mandatory, or it is not permitted.

For all information about CE marking, notification and European Directives, go to the European Commission's dedicated web site.




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Who's going to enforce the requirement for CE Marking

Each member state of the European Union (EU) is bound by the
"General Product Safety Directive" to adopt laws, regulations and administrative provisions to ensure that products placed on the market are safe. Each country has its own way of handling enforcement.

Many have added staffs specifically to conduct spot checks against implemented directives and respond to complaints. Countries have also set in place a combination of Return-to-Origin procedures, financial penalties, etc.
EU legislations make EU importers liable for the products they import, including the machinery they provide to their employees for work. Many non-EU exporters are finding that no matter how interested a prospective EU importer may be in the product, the importer will NOT risk importing non-conforming products (i.e. the products without CE Marking) which, in case of accident, may generate legal action against them.



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Does my Product need CE Marking?

The CE Marking is a mandatory European marking for certain products group in conformance with the CE Directives. These CE Marking can be regarded as the product trade passage for Europe and many other countries worldwide who also accept and follow to CE Mark requirements.

List of Products need CE Marking:-

  1. Appliances Burning Gaseous Fuels (AppliGas)
    The "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 105 gC. Forced draught burners and heating bodies to be equipped with such burners will also be considered as appliances. The "gaseous fuel" means any fuel which is in a gaseous state at a temperature of 15 gC under a pressure of 1 bar.
    Read More..?

  2. Cableway Installations to Carry Persons
    The "cableway installations designed to carry persons" shall mean installations made up of several components, designed, manufactured, assembled and put into service with the object of carrying persons. These on-site installations are used for the carriage of persons in vehicles or by towing devices, whereby the suspension and/or traction is provided by cables positioned along the line of travel.
    Read More..?

  3. Low Voltage Electrical Equipment
    The "Electrical Equipment" means any equipment designed for use with a voltage rating of between
    50 and 1000 V for alternating current (A.C.) and between 75 and 1500 V for direct current (D.C.). Therefore, it is called often "Low Voltage Electrical Equipment" which includes the vast majority of electrical equipment in everyday use. Read More..?

  4. 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.
    Read More..?

  5. Equipment and Protective Systems for Used in Potentially Explosive Atmospheres (Atex)
    • 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.
    Potentially explosive atmosphere means an atmosphere which could become explosive due to local and operational conditions. Read More..?

  6. Explosives for Civil Uses
    The "Explosives" here shall mean the materials and articles considered to be such in the
    United Nations recommendations on the transport of dangerous goods and falling within Class 1 of those recommendations. Read More..?

  7. Hot Water Boilers
    The "hot-water boilers" here means a boiler fired by liquid or gaseous fuels with a rated output of between
    4 kW and 400 kW (including 4 kW and 400 kW). Read More..?

  8. Lift
    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. Read More..?

    • 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. Read More..?

      • Measuring Instruments
        the "measuring instrument" means: any device or system with a measurement function that is covered by Articles 1 and 3;
        Read More..?

      • 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
          and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted by such means.
          Read More..?

        • Active Implantable Medical Devices
          The "active medical device" means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity.
          The "active implantable medical device" means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure.
          Read More..?

        • 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:
          • concerning a physiological or pathological state, or
          • concerning a congenital abnormality, or
          • to determine the safety and compatibility with potential recipients, or
          • to monitor therapeutic measures. Read More..?

          • Non-automatic Weighing Instruments
            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.
            Read More..?

          • Radio Equipment & Telecommunications Terminal Equipment (R&TTE)
            A "radio equipment" means a product, or relevant component thereof, capable of communication by means of the emission and/or reception of radio waves utilising the spectrum allocated to terrestrial/space radiocommunication.
            A "telecommunications terminal equipment" means a product enabling communication or a relevant component thereof which is intended to be connected directly or indirectly by any means whatsoever to interfaces of public telecommunications networks (that is to say, telecommunications networks used wholly or partly for the provision of publicly available telecommunications services).
            Read More..?

          • Personal Protective Equipment (PPE)
            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.
            Read More..?

          • Simple 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.
            Read More..?

          • 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), and
            • 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.
              Read More..?

            • 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. Read More..?

            • 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.
              Read More..?



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              1 comment:

              Unknown said...

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