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What is
the CE Mark?
Regulation (EC) 765/2008
List of Directives
The CE marking is used to
indicate that a product is in compliance with one of the Directives
of the
European Union (the initials CE do not abbreviate anything). Use of
the CE mark is strictly limited by
Regulation (EC) 765/2008:
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It may be affixed to products
only when its use is required by EU
"harmonization" legislation (i.e. it is not a general sign of compliance for all
products destined for the European market) |
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It may be
affixed only by the manufacturer of the product (i.e. it is not affixed by the
conformity assessment body which tests or certifies the product) |
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It must be
at least 5 mm high and permanently
affixed (i.e. visibly, legibly and indelibly) to the
product itself. If this is not possible
due to the size or nature of the product, it should be affixed to
the packaging and accompanying documents |
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Member States must ensure the correct
application of the CE mark and provide penalties for its misuse |
Currently, there
are twenty-one
New Approach Directives that require the use of the
CE mark:
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98/37/EC |
Machinery: an assembly of moving
parts for the processing/treatment/moving/packaging of material; excludes medial
devices, steam boilers/pressure vessels, pipelines/storage tanks,
vehicles/trailers, seagoing vessels/offshore units,
cableways/railways, agricultural/forestry tractors, lifts/elevators,
firearms, machines for military/police, radioactive equipment |
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87/404/EEC |
Simple
pressure vessels manufactured in series: intended to
contain air or nitrogen; 0.5 to 30 bar pressure |
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97/23/EC |
Pressure
equipment: vessels and piping with a maximum allowable
pressure greater than 0.5 bar; excludes pipelines, water
distribution networks and simple pressure vessels |
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90/396/EEC |
Appliances
burning gaseous fuels: used for cooking, washing, hot
water production, heating, lighting and refrigeration |
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92/42/EEC |
Hot-water
boilers fired with liquid or gaseous fuels |
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2006/95/EC |
Low voltage
electrical equipment: 50 to 1,000 V for alternating
current; 75 to 1,500 V for direct current |
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1999/5/EC |
Radio/telecommunications terminal equipment
(R&TTE): radio equipment uses radio waves to communicate;
telecommunications terminal equipment connects to a publicly
available telecommunications network; covers medical devices and vehicles |
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2004/108/EC |
Electromagnetic compatibility (EMC): for radio and
telecommunication terminal equipment, aeronautical
products/parts/appliances used in civil aviation |
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2004/22/EC |
Measuring instruments: water meters, gas meters, electrical energy meters, heat meters,
measuring systems for liquids other than water, automatic weighing
instruments, taximeters, material measures, dimensional measuring
instruments, exhaust gas analyzers |
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90/384/EEC |
Non-automatic
weighing instruments: mass-related measuring instruments
which require an operator |
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89/106/EEC |
Construction
products used in buildings and civil engineering works |
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93/15/EEC |
Explosives
for civil uses |
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94/9/EC |
Equipment and protective systems
intended for use in potentially explosive
atmospheres (ATEX): equipment which
generates/transfers/controls/converts energy for the processing of
materials in locations with potentially explosive mixtures of
air/gases/dust (e.g. mines or chemical plants) |
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89/686/EEC |
Personal
protective equipment (PPE): devices designed to be
worn or held for protection against health/safety hazards, including
its supporting equipment |
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93/42/EEC |
Medical
devices: any material/instrument/appliance used in human
beings for the diagnosis/prevention/treatment of
disease/injury/control of conception whose principal means of action
is not pharmacological/metabolic |
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90/385/EEC |
Active
implantable medical devices: medical devices that are
introduced into the human body, that remain in the body after the
procedure, and that rely on an external source of power/electricity |
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98/79/EC |
In vitro
diagnostic medical devices: apparatus/materials/
kits/instruments used to perform diagnostic procedures on
blood/tissue specimens outside the human body |
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88/378/EEC |
Toys:
used for play by children less than 14 years of age |
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94/25/EC |
Recreational
craft, personal watercraft and outboard engines |
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95/16/EC |
Lifts
(elevators) used for transport of people or goods in buildings;
excludes lifts used in construction/workplace/ theater/public
transportation or by police/military |
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2000/9/EC |
Cableway
installations designed to carry persons |
The
proposed revision
to the RoHS directive (RoHS2) would require
the affixing of the CE mark in conjunction with the type, batch or serial number of the production run.
This would expand the use of the CE mark to virtually all electrical and electronic equipment. Manufacturers
would also be required to furnish EC declarations of conformity.
This summary is intended to give you an easy-to-understand overview and does
not constitute legal advice. The actual standard in the original language
should be reviewed and used for all business, legal, and product compliance
purposes.
If you need assistance
in implementing or managing your company's RoHS compliance, we stand ready
to help you. Just
email
us or give us a call at 972-679-8996 for a timely and personalized response.
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Technical Consulting
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