Guide to Products Conforming to International Standards
“CE” came originally from the French “Communauté Européenne” (the European Community, predecessor of the European Union) and now stands for “Conformité Européenne” (European Conformity).
As of March 2011
|Purpose of CE Marking
CE marking signifies that the product or device to which it is applied meets all essential requirements of applicable EC directives.
Since January 1995, all products and devices exported to EU member countries must carry a CE mark.
CE marking is a standard managed by the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC). Certification and CE marking are essential for exports to Europe.
In this respect, products and devices subject to EC directives that are exported from Japan to EC member countries or distributed in such markets must conform to the relevant EC directives.
By preparing a Declaration of Conformity and affixing the CE mark, the manufacturer itself, usually in a process of “self-certification,” states that its product or device is safe and in compliance – and on that basis is free to distribute it within EU member countries and various other countries.
Without the CE mark showing compliance, distribution in EU member countries is not allowed.
|Countries Requiring CE Marking
CE marking is required in EU countries. It is also required by, among others, Norway, Iceland and Liechtenstein as members of trading communities in Europe such as the European Free Trade Association (EFTA), and by Turkey, which does not belong to either the EU or the EFTA (as of November 2010).
|EC Directives and EN Standards
EC directives require EU member countries to incorporate a specified result into their domestic laws and are formally called “Directive of the European Parliament and of the Council on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States.” As a result, national laws throughout the member countries are made consistent and technical obstacles are eliminated. Products covered by EC directives are required to show conformity with such directives through the affixing of the CE mark.
Major directives related to SMC products are as follows:
1. Low Voltage Directive
This directive applies to equipment with rated voltage between 50 and 1000 VAC or between 75 and 1500 VDC, and requires prevention of electrical danger.
2. EMC Directive
This directive relates to electromagnetic compatibility (EMC), and requires prevention of electromagnetic noise emissions with adverse effects on other equipment, and protection (emissions immunity) from electromagnetic noise emitted by other equipment.
3. Machinery Directive
This directive applies to industrial machinery, primarily machine tools, injection molding machines and automated machines, and requires all essential safety items.
EC directives give required results, not details of designs or design standards, test standards or the like. Such details are then described in EN standards, which are harmonized standards.
Included are medical devices, simple pressure vessels, building materials, gas-fuel-fired equipment and body protective gear, as well as toy safety and machine safety. All prescribed products must carry CE marks. In order to use the CE mark, a document showing that the product meets required standards is necessary.
|Affixing CE Marks and Declaration of Conformity
Affixing the CE mark means that the manufacturer itself has determined that the product conforms to applicable EC directives. The manufacturer is responsible for affixing the mark, usually in association with a declaration of conformity.
If there is a safety problem with a product or device bearing the CE mark and the product had been properly used, or if nonconformity with EC directives is determined, the relevant EU member country may take appropriate action. It can restrict free movement of the product or device, remove it from the market, prohibit shipment, operation and use, and more.
|SMC Attitude and Commitment
For almost all its products falling under EC directives, in order to make its self-declarations more reliable, SMC clarifies criteria for the applicable standards and reaffirms safety.