What are standards?
The formal definition of "Standards" from the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) is "A document, established by consensus and approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context.”
Standards in the EU
There are mandatory standards which are enforced through a regulation or a directive (wherein the word “shall” is typically employed). They represent about 20% of standards produced. Products being put on the EU market must undergo conformity assessment by an EU Notified Body to demonstrate that they comply to the harmonised standard, examples include Medical Devices, as all medical devices are currently required to have a CE Mark affixed on their product. There are also voluntary standards which represent the bulk of current standards.
There are typically 4 categories of standards:
- International Standards
- Harmonised European (hEN) Standards
- European (non-hEN) Standards
- National standards
International standards are standards which are adopted by an international standardization body, such as the International Organization for Standardization (ISO) or the International Electrotechnical Commission (IEC).
Harmonised European (hEN) Standards
Harmonised standards are produced in response to a mandate from the European Commission to the European standards organizations, the Comité Européen de Normalisation (CEN), the European Committee for Electrotechnical Standardisation (CENELEC) and the European Telecommunications Standards Institute (ETSI). When adopted, they are listed in the Official Journal of the European Union. Products within the scope of the relevant Directive, produced in accordance with Harmonised standards, will enjoy a presumption of conformity with the relevant Essential Requirements (ERs).
European (EN) Standards
European standards are voluntary recognised standards issued by one of the three EU standardization bodies (the Comité Européen de Normalisation [CEN], the European Committee for Electrotechnical Standardisation [CENELEC] and the European Telecommunications Standards Institute [ETSI]) and are developed in conjunction with interested parties e.g. Manufacturers, etc. They impose no obligation, but they do indicate a recognised standard to which certain products should conform.
A national standard is a standard adopted by a national standardization body.
NSAI is the national standardisation body for Ireland and produces Irish Standards (I.S.)
All standardisation organizations in Europe are obliged to not only withdraw national standards if a European one is being developed, but if they wish to develop a national standard, they must first ask their European counterparts if they are interested in developing a European standard before commencing such work at a national level.
Why are standards so important in the EU?
In the EU, a common regulatory framework ensures a level playing field. Member States implement common rules and work to put in place a common European standards framework, which guarantees that no Member State could gain a competitive advantage by undercutting a common set of standards or regulations.
Brexit's impacts on standards
Looking ahead in the long-term, it is likely that internationally recognised standards will continue to be acknowledged and trusted all over the world as a mark of value, transparency and an assurance that a level of quality has been reached. As trade becomes increasingly global, internationally recognised standards will become more important.