CE Marking - The directives

New Approach directives (directives providing for CE Marking)

Click on the directive name to get a brief description of the scope

Directive

Short title of directive

2006/95/EC

(73/23/EEC)

Low Voltage

87/404/EEC

Simple Pressure Vessels

88/378/EEC

Safety of toys

89/106/EEC

Construction products

2004/108/EC

Electromagnetic compatibility (EMC)

98/37/EC

Machinery

89/686/EEC

Personal protective equipment (PPE)

90/384/EEC

Non-automatic weighing instruments

90/385/EEC

Active implantable medical devices

90/396/EEC

Appliances burning gaseous fuels

92/42/EEC

Efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels

93/15/EEC

Explosives for civil uses

93/42/EEC

Medical devices

94/9/EC

Equipment explosive atmospheres (ATEX)

94/25/EC

Recreational craft

95/16/EC

Lifts

97/23/EC

Pressure equipment

98/79/EC

In vitro diagnostic medical devices

1999/5/EC

Radio Equipment and Telecommunications Terminal Equipment and the Mutual Recognition of their Conformity

2000/9/EC

Cableway installations designed to carry persons

2004/22/EC

Measuring instruments

New Approach directives (directives providing for CE Marking)

Directive

Brief outline of scope

Low Voltage

2006/95/EC

Codified version replaces 73/23/EEC

The LVD applies to electrical equipment with a voltage rating ranging from 50V – 1000V A.C. and 75V – 1500V D.C. and covers all risks arising from the use of the equipment (including mechanical and chemical risks).    

Equipment and phenomena listed below are explicitly excluded

• Electrical equipment for use in an explosive atmosphere

• Electrical equipment for radiology and medical purposes

• Electrical parts for goods and passenger lifts

• Electricity meters

• Plugs and socket outlets for domestic use

• Electric fence controllers

• Radio-electrical interference

• Specialized electrical equipment, for use on ships, aircraft or railways, which complies with the safety provisions drawn up by international bodies in which the Member States participate.

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Simple Pressure Vessels

87/404/EEC

This Directive applies to simple pressure vessels manufactured in series. 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.  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.

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.

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Safety of toys 88/378/EEC

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.

The products listed in below are not regarded as toys for the purposes of this Directive

• Christmas decorations

• Detailed scale models for adult collectors

• Equipment intended to be used collectively in playgrounds

• Sports equipment

• Aquatic equipment intended to be used in deep water

• Folk dolls and decorative dolls and other similar articles for adult collectors

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

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

• Air guns and air pistols

• Fireworks, including percussion caps (1)

• Slings and catapults

• Sets of darts with metallic points

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

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

• Vehicles with combustion engines

• Toy steam engines

• Bicycles designed for sport or for travel on the public highway

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

• Babies’ dummies

• Faithful reproductions of real fire arms.

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Construction products 89/106/EEC

For the purposes of the 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

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Electromagnetic compatibility (EMC) 89/336/EEC

The EMC directive applies in principle to all electrical and electronic equipment and is intended to minimise the contamination of the EM spectrum and supply and to reduce problems arising from external interference. The provisions of the directive that are to be applied depend both on the functional characteristics of the product and its method of commercial distribution.  This directive is not considered to be a “Safety directive” but is mandatory to ensure that the levels of EM “contamination” are kept with acceptable limits.

Note 1:   As of July 2007, the current EMC directive 89/336/EEC is replaced by the new directive 2004/108/EC.

Note 2:   This directive does not apply to the parts of the product that contains “intentional transmitters/receivers”

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Machinery 98/37/EC

For the purposes of this Directive: 

Machinery means: 

• an assembly of linked parts or components, at least one of which moves, with the appropriate actuators, control and power circuits, etc., joined  together for a specific application, in particular for the processing, treatment, moving or packaging of a material

• an assembly of machines which, in order to achieve the same end, which are arranged and controlled so that they function as an integral whole,

• interchangeable equipment modifying the function of a machine, which is placed on the market for the purpose of being assembled with a machine or a series of different machines or with a tractor by the operator himself in so far as this equipment is not a spare part or a tool

It shall also apply to safety components placed on the market separately.  ‘safety components’ mean a component, provided that it is not interchangeable equipment, which the manufacturer or his authorised  representative established in the Community places on the market to fulfil a safety function when in use and the failure or malfunctioning of which endangers the safety or health of exposed persons.

The following are excluded from the scope of this Directive:

• Machinery whose only power source is directly applied manual effort, unless it is a machine used for lifting or lowering loads

• Medical devices,

• Special equipment for use in fairgrounds and/or amusement parks,

• Steam boilers, tanks and pressure vessels,

• Machinery specially designed or put into service for nuclear purposes which, in the event of failure, may result in an emission of radioactivity,

• Radioactive sources forming part of a machine,

• Firearms,

• Storage tanks and pipelines for petrol, diesel fuel, inflammable liquids and dangerous substances,

• Means of transport, i.e. vehicles and their trailers intended solely for transporting passengers by air or on road, rail or water networks, as well as means of transport in so far as such means are designed for transporting goods by air, on public road or rail networks or on water. Vehicles used in the mineral extraction industry shall not be excluded,

• Seagoing vessels and mobile offshore units together with equipment on board such vessels or units

• Cableways, including funicular railways, for the public or private transportation of persons

• Agricultural and forestry tractors

• Machines specially designed and constructed for military or police purposes,

• Lifts which permanently serve specific levels of buildings and constructions, having a car moving between guides which are rigid and inclined at an angle of more than 15 degrees to the horizontal and designed for the transport of: (i) persons; (ii) persons and goods; (iii) goods alone if the car is accessible.

• Means of transport of persons using rack and pinion rail mounted vehicles,

• Mine winding gear,

• Theatre elevators,

• Construction site hoists intended for lifting persons or persons and goods.

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Personal protective equipment (PPE) 89/686/EEC

This Directive applies to personal protective equipment, ‘PPE’. For the purposes of this Directive, PPE shall mean any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards. PPE shall also cover: 

• Units constituted by several devices or appliances which have been integrally combined by the manufacturer for the protection of an individual against one or more potentially simultaneous risks

• Protective devices or appliances combined with personal non-protective equipment worn or held by an individual for the execution of a specific activity

• Interchangeable PPE components which are essential to its satisfactory functioning and used exclusively for such equipment.

Any system placed on the market in conjunction with PPE for its connection to another external, additional device shall be regarded as an integral part of that equipment even if the system is not intended to be worn or held permanently by the user for the entire period of risk exposure.

This Directive does not apply to PPE covered by another directive designed to achieve the same objectives as this Directive with regard to placing on the market, free movement of goods and safety or the PPE classes specified in the list below

• PPE designed and manufactured specifically for use by the armed forces or in the maintenance of law and order (helmets, shields, etc.).

• PPE for self-defence (aerosol canisters, personal deterrent weapons, etc.).

• PPE designed and manufactured for private use against: adverse atmospheric conditions (headgear, seasonal clothing, footwear, umbrellas, etc.), damp and water (dish-washing gloves, etc.), heat (gloves etc.).

• PPE intended for the protection or rescue of persons on vessels or aircraft, not worn all the time.

• Helmets and visors intended for users of two- or three-wheeled motor vehicles.

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Non-automatic weighing instruments 90/384/EEC

This Directive applies to all non-automatic weighing instruments. A weighing instrument is defined as a measuring instrument serving to determine the mass of a body by using the action of gravity on that body. A weighing instrument may also serve to determine other mass-related magnitudes, quantities, parameters or characteristics. A non-automatic weighing instrument is defined as a weighing instrument requiring the intervention of an operator during weighing.

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Active implantable medical devices 90/385/EEC

This Directive applies to active implantable medical devices. An ‘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; An ‘active implantable medical device’ means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure

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Appliances burning gaseous fuels 90/396/EEC

This Directive applies 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 °C, 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 devices and subassemblies, 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'. For the purposes of this Directive, ‘gaseous fuel' means any fuel which is in a gaseous state at a temperature of 15 °C under a pressure of 1 bar.

Appliances specifically designed for use in industrial processes carried out on industrial premises are excluded from the scope

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Efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels 92/42/EEC

This Directive, which comes under the SAVE programme concerning the promotion of energy efficiency in the Community, determines the efficiency requirements applicable to new hot-water boilers fired by liquid or gaseous fuels with a rated output of no less than 4 kW and no more than 400 kW,

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Explosives for civil uses 93/15/EEC

This Directive applies to explosives for civil uses.  'Explosives' 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.  

This Directive does not apply to:

• explosives, including ammunition, intended for use, in accordance with national law, by the armed forces or the police,

• pyrotechnical articles,

• ammunition

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Medical devices 93/42/EEC

This Directive applies to medical devices and their accessories. Accessories are treated as medical devices in their own right.  

The following definitions apply: ‘medical device’ means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the  software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:

• diagnosis, prevention, monitoring, treatment or alleviation of disease,

• diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

• investigation, replacement or modification of the anatomy or of a physiological process,

• control of conception,

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

An ‘accessory’ means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device. 

Some devices are excluded from the scope of this directive, i.e. in-vitro and active implantable devices.

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Equipment explosive atmospheres (ATEX) 94/9/EC

This Directive applies to equipment and protective systems intended for use in potentially explosive atmospheres. Safety devices, controlling devices and regulating devices intended for use outside potentially explosive atmospheres but required for or contributing to the safe functioning of equipment and protective systems with respect to the risks of explosion are also covered by the scope of this Directive.

The following definitions apply: 

• ‘Equipment'’ means machines, apparatus, fixed or mobile devices, control components and instrumentation thereof and detection or prevention systems which, separately or jointly, are intended for the generation, transfer, storage, measurement, control and conversion of energy and/or the processing  of material and which are capable of causing an explosion through their own potential sources of ignition.

• ‘Protective systems’ means devices other than components of the equipment defined above which are intended to halt incipient explosions immediately and/or to limit the effective range of an explosion and which are separately placed on the market for use as autonomous systems.

• Components'’ means any item essential to the safe functioning of equipment and protective systems but with no autonomous function.

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Recreational craft 94/25/EC

This Directive applies to the design and construction,

• Recreational craft and partly completed boats;

• Personal watercraft

• Certain components

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Lifts 95/16/EC

This Directive applies to lifts permanently serving buildings and constructions. It shall also apply to the safety components for use in such lifts. For the purposes of this Directive, ‘lift’ shall mean an appliance serving specific levels, having a car moving along guides which are rigid and inclined at an angle of more than 15 degrees to the horizontal and intended for the transport of:

• — persons,

• — persons and goods,

• — goods alone if the car is accessible, that is to say, a person may enter it without difficulty, and fitted with controls situated inside the car or within  reach of a person inside.

Lifts moving along a fixed course even where they do not move along guides which are rigid shall fall within the scope of this Directive (for example, scissor lifts).

The Directive shall not apply to:

• Cableways, including funicular railways, for the public or private transportation of persons,

• Lifts specially designed and constructed for military or police purposes,

• Mine winding gear,

• Theatre elevators,

• Lifts fitted in means of transport,

• Lifts connected to machinery and intended exclusively for access to the workplace,

• Rack and pinion trains,

• Construction-site hoists intended for lifting persons or persons and goods.

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Pressure equipment 97/23/EC

This Directive applies to the design, manufacture and conformity assessment of pressure equipment and assemblies with a maximum allowable pressure PS greater than 0.5 bar. ‘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, upports, lifting lugs, etc

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In-vitro diagnostic medical devices 98/79/EC

This Directive applies to in vitro diagnostic medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as in vitro diagnostic medical devices in their own right. Both in vitro diagnostic medical devices and accessories shall hereinafter be termed devices. An ‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

• concerning a physiological or pathological state or

• concerning a congenital abnormality or

• to determine the safety and compatibility with potential recipients or

• to monitor therapeutic measures.

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Radio Equipment and Telecommunications Terminal Equipment and the Mutual Recognition of their Conformity 1999/5/EC

This directive applies radio equipment and telecommunications terminal equipment. In this context radio equipment means a product, or relevant component thereof, capable of communication by means of the emission and/or reception of radio waves utilising the spectrum allocated.  Products that fall within the scope of this directive are excluded from the scope of the EMC directive with the exception of the essential protection and safety requirements.

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Cableway installations designed to carry persons  2000/9/EC

This directive applies to cableway installations intended to carry persons and covers installations made up of several components, designed, manufactured, assembled and put into service with the object of carrying persons. i.e. funicular railways, cable cars and drag lifts.

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Measuring instruments 2004/22/EC

This Directive applies to the devices and systems with a measuring function defined in the instrument-specific annexes i.e.

• 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)

• Exhaust gas analysers (MI-010).

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