|
|
NIST SP 951
Another striking difference between the two is policy regarding membership in standards bodies. Membership in a national standards body in Europe requires that the member be European or have a business interest or manufacturing presence in Europe (membership in a national standards body is a prerequisite for participation in the European Standard Bodies, except for ETSI, where participation is open to other nationals). In the United States, in the large, full consensus standards developing bodies, membership is unrestricted. Depending on the sector and global interest in the subject, therefore, membership on a U.S. technical committee can be international in scope. The RelationshipsThere is a relationship between U.S. standards activities and those in the EU. Two organizations, the American National Standards Institute (ANSI) in the United States, and the International Organization for Standardization (ISO) in Geneva, Switzerland, act as bridges to CEN, and ANSI, via the United States National Committee (USNC), and the International Electrotechnical Commission (IEC) in Geneva, Switzerland, act as bridges to CENELEC. The American National Standards Institute (ANSI) is the U.S. representative to the ISO. It is also, via the USNC, the U.S. representative to the IEC. Each European national standards body represents its country in the ISO and the IEC. The technical committees of both the ISO and the IEC, therefore, are where technical experts from the EU countries meet technical experts from the United States to develop international standards. In addition, there are technical cooperation agreements between CEN and the ISO and CENELEC and the IEC. These agreements more closely align their work. These agreements are known as the Vienna (CEN/ISO) and Dresden (CENELEC/IEC) Agreements. In certain areas (such as recreational craft), the standards recognized for use in connection with European legislation are in effect the ISO standards. It is also possible for U.S. interested parties to comment on draft CEN and CENELEC standards through ANSI. ISO 9000The first quality management system standard was developed in Europe by the British Standards Institution (BSI) in 1979. BSI took the activity into the ISO, and the result was the ISO 9000 series of standards that are so well known and widely used throughout the world today. When the European Commission adopted these standards as part of the Global Approach, they became an integral and official part of the European conformity assessment scheme. The European designation for this set of standards is EN 29000 (See Modules). Two New Approach Directives (Active Implantable Medical Devices and the Radio Equipment and Telecommunications Terminal Equipment and the Mutual Recognition of their Conformity) designate a full quality management system (EN 46001 for Medical Devices and EN 29001 for RTTE) as a full route to CE marking. However, a less comprehensive form of this standard may be used, along with other methods of conformity assessment, to meet the essential requirements of this directive and other directives as well. Return to the Table of Contents
|
Previous Page