CE Marking
The European Union had been ensuring the quality and safety of products by establishing their own standards. After the merger of the European market, however, these standards disturbed the products to be liberalized in distribution to the EU market.
In 1985, the varied standards on the product safety and quality among the EU member nations were unified, abolishing the technical trade friction, and adopting a new approach, which is "Harmonized Technical Standards for Products" aiming at smooth distribution of the product whose safeness has been assured.
By adopting this resolution, the EU Directive stipulated the safety standards to meet the specific fields of the product and their characteristics. Each EU nation adjusted the safety regulation, thus a common safety standard established within the region.
This directive relating unification of product safety and quality is called "The New Approach Directive".
The CE mark must be affixed to a product as a sign of meeting the requirement under "The New Approach Directive" and the manufacturers, exporters and agents undertake obligations.
By affixing this legal CE mark, the free distribution in the EU market will be accepted.
CE:These are the initial letters of" Communaute Europeenne" in the French words. The dimensions of the letters can be scaled up and down in proportion. The height of the letters shall be at least 5mm.
EU Directive
EU Directive regulates the human essential health and safety requirements based on "The New Approach Directive" to establish a conformity evaluation method. The harmonic standard is used to meet the basic requirements on each Directive.
The table shown below is an example of the major directives. EMC Kashima offers the service for the EMC Directive, the Low Voltage Directive, the Machine Directive etc.
| Subject of Directives | Equipment applied | Directive Reference |
|---|---|---|
| EMC Directive | Equipment that is likely to generate electromagnetic disturbance, or equipment whose function is likely to be affected by such disturbances. | 2004/108/EC |
| Low Voltage Equipment directive | Equipment that works less than AC1000V, DC1500V. It covers house hold appliances, business equipment and industrial equipment. |
2006/95/EC |
| Medical Devices directive | Medical devices that are applicable for instruments, apparatus, materials or other articles to be used for human beings for the purpose of treatment, diagnosis, etc. | 93/42/EEC |
| R&TTE | The wired equipment such as a fax machine and a modem that are connected to a public circuit and the wireless equipment intended for a short distance communication. | 1999/5/EC |
| Machinery Safety | Any machine which has at least one operating part such as a machine tool, construction machinery, woodworking machinery, textile machinery, Robot, Parts mounting machinery, and Testing machinery | 98/37/EEC |
Modules
Each directive has specified a conformity assessment procedure to meet the essential requirements.
There are eight types of modules from A to H and which module you should select is determined by the conditions stated below.
- The stage of development of the product
- The type of assessment involved
- Who carries out the assessment
It is common to all modules that the manufacturers themselves draw up the declaration of conformity and affix the CE marking to each product. Most of the products distributed in the EU market are of the declaration of conformity of Module A or Aa.
Module A
Module A is the easiest way for the manufacturer to assess the conformity of their products.
This is a method to declare that the product meets the requirement by making a technical document (TCF: Technical Construction File) to verify it.
Module a
Module Aa is the way of self-declaration by performing the individual test of their Module A products at the outside accredited lab.
Required documentation for CE Marking
DoC:Declaration of Conformity
The documentation needs to include following contents.
- Name of manufacturer or agent and location
- Name of product, model, serial number and other information related to the product
- The directive and harmonic standard applied
- Supplementary situation such as the classification and field (if necessary)
- Date and signature of the document and title of the signatory and others
Technical Construction File (TCF)
One or more copies of this document shall be preserved in the EU region for ten years from the termination date of manufacturing the product. Incase that there is an overseas subsidiary or a deputy of the importer in EU, they shall keep this/these copies in custody. For example, the document includes the followings.
- General explanation such as instructions and specifications
- System block diagram, wiring diagram, and schematic diagram and others
- Explanation of content for safety measures carried out to meet the requirement on standard list and directives.
- Inspection of contents that was performed.
- Test report
CE Marking Support Service
EMC Kashima supports customers to obtain the CE marking by focusing on EMC Directive, Low Voltage Directive and Machinery Directive.
