International Standardisation - Objectives and Procedures

In the field of cleanroom technology, international harmonisation of standards is driven by two entities:

 on a European level by CEN, the European Committee for Standardization;

 on a totally global level by ISO, the International Organization for Standardization.

ISO, established in 1947, is a worldwide confederation of national standards bodies - one per nation - and it comprises at present 146 members³, both technically developed nations and nations in development. Of these, 94 are full members enjoying voting rights, the remaining member bodies being correspondent and subscriber members. The scope of activities covers all kinds of technical standardization except electrical engineering and electronics. Its objective is to promote standardization on a world wide basis: it aims at facilitating international exchange of goods and services, and at developing co-operation in the spheres of intellectual, scientific, technological and economic activity. ISO is independent from the various political and economical blocks in existence throughout the world.

CEN, on the other hand, has been established in 1975 as a common organ of the European Community (now European Union EU) and the European Free Trade Association EFTA. Its objective is the elimination of technical barriers to trade between the CEN member nations through harmonisation of the European technical standards. Its scope of work is identical with that of ISO. Presently, it embraces the 18 standardization bodies of the EU and EFTA nations plus those of the Czech Republic, Hungary, Maltaand Slovakia. The other nations now applying for EU membership are expected, and indeed required, to join before long.

ISO and CEN have harmonised their standardization activities to the widest possible extent through the Vienna Agreement on Technical Co-operation between ISO and CEN. It entered into force in 1991 and establishes procedures for the mutual recognition of standards developed within one or the other of the two organisations.

What is the impact of this agreement on mutual recognition of standards?

If ISO and CEN agree on the development of standards for a given technical field, the ISO and CEN approval procedures will be triggered in parallel. If through this procedure a standard is approved on ISO level, it will be published in the ISO collection of standards as International Standard. Each nation is then free to decide whether it wishes also to include it in its own national collection of standards. If the standard has also been approved during the parallel CEN voting, then all CEN nations are bindingly obliged to include this standard into their national standards collections as European Standards. Furthermore, all national standards conflicting with the European Standard thus adopted must be withdrawn, and no new national standards on the same subject may be elaborated henceforth.