National and international standards systems and Identification of standards:
A country may have many voluntary standards bodies. However, normally there is one official national organization that coordinates and accredits the standards development bodies in the country. This official national organization would have the authority to endorse a document as a national standard in accordance with official criteria, and it also represents the country in the various international standards organizations. In the United States, the American National Standards Institute (ANSI), a private, non-profit organization, is an official national organization. In Canada, it is the Standards Council of Canada (SCC), a crown (government) corporation. In Europe there is a committee composed of CEN (Comité Européen de Normalisation), CENELEC (the European Committee for Electrotechnical Standardization) and ETSI (the European Telecommunication Standards Institute) that supercedes the various European national standards bodies that were in place previously.
For developing countries, reference to a standards system not only helps medical device administration, it is also important for other industrial and economic developments. International development agencies increasingly realize that a standardized infrastructure is a basic requirement for the success of economic policies that will improve productivity, market competitiveness and export capability.
The three major international standardization organizations are the International Organization for Standardization (ISO), the International Electrotechnical Commission (IEC), and the International Telecommunication Union (ITU). Generally, ITU covers telecommunications, IEC covers electrical and electronic engineering, and ISO covers the remainder. For information technology, risk management, quality systems and many other areas, joint ISO/IEC technical committees manage standardization.
Other organizations also produce documents on international standardization. Their documents are usually adopted by ISO/IEC/ITU as international standards if they have been developed in accordance with international consensus criteria. Any grouping of five member countries can also propose a standard to be considered by ISO for adoption as an international standard.
Useful web sites include: www.iso.ch, www.IEC.ch, and www.itu.int/ for the ISO, IEC and ITU respectively. From here, links to national or regional standard organizations are indicated.
Identification of standards:
Standards are generally designated by an alphabetical prefix and a number. The letters (e.g. ISO, IEC, ANSI, CAN, EN, DIN) indicate the body that has approved them, while the numbers identify the specific standard and the year in which it was finalized. The standard reference code often gives an indication of adoption where standards are equivalent. For example:
1. CAN/CSA-Z386-94 means a standard developed in 1994 by the Canadian Standards Association (CSA, one of four accredited Canadian standards development organizations) and designated by the Standards Council of Canada (SCC) as a Canadian national standard.
2. ANSI/AAMI/ISO 15223:2000 means the international standard ISO 15223 (established in 2000) adopted by the Association for the Advancement of Medical Instrumentations in the United States, which in turn is designated by the American National Standards Institute (ANSI) as an American national standard.
3. UNI EN ISO 9001 indicates an Italian national standard (UNI) which is an adoption of a European standard (EN), which is itself an adoption of the International Standard ISO 9001.
National and international standards systems and Identification:
