NIST SP 951
A Guide to EU Standards and Conformity Assessment
Technical Harmonization: Standardization
The harmonization of standards, like laws and conformity assessment procedures, has greatly simplified technical regulation in Europe. Prior to harmonization, each country developed its own standards through a national standards body. And, like differing and conflicting laws and conformity assessment procedures, fifteen sets of standards were not only costly, but also created technical barriers to trade between European countries. It became necessary to create a new, integrated, European system of standardization.
The European Standards Bodies: CEN, CENELEC, and ETSI
The new system provides for three standards bodies to create standards on a Europe-wide level: (1) The European Committee for Standardization (CEN) in Brussels, Belgium; (2) the European Committee for Electrotechnical Standardization (CENELEC) in Brussels, Belgium; and (3) The European Telecommunications Standards Institute (ETSI), in Sophia Antipolis, France. CENELEC activities are in the electrotechnical sector, while ETSI specializes in telecommunications. All other sectors are covered by CEN.
CEN and CENELEC's principal members are national standards bodies (See Table 3 and Table 4). ETSI's membership incorporates a wider range of interested parties (See Table 5). These three are the only recognized bodies from which a European Standard (EN) can emanate. When the development of a European Standard begins in one of these organizations, development of a national standard must stop. European Standards, like European laws and European conformity assessment procedures, preempt national (Member State) standards, and replace them.
The Role of Standards in New Approach Directives
The European Standards (ENs) that play a role in New Approach Directives are known as Harmonized Standards. Harmonized Standards are standards that support European legislation. They (1) have been mandated by the European Commission, (2) have been developed by the European Standards Bodies above, (3) address essential requirements of New Approach Directives; and (4) notification of their development has been published in the Official Journal of the European Communities.
For example, the following harmonized standards have met all the conditions above and relate to certain Essential Health and Safety Requirements of the Safety of Machines Directive (98/37/EC):
| CEN | EN 894-1 | Safety of machinery – Ergonomics requirements for the design of displays and control actuators – Part 1: General principles for human interactions with displays and control actuators |
| CEN | EN 894-2 | Safety of machinery – Ergonomics requirements for the design of displays and control actuators – Part 2: Displays |
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