What is CE Marking-Information

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    What is CE Marking (CE Mark)?

    CE Markingis the symbol as shown on the top of this page. The letters "CE" are theabbreviation of French phrase "Conformit Europene" which literaturely means "European

    Conformity". The term initially used was "EC Mark" and it was officially replaced by "CEMarking" in the Directive 93/68/EECin 1993. "CE Marking" is now used in all EU(European Union) official documents.The CE Mark is a visible declaration by the manufacturer (or his representative, importer,etc.) that the equipment, which is marked, complies with all the requirements of all theapplicable directives. CE mark ensured that the equipment does indeed meet all theserequirements (including all the administrative requirements involved in being able todemonstrate compliance).CE marking is similar to the UL or CSA marks of North America. However, unlike UL orCSA which require independent laboratory testing, the CE mark can be applied by the motormanufacturer through "self certifying" that its products are designed to the appropriate

    standards.The letters, "CE", indicate that the manufacturer has undertaken all assessment proceduresrequired for the product. The CE mark is not a quality mark and does not indicate conformityto a standard; rather, it indicates conformity to the legal requirements of the EU (EuropeanUnion) Directives.CE Marking on a product is a manufacturer's declaration that the product complies with theessential requirements of the relevant European health, safety and environmental protectionlegislations, in practice by many of the so-calledProduct Directives.*

    *Product Directives contains the "essential requirements" and/or "performance levels" and"Harmonized Standards" to which the products must conform. Harmonized Standards are the technicalspecifications (European Standards or Harmonization Documents), which are established by severalEuropean standards agencies (CEN, CENELEC, etc).

    CEN stands for European Committee for Standardization.CENELEC stands for European Committee for Electro technical Standardization.

    CE Marking on a product indicates to governmental officials that the product may be legallyplaced on the market in their country. CE Marking on a product ensures the free movementof the product within the EFTA (European Free Trade Association) & European Union(EU) single market (total 28 countries), and it also permits the withdrawal of the non-conforming products by customs and enforcement/vigilance authorities.

    In shortCE Markingis the "Trade Passport to Europe" for non-EU Products

    Why product need CE Marking?

    Why it is important?The "CE" mark is now mandatory for regulated products sold in the European Union. Thisapplies to prototypes and commercial freebies.

    CE marking is a mandatory European product marking and certification system.

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    The CE marking system promotes free trade to and within Europe by providing a single setof safety and environmental requirements a product must meetProducts complying with CE marking are now accepted and presumed to be safe in 28European countries.This is a market of 455 million people with a GNP over $9 trillion. CE marking isaccelerating as a globally accepted system for ensuring productsafety and environmentalrequirements are met.

    How does CE Marking affect the export to Europe?

    If the new product directives apply to your products and you want to continue to export to theEuropean market (or introduce new products), then CE Marking will be crucial to yoursuccess.

    It is NOT unusual nowadays that non-EU manufacturers and exporters have had their product(s) seized bycustoms officials in the European Union at the worst or returned to them because they do not have the CEmarking affixed to the product(s).

    How many countries are currently requiring products to bear CE Marking?

    Total 18 countries before May 1, 2004. These were the 15 European Union (EU) membercountries: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy,Luxemburg, the Netherlands, Portugal, Spain, Sweden and United Kingdom (Great Britain)plus the European Free Trade Association - EFTA's 3 member states: Iceland, Liechtensteinand Norway.

    From May 1 2004, on which 10 new member states joined the EU, the 10 new EU memberstates thus also adopt the CE-Marking requirements.

    Which type of products CE marking is required

    CE Marking is most probably required if you export to the 25 European Union (EU) and 3European Free Trade Association (EFTA) member states the following 22 groups of products-

    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 105gC. Forced draught burners and heating bodies to be equipped with such burners will also beconsidered as appliances.The "gaseous fuel" means any fuel which is in a gaseous state at a temperature of 15 gC under apressure of 1 bar.

    2. Cableway Installations to Carry PersonsThe "cableway installations designed to carry persons" shall mean installations made up of severalcomponents, designed, manufactured, assembled and put into service with the object of carryingpersons.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. .

    3. Low Voltage Electrical EquipmentThe "Electrical Equipment" means any equipment designed for use with a voltage rating of between 50and 1000 V for alternating current (A.C.) and between 75 and 1500 V for direct current (D.C.).

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    Therefore, it is called often "Low Voltage Electrical Equipment" which includes the vast majority ofelectrical equipment in everyday use.

    4. Construction ProductsThe "construction product" means any product which is produced for incorporation in a permanentmanner in construction works, including both buildings and civil engineering works.

    5. Equipment and Protective Systems for Used in Potentially Explosive

    Atmospheres (Atex)o Equipment means machines, apparatus, fixed or mobile devices, control components and

    instrumentation thereof and detection or prevention systems which, separately or jointly, areintended for the generation, transfer, storage, measurement, control and conversion of energyfor the processing of material and which are capable of causing an explosion through theirown potential sources of ignition.

    o 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 foruse as autonomous systems.

    o Components means any item essential to the safe functioning of equipment and protective

    systems but with no autonomous function. Explosive atmospheres Mixture with air, underatmospheric conditions, of flammable substances in the form of gases, vapours, mists or dustsin which, after ignition has occurred, combustion spreads to the entire unburned mixture.

    Potentially explosive atmosphere means an atmosphere, which could become explosive due to localand operational conditions. .

    6. Explosives for Civil UsesThe "Explosives" here shall mean the materials and articles considered to be such in the UnitedNations recommendations on the transport of dangerous goods and falling within Class 1 of thoserecommendations.

    7. Hot Water BoilersThe "hot-water boilers" here means a boiler fired by liquid or gaseous fuels with a rated output ofbetween 4 kW and 400 kW (including 4 kW and 400 kW).

    8. Household Refrigerators & Freezers

    9. LiftThe "lift" here means an appliance serving specific levels, having a car moving along guides which arerigid and inclined at an angle of more than 15 degrees to the horizontal and intended for the transportof:

    - 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.

    10. Machinerythe "machinery" means:o 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, inparticular for the processing, treatment, moving or packaging of a material,

    o an assembly of machines which, in order to achieve the same end, are arranged and controlled

    so that they function as an integral whole,o 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 orwith a tractor by the operator himself in so far as this equipment is not a spare part or a tool.

    11. Marine EquipmentThe "Marine Equipment" here means items listed in Directive 96/98/ec Annexes A.1 and A.2 which

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    must be placed on board a ship for use in order to comply with international instruments or arevoluntarily placed on board for use, and for which the approval of the flag State administration isrequired according to international instruments

    12. Medical DevicesA "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 forthe proper application, intended by the manufacturer to be used for human beings for the purpose of :

    o diagnosis, prevention, monitoring, treatment or alleviation of a disease, an injury or a

    handicap.

    o investigation, replacement or modification of the anatomy or of a physiological process.o control of conception

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

    13. Active Implantable Medical DevicesThe "active medical device" means any medical device relying for its functioning on a source ofelectrical energy or any source of power other than that directly generated by the human body orgravityThe "active implantable medical device" means any active medical device which is intended to betotally or partially introduced, surgically or medically, into the human body or by medical interventioninto a natural orifice, and which is intended to remain after the procedure.

    14. In Vitro Diagnostic Medical DevicesThe "in vitro diagnostic medical device" means any medical device which is a reagent, reagentproduct, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether usedalone or in combination, intended by the manufacturer to be used in vitro for the examination ofspecimens, including blood and tissue donations, derived from the human body, solely or principallyfor 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..

    15. Non-automatic Weighing InstrumentsA "Weighing Instrument" is defined as a measuring instrument serving to determine the mass of abody by using the action of gravity on that body. A weighing instrument may also serve to determineother mass-related magnitudes, quantities, parameters or characteristics.A "non-automatic weighing instrument" is defined as a weighing instrument requiring the interventionof an operator during weighing.

    16. Radio Equipment & Telecommunications Terminal Equipment (R&TTE)A "radio equipment" means a product, or relevant component thereof, capable of communication bymeans of the emission and/or reception of radio waves utilising the spectrum allocated toterrestrial/space radio communication.

    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 whatsoeverto interfaces of public telecommunications networks (that is to say, telecommunications networks usedwholly or partly for the provision of publicly available telecommunications services).

    17. Personal Protective Equipment (PPE)The "personal protective equipment" means any device or appliance designed to be worn or held by anindividual for protection against one or more health and safety hazards.

    18. Simple Pressure VesselsThe "simple pressure vessel" means any welded vessel subjected to an internal gauge pressure greaterthan 0,5 bar which is intended to contain air or nitrogen and which is not intended to be fired.

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    19. Pressure EquipmentThe "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 directattachments up to the coupling point connecting it to other equipment. A vessel may be composed ofmore than one chamber.'Piping` means piping components intended for the transport of fluids, when connected together forintegration 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 limitsbeing exceeded. Such devices include:

    - devices for direct pressure limitation, such as safety valves, bursting disc safety devices, bucklingrods, controlled safety pressure relief systems (CSPRS), and

    - limiting devices, which either activate the means for correction or provide for shutdown orshutdown 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-bearinghousings.'Assemblies` means several pieces of pressure equipment assembled by a manufacturer to constitute anintegrated and functional whole.

    20. Recreational CraftThe "Recreational craft" means any boat of any type, regardless of the means of propulsion, from 2,5to 24 m hull length, measured according to the appropriate harmonized standards intended for sportsand leisure purposes.

    21. ToysA "toy" shall mean any product or material designed or clearly intended for use in play by children ofless than 14 years of age.

    22. Trans-European Conventional Rail SystemThe "Trans-European Conventional Rail system" means the structure composed of lines and fixedinstallations, of the trans-European transport network, built or upgraded for conventional rail transportand combined rail transport, plus the rolling stock designed to travel on that infrastructure

    How to obtain CE Marking for the product?

    There are a series of steps outlined below. Depending upon your product and the nature ofthe risks it presents:

    Minimal Risk

    Options for products with minimal riskinclude self-certification where the manufacturerprepares Declaration of Conformity and affixes the CE Marking to their own product.

    Greater Risks

    Many directives require products/systems with greater risks to be independently certified;this must be done by a "Notified Body". This is an organization that has been nominated byMember Government and has been notified by the European Commission. Notified bodiesserve as independent test labs and perform the steps called out by directives. They musthave the necessary qualifications to meet the testing requirements set forth in the directives.Notified bodies may be a private sector organization or a government agency. Manufacturersmay choose a notified body in any member state of the European Union. Lists of notified

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    bodies are published by the European Commission in the Official Journal of the EuropeanCommunities.

    Essential requirements.

    - Legal representative in European union.- Compliance to relevant EN standard.- Technical & legal bindings on manufacturers and exporters.- Responsibility with manufacturer, if European.- Responsibility with importer / representative, if manufacturer is non-European.

    Routes to Conformity

    1. Voluntary Certification

    Self Certification ( EN standards only )

    Self Certification ( EN standards only ) withTechnical Construction File. ( T.C.F.)

    2. Mandatory Certification

    EC Type Examination & Production Q.A.EC Type Examination & Product Q.A.EC Design Verification ( Full Q.A.)

    1. Voluntary Certification

    Self- Certification &

    Self- Certification with Technical Construction File ( T.C.F.)

    1. Identify applicable directive(s).2. Identify applicable EN standard(s).3. Comply with tests and evaluations.4. Compile technical documentation.5. Draw EC Declaration of Conformity.6. Affix CE Mark.

    1. Identify applicable directive(s).

    Determine if any directives apply to your product. If more than one applies, you will have to

    comply with all of them. Determine the extent to which your product complies with theessential requirements for design and manufacturing in the applicable directive(s). i.e.Identify all applicable EU Directives (laws).

    2. Identify applicable EN standard(s).

    EN standards.

    Locate European harmonized standards (EN standards) available for your product to addressthe essential requirements listed in all applicable directives. In some cases, you will find that

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    EN standards have not been developed for your product. If so, you will have to identify otherstandards to use that effectively address the same concerns.

    - I E C ( International Electro technical Commission )

    - C I S P E R (International Special Committee on Radio Interference)

    - C E N ELEC. (European Committee for Electrotechnical Standardization)

    - European member countries adopt EN standards.

    Types of EN standards.

    - Basic Standards: - Define particular Phenomenon / simulation / test method.- Product family standards: - Cover a family of products.- Product specific standards: - Cover particular product.- Generic standards: - Applicable to products for which no product specific or product familystd. Exists.

    3. Comply with tests and evaluations.

    Testing of Product

    You may need arrange laboratory testing for your product to demonstrate compliance withthe essential requirements and standards.

    If the directives not required a Technical Documentation (Technical File) preparation by themanufacturer, in that case only test certificates are also sufficient for self-certification.

    - Directive does not call for testing but due diligence does.- All tests according to standards must for self Certification.- Partial testing T.C.F. (Technical Construction File)- Testing can be done in house or third party.- Demonstrable proof of Compliance (Test reports)

    4. Compile technical documentation.

    The directives require for many products that a Technical Documentation (Technical File) be prepared by the manufacturer. The Technical Documentation (Technical File) holdsinformation that verifies that the testing was conducted properly and that the productcomplies with applicable standards. We will have to develop a "technical file" in accordancewith all applicable directives that documents the application of all directives, essentialrequirements, standards and other relevant product safety information proving compliance.

    Technical file -

    - Describe the equipment to which it relates.- Contains information about the product and company.- Contains Test reports.- Contains Declaration of Conformity.- Must be kept within European union for at least 10 years after manufacture of theequipment.

    5. Draw EC Declaration of Conformity.

    - Declaration of Conformity (Title)

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    - Name & address of Company- Description of the apparatus- Directives Applied- Number and titles of standards applied- Declaration that the product confirms with the protective requirements of the directive- Signature of (or on behalf of) manufacturer or authorized representative- Date of Issue.Must be enclosed in manual / packaging.

    6. Affix CE Mark.

    Strict guidelines regarding the size and placing of the mark. These guidelines address the sizeand location of the Marking; affixing the CE Marking to products, packaging and material ordocuments shipped with the product; and specific limitations on when and who is permittedto affix the CE Marking.

    Letter consists of semicircles. The length of the center stroke in the E must be 80% of theradius of the semicircle. The size of the CE marking must be atleast 5 mm. The CE markingshould be affixed directly on the product or on a nameplate or packing and in the attachedtechnical documents. Affix the CE mark in accordance with the laws (the format of the CEmark and its proper location is described in Directive 93/44/EEC, dated 1 January 1997.)

    2. Mandatory Certification:

    A Notified Body is usually able to offer some of the services required:

    Product testing Type examination certificate issue Technical File and design dossier evaluation Surveillance of product and quality system Identification of standards

    If your products need to be certified by a Notified Body, then you will need to do as thefollows:

    Select the applicable product standards and test methods for your product and select aNotified Body.

    Steps for obtain CE Marking through NOTIFIED BODY

    1. Determine if any directives apply to your product. If more than one applies you will haveto comply with all of them. Determine the extent to which your product complies with the

    essential requirements for design and manufacturing in the applicable directive(s). i,e.Identify all applicable EU Directives (laws).

    2. Choose the conformity assessment procedure from the options(modules) called out bythe directive for your product. There are several modules available for theConformityAssessment Procedures as listed below:Module A: internal production control

    Module Aa: intervention of a Notified Body

    Module B: EC type-examination

    Module C: conformity to type

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    Module D: production quality assurance

    Module E: product quality assurance

    Module F: product verification

    Module G: unit verification

    Module H: full quality assurance

    Choose the appropriate conformity assessment module manufacturers declaration underModule A, or one of the other modules where the use of third parties is required.

    Determine the applicable standards, international, European or national.

    If required, choose a "competent body" in the U.S. to perform test on products (an updatedlist is maintained by the U.S. Department of Commerce).

    3. Establish an Authorized Representative in the European Union for your product.

    Some directives require that a manufacturer designate in the European Union an authorizedrepresentative to produce Technical Documentation (or sometimes called Technical File) in atimely fashion when called upon to do so. The CE Marking itself is not meant to providedetails about the product to Surveillance Authorities.

    If required, you will have to appoint an "authorized representative" in the EU. An authorizedrepresentative is an agent who holds your "technical file" and "declaration of conformity" inthe EU for at least 10 years after production of a product has ended. Surveillance authoritiesmay contact your authorized representative if any questions arise about the CE markingcompliance of your product.

    4. Technical Documentation (Technical File).The directives require for many products that a Technical Documentation (Technical File) beprepared by the manufacturer. The Technical Documentation (Technical File) holdsinformation that verifies that the testing was conducted properly and that the productcomplies with applicable standards.You will have to develop a "technical file" in accordance with all applicable directives thatdocuments the application of all directives, essential requirements, standards and otherrelevant product safety information proving compliance.

    5. Prepare a Declaration of Conformity.The Declaration of Conformity must contain information adequate for tracing the productback to the manufacturer or the authorized representative in the European Union. It mayinclude a list the directives and standards that your product conforms to, productidentification, the manufacturer's name, address and signature.

    6. Register your product in EU.

    Many products, for instance, Class I Medical Devices, are required to be registered in the EUand, if proved, get a Certificate of Registration. Without this Certificate of Registration, theproducts are NOT allowed to be affixed with the CE Marking and be placed on the market.

    7. Affix the CE Marking to your product.There are specific rules to adhere to for the CE Marking. These rules address the size andlocation of the Marking; affixing the CE Marking to products, packaging and material ordocuments shipped with the product; and specific limitations on when and who is permitted

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    to affix the CE Marking. Affix the CE mark in accordance with the laws (the format of theCE mark and its proper location is described in Directive 93/44/EEC, dated 1 January 1997.)

    What are directives?

    Directives are the mechanism by which European-wide legislation is enacted.Directives are issued from Brussels (after consultation and agreement by member states).These are then adopted by each state by the incorporation of corresponding legislation

    according to their own national legal framework.EC Directives are issued covering a whole host of matters, however of particular relevanceare certain Directives known as the 'New Approach Directives'. These are a set of Directiveswhich serve two primary purposes.Firstly, they ensure that all products which are covered by them are safe, by specifyingrequirements, (principally safety related) which the products must meet.Secondly, they provide a 'level playing field' for products within Europe, by the introductionof a single market. All products which meet all the requirements of the directives may befreely marketed anywhere within the European Economic Area without further approvalsbeing required.

    Brief Introduction of CE Marking Directive: 93/68/EEC

    COUNCIL DIRECTIVE 93/68/EEC of 22 July 1993THE COUNCIL OF THE EUROPEAN COMMUNITIES, has adopted this directive:

    Article 1

    The following Council Directives are hereby amended:1. 87/404/EEC of 25 June 1987 (simple pressure vessels) (7);2. 88/378/EEC of 3 May 1988 (safety of toys) (8);3. 89/106/EEC of 21 December 1988 (construction products) (9);4. 89/336/EEC of 3 May 1989 (electromagnetic compatibility) (10);5. 89/392/EEC of 14 June 1989 (machinery) (11);6. 89/686/EEC of 21 December 1989 (personal protective equipment) (12);7. 90/384/EEC of 20 June 1990 (non-automatic weighing instruments) (13);8. 90/385/EEC of 20 June 1990 (active implantable medical devices) (14);9. 90/396/EEC of 29 June 1990 (appliances burning gaseous fuels) (15);10. 91/263/EEC of 29 April 1991 (telecommunications terminal equipment, including the mutual recognition oftheir conformity) (16);11. 92/42/EEC of 21 May 1992 (efficiency requirements for new hot-water boilers fired with liquid or gaseousfuels) (17);12. 73/23/EEC of 19 February 1973 (electrical equipment designed for use within certain voltage limits) (18).

    From Article 2 to Article 13

    Detailed amendments were given, throughout from Article 2 to Article 13, to the 12 CouncilDirectives listed in Article 1. Amendments varied from Directive to Directive. But, ingeneral, the following basic points were included in the amendments to almost everyDirective:

    1. Throughout the text, the term EC markwas replaced by CE marking;2. Member States shall presume that products bearing the CE marking comply with all

    the provisions of this Directive, including the conformity assessment procedures;

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    3. (a) Where the products are subject to other Directives covering other aspects andwhich also provide for the affixing of the CE marking, the latter shall indicate that theproducts in question are also presumed to conform to the provisions of those otherDirectives.(b) However, where one or more of those Directives allow the manufacturer, during atransitional period, to choose which arrangements to apply, the CE marking shallindicate conformity only to the Directives applied by the manufacturer. In this case,particulars of the Directives applied, as published in the Official Journal of theEuropean Communities, must be given in the documents, notices or instructionsrequired by the Directives and accompanying such products;

    4. EC verification4.1 EC verification is the procedure whereby a manufacturer or his authorizedrepresentative established within the Community ensures and declares that theproducts are in conformity to the type described in the EC type-examinationcertificate or with the design and manufacturing schedule referred to in Annex IIsection 3 having received a certificate of adequacy;4.2 The manufacturer shall take all the necessary measures for the manufacturingprocess to ensure that the products conform to the type described in the EC type-examination certificate or to the design and manufacturing schedule referred to inAnnex II section 3. The manufacturer or his authorized representative establishedwithin the Community shall affix the CE marking to each product and draw up adeclaration of conformity;4.3 The approved body shall carry out the appropriate examinations and tests in orderto check the conformity of the products with the requirements of this Directive byexamination and testing of products;4.4 The manufacturer or his authorized representative must be able to supply onrequest the approved body's certificates of conformity;

    5. (a) where a Member State establishes that the CE marking has been affixed unduly,the manufacturer or his authorized representative established within the Communityshall be obliged to make the product conform as regards the provisions concerningthe CE marking and to end the infringement under the conditions imposed by the

    Member State;(b) where non-conformity continues, the Member State must take all appropriatemeasures to restrict or prohibit the placing on the market of the product in questionor to ensure that it is withdrawn from the market ;

    6. The CE conformity marking shall consist of the initials "CE " in the form shownbelow;

    7. If the CE marking is reduced or enlarged the proportions given in the above graduateddrawing must be respected.

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    - The various components of the CE marking must have substantially the samevertical dimension, which may not be less than 5 mm;

    8. The affixing of markings on the products which are likely to deceive third parties asto the meaning and form of the CE marking shall be prohibited. Any other markingmay be affixed to the products or the data plate provided that the visibility andlegibility of the CE marking is not thereby reduced;

    9. EC declaration of conformityThe EC declaration of conformity must contain certain elements;

    10. The manufacturer must establish the technical documentation and he or hisauthorized representative established within the Community must keep it onCommunity territory at the disposal ofthe relevant national authorities forinspection purposes for a certain period after the last product has been manufactured;Where neither the manufacturer nor his authorized representative is established withinthe Community, this obligation is the responsibility of the person who places theproducts on the Community market, e.g. the importer;

    11. Technical documentation must enable the conformity of the product to therequirements of this Directive to be assessed. It must, as far as relevant for suchassessment, cover the design, manufacture and operation of the product. It mustinclude certain information;

    Article 14

    1. 1. Member States shall adopt and publish the laws, regulations and administrativeprovisions necessary to comply with this Directive by 1 July 1994.They shall apply these provisions from 1 January 1995.2. Until 1 January 1997 Member States shall allow the placing on the market and thebringing into service of products which comply with the marking arrangements inforce before 1 January 1995.

    Benefits & Disadvantages:The CE Marking can be, at the same time, of both benefits and disadvantages

    Benefits:

    With this "passport" your products can easily gain access to the entire EuropeanUnion (EU) plus European Free Trade Association (EFTA) market.

    There will be only one set of laws and regulations for the entire marketplace whichguide the designing, manufacturing and labeling of products. The multiple andconflicting national restrictions on regulated products will be eliminated. Thus the CEMarking on your product will make your trade with EU countries cheaper and easier.

    Your product will be made safer for consumers and thus the damage claims andliability premiums will be reduced.

    Disadvantages:

    New product directives may exceed the current national laws and regulations. It maycost a manufacturer extra to modify the currently existed design and/or productionline in order to continue exporting to or gain access to this huge European market.

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    Extra costs in obtaining the product Certificate of Registration for CE Marking andany, if applicable, required testing certification.

    The European Union has issued 24 directives related to the CE mark. Three Directivesapply to electric motors.

    1. Low Voltage Directive

    The Low Voltage Directive (73/23/EEC) as amended 93/68/EEC

    The Electrical Equipment (Safety) Regulations 1994 (SI 1994/3260)

    DTI Guidance Notes on the Electrical Equipment, UK Regulations (ref. URN 00/598)

    The relevant Harmonised Standards listed on the following web-site address

    http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist.html

    The Electrical Equipment (Safety) Regulations (LVD) applies to all electrical equipmentdesigned for use with a voltage rating of between 50 and 1000 V AC and between 75 and1500 V DC. Plugs and Sockets are covered by separate legislation namely the Plugs and

    SocketsEtc. (Safety) Regulations 1994 (SI 1994 No. 1768). Broadly the scope of the LVDcovers consumer and capital goods designed to operate within those voltage limits, includingin particular electrical appliances, lighting equipment including ballasts, switch gear andcontrol gear, electric wiring, appliance couplers and cord sets, electrical installationequipment, etc. and electrical equipment intended for incorporation into other equipmentsuch as transformers and motors.The Directive covers all risks arising from the use of electrical equipment, including not justelectrical ones but also mechanical, chemical (such as, in particular, emission of aggressivesubstances), health aspects of noise and vibrations, and ergonomic aspects as far asergonomic requirements are necessary to protect against hazards in the sense of the Directive.The LVD lays down eleven safety objectives, which represent the essential requirements of

    this Directive.Products are presumed to conform to the safety objectives of the LVD where the equipmenthas been manufactured in accordance with a harmonised standard. Alternatively, themanufacturer may construct the product in conformity with the essential requirements (safetyobjectives) of the LVD, without applying harmonised, international or national standards. Insuch a case the product will not benefit from presumption of conformity and therefore themanufacturer must include in the technical documentation a description of the solutionsadopted to satisfy the safety aspects of the Directive.

    Before a product is placed on the market the following must happen:

    The manufacturer must put together a technical documentation which makes itpossible to assess whether the product complies with the directive

    The manufacturer or the authorised representative must draw up a declaration ofconformity.

    The manufacturer or the authorised representative must affix the CE marking

    LVD Services Offered

    Advice on the applicability and completeness of standards to products

    Testing to harmonised, international, national standards, or clients own specification.

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    Assessment for compliance with the LVD

    Assessment of the technical documentation

    A notified body report in accordance with article 11 of the LVD.

    2. Machinery Directive 89/392/EEC (Amended 98/37/EEC)

    On 14 June 1989 the Council of the European Communities adopted a Directive(89/392/EEC) requiring the approximation of the laws of the member states relating to

    machinery.The Machinery Directive has been implemented in the United Kingdom by the Supply ofMachinery (Safety) Regulations 1992 which came into force on 1 January 1993.The Second Amending Directive (93/44/EEC) was incorporated into the UK Regulations byStatutory Instrument 1994 No. 2063. The Third Amending Directive (98/37/EC) has not yetbeen incorporated into UK Regulation.BSI can offer services approving many products defined in Annex IV of the directive and canhelp manufacturers with testing and compliance needs for the whole range of productsdenfined in the directive.

    3. EMC Directive ( 89/336/EEC)Electromagnetic Compatibility (EMC) Directive 89/336/EEC as amended by 91/31/EEC and93/68/EEC.UK Regulations SI 1992/2372 as amended by SI 1994/3080 and SI 1995/3180

    Since January 1 1996, most electrical and electronic products to be placed on the market inthe EEA (European Economic Area) must comply to the following requirements as detailedin the EMC Directive:

    Products must be constructed so that they do not cause excessive electromagnetic

    interference and are not unduly affected by electromagnetic interference. Certain radio-transmitting equipment must be subjected to EC type examination by a notified body.

    This process will ultimately lead to affixing of a CE mark on the product when coupled withall other relevant requirements of applicable new approach directives.

    BSI Product Services is authorised as a Competent Body for the EMC Directive. With adedicated EMC facilityon site we are able to offer a complete EMC service across a broadrange of industries.

    The testing facility holds accreditation:

    UKAS and EMCTLA

    VCCI

    ACA and FCC

    Technical Service status for VCA

    BSI Product Services have dedicated EMC certification and testing staff to helpmanufacturers through the complexities of CE marking

    http://www.bsi-global.com/ProductTesting/EMC/index.xalterhttp://www.bsi-global.com/ProductTesting/EMC/index.xalterhttp://www.bsi-global.com/ProductTesting/EMC/index.xalter
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    Complete lists of CE marking-related European & International Standards

    The information contained in this summary list is a compilation of the references of standardswhich have been published in the Official Journal of the European Communities. Although

    the list is updated regularly, it may not be complete.

    No./Code of

    DirectiveTitle of Directive

    73/23/EEC Low voltage

    87/404/EEC Simple pressure vessels

    88/378/EEC Safety of toys

    89/336/EEC Electromagnetic compatibility

    89/686/EEC Personal protective equipment

    90/384/EEC Non-automatic weighing instruments

    90/385/EEC Active implantable medical devices

    90/396/EEC Appliances burning gaseous fuels

    93/15/EEC Explosives for civil uses

    93/42/EEC Medical devices

    94/9/ECEquipment and protective systems intended for use in potentiallyexplosive atmospheres

    94/25/EC Recreational craft

    95/16/EC Lifts

    96/48/EC Interoperability of the Trans-European high-speed rail system

    97/23/EC Pressure equipment

    98/37/EC Machinery

    98/79/EC In vitro diagnostic medical devices99/5/EC Radio and telecommunications terminal equipment

    CE Marking Publications Directives, Guidelines, Frameworks & Agreements

    Directive or

    GuidelineProducts or Title

    Mandatory

    from

    Version of

    Languages

    Type A: Basic Directives ( for all products)

    85/374/EEC Liability for Defective Products 30 Jul 1988 en/fr/pt/es/sv

    1999/34/EC Liability for Defective Products (amending) 10 May 1999 en/fr/pt/es/sv

    92/59/EEC General Products Safety 1 Jan 1997 en/fr/pt/es/sv

    2001/95/EC (new) General Products Safety Directive 1 Jan 2003 en/fr/pt/es/sv

    93/68/EEC "CE Marking" Directive 22 Jul 1993 en/fr/pt/es/sv

    93/465/EECConformity Assessment Procedures & CE

    Marking Rules22 Jul 1993 en/fr/pt/es/sv

    Guideline Guide to Implementation of directives based Pub. 2000 en

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    on new approach & global approach

    Type B: Generic Directives(take precedence over Type A)

    73/23/EECLow Voltage Electrical Equipment (LVD)

    1 Jan 1997 en/fr/pt/es/sv

    Framework2000&2001 Framework of implementation of

    LVD 73/23/eec (79pages)Pub. 2001 en

    GuidelineGuideline on Low Voltage Directive (LVD)

    73/23/EEC & Annex I, IIPub. Jul 1997 en

    89/336/EEC Electromagnetic Compatibility (EMC) 1 Jan 1996 en/fr/pt/es/sv

    GuidelineGuideline on Directive ofElectromagnetic

    Compatibility (EMC) 89/336/eecPub. 2001 en/fr/de

    Tech-AspectsTechnical-Aspects relating ElectromagneticCompatibility EMC 89/336/eec (150pages) Pub. 2001 en

    Frameworkframework of implementation of EMC

    Directive 89/336/EECPub. 2000 en

    2002/95/EC RoHS- Restriction of use of HazardousSubstances in Electrical and ElectronicEquipment

    - en/fr/pt/es/sv

    2002/96/ECWEEE- Waste from Electrical and Electronic

    Equipment- en/fr/pt/es/sv

    Type C: Product-Specific Directives(take precedence over Type A & B)

    87/404/EEC Simple Pressure Vessels 1 Jul 1992 en/fr/pt/es/sv

    88/378/EEC Toys 1 Jan 1990 en/fr/pt/es/sv

    GuidelineGuidance to 88/378/eec Toys (for Scooter &

    FloatingSeats)Pub. 2001 en

    89/106/EEC Construction Products 27 Jun 1991 en/fr/pt/es/sv

    GuidelineGuidance to Directive 89/106/eec:

    Construction ProductsPub. 2001 en

    89/686/EEC Personal Protective Equipment (PPE) 1 Jul 1995 en/fr/pt/es/sv

    UsefulFactsUseful Facts relating to Directive 89/686/eec

    PPE (143pages)Pub. 2001 en

    FrameworkFramework of implementation of (PPE)

    Directive 89/686/eec (13pages)Pub. 2001 en

    90/384/EECNon-automatic Weighing Instruments

    1 Jan 2003 en/fr/pt/es/sv

    90/396/EECAppliances Burning Gaseous Fuels

    (AppliGas)1 Jan 1996 en/fr/pt/es/sv

    FrameworkFramework of implementation of (AppliGas)

    Directive 90/396/eecPub. 2001 en

    92/42/EECEfficiency of (Liquid or Gaseous fueled) Hot

    Water Boilers1 Jan 1998 en/fr/pt/es/sv

    93/15/EEC Explosives for Civil Uses 1 Jan 2003 en/fr/pt/es/sv

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    93/42/EEC Medical Devices 14 Jun 1998 en/fr/pt/es/sv

    GuidelinesGuidelines for Classification of Medical

    DevicesPub. 2001 en

    Guideline

    Guideline relating to the demarcationbetween Directives 90/385/eec, 93/42/eec

    and 65/65/eec.

    Pub. 1998 en

    90/385/EEC Active Implantable Medical Devices 1 Jan 1995 en/fr/pt/es/sv

    98/79/EC In Vitro Diagnostic Medical Devices 7 Dec 2003 en/fr/pt/es/sv

    GuidelineGuideline on Medical Devices Vigilance

    SystemPub. 1998 en

    93/65/EECAir Traffic Management Equipment &

    Systems19 Jul 1994 en/fr/pt/es/sv

    94/9/ECEquipment used in Potentially Explosive

    Atmospheres (Atex)1 Jul 2003 en/fr/pt/es/sv

    FrameworkFramework of implementation of (Atex)

    Directive 94/9/ec, 7pagesPub. 2001 en

    Guideline Guideline on directive 94/9/ec (Atex) Pub. 2000 en

    94/25/EC Recreational Craft 16 Jun 1998 en/fr/pt/es/sv

    Guid&FrameGuidelines&Framework: directive 94/25/ec

    (RecCraft) (106pages)Pub. 2001 en

    95/16/EC Lifts 30 Jun 1999 en/fr/pt/es/sv

    96/48/ECTrans-European High-speed Rail System

    8 Oct 1996 en/fr/pt/es/sv

    96/57/ECEnergy Efficiency: Household Refrigerators

    & Freezers3 Sep 1999 en/fr/pt/es/sv

    96/98/EC Marine Equipment 1 Jan 1999 en/fr/pt/es/sv

    97/23/EC Pressure Equipment 29 May 2002 en/fr/pt/es/sv

    Framework2000&2001 Framework of implementation of

    Directive 97/23/ecPub. 2001 en

    1998/37/EC Machinery 1 Jan 1995 en/fr/pt/es/sv

    CommentsComments on Directive of Machinery

    98/37/ec (269pages)Pub. 2000 en

    UsefulFactsUseful Facts relating to Directive of

    Machinery 98/37/ec (266pages)Pub. 2001 en

    Proposal2001 Proposal to amend Directive 98/37/ec

    Machinery (106pages)Pub. 2001 en

    2000/14/ECNoise Emission in the environment by

    equipment for use outdoors (78pages)

    3 Jul 2000(entry into

    force)en/fr/pt/es/sv

    1999/5/ECRadio Equipment & Telecommunications

    Terminal Equipment (R&TTE)variable en/fr/pt/es/sv

    Guidelines Guidance to Directive 99/5/ec R&TTE, Pub. 2001 en

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    38pages

    Framework2001 Framework of implementation of

    99/5/ec R&TTEPub. 2001 en

    1999/36/ECTransportable Pressure Equipment Directive

    - en/fr/pt/es/sv

    2000/9/EC Cableway Installations to Carry Persons - en/fr/pt/es/sv

    AGREEMENTs on mutual recognition of conformity

    assessment between European Union and Other countries

    AgreementAgreement between EU and United States

    (173pages)Pub. 1999 en

    AgreementAgreement between EU and United States,

    amendation (24pages)Pub. 2000 en

    AgreementAgreement between EU and Canada

    (137pages)Pub. 1998 en

    Agreement Agreement between EU and Australia Pub. 1998 en

    AgreementAgreement between EU and New Zealand

    Pub. 1998 en

    Agreement Agreement between EU and Israel Pub. 1999 en

    AgreementAgreement between EU and Japan 2001

    proposalPub. 2001 EN

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