The CE Mark ...
 
The Single European market
Europe is a prize market, easier to access than ever before. Too many exporters, especially small and medium sized enterprises, avoid it because the technical requirements for entry seem too complicated, too difficult, or too expensive. The manufacturers who have successfully accessed the European market know that the time to understand the European system is well worth the effort.
                             
Main Points :
  • COUNCIL DIRECTIVE 93/68/EEC of 22 July 1993 about CE Mark .

  • The CE Mark System.

  • CE marking participating countries.

  • CE Marking Directives Covered.

  • Testing/Certifying Labs.

  • Technical File Procedures.

  • Declaration of Conformity (Supplier's declarations EC).

  • The CE Marking affixed.

  • The European Union standard for accreditation developed.

    • European Committee for Standardization (CEN).
    • European Committee for Electrotechnical Standardization (CENELEC).
    • European Telecommunications Standards Institute (ETSI).

  • European Standards Institutions.

    • British Standards Institution (BSI).
    • Deutsches Institut fur Normung (DIN).
    • Association Francaise de Normalisation (AFNOR).
    • Denmark - Dansk Standard (DS).
    • Ente Nazionale Italiano di Unificazione (UNI).
 
COUNCIL DIRECTIVE 93/68/EEC of 22 July 1993 (The CE Mark Directive):
In Article (1) this directives was amended the following council Directives:
 
1
87/404/EEC of 25 June 1987 Simple pressure vessels
2
88/378/EEC of 3 May 1988 Safety of toys
3
89/106/EEC of 21 December 1988 Construction products
4
89/336/EEC of 3 May 1989 Electromagnetic compatibility
5
89/392/EEC of 14 June 1989 Machinery
6
89/686/EEC of 21 December 1989 Personal protective equipment
7
90/384/EEC of 20 June 1990 Non-automatic weighing instruments
8
90/385/EEC of 20 June 1990 Active implantable medical devices
9
90/396/EEC of 29 June 1990 Appliances burning gaseous fuels
10
91/263/EEC of 29 April 1991 Telecommunications terminal equipment, including the mutual recognition of their conformity
11
92/42/EEC of 21 May 1992 Efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels
12
73/23/EEC of 19 February 1973 Eectrical equipment designed for use within certain voltage limits
                             
From Article 2 to Article 13:
Detailed amendments were given, throughout from Article 2 to Article 13, to the 12 Council Directives listed in Article 1. Amendments varied from Directive to Directive. But, in general, we can find more important amendments:

  1. The Term EC Mark was replaced by CE marking.

  2. 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.

  3. CE Marking and Inscriptions :

    a- The CE Conformity marking shall consist of the initials CE in the following form:
       

    • If the CE marking is reduced or enlarged the proportions given in the above graduated drawing must be respected.
    • The Various components of the CE marking must have substantially the same dimension, which may not be less than 5mm.

    b- Inscriptions.

  4. CE Conformity marking and information.

  5. Administrative Provisions:
    • On request, each notified body shall make available to the other notified bodies and the    competent authority, all relevant information on EC type-examination certificates and addends    issued, refused or withdrawn.
    • The manufacturer or his authorized representative shall keep with the technical    documentation a copy of the Ec type-examination certificate and the supplements to them for a    period of at least five years from the manufacture of the last appliance.

  6. Verification by checking and testing of each appliance.

  7. Statistical Verification.

  8. EC unit Verification.

  9. CE conformity marking and additional specific markings.

  10. EC DECLARATION OF CONFORMITY TO TYPE (guarantee of production quality).

  11. Internal production control.
                             
From Article 14 to Article 15
Article 14
  1. Member States shall adopt and publish the laws, regulations and administrative provisions 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 the bringing into service of products which comply with the marking arrangements in force before 1 January 1995.

  3. Member States shall Communicate to the Commission the Texts of the Provisions of national law which they adopt in the field covered by this directive. the commission shall inform the other member states thereof.
Article 15
This Directive is addressed to the member States.
Done at Brussels, 22 July 1993.
                             
The CE Mark System
The CE Mark History
  1. Since the signing of the Treaty of Rome in 1957, the European community has continued to pursue the plans for economic development laid out in that document.

    In The Treaty of Rome, article 8a
    "The community shall adopt measures with the aim of progressively establishing the internal market ... The internal market shall comprise an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured"

  2. 1975 The European Court of Justice via "the rule of reason" permits European Union (then called European Community) members to set national rules so long as trade between member states is not restricted. However, product restrictions were permitted for health, safety or environmental reasons.

  3. 1979 The European Court of Justice upholds "mutual recognition" permitting products manufactured (or imported) by a member state which do not present a health, safety or environmental threat, to travel freely among other states.

  4. 1986 The European Council requests the European Commission to propose revised legislation for health, safety and environmental product restrictions. The European Council approves "New Approach" legislation, eliminating national regulations that restrict trade and establishing community-wide standards, testing and certification procedures.

  5. 1992 The Vice President of the Commission of Brussels along with ministers from the EU and the EFTA sign an agreement organizing the free movement of goods, persons, services and capital within the European Economic Area (EEA).
                             
CE Mark Definitions
  1. The CE marking is a symbol that indicates that a particular product complies with European product safety, health and environmental requirements.
    The CE marking system promotes free trade with Europe by providing a single set of safety and environmental requirements a product must meet. Products complying with CE marking are currently accepted in 32 European countries.
    This is a market of 400 million people with a GNP over $8 trillion. CE marking is accelerating as the “globally accepted system” for ensuring product safety and environmental requirements. Possible extensions to other areas of the world are being negotiated at this time.

  2. CE marking is a declaration by the manufacturer that the product meets all the appropriate provisions of the relevant legislation implementing certain European Directives.

  3. CE marking gives companies easier access into the European market to sell their products without adaptation or rechecking

  4. The Implementation of Directives Based on the New Approach

  5. Before you Export to EU You Must establish first which, if any, of the New Approach Directives or older Global Approach Directives applies to your product. Because CE marking only applies to products within the scope of these Directives. It should not be applied to products if they are outside the scope of the Directives.

  6. The European Commission refers to the CE Marking of products as a "passport" which can allow a manufacturer to freely circulate their products within the European marketplace.
                             
The Market Requirements
The Market Access Requirements, which are demanded by either EU governments or private sector parties, are based on:
  1. Consumer health.

  2. Product safety.

  3. Environmental.

  4. Social and quality concerns.
                             
Procedures for CE Marking
Before CE marking can be affixed to the product, the manufacturer must follow certain procedures which may differ for each directive and each product. A manufacturer must :
  1. Identify which New Approach directives apply to the product.

  2. Prepare the Declaration of Conformity.

  3. Draw up the Technical Construction File (TCF)7

  4. Compile the CE User Manual.
                             
CE marking participating countries
i) European Union Countries:
 
Austria
Ireland
Cyprus
Slovenia
Belgium
Italy
Czech Republic
Denmark
Luxembourg
Hungary
Finland
Netherlands
Latvia
France
Portugal
Lithuania
Germany
Spain
Estonia
Greece
Sweden
Malta
U.K.
Poland
Slovakia
Bulgaria
Romania
                             
ii) EFTA COUNTRIES
Iceland
Liechtenstein
Norway
Switzerland
                             
iii) A candidate for accession
Turkey
                             
CE Marking Directives Covered
The Directives(New Approach)
  1. In the period up to 1992, and subsequently, the European Parliament has enacted a series of measures intended to put the Single Market into practice.
    Some of these Directives have been aimed at removing barriers of a purely customs/excise nature, others have concentrated on transport arrangements to ensure the free movement of goods, while a series of Directives (produced under the heading of `New Approach Directives') are intended to provide controls on product design, with the principal objective being to provide a `level playing field' for product safety requirements across the European Community.

  2. The directives cover a very wide range of product areas. One of the first to be implemented concerned the safety of children's toys.
    Subsequent directives have included provisions for machinery, electromagnetic compatibility (EMC), personal protective equipment, medical devices, gas appliances and commercial explosives, among others.
    Also relevant is the Low Voltage Directive. Strictly speaking the LVD, which was first enacted in 1973, pre-dates the New Approach directives, but subsequent amendments have given it a very similar function and legal structure, and the amendment which introduced the requirement to CE mark products recognised that the LVD should broadly be treated as if it were a New Approach directive
                             
Important Notes
The General Product Safety Directive (GPSD) covers all products not specifically covered by CE marking directives but which do require some level of safety regulation. These products may also be regulated at the national level by member states.
                             
Mandatory Directives (directives providing for CE marking)
Directives
Lists of references of harmonized standards and general information
2006/95/EC
Low Voltage

Article 1
For the purposes of this Directive, "electrical equipment" means any equipment designed for use with a voltage rating of between 50 and 1000 V for alternating current and between 75 and 1500 V for direct current, other than the equipment and phenomena listed in Annex II.

Article 2
The Member States shall take all appropriate measures to ensure that electrical equipment may be placed on the market only if, having been constructed in accordance with good engineering practice in safety matters in force in the Community, it does not endanger the safety of persons, domestic animals or property when properly installed and maintained and used in applications for which it was made…

Article 4
In relation to electrical equipment, the Member States shall ensure that stricter safety requirements than those laid down in Article 2 are not imposed by electricity supply bodies for connection to the grid, or for the supply of electricity to users of electrical equipment.

Article 12
This Directive shall not apply to electrical equipment intended for export to third countries.

Article 15
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Article 16
This Directive is addressed to the Member States. Done at Strasbourg, 12 December 2006.

87/404/EEC 90/488/EEC 93/68/EEC
Simple Pressure Vessels
Article 1  
  1. This Directive applies to simple pressure vessels manufactured in series.

  2. For the purposes of this Directive, ‘simple pressure vessel’ means any welded vessel subjected to an internal gauge pressure greater than 0.5 bar which is intended to contain air or nitrogen and which is not intended to be fired.
  3. moreover,

    • The parts and assemblies contributing to the strength of the vessel under pressure shall be made either of non-alloy quality steel or of non-alloy aluminium or non-age hardening aluminium alloys.

    • The vessel shall be made of Either a cylindrical part of circular cross-section closed by outwardly dished and/or flat ends which revolve around the same axis as the cylindrical part, or two dished ends revolving around the same axis.

    • The maximum working pressure of the vessel shall not exceed 30 bar and the product of that pressure and the capacity of the vessel (PS.V) shall not exceed 10 000 bar/litre.

    • The minimum working temperature must be no lower than ? 50 ºC and the maximum working temperature shall not be higher than 300 ºC for steel and 100 ºC for aluminium or aluminium alloy vessels.

  4. The following vessels shall be excluded from the scope of the Directive:
    • Vessels specifically designed for nuclear use, failure of which may cause an emission of radioactivity.

    • Vessels specifically intended for installation in or the propulsion of ships and aircraft.

    • fire extinguishers
   
88/378/EEC 93/68/EEC
Safety of toys
Article 1
  1. 1. This Directive shall apply to 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.

  2. The products listed in Annex I shall not be regarded as toys for the purposes of this Directive.
Article 3
Member States shall take all steps necessary to ensure that toys cannot be placed on the market unless they meet the essential safety requirements set out in Annex II.
ANNEX I
PRODUCTS NOT REGARDED AS TOYS FOR THE PURPOSE OF THIS DIRECTIVE
  1. Christmas decorations.

  2. Detailed scale models for adult collectors.

  3. Equipment intended to be used collectively in playgrounds.

  4. Sports equipment.

  5. Aquatic equipment intended to be used in deep water.

  6. Folk dolls and decorative dolls and other similar articles for adult collectors.

  7. ‘Professional' toys installed in public places (shopping centres, stations, etc.).

  8. Puzzles with more than 500 pieces or without picture, intended for specialists.

  9. Air guns and air pistols.

  10. Fireworks, including percussion caps (1).

  11. Slings and catapults.

  12. Sets of darts with metallic points.

  13. Electric ovens, irons or other functional products operated at a nominal voltage exceeding 24 volts.

  14. Products containing heating elements intended for use under the supervision of an adult in a teaching context.

  15. Vehicles with combustion engines.

  16. Toy steam engines.

  17. Bicycles designed for sport or for travel on the public highway.

  18. Video toys that can be connected to a video screen, operated at a nominal voltage exceeding 24 volts.

  19. Babies’ dummies.

  20. Faithful reproductions of real fire alarms.

  21. Fashion jewellery for children.

89/106/EEC 93/68/EEC

Regulation (EC) No 1882/2003

Construction products
Safety and performance of building products including requirements for mechanical stability, fire resistance, hygiene, noise and energy efficiency.
Article 1
  1. This Directive shall apply to construction products in so far as the essential requirements in respect of construction works under Article 3 (1) relate to them.

  2. For the purposes of this Directive, ‘construction product’ means : Any product which is produced for incorporation in a permanent manner in construction works, including both buildings and civil engineering works. ‘Construction Products’ are hereinafter referred to as ‘products’; Construction works including both buildings and civil engineering works are hereinafter referred to as ‘works’.
ANNEX I
ESSENTIAL REQUIREMENTS
The products must be suitable for construction works which (as a whole and in their separate parts) are fit for their intended use, account being taken of economy, and in this connection satisfy the following essential requirements where the works are subject to regulations containing such requirements. Such requirements must, subject to normal maintenance, be satisfied for an economically reasonable working life. The requirements generally concern actions which are forseeable.
  1. Mechanical resistance and stability
    The construction works must be designed and built in such a way that the loadings that are liable to act on it during its constructions and use will not lead to any of the following:

  2. (a) collapse of the whole or part of the work.

    (b) major deformations to an inadmissible degree.

    (c) damage to other parts of the works or to fittings or installed       equipment as a result of major deformation of the load-       bearing construction.

    (d) damage by an event to an extent disproportionate to the       original cause.

  3. Safety in case of fire
    The construction works must be designed and built in such a way that in the event of an outbreak of fire:
    • The load-bearing capacity of the construction can be assumed for a specific period of time.

    • The generation and spread of fire and smoke within the works are limited.

    • The spread of the fire to neighbouring construction works is limited.

    • Occupants can leave the works or be rescued by other means.

    • The safety of rescue teams is taken into consideration.

  4. Hygiene, health and the environment
    The construction work must be designed and built in such a way that it will not be a threat to the hygiene or health of the occupants or neighbours, in particular as a result of any of the following:
    • The giving-off of toxic gas.

    • The presence of dangerous particles or gases in the air.

    • The emission of dangerous radiation.

    • pollution or poisoning of the water or soil.

    • faulty elimination of waste water, smoke, solid or liquid wastes.

    • The presence of damp in parts of the works or on surfaces within the works.
  5. Safety in use
    The construction work must be designed and built in such a way that it does not present unacceptable risks of accidents in service or in operation suchas slipping, falling, collision, burns, electrocution, injury from explosion.

  6. Protection against noise
    The construction works must be designed and built in such a way that noise perceived by the occupants or people nearby is kept down to a level that will not threaten their health and will allow them to sleep, rest and work in satisfactory conditions.

  7. Energy economy and heat retention
    The construction works and its heating, cooling and ventilation installations must be designed and built in such a way that the amount of energy required in use shall be low, having regard to the climatic conditions of the location and the occupants.
89/336/EEC 92/31/EC 93/68/EEC 2004/108/EC
Electromagnetic compatibility (EMC)
Noise immunity and emissions performance of electrical equipment.
Article 1
For the purposes of this Directive:
  1. ‘Apparatus' means all electrical and electronic appliances together with equipment and installations containing electrical and/or electronic components.

  2. ‘Electromagnetic disturbance' means any electromagnetic phenomenon which may degrade the performance of a device, unit of equipment or system. An electromagnetic disturbance may be electromagnetic noise, an unwanted signal or a change in the propagation medium itself.

  3. ‘Immunity' means the ability of a device, unit of equipment or system to perform without degradation of quality in the presence of an electromagnetic disturbance.

  4. ‘Electromagnetic compatibility' means the ability of a device, unit of equipment or system to function satisfactorily in its electromagnetic environment without introducing intolerable electromagnetic disturbances to anything in that environment.

  5. ‘competent body' means any body which meets the criteria listed in Annex II and is recognized as such.

  6. ‘EC type-examination certificate' is a document in which a notified body referred to in Article 10 (6) certifies that the type of equipment examined complies with the provisions of this Directive which concern it.
ANNEX III
Illustrative list of the principal protection requirements
The maximum electromagnetic disturbance generated by the apparatus shall be such as not to hinder the use of in particular the following apparatus:

(a) Domestic radio and television receivers

(b) Industrial manufacturing equipment

(c) Mobile radio equipment

(d) Mobile radio and commercial radiotelephone equipment

(e) Medical and scientific apparatus

(f) Information technology equipment

(g) Domestic appliances and household electronic equipment

(h) Aeronautical and marine radio apparatus

(i) Educational electronic equipment

(j) Telecommunications networks and apparatus

(k) Radio and television broadcast transmitters

(l) Lights and fluorescent lamps.

Apparatus, and especially the apparatus referred toin (a) to(l), should be constructed in such a way that it has an adequate level of electromagnetic immunity in the usual electromagnetic compatibility environment where the apparatus is intended to work so as to allow its unhindered operation taking into account the levels of disturbance generated by apparatus complying with the standards laid down in Article 7.

The information required to enable use in accordance with the intended purpose of the apparatus must be contained in the instructions accompanying the apparatus.

98/37/EC 98/79/EC 2006/42/EC
Machinery
Safety of all machines with moving parts.
Article 1
Scope
  1. This Directive applies to the following products:
  2. (a) machinery.

    (b) interchangeable equipment.

    (c) safety components.

    (d) lifting accessories.

    (e) chains, ropes and webbing.

    (f) removable mechanical transmission devices.

    (g) partly completed machinery.

  3. The following are excluded from the scope of this Directive:

  4. (a) safety components intended to be used as spare parts to replace identicalcomponents and supplied by the manufacturer of the original machinery.

    (b) specific equipment for use in fairgrounds and/or amusement parks.

    (c) machinery specially designed or put into service for nuclear purposes which, in the event of failure, may result in an emission of radioactivity.

    (d) weapons, including firearms.

    (e) the following means of transport:

    • Agricultural and forestry tractors for the risks covered by Directive 003/37/EC, with the exclusion of machinery mounted on these vehicles.

    • Motor vehicles and their trailers covered by Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (1), with the exclusion of machinery mounted on these vehicles.

    • Vehicles covered by Directive 2002/24/EC of the European Parliament and of the Council of 18 March 2002 relating to the type-approval of two or three-wheel motor vehicles (2), with the exclusion of machinery mounted on these vehicles.

    • Motor vehicles exclusively intended for competition.

    • Means of transport by air, on water and and on rail networks with the exclusion of machinery mounted on these means of transport.

    (f) seagoing vessels and mobile offshore units and machinery installed on board such vessels and/or units.

    (g) machinery specially designed and constructed for military or police purposes.

    (h) machinery specially designed and constructed for research purposes for temporary use in laboratories.

    (i) mine winding gear.

    (j) machinery intended to move performers during artistic performances.

Article 13

Procedure for partly completed machinery

  1. The manufacturer of partly completed machinery or his authorised representative shall, before placing it on the market, ensure that:

  2. (a) the relevant technical documentation described in Annex VII, part B is prepared.

    (b) assembly instructions described in Annex VI are prepared.

    (c) a declaration of incorporation described in Annex II, part 1, Section B has been drawn up.

  3. The assembly instructions and the declaration of incorporation shall ccompany the partly completed machinery until it is incorporated into the final machinery and shall then form part of the technical file for that machinery.

89/686/EEC 93/68/EEC 93/95/EEC 96/58/EC
Personal protective equi pment (PPE)
Performance of equipment designed to protect the user from injury.
90/384/EEC 93/68/EEC
Non-automatic weighing instruments
Performance and calibration procedures for commercial weigh-scales.
90/385/EEC 93/42/EEC 93/68/EEC
Active implantable medical devices
Active Implantable Medical Devices Directive 90/385/EEC.
90/396/EEC 93/68/EEC
Appliances burning gaseous fuels
Article 1
  1. This Directive shall apply to:

    • Appliances burning gaseous fuels used for cooking, heating, hot water production, refrigeration, lighting or washing and having, where applicable, a normal water temperature not exceeding 105 gC, hereinafter referred to as 'appliances'. Forced draught burners and heating bodies to be equipped with such burners will also be considered as appliances.

    • Safety devices, controlling devices or regulating decives and sub-assemblies, other than forced draught burners and heating bodies to be equipped with such burners separately marketed for trade use and designed to be incorporated into an appliance burning gaseous fuel or assembled to constitute such an appliance, hereinafter referred to as 'fittings'.

  2. Appliances specifically designed for use in industrial processes carried out on industrial premises are excluded from the scope defined in paragraph 1.

  3. For the purposes of this Directive, 'gaseous fuel' means any fuel which is in a gaseous state at a temperature of 15 gC under a pressure of 1 bar.

  4. For the purposes of this Directive, an appliance is said to be 'normally used' when it is:

    • Correctly installed and regularly serviced in accordance with the manufacturer's instructions.

    • Used with a normal variation in the gas quality and a normal fluctuation in the supply pressure.

    • Used in accordance with its intended purpose or in a way which can be reasonably foreseen.
92/42/EEC 93/68/EEC 2004/8/EC 2005/32/EC
Efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels
Requirements for testing to ensure the mutual recognition of type approval of telecoms apparatus.

93/15/EEC
Explosives for civil uses
Performance and safety of commercial explosives excluding ammunition and pyrotechnics.

93/42/EEC 98/79/EC 2000/70/EC 2001/104/EC
Medical devices
Safety of all medical equipment not covered by directives on In-Vitro fertilization or active implantable devices.
94/9/EC
Equipment explosive atmospheres (ATEX)
Safety requirements for control systems and equipment for use in explosive atmospheres e.g. coal mines.

94/25/EC 2003/44/EC
Recreational craft
Design and construction of boats of 2.5 to 24m, plus specified components, excluding hydrofoils and hover craft, and craft for charter.

95/16/EC
Lifts
Safety of Lifts provide an essential means of comfortable and safe access to modern buildings.

97/23/EC
Pressure equipment
Pressure equipment, accessories and assemblies with a maximum allowable pressure greater than 0.5 bar above atmospheric pressure.

98/79/EC
In vitro diagnostic medical devices
Design and manufacture of In-Vitro medical devices and their accessories.

1999/5/EC
Radio Equipment and Telecommunications Terminal Equipment and the Mutual Recognition of their Conformity
Encompasses all products using the radio frequency spectrum e.g. car door openers, mobile communications equipment like cellular telephones, CB radio, broadcast transmitters, etc. and all equipment attached to public telecommunications networks e.g. ADSL modems, telephones, telephone switches.

2000/9/EC
Cableway installations designed to carry persons
They mainly Consists of funicular railways, cable cars, gondolas, chairlifts and drag lifts designed, manufactured, put into service and operated with the object of carrying persons in safe conditions.

2004/22/EC
Measuring instruments
Measuring instruments are an essential tool of Ensuring accuracy of measurement.
Article 1
Scope
This Directive applies to the devices and systems with a measuring function defined in the instrument-specific annexes concerning water meters (MI-001), gas meters and volume conversion devices (MI-002), active electrical energy meters (MI-003), heat meters (MI-004), measuring systems for continuous and dynamic measurement of quantities of liquids other then water (MI-005), automatic weighing instruments (MI-006), taximeters (MI-007), material measures (MI-008), dimensional measuring instruments (MI-009) and exhaust gas analysers (MI-010).
 
Article 3
Object
This Directive establishes the requirements that the devices and systems referred to in Article 1 have to satisfy with a view to their being placed on the market and/or put into use for those tasks mentioned in Article 2(1). This Directive is a specific Directive in respect of requirements for electromagnetic immunity in the sense of Article 2(2) of Directive 89/336/EEC. Directive 89/336/EEC continues to apply with regard to emission requirements.
 
Article 4
Definitions
For the purposes of this Directive:

(a) ‘measuring instrument’ means any device or system with a measurement function that is covered by Articles 1 and 3

(b) ‘sub-assembly’ means a hardware device, mentioned as such in the specific annexes, that functions independently and makes up a measuring instrument together

  • With other sub-assemblies with which it is compatible.
  • With a measuring instrument with which it is compatible.

(c) ‘legal metrological control’ means the control of the measurement tasks intended for the field of application of a measuring instrument, for reasons of public interest,public health, public safety, public order, protection of the environment, levying of taxes and duties, protection of the consumers and fair trading.

(d) ‘manufacturer’ means a natural or legal person responsible for the conformity of the measuring instrument with this Directive with a view to either placing it on the market under his own name and/or putting it into use for his own purposes.

(e) ‘placing on the market’ means making available for the first time in the Community an instrument intended for an end user, whether for reward or free of charge.

(f) ‘putting into use’ means the first use of an instrument intended for the end user for the purposes for which it was intended.

(g) ‘authorised representative’ means a natural or legal person who is established within the Community and authorized by a manufacturer, in writing, to act on his behalf for specified tasks within the meaning of this Directive.

(h) ‘harmonised standard’ means a technical specification adopted by CEN, CENELEC or ETSI or jointly by two or all of these organisations, at the request of the Commission pursuant to Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (1) and prepared in accordance with the General Guidelines agreed between the Commission and the European standards organisations.

(i) ‘normative document’ means a document containing technical specifications adopted by the Organisation Internationale

                             
  • Testing/Certifying Labs.

  • Technical File Procedures.

  • Declaration of Conformity (Supplier's declarations EC).

  • The CE Marking affixed.

  • The European Union standard for accreditation developed

    • European Committee for Standardization (CEN)

    • European Committee for Electrotechnical Standardization (CENELEC)

    • European Telecommunications Standards Institute (ETSI)


  • European Standards Institutions

    • British Standards Institution (BSI).


    • Deutsches Institut fur Normung (DIN).


    • Association Francaise de Normalisation (AFNOR).


    • Denmark - Dansk Standard (DS).


    • Ente Nazionale Italiano di Unificazione (UNI).
                             
Please click here for more details ...