CE Mark Interducaton
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Transcript of CE Mark Interducaton
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ECSEI
The Egyptian Center
Europe is a prize market,
especially small and med
requirements for entry s
manufacturers who have
time to understand the E
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COUNCIL DIRECTIV The CE Mark Syste
CE marking particip
CE Marking Directiv
Testing/Certifying L
Technical File Proce
Declaration of Conf
The CE Marking affi
The European Unio
European Co
European Co
European Tel
European Standar
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Association
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www.ecsei-eg.com
r Studies of Export & Import
easier to access than ever before. Too man
ium sized enterprises, avoid it because the
em too complicated, too difficult, or too ex
successfully accessed the European market
uropean system is well worth the effort.
93/68/EEC of 22 July 1993 about CE Mark
ating countries
es Covered
abs
dures
ormity (Supplier's declarations EC)
xed
standard for accreditation developed
mmittee for Standardization (CEN)
mmittee for Electrotechnical Standardization (CENE
ecommunications Standards Institute (ETSI)
ds Institutions
dards Institution (BSI)
nstitut fur Normung (DIN)
Francaise de Normalisation (AFNOR)
ansk Standard (DS)
ale Italiano di Unificazione (UNI)
Page 1
Single European Market
exporters,
echnical
pensive. The
know that the
EC)
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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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CCCEEE mmmaaarrrkkkiiinnnggg pppaaarrrtttiiiccciiipppaaatttiiinnnggg cccooouuunnntttrrriiieeesss:::
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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