ce mark interducaton

8/14/2019 CE Mark Interducaton

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ECSEI www.ecsei-eg.com [email protected]

The Egyptian Center for Studies of Export & Import

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In Arcle (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 devices9 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 Arcle 2 to Arcle 13:

Detailed amendments were given, throughout from Arcle 2 to Arcle 13, to the 12

Council Direcves listed in Arcle 1. Amendments varied from Direcve to Direcve.

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 schedulereferred to in Annex II secon 3 having received a cerficate of adequacy.

3. CE Marking and Inscriptions :a- The CE Conformity marking shall consist of the initials CE in the following

form:

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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 substantiallythe 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 thetechnical 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)

10- EC declaration of Conformity11- Internal production control

From Article 14 to Article 15

Arcle 14

1. Member States shall adopt and publish the laws, regulations and administrative

provisions

necessary to comply with this Direcve by 1 July 1994.

They shall apply these provisions from 1 January 1995.

2. Unl 1 January 1997 Member States shall allow the placing on the market and thebringing 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.

Arcle 15

This Directive is addressed to the member StatesDone at Brussels, 22 July 1993.

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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, arcle 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 Jusce 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 Jusce upholds "mutual recognition" permittingproducts manufactured (or imported) by a member state which do not present a

health, safety or environmental threat, to travel freely among other states.

4. 198

The European Council requests the European Commission to propose revisedlegislation 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 accelerang 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.

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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 Europeanmarketplace.

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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 Construcon File (TCF)74) compile the CEUser Manual.

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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

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 theseDirectives 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.

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Turkey


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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), personalprotective 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

IIImmmpppooorrrtttaaannnttt NNNooottteeesss 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.

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The Directives Lists of references of harmonized standards and general

information

2006/95/EC Low VoltageArcle 1

For the purposes of this Directive, "electrical equipment" means any

equipment designed for use with a voltage rang of between 50 and 1000V for alternang current and between 75 and 1500 V for direct current,

other than the equipment and phenomena listed in Annex II.

Arcle 2

1. 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

Arcle 4

In relation to electrical equipment, the Member States shall ensure thatstricter safety requirements than those laid down in Arcle 2 are not

imposed by electricity supply bodies for connection to the grid, or for the

supply of electricity to users of electrical equipment.

Arcle 12

This Directive shall not apply to electrical equipment intended for export

to third countries.

Arcle 15

This Directive shall enter into force on the twentieth day following that of

its publication in the Official Journal of the European Union.

Arcle 16


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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 VesselsArcle 1

1.This Directive applies to simple pressure vessels manufactured in

series.

2. For the purposes of this Direcve, 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-alloyaluminium 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/liter,

The minimum working temperature must be no lower than 50 C

and the maximum working temperature shall not be higher than 300 C for

steel and 100 .C for aluminums or aluminum alloy vessels

3. 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

Arcle 1

1. This Direcve shall apply to toys. A toy' shall mean any product or

material designed or clearly intended for use in play by children ofless than 14 years of age.

2. The products listed in Annex I shall not be regarded as toys for the

purposes of this Directive.

Arcle 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


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PRODUCTS NOT REGARDED AS TOYS FOR THE PURPOSE OF THIS DIRECTIVE

1.Christmas decorations

2. Detailed scale models for adult collectors3. Equipment intended to be used collecvely in playgrounds

4. Sports equipment

5. Aquatic equipment intended to be used in deep water

6. Folk dolls and decorave dolls and other similar arcles for adult collectors

7. Professional' toys installed in public places (shopping centres, staons, 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 funconal products operated at a nominal

voltage exceeding 24 volts

14. Products containing heang elements intended for use under the supervision

of an adult in a teaching context

15. Vehicles with combuson 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 reproducons of real fire arms

21. Fashion jewellery for children

89/106/EEC

93/68/EECRegulation (EC)No 1882/2003

Construction products

(Safety and performance of building products including requirements for

mechanical stability, fire resistance, hygiene, noise and energy efficiency.)

Arcle 1

1. This Direcve shall apply to construcon products in so far as the

essenal requirements in respect of construcon works under Arcle 3

(1) relate to them.

2. For the purposes of this Direcve, 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


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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:

(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.

2. 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.

3. 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.

4. Safety in use

The construction work must be designed and built in such a way that it doesnot present unacceptable risks of accidents in service or in operation suchas

slipping, falling, collision, burns, electrocution, injury from explosion.

5. 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.

6. 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.)Arcle 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.


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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 anelectromagnetic 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 Arcle 10 (6) cerfies 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 Arcle 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.)Arcle 1Scope

1. This Direcve applies to the following products:

(a) machinery;

(b) interchangeable equipment;

(c) safety components;

(d) lifting accessories;

(e) chains, ropes and webbing;

(f) removable mechanical transmission devices;


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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, hereinaer 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 Direcve, '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 Direcve, 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, and

- 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/EC2000/70/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 inexplosive atmospheres (e.g. coal mines).

94/25/EC

2003/44/EC

Recreational craft(Design and construction of boats of 2.5 to 24m, plus specifiedcomponents, excluding hydrofoils and hover craft, and craft for

charter.)


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95/16/EC Lifts

(Safety of Lifts provide an essential means of comfortable and safeaccess to modern buildings)

97/23/EC Pressure equipment

(Pressure equipment, accessories and assemblies with a maximumallowable 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 theiraccessories).

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 cellulartelephones, 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, chairliftsand 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).Arcle 1

ScopeThis 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), acve 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 3Object

This Directive establishes the requirements that the devices and systems referred

to in Arcle 1 have to sasfy with a view to their being placed on the market

and/or put into use for those tasks menoned in Arcle 2(1).

This Directive is a specific Directive in respect of requirements for

electromagnec immunity in the sense of Arcle 2(2) of Direcve 89/336/EEC.

Direcve 89/336/EEC connues to

apply with regard to emission requirements.

Article 4Definitions

For the purposes of this Directive:

(a) measuring instrument means any device or system with a measurement


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funcon that is covered by Arcles 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 Direcve 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

Informaon Society services (1) and prepared in accordance with the General

Guidelines agreed between the Commission and the European standardsorganisations;

(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)

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ECSEI

The Egyptian Center

European Stan British Sta

Deutsches Associatio

Denmark -

Ente Nazio

www.ecsei-eg.com

r Studies of Export & Import

ards Institutionsdards Institution (BSI)

Institut fur Normung (DIN)Francaise de Normalisation (AFNOR)

Dansk Standard (DS)

nale Italiano di Unificazione (UNI)

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