NIST SP 951
A Guide to EU Standards and Conformity Assessment

Perhaps more importantly, ISO 9000 registration (or EN 29000 certification) is used voluntarily but extensively in Europe as a condition of acceptance of a manufacturer's product or as a means of recognition of the manufacturer's credibility. It is estimated that, as of 1994, 78% of all ISO certificates worldwide were issued in Europe. The U.S. exporter, therefore, should be aware not only of the use of EN 29000 in regulation, but of its use in contractual arrangements with a European customer.

It is important to note that a manufacturer with a quality system in place (such as ISO 9000) should not automatically assume that his or her products are CE compliant because of the quality system alone. The appropriate New Approach Directive(s) will prescribe the correct and full route to conformity assessment.

Introduction to the Basic Principles of Compliance

CE Marking

The CE mark is aptly called the passport to Europe for products. CE marking a product, like carrying a passport when entering a foreign country, is not an option. It is required by law if the product falls under one of the New Approach Directives. It is not a quality mark, nor is it a mark for consumers. Intended for Member State authorities, it is the visible sign to those authorities that your product is in compliance with the New Approach Directives. All manufacturers, European, American, Japanese, or other, are required to affix the CE mark to products that are governed by New Approach Directives. CE marking on a product indicates to all authorities that the product is in compliance with the essential health and safety requirements of all directives that apply to the product.

Determining Which Directives Apply to the Product

The first step to compliance is determining which directives apply to the product. A product may be regulated by more than one directive. For example, machinery is obviously regulated by the Machinery Directive (98/23/EC); but machinery that is powered by electricity is also regulated by the Low Voltage Directive (73/23/EEC). The LVD addresses the hazards associated with the electrical aspects of the machine. Likewise, all electrical products are governed by the Electromagnetic Compatibility Directive (89/336/EEC), which addresses the hazards associated with electromagnetic interference. Most machinery is regulated by at least three New Approach Directives: (1) Safety of Machinery, (2) Low Voltage, and (3) Electromagnetic Compatibility. But there may be others that apply. If a machine contains a pressure vessel, for example, it would also be regulated by the Simple Pressure Vessel Directive (87/404/EEC). The CE marking affixed to a piece of machinery, therefore, would indicate to authorities that the product has addressed all the risks associated with the product, whether or not those risks are defined in the Machinery Directive, the Low Voltage Directive, the EMC Directive, or any other directive that addresses a risk associated with the machine. Before affixing the CE mark, therefore, the manufacturer must make sure the product complies with the law by (1) determining which New Approach Directives govern the product, (2) applying the appropriate standards, and (3) carrying out the appropriate method of conformity assessment.

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Technology Services, Standards Services Division, Global Standards and Information Group Contact: maureen.breitenberg@nist.gov A Guide to EU Standards and Conformity Assessment, NIST SP 951

Date Created: 05/31/00 Last Modified: 05/31/00