CE Marking is an association sign which were prepared within the context of new
approach policy and shows the conformity of the products which are related to New
Approach Directives and conformed to conformity assessments and which were adopted
as a part of accordance to the regulation in 1985 by The European Union. CE Marking is a
sign which shows that in case the products are used accordance with the purposes, they
cannot damage for human life and property, plant and animal being; in other words, is a
sign shows that the product is safe.
The European Union, new approach, global and modular approach directives which act an
important part for European Union to reach the European single market target and are
one of the corner stone for technical conformance, are listed below.
The directives which were improved as a part of this policy have been published firstly in
1987 and are growth 20 directives at the present day. These directives have two basic
purposes: First is supplying free flow of goods, second is performing the maximum
protection. The common points of these directives are basic requirements which are
compulsory to suit and to be performed, description of conformity assessment and usage
of CE marking. For this purpose, The European Union standardization institutes have
being charged to technical specifications which perform the conformance in an only
http://www.eotc.be/
http://www.newapproach.org/
| NEW APPROACH DIRECTIVES WHICH NEEDS CE MARKING |
| Product Name |
The Related European Union Regulation |
Directive |
| 1. Low Voltage Devices |
Low voltage
equipment |
(73/23/EEC) |
| 2. Simple Pressure Vessels |
Simple pressure vessels |
(87/404/EEC) |
| 3. Gas Appliances |
Gas appliances |
(90/396/EEC) |
| 4. Hot Water Boilers |
Hot water boilers |
(92/42/EEC) |
| 5. Electromagnetic Compatibility |
Electromagnetic compatibility |
(89/336/EEC) |
| 6. Machinery |
Machinery |
(98/37/EC) |
| 7. Civil Explosives |
Civil explosives |
(93/15/EEC) |
| 8. Non-automatic Weighingi |
Non-automatic weighing instruments |
(90/384/EEC) |
| 9. Equipment and Protectiver |
Equipment and protective systems intended for use in Potentially explosive atmospheres |
(94/9/EC) |
| 10. Lifts |
Lifts |
(95/16/EC) |
| 11. Pressure equipment |
Pressure equipment |
(97/23/EC) |
| 12.Active implantable medical devices |
Active implantable medical devices |
(90/385/EEC) |
| 13.Medical
devices |
Medical
devices |
(93/42/EEC) |
| 14.In vitro diagnostik týbbi cihazlar |
In vitro diagnostic medical devices |
(98/79/EC) |
| 15.Toys |
Toys |
(88/378/EEC) |
| 16.Recreational craft |
Recreational craft |
(94/25/EC) |
| 17.Construction products |
Construction products |
(89/106/EEC) |
| 18.Personal protective equipment |
Personal protective equipment |
(89/686/EEC) |
| 19.Radio and telecommunications terminal equipment |
Radio and telecommunications terminal equipment |
(99/5/EC) |
| 20.Cableway installations designed to carry persons |
Cableway installations designed to carry persons |
(2000/9/EC) |
The Directives Which Were Improved Within Context of New Approach and
Global Approach However CE Marking Usage Is Not Compulsory:
94/62/EC Packaging and Packaging Waste Directive (20.12.1994 dated and 94/62/EC
numbered European Parliament and Council Directive)
96/48/EC Trans-European High Speed Rail System (23.07.1996 dated and 96/48/EC
numbered Council Directive)
2001/16/EC EC Conventional Rail System (19.03.2001 dated and 2001/16/EC
numbered European Parliament and Council Directive)
Global Approach Directives
96/98/EC Marine Equipments http://www.mared.org/
96/57/EC Energy efficiency requirements for household electric refrigerators,
freezers and their combinations
1999/36/EC Transportable pressure equipment
2000/14/EC Noise emission in the environment by equipments for use outdoors
2000/55/EC Energy efficiency requirements for ballasts of fluorescent lighting
Conformity Assessment - Modules
A. Internal control of production
B. EC type-examination
C. Conformity to type
D. Production quality assurance
E. Product quality assurance
F. Product verification
G. Unit verification
H. Full quality assurance (ISO 9001)
Technical Documentation
A general description of the product
• Design and manufacturing drawings, descriptions and explanations necessary for
the understanding of drawings, results of design calculation made, examinations
• A list of the standards referred to in specific article of the Directive, applied in full
or in part, and descriptions of the solutions adopted to meet the essential
requirements where standards have not been applied,
• A detailed description of manufacture.
• A description of the means (such as the use of test report or technical file),
whereby the manufacturer ensures conformity with the approved model.
• Copies of the documents the manufacturer has submitted to an approved body in
accordance with specified article for some directives.
• The test certificate for the sample or a certificated copy thereof.
Declaration of Conformity
The name and address of the manufacturer or the authorized representative
issuing the declaration;
• The identification of the product (name, type or model number, and any relevant
supplementary information, such as lot, batch or serial number, sources and
numbers of items)
• All relevant provisions complied with; the referenced standards or other normative
documents (such as national technical standards and specifications) in a precise,
complete and clearly defined way;
• All supplementary information that may be required
• The date of issue of the declaration; signature and title or an equivalent marking
of authorized person
• The statement that the declaration is issued under the sole responsibility of the
manufacturer and, if applicable, the authorized representative.
A manufacturer in Turkey must do followings in order to affix CE Marking
Determinations of new approach directives regarding the product
• Determination of the standards referred in product directives or if no reference,
determination of general security standards.
• To plan appropriate production to standard
• Determination of a module appropriate its structure as defined in directives
• If mandatory, applying to a NOTIFIED BODY and conformity assessment
operation.
• Preparing the technical file
• Affixing CE Marking by Declaration of Conformity
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