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CE Marking is the symbol as shown on the top of this page. The letters "CE" are the abbreviation of French phrase "Conformité Européene" which literaturely means "European Conformity". The term initially used was "EC Mark" and it was officially replaced by "CE Marking" in the Directive 93/68/EEC in 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 the applicable directives. CE mark ensured that the equipment does indeed meet all these requirements (including all the administrative requirements involved in being able to demonstrate compliance). CE marking is similar to the UL or CSA marks of North America. However, unlike UL or CSA which require independent laboratory testing, the CE mark can be applied by the motor manufacturer through "self certifying" that its products are designed to the appropriate standards. The letters, "CE", indicate that the manufacturer has undertaken all assessment procedures required for the product. The CE mark is not a quality mark and does not indicate conformity to a standard; rather, it indicates conformity to the legal requirements of the EU (European Union) Directives. CE Marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislations, in practice by many of the so-called Product Directives.*
*Product Directives contains the "essential requirements" and/or "performance levels" and "Harmonized Standards" to which the products must conform. Harmonized Standards are the technical specifications (European Standards or Harmonization Documents), which are established by several European 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 legally placed on the market in their country. CE Marking on a product ensures the free movement of 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 nonconforming products by customs and enforcement/vigilance authorities. In short CE Marking is 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. This applies to prototypes and commercial freebies. CE marking is a mandatory European product marking and certification system.
heating. These were the 15 European Union (EU) member countries: Austria. Belgium. refrigeration. whereby the suspension and/or traction is provided by cables positioned along the line of travel. Cableway Installations to Carry Persons The "cableway installations designed to carry persons" shall mean installations made up of several components. It is NOT unusual nowadays that non-EU manufacturers and exporters have had their product(s) seized by customs officials in the European Union at the worst or returned to them because they do not have the CE marking affixed to the product(s). Spain. Liechtenstein and Norway. .EFTA's 3 member states: Iceland. Finland. The "gaseous fuel" means any fuel which is in a gaseous state at a temperature of 15 gC under a pressure of 1 bar.C. on which 10 new member states joined the EU. then CE Marking will be crucial to your success. Sweden and United Kingdom (Great Britain) plus the European Free Trade Association . manufactured.).The CE marking system promotes free trade to and within Europe by providing a single set of safety and environmental requirements a product must meet Products complying with CE marking are now accepted and presumed to be safe in 28 European countries. the 10 new EU member states thus also adopt the CE-Marking requirements. a normal water temperature not exceeding 105 gC. This is a market of 455 million people with a GNP over $9 trillion. Ireland. Denmark. Italy. How many countries are currently requiring products to bear CE Marking? Total 18 countries before May 1. assembled and put into service with the object of carrying persons. Forced draught burners and heating bodies to be equipped with such burners will also be considered as appliances. Luxemburg. Appliances Burning Gaseous Fuels (AppliGas) The "appliances burning gaseous fuels" used for cooking. 2. These on-site installations are used for the carriage of persons in vehicles or by towing devices. where applicable. Germany. France.C. designed. From May 1 2004. 3.) and between 75 and 1500 V for direct current (D. Portugal. 2004. Greece. hot water production. 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. the Netherlands. CE marking is accelerating as a globally accepted system for ensuring product safety and environmental requirements are met. lighting or washing and having. 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 the European market (or introduce new products). Which type of products CE marking is required CE Marking is most probably required if you export to the 25 European Union (EU) and 3 European Free Trade Association (EFTA) member states the following 22 groups of products 1. .
of flammable substances in the form of gases. 10. . Explosive atmospheres Mixture with air. are arranged and controlled so that they function as an integral whole. 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. storage. vapours.persons. are intended for the generation. it is called often "Low Voltage Electrical Equipment" which includes the vast majority of electrical equipment in everyday use. a person may enter it without difficulty.goods alone if the car is accessible. apparatus. 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). Household Refrigerators & Freezers 9. 7. 8. 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. etc. in particular for the processing. after ignition has occurred. mists or dusts in which. control components and instrumentation thereof and detection or prevention systems which. control and power circuits. combustion spreads to the entire unburned mixture. which could become explosive due to local and operational conditions. transfer. . o o Potentially explosive atmosphere means an atmosphere.1 and A. 6. measurement. joined together for a specific application. treatment.Therefore. Marine Equipment The "Marine Equipment" here means items listed in Directive 96/98/ec Annexes A.2 which . and fitted with controls situated inside the car or within reach of a person inside. 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. . separately or jointly.. with the appropriate actuators. Components means any item essential to the safe functioning of equipment and protective systems but with no autonomous function. that is to say. 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. fixed or mobile devices. Construction Products The "construction product" means any product which is produced for incorporation in a permanent manner in construction works. Machinery the "machinery" means: o an assembly of linked parts or components. 5. including both buildings and civil engineering works. o interchangeable equipment modifying the function of a machine.persons and goods. Lift The "lift" here means an appliance serving specific levels. in order to achieve the same end. Equipment and Protective Systems for Used in Potentially Explosive Atmospheres (Atex) o Equipment means machines. o an assembly of machines which. 11. under atmospheric conditions. moving or packaging of a material. 4. at least one of which moves. 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: . Protective systems may be integrated into equipment or separately placed on the market for use as autonomous systems.
but which may be assisted by such means.to determine the safety and compatibility with potential recipients. 13. 18. or system. kit. Radio Equipment & Telecommunications Terminal Equipment (R&TTE) A "radio equipment" means a product. derived from the human body. immunological or metabolic means. Simple Pressure Vessels The "simple pressure vessel" means any welded vessel subjected to an internal gauge pressure greater than 0. 15.to monitor therapeutic measures. replacement or modification of the anatomy or of a physiological process. including the software necessary for the proper application. apparatus. equipment. or . 16. monitoring. A "non-automatic weighing instrument" is defined as a weighing instrument requiring the intervention of an operator during weighing. prevention. reagent product. A weighing instrument may also serve to determine other mass-related magnitudes.. instrument. intended by the manufacturer to be used for human beings for the purpose of : o diagnosis. or . into the human body or by medical intervention into a natural orifice. In Vitro Diagnostic Medical Devices The "in vitro diagnostic medical device" means any medical device which is a reagent. 14. . material or other article. o control of conception and which does not achieve its principal intended action in or on the human body by pharmacological. o investigation. appliance. including blood and tissue donations. 17. control material. 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. and for which the approval of the flag State administration is required according to international instruments 12.5 bar which is intended to contain air or nitrogen and which is not intended to be fired. quantities. intended by the manufacturer to be used in vitro for the examination of specimens. surgically or medically. 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. calibrator. whether used alone or in combination. Medical Devices A "Medical Device" is defined in Directive (93/42/EEC) as: any instrument. an injury or a handicap. solely or principally for the purpose of providing information: . 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. parameters or characteristics. or .concerning a congenital abnormality.must be placed on board a ship for use in order to comply with international instruments or are voluntarily placed on board for use. telecommunications networks used wholly or partly for the provision of publicly available telecommunications services). capable of communication by means of the emission and/or reception of radio waves utilising the spectrum allocated to terrestrial/space radio communication.concerning a physiological or pathological state. whether used alone or in combination. 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. and which is intended to remain after the procedure. treatment or alleviation of a disease. apparatus. or relevant component thereof.
limiting devices. Notified bodies serve as independent test labs and perform the steps called out by directives. such as pressure switches or temperature switches or fluid level switches and 'safety related measurement control and regulation (SRMCR)` devices. safety accessories and pressure accessories. 21. Heat exchangers consisting of pipes for the purpose of cooling or heating air shall be considered as piping. Depending upon your product and the nature of the risks it presents: Minimal Risk Options for products with minimal risk include self-certification where the manufacturer prepares Declaration of Conformity and affixes the CE Marking to their own product. bursting disc safety devices. measured according to the appropriate harmonized standards intended for sports and leisure purposes. of the trans-European transport network. piping. Greater Risks Many directives require products/systems with greater risks to be independently certified. or other pressure-bearing components as appropriate.19. regardless of the means of propulsion. pressure equipment includes elements attached to pressurized parts. lifting lugs. etc. couplings. controlled safety pressure relief systems (CSPRS). hoses. Manufacturers may choose a notified body in any member state of the European Union. such as flanges.5 to 24 m hull length. from 2. 'Assemblies` means several pieces of pressure equipment assembled by a manufacturer to constitute an integrated and functional whole. Where applicable. supports. 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. when connected together for integration into a pressure system. They must have the necessary qualifications to meet the testing requirements set forth in the directives. Lists of notified . '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. and . such as safety valves. A vessel may be composed of more than one chamber. expansion joints. this must be done by a "Notified Body". nozzles. buckling rods. built or upgraded for conventional rail transport and combined rail transport. 'Pressure accessories` means devices with an operational function and having pressure-bearing housings. 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. fittings. which either activate the means for correction or provide for shutdown or shutdown and lockout. 'Safety accessories` means devices designed to protect pressure equipment against the allowable limits being exceeded. Recreational Craft The "Recreational craft" means any boat of any type. This is an organization that has been nominated by Member Government and has been notified by the European Commission. 20. Trans-European Conventional Rail System The "Trans-European Conventional Rail system" means the structure composed of lines and fixed installations. 22. Piping includes in particular a pipe or system of pipes. 'Piping` means piping components intended for the transport of fluids. Notified bodies may be a private sector organization or a government agency. Such devices include: . tubing.devices for direct pressure limitation. Pressure Equipment The "Pressure Equipment" means vessels.
EC Type Examination & Product Q. .Compliance to relevant EN standard.Responsibility with importer / representative. Draw EC “ Declaration of Conformity”. Locate European harmonized standards (EN standards) available for your product to address the essential requirements listed in all applicable directives.F. Identify applicable directive(s).F.Certification with Technical Construction File ( T. Affix “ CE “ Mark. Identify all applicable EU Directives (laws).A. you will find that .Technical & legal bindings on manufacturers and exporters. . 3. . Voluntary Certification Self.Certification & Self. Identify applicable ‘EN’ standard(s).) 2. Identify applicable directive(s).C. EC Design Verification ( Full Q. if European. Voluntary Certification Self Certification ( ‘EN ‘ standards only ) Self Certification ( ‘EN ‘ standards only ) with Technical Construction File. If more than one applies. you will have to comply with all of them.A. EN standards. In some cases.e. 1.) 1.Responsibility with manufacturer. . Comply with tests and evaluations. Essential requirements. 2. Determine the extent to which your product complies with the essential requirements for design and manufacturing in the applicable directive(s).C.bodies are published by the European Commission in the Official Journal of the European Communities. 5. 4.Legal representative in European union. 6. 2. Identify applicable ‘EN’ standard(s).) 1. ( T. if manufacturer is non-European. Mandatory Certification EC Type Examination & Production Q. Compile technical documentation. .A. Determine if any directives apply to your product. Routes to Conformity 1. i.
. Exists.I E C ( International Electro technical Commission ) . . If the directives not required a Technical Documentation (Technical File) preparation by the manufacturer. you will have to identify other standards to use that effectively address the same concerns.Testing can be done in house or third party. . .Contains Declaration of Conformity. 3.All tests according to standards must for self – Certification. The Technical Documentation (Technical File) holds information that verifies that the testing was conducted properly and that the product complies with applicable standards. Draw EC “ Declaration of Conformity”.Basic Standards: . Compile technical documentation. The directives require for many products that a Technical Documentation (Technical File) be prepared by the manufacturer.Cover a family of products. Technical file .C E N ELEC.Product family standards: . If so.Declaration of Conformity – (Title) .Applicable to products for which no product specific or product family std.Demonstrable proof of Compliance (Test reports) 4.Define particular Phenomenon / simulation / test method. .Describe the equipment to which it relates. Comply with tests and evaluations. We will have to develop a "technical file" in accordance with all applicable directives that documents the application of all directives.C. .F. (Technical Construction File) .Contains Test reports.EN standards have not been developed for your product.Cover particular product. Types of EN standards. .Contains information about the product and company. standards and other relevant product safety information proving compliance. . .Generic standards: . . essential requirements.Must be kept within European union for at least 10 years after manufacture of the equipment.Directive does not call for testing but due – diligence does. Testing of Product You may need arrange laboratory testing for your product to demonstrate compliance with the essential requirements and standards.Partial testing – T. 5. in that case only test certificates are also sufficient for self-certification. .European member countries adopt EN standards. .Product specific standards: .C I S P E R (International Special Committee on Radio Interference) . (European Committee for Electrotechnical Standardization) . . .
There are several modules available for the Conformity Assessment 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 .Date of Issue. packaging and material or documents shipped with the product. Determine if any directives apply to your product. dated 1 January 1997. Letter consists of semicircles.Declaration that the product confirms with the protective requirements of the directive .Number and titles of standards applied . i. 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.Name & address of Company . If more than one applies you will have to comply with all of them.Description of the apparatus . The size of the CE marking must be atleast 5 mm. 2. affixing the CE Marking to products. and specific limitations on when and who is permitted to affix the CE Marking.) 2. 6. Determine the extent to which your product complies with the essential requirements for design and manufacturing in the applicable directive(s). Affix the CE mark in accordance with the laws (the format of the CE mark and its proper location is described in Directive 93/44/EEC. These guidelines address the size and location of the Marking. The length of the center stroke in the “ E “ must be 80% of the radius of the semicircle. Steps for obtain CE Marking through NOTIFIED BODY 1.Directives Applied . Must be enclosed in manual / packaging. The CE marking should be affixed directly on the product or on a nameplate or packing and in the attached technical documents. then you will need to do as the follows: Select the applicable product standards and test methods for your product and select a Notified Body.Signature of (or on behalf of) manufacturer or authorized representative . Identify all applicable EU Directives (laws).. Choose the conformity assessment procedure from the options (modules) called out by the directive for your product. Affix “ CE “ Mark.e. Strict guidelines regarding the size and placing of the mark.
Prepare a Declaration of Conformity. if proved.S. get a Certificate of Registration. or one of the other modules where the use of third parties is required. Determine the applicable standards. are required to be registered in the EU and. European or national. There are specific rules to adhere to for the CE Marking. 3. the manufacturer's name. 4. These rules address the size and location of the Marking. Affix the CE Marking to your product. Without this Certificate of Registration. 5. Class I Medical Devices. address and signature. The Declaration of Conformity must contain information adequate for tracing the product back to the manufacturer or the authorized representative in the European Union. for instance. If required. affixing the CE Marking to products. Department of Commerce). 6.S. international. 7. choose a "competent body" in the U. The directives require for many products that a Technical Documentation (Technical File) be prepared by the manufacturer. to perform test on products (an updated list is maintained by the U. Technical Documentation (Technical File). Some directives require that a manufacturer designate in the European Union an authorized representative to produce Technical Documentation (or sometimes called Technical File) in a timely fashion when called upon to do so. packaging and material or documents shipped with the product. The CE Marking itself is not meant to provide details about the product to Surveillance Authorities. An authorized representative is an agent who holds your "technical file" and "declaration of conformity" in the EU for at least 10 years after production of a product has ended. essential requirements. If required.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 under Module A. You will have to develop a "technical file" in accordance with all applicable directives that documents the application of all directives. Surveillance authorities may contact your authorized representative if any questions arise about the CE marking compliance of your product. Register your product in EU. and specific limitations on when and who is permitted . you will have to appoint an "authorized representative" in the EU. The Technical Documentation (Technical File) holds information that verifies that the testing was conducted properly and that the product complies with applicable standards. product identification. It may include a list the directives and standards that your product conforms to. the products are NOT allowed to be affixed with the CE Marking and be placed on the market. standards and other relevant product safety information proving compliance. Many products. Establish an Authorized Representative in the European Union for your product.
10. 6. 89/106/EEC of 21 December 1988 (construction products) (9). the term EC mark was replaced by CE marking. 5. the following basic points were included in the amendments to almost every Directive: 1. 8. 89/336/EEC of 3 May 1989 (electromagnetic compatibility) (10). Directives are issued from Brussels (after consultation and agreement by member states). 11. 9. dated 1 January 1997. 91/263/EEC of 29 April 1991 (telecommunications terminal equipment. in general. 88/378/EEC of 3 May 1988 (safety of toys) (8). by specifying requirements. 90/385/EEC of 20 June 1990 (active implantable medical devices) (14). These are a set of Directives which serve two primary purposes. 90/384/EEC of 20 June 1990 (non-automatic weighing instruments) (13). 4.) What are directives? Directives are the mechanism by which European-wide legislation is enacted. Brief Introduction of CE Marking Directive: 93/68/EEC COUNCIL DIRECTIVE 93/68/EEC of 22 July 1993 THE COUNCIL OF THE EUROPEAN COMMUNITIES. to the 12 Council Directives listed in Article 1. however of particular relevance are certain Directives known as the 'New Approach Directives'. 12. 89/392/EEC of 14 June 1989 (machinery) (11). including the mutual recognition of their conformity) (16). 3. But. 87/404/EEC of 25 June 1987 (simple pressure vessels) (7). Secondly. 89/686/EEC of 21 December 1989 (personal protective equipment) (12). including the conformity assessment procedures. has adopted this directive: Article 1 The following Council Directives are hereby amended: 1. Firstly. they ensure that all products which are covered by them are safe. 2. throughout from Article 2 to Article 13. 73/23/EEC of 19 February 1973 (electrical equipment designed for use within certain voltage limits) (18). Member States shall presume that products bearing the CE marking comply with all the provisions of this Directive. they provide a 'level playing field' for products within Europe. 2. 7. . All products which meet all the requirements of the directives may be freely marketed anywhere within the European Economic Area without further approvals being required.to affix the CE Marking. Throughout the text. These are then adopted by each state by the incorporation of corresponding legislation according to their own national legal framework. 90/396/EEC of 29 June 1990 (appliances burning gaseous fuels) (15). by the introduction of a single market. From Article 2 to Article 13 Detailed amendments were given. Affix the CE mark in accordance with the laws (the format of the CE mark and its proper location is described in Directive 93/44/EEC. 92/42/EEC of 21 May 1992 (efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels) (17). EC Directives are issued covering a whole host of matters. Amendments varied from Directive to Directive. (principally safety related) which the products must meet.
4. the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market . 4. must be given in the documents. 4. the latter shall indicate that the products in question are also presumed to conform to the provisions of those other Directives. The manufacturer or his authorized representative established within the Community shall affix the CE marking to each product and draw up a declaration of conformity. 6. as published in the Official Journal of the European Communities. (b) However. where one or more of those Directives allow the manufacturer. If the CE marking is reduced or enlarged the proportions given in the above graduated drawing must be respected. The CE conformity marking shall consist of the initials "CE " in the form shown below.1 EC verification is the procedure whereby a manufacturer or his authorized representative established within the Community ensures and declares that the products are in conformity to the type described in the EC type-examination certificate or with the design and manufacturing schedule referred to in Annex II section 3 having received a certificate of adequacy.4 The manufacturer or his authorized representative must be able to supply on request the approved body's certificates of conformity. EC verification 4. notices or instructions required by the Directives and accompanying such products. during a transitional period. the manufacturer or his authorized representative established within the Community shall be obliged to make the product conform as regards the provisions concerning the CE marking and to end the infringement under the conditions imposed by the Member State.3. 4. (a) where a Member State establishes that the CE marking has been affixed unduly.3 The approved body shall carry out the appropriate examinations and tests in order to check the conformity of the products with the requirements of this Directive by examination and testing of products. (a) Where the products are subject to other Directives covering other aspects and which also provide for the affixing of the CE marking. 5. particulars of the Directives applied. 7. to choose which arrangements to apply. .2 The manufacturer shall take all the necessary measures for the manufacturing process to ensure that the products conform to the type described in the EC typeexamination certificate or to the design and manufacturing schedule referred to in Annex II section 3. (b) where non-conformity continues. the CE marking shall indicate conformity only to the Directives applied by the manufacturer. In this case.
Disadvantages: • New product directives may exceed the current national laws and regulations. this obligation is the responsibility of the person who places the products on the Community market. The manufacturer must establish the technical documentation and he or his authorized representative established within the Community must keep it on Community territory at the disposal of the relevant national authorities for inspection purposes for a certain period after the last product has been manufactured. Benefits & Disadvantages: The CE Marking can be. There will be only one set of laws and regulations for the entire marketplace which guide the designing. e. It must include certain information. manufacturing and labeling of products. 11. 9. 2. Any other marking may be affixed to the products or the data plate provided that the visibility and legibility of the CE marking is not thereby reduced. at the same time. The affixing of markings on the products which are likely to deceive third parties as to the meaning and form of the CE marking shall be prohibited. It must.. the importer. Where neither the manufacturer nor his authorized representative is established within the Community. Member States shall adopt and publish the laws. regulations and administrative provisions necessary to comply with this Directive by 1 July 1994. Thus the CE Marking on your product will make your trade with EU countries cheaper and easier. The multiple and conflicting national restrictions on regulated products will be eliminated. Until 1 January 1997 Member States shall allow the placing on the market and the bringing into service of products which comply with the marking arrangements in force before 1 January 1995. Your product will be made safer for consumers and thus the damage claims and liability premiums will be reduced. Article 14 1. They shall apply these provisions from 1 January 1995. which may not be less than 5 mm. manufacture and operation of the product. cover the design. 1. Technical documentation must enable the conformity of the product to the requirements of this Directive to be assessed. 10. . 8. as far as relevant for such assessment.The various components of the CE marking must have substantially the same vertical dimension. It may cost a manufacturer extra to modify the currently existed design and/or production line in order to continue exporting to or gain access to this huge European market. EC declaration of conformity The EC declaration of conformity must contain certain elements.g. of both benefits and disadvantages Benefits: • • • With this "passport" your products can easily gain access to the entire European Union (EU) plus European Free Trade Association (EFTA) market.
Broadly the scope of the LVD covers consumer and capital goods designed to operate within those voltage limits. The Directive covers all risks arising from the use of electrical equipment. including not just electrical ones but also mechanical. in particular. required testing certification. 1. The European Union has issued 24 directives related to the CE mark. international or national standards. etc. UK Regulations (ref. health aspects of noise and vibrations. and electrical equipment intended for incorporation into other equipment such as transformers and motors. Three Directives apply to electric motors. Alternatively.int/comm/enterprise/newapproach/standardization/harmstds/reflist. Products are presumed to conform to the safety objectives of the LVD where the equipment has been manufactured in accordance with a harmonised standard. the manufacturer may construct the product in conformity with the essential requirements (safety objectives) of the LVD. (Safety) Regulations 1994 (SI 1994 No. . chemical (such as. emission of aggressive substances). or client’s own specification.• Extra costs in obtaining the product Certificate of Registration for CE Marking and any. including in particular electrical appliances. The LVD lays down eleven “safety objectives”. national standards. electric wiring. and ergonomic aspects as far as ergonomic requirements are necessary to protect against hazards in the sense of the Directive. international. URN 00/598) The relevant Harmonised Standards listed on the following web-site address http://europa. electrical installation equipment. 1768). 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. In such a case the product will not benefit from presumption of conformity and therefore the manufacturer must include in the technical documentation a description of the solutions adopted to satisfy the safety aspects of the Directive. appliance couplers and cord sets.eu. which represent the essential requirements of this Directive. Plugs and Sockets are covered by separate legislation namely the Plugs and Sockets Etc.html The Electrical Equipment (Safety) Regulations (LVD) applies to all electrical equipment designed for use with a voltage rating of between 50 and 1000 V AC and between 75 and 1500 V DC. without applying harmonised. 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. Before a product is placed on the market the following must happen: • • • The manufacturer must put together a technical documentation which makes it possible to assess whether the product complies with the directive The manufacturer or the authorised representative must draw up a ‘declaration of conformity’. switch gear and control gear. if applicable. lighting equipment including ballasts.
most electrical and electronic products to be placed on the market in the EEA (European Economic Area) must comply to the following requirements as detailed in the EMC Directive: Products must be constructed so that they do not cause excessive electromagnetic interference and are not unduly affected by electromagnetic interference. 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 help manufacturers through the complexities of CE marking . The Second Amending Directive (93/44/EEC) was incorporated into the UK Regulations by Statutory Instrument 1994 No.• • • Assessment for compliance with the LVD Assessment of the technical documentation A notified body report in accordance with article 11 of the LVD. 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. This process will ultimately lead to affixing of a CE mark on the product when coupled with all other relevant requirements of applicable new approach directives. Certain radiotransmitting equipment must be subjected to EC type – examination by a notified body. BSI Product Services is authorised as a Competent Body for the EMC Directive. 2. EMC Directive (89/336/EEC) Electromagnetic Compatibility (EMC) Directive 89/336/EEC as amended by 91/31/EEC and 93/68/EEC. BSI can offer services approving many products defined in Annex IV of the directive and can help manufacturers with testing and compliance needs for the whole range of products denfined in the directive. With a dedicated EMC facility on site we are able to offer a complete EMC service across a broad range of industries. UK Regulations SI 1992/2372 as amended by SI 1994/3080 and SI 1995/3180 Since January 1 1996. 2063. 3. The Third Amending Directive (98/37/EC) has not yet been incorporated into UK Regulation. The Machinery Directive has been implemented in the United Kingdom by the Supply of Machinery (Safety) Regulations 1992 which came into force on 1 January 1993.
Frameworks & Agreements Directive or Guideline 85/374/EEC 1999/34/EC 92/59/EEC 2001/95/EC 93/68/EEC 93/465/EEC Guideline Products or Title Mandatory from 30 Jul 1988 10 May 1999 1 Jan 1997 1 Jan 2003 Version of Languages en/fr/pt/es/sv en/fr/pt/es/sv en/fr/pt/es/sv en/fr/pt/es/sv en/fr/pt/es/sv en/fr/pt/es/sv en Type A: Basic Directives ( for all products) Liability for Defective Products Liability for Defective Products (amending) General Products Safety (new) General Products Safety Directive 22 Jul 1993 "CE Marking" Directive Conformity Assessment Procedures & CE 22 Jul 1993 Marking Rules Guide to Implementation of directives based Pub. it may not be complete. Guidelines. 2000 . No./Code of Directive 73/23/EEC 87/404/EEC 88/378/EEC 89/336/EEC 89/686/EEC 90/384/EEC 90/385/EEC 90/396/EEC 93/15/EEC 93/42/EEC 94/9/EC 94/25/EC 95/16/EC 96/48/EC 97/23/EC 98/37/EC 98/79/EC 99/5/EC Title of Directive Low voltage Simple pressure vessels Safety of toys Electromagnetic compatibility Personal protective equipment Non-automatic weighing instruments Active implantable medical devices Appliances burning gaseous fuels Explosives for civil uses Medical devices Equipment and protective systems intended for use in potentially explosive atmospheres Recreational craft Lifts Interoperability of the Trans-European high-speed rail system Pressure equipment Machinery In vitro diagnostic medical devices Radio and telecommunications terminal equipment CE Marking Publications Directives.Complete lists of CE marking-related European & International Standards The information contained in this summary list is a compilation of the references of standards which have been published in the Official Journal of the European Communities. Although the list is updated regularly.
2001 en LVD 73/23/eec (79pages) Guideline on Low Voltage Directive (LVD) Guideline Pub. 2001 1 Jul 1995 Pub. II 89/336/EEC Electromagnetic Compatibility (EMC) 1 Jan 1996 en/fr/pt/es/sv Guideline on Directive of Electromagnetic Guideline Pub. 2001 en/fr/pt/es/sv en/fr/pt/es/sv en en/fr/pt/es/sv en en/fr/pt/es/sv en en en/fr/pt/es/sv en/fr/pt/es/sv en en/fr/pt/es/sv en/fr/pt/es/sv 1 Jan 2003 Non-automatic Weighing Instruments Appliances Burning Gaseous Fuels 1 Jan 1996 (AppliGas) Framework of implementation of (AppliGas) Pub. 2001 Pub. 2001 Directive 90/396/eec Efficiency of (Liquid or Gaseous fueled) Hot 1 Jan 1998 Water Boilers Explosives for Civil Uses 1 Jan 2003 .Restriction of use of Hazardous 2002/95/EC Substances in Electrical and Electronic en/fr/pt/es/sv Equipment WEEE. 2001 en/fr/de Compatibility (EMC) 89/336/eec Technical-Aspects relating Electromagnetic Tech-Aspects Compatibility EMC 89/336/eec (150pages) Pub. 2001 27 Jun 1991 Pub. Jul 1997 en 73/23/EEC & Annex I. 2000 en Directive 89/336/EEC RoHS.Waste from Electrical and Electronic 2002/96/EC en/fr/pt/es/sv Equipment Type C: Product-Specific Directives (take precedence over Type A & B) Framework 87/404/EEC 88/378/EEC Guideline 89/106/EEC Guideline 89/686/EEC UsefulFacts Framework 90/384/EEC 90/396/EEC Framework 92/42/EEC 93/15/EEC Simple Pressure Vessels Toys Guidance to 88/378/eec Toys (for Scooter & FloatingSeats) Construction Products Guidance to Directive 89/106/eec: Construction Products Personal Protective Equipment (PPE) Useful Facts relating to Directive 89/686/eec PPE (143pages) Framework of implementation of (PPE) Directive 89/686/eec (13pages) 1 Jul 1992 1 Jan 1990 Pub.73/23/EEC Framework on new approach & global approach Type B: Generic Directives (take precedence over Type A) Low Voltage Electrical Equipment (LVD) 1 Jan 1997 en/fr/pt/es/sv 2000&2001 Framework of implementation of Pub. 2001 en framework of implementation of EMC Pub.
93/42/eec and 65/65/eec. 2001 1 Jan 1995 Pub. 2001 Pub.93/42/EEC Guidelines Guideline 90/385/EEC 98/79/EC Guideline 93/65/EEC 94/9/EC Framework Guideline 94/25/EC Guid&Frame 95/16/EC 96/48/EC 96/57/EC 96/98/EC 97/23/EC Framework 1998/37/EC Comments UsefulFacts Proposal 2000/14/EC 1999/5/EC Guidelines Medical Devices Guidelines for Classification of Medical Devices Guideline relating to the demarcation between Directives 90/385/eec. 2000 Pub. 7pages Guideline on directive 94/9/ec (Atex) Recreational Craft Guidelines&Framework: directive 94/25/ec (RecCraft) (106pages) Lifts Trans-European High-speed Rail System Energy Efficiency: Household Refrigerators & Freezers Marine Equipment Pressure Equipment 2000&2001 Framework of implementation of Directive 97/23/ec Machinery Comments on Directive of Machinery 98/37/ec (269pages) Useful Facts relating to Directive of Machinery 98/37/ec (266pages) 2001 Proposal to amend Directive 98/37/ec Machinery (106pages) Noise Emission in the environment by equipment for use outdoors (78pages) Radio Equipment & Telecommunications Terminal Equipment (R&TTE) Guidance to Directive 99/5/ec R&TTE. Active Implantable Medical Devices In Vitro Diagnostic Medical Devices Guideline on Medical Devices Vigilance System Air Traffic Management Equipment & Systems Equipment used in Potentially Explosive Atmospheres (Atex) Framework of implementation of (Atex) Directive 94/9/ec. 2001 Pub. 2001 Pub. 2001 30 Jun 1999 8 Oct 1996 3 Sep 1999 1 Jan 1999 29 May 2002 Pub. 2001 3 Jul 2000 (entry into force) variable Pub. 1998 19 Jul 1994 1 Jul 2003 Pub. 14 Jun 1998 Pub. 1998 1 Jan 1995 7 Dec 2003 Pub. 2000 16 Jun 1998 Pub. 2001 en/fr/pt/es/sv en en en/fr/pt/es/sv en/fr/pt/es/sv en en/fr/pt/es/sv en/fr/pt/es/sv en en en/fr/pt/es/sv en en/fr/pt/es/sv en/fr/pt/es/sv en/fr/pt/es/sv en/fr/pt/es/sv en/fr/pt/es/sv en en/fr/pt/es/sv en en en en/fr/pt/es/sv en/fr/pt/es/sv en .
1998 Pub. 1999 Pub. 1998 en (137pages) Agreement between EU and Australia Agreement between EU and New Zealand Agreement between EU and Israel Agreement between EU and Japan 2001 proposal Pub. 2000 en amendation (24pages) Agreement between EU and Canada Pub. 1998 Pub. 2001 EN en en en . 1999 en (173pages) Agreement between EU and United States.Framework 1999/36/EC 2000/9/EC 38pages 2001 Framework of implementation of 99/5/ec R&TTE Transportable Pressure Equipment Directive Pub. Pub. 2001 - en en/fr/pt/es/sv Agreement Agreement Agreement Agreement Agreement Agreement Agreement Cableway Installations to Carry Persons en/fr/pt/es/sv AGREEMENTs on mutual recognition of conformity assessment between European Union and Other countries Agreement between EU and United States Pub.