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The formal definition of "Standards" from the International Organization for Standardisation (ISO) and the International Electrotechnical Commission (IEC) is "A document, established by consensus and approved by a recognised 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.”

The standards themselves impose no obligations on manufacturers, but they are often cited in European and national laws and regulations. Where they are cited in legislation, they become the legal standard to which products must conform.

A range of standards are referenced in Irish and UK legislation. These include:

  • International standards (ISO, IEC, etc.),
  • European Standards (including harmonised European Standards),
  • Irish national standards (i.e. a standard specification declared or deemed to have been declared under section 16 of the National Standards Authority Act 1996),
  • British national standards
  • National standards from other countries and
  • Standards developed by trade bodies and other entities.

They are also referenced in other documents, including guidelines, by-laws, regulations, standards (i.e. guidance documents published by State bodies) and other regulatory frameworks.

International Standards

International standards are standards which are adopted by an international standardisation body, such as the International Organization for Standardisation (ISO) or the International Electrotechnical Commission (IEC).

European (EN) Standards

European standards are standards issued by one of the three European standardisation bodies (the Comité Européen de Normalisation – CEN, the European Committee for Electrotechnical Standardisation – CENELEC, and the European Telecommunications Standards Institute – ETSI). They can be identified by the designation ‘EN’.

All national standards bodies who are members of CEN, CENELEC or ETSI must adopt their European standards as national standards and remove any conflicting national standards. This means that ENs are the generally the same in all European countries.

Harmonised European (hEN) Standards

Harmonised standards are a special set of European Standards which are used to underpin EU product legislation and are given a legal basis by Regulation (EC) 765/2008.

Harmonised standards are produced by CEN, CENELEC and ETSI in response to a mandate from the European Commission. The take on their specialised status when the European Commission lists them in the Official Journal of the European Union. Products which meet the relevant harmonised standards enjoy a presumption of conformity with the relevant essential requirements set out in the EU product legislation.

Where a hEN exists the manufacturer must use a hEN when demonstrating conformity as part of their product certification process (CE marking) of all products placed on the EU Single Market.

National Standards

A national standard is a standard adopted by a national standardisation body (NSB). They can be international (ISO) or European standards (EN, hEN) adopted as national standards or they can be developed by the NSB where no international or European standard exists

NSAI is the national standardisation body for Ireland and produces Irish Standards (I.S.).

The British Standards Institute (BSI) is the NSB for the UK and develops and adopts British Standards (BS).


UK Designated Standards

Designated standards can help manufacturers demonstrate that their products, services or processes are in compliance with Great Britain law. A designated standard is one which has been developed by consensus and is recognised by UK government in part or in full by publishing its reference on in a formal notice of publication. 

A UK designated standard can be a standard adopted by any of the recognised standards bodies or international standardising bodies below:

  • British Standards Institute (BSI)
  • European Committee for Standardisation (CEN)
  • European Committee for Electrotechnical Standardisation (CENELEC)
  • European Telecommunications Standards Institute (ETSI)
  • International Organisation for Standardisation (ISO)
  • International Electrotechnical Commission (IEC)
  • International Telecommunication Union (ITU)

Further information on UK designated standards can be found at the links below:

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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.

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.

It may not be possible to use British Standards (BS) to demonstrate conformity to EU product legislation where Regulation (EC) 765/2008 applies, even if the BS is identical to the equivalent hEN by virtue of being adopted from the same European Standard.

Manufacturers are advised to consult with relevant regulatory authorities before using a BS as part of their conformity assessment.

A range of standards are referenced in UK legislation, including  international standards (ISO, etc.), European Standards (EN), harmonised European Standards (hEN), UK national standards (BS), national standards form other countries, and standards developed by trade bodies and other entities.

They are also referenced in other documents, including guidelines, by-laws, regulations, standards (i.e. guidance documents published by State bodies).

The national building regulations regulate the use of construction products in construction projects in the UK. The aim of the building regulations is to provide for the safety and welfare of people in and about buildings.  The building regulations apply to the design and construction of a new building (including a dwelling) or an extension to an existing building.  The minimum performance requirements that a building must achieve are set out in the second schedule to the building regulations.