Management Systems Certification Application Form
CE Marking Aplication Form







CE Mark Marking Certificate

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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