This article answers questions, such as “What is a standard?”, “What are EN, ISO and IEC standards?” and “How to select the correct safety standards?”.
According to the International Organisation for Standardization (ISO), standards are: “documented agreements containing technical specifications, requirements or other criteria to be used as rules or definitions of characteristics to ensure that materials, products, processes and services are fit for their purpose.” In other words, a standard is a technical document that states how to comply with a product directive. Also, safety standards provide assurances that a specific product will not cause injuries or death to their users.
Standards can pose significant barriers to international trade. For insiders, the development and enforcement of national standards based on their products’ unique properties can serve to protect national markets. However, for outsiders, the use of unique national standards in export markets can limit market access. As a result, the international struggles to differentiate or harmonise national standards in different countries are often key elements in the ongoing competition for international markets.
Overall, standards support market-based competition and help ensure the interoperability of complementary products and services. They reduce costs, improve safety, and enhance competition. In addition, standards ensure safe and quality products, services, and systems.
The use of safety standards is voluntary unless legislation, contracts or negotiated agreements (such as using ISO 9001) are applicable. More than 20 000 standards are available, covering almost every industry, from technology to food safety to agriculture and healthcare. Moreover, the standards are constantly withdrawn, newly developed or updated.
Standardisation is the process of implementing and creating technical standards based on the consensus of different parties, e.g. firms, users, interest groups, standards organisations and governments. Standardisation organisations develop and publish standards on national, international and European level.
National standardisation bodies can submit a request to an international standardisation organisation (e.g. ISO, IEEE, and IEC) to develop a safety standard. Once approved, the inquiry is allocated to a Technical Committee (TC), where the compliance experts agree on the product, process, test method, or service requirements. Then, the national standard committee works out a draft, which the public can comment on. When all comments have been reviewed, the draft standard is approved and published.
EN safety standards, a.k.a. European harmonised standards, are an integral part of CE marking. Thus, they help prove compliance with the essential requirements of the European CE directives. EN standards are developed by a standardisation institute (CEN, CENELEC, or ETSI), mandated by the European Commission. Products that meet EU harmonised standards’ requirements benefit from an automatic presumption of conformity with the corresponding essential requirements.
EN safety standards have the following content:
EN standards can be categorised into horizontal and vertical standards. Horizontal safety standards (a.k.a. basic or general standards) contain fundamental principles, concepts, definitions and terminology for a broad subject, while vertical standards, a.k.a. application standards, apply to specific products or product groups. For instance, “EN 455 medical gloves” is a typical vertical safety standard.
Moreover, EN standards can also be categorised into four major types:
Compliance with EN standards is voluntary, and manufacturers must purchase the standards to use them. National organisations and international standard organisations sell EN standards via their websites.
Find EN standards and regulations with ease using the compliance management system of Clever Compliance!
ISO standards lay out the framework for establishing a management system to address needed controls and requirements in areas such as:
Groups of experts from all around the world are responsible for developing ISO standards. These experts are usually part of technical committees and can negotiate all aspects of the standard, including its scope, key definitions and content.
Most ISO standards share the following three commonalities:
IEC standards are international standards for all electrical, electronic and related technologies. Therefore, these safety standards cover a massive range of technologies from power generation and distribution to office equipment, semiconductors, batteries, solar energy, marine energy, nanotechnology, and many others.
The International Electrotechnical Commission (IEC) is responsible for preparing and publishing IEC standards. Experts from the participating countries develop each IEC standard in a consensus process. IEC standards are often used as a foundation to globally harmonise technical requirements and specifications in IEC member and non-member countries.
IEC standards have numbers ranging from 60000 to 79999 and titles such as IEC 60417: Graphical symbols for use on equipment. Furthermore, some IEC standards are developed jointly with ISO. In such situations, the title of the standard has the following structure: ISO/IEC XXXXX.
The purpose of EN standards is to harmonise technical rules and laws within the European market. Existing ISO standards must generally be adopted as EN standards in unaltered form. However, if an IEC standard is adopted as a European standard, its technical part has minor modifications as per EN requirements.
ISO standards are standards developed by the standardisation institute ISO, and IEC standards are developed by the International Electrotechnical Commission (IEC). EN standards are usually ISO or IEC standards that the European Commission has harmonised.
ISO can develop a standard, e.g. the ISO 12100-1:2003 “Safety of machinery”. When the EU Member States approve the safety standard, the European Commission has to publish it. From that moment on, the standard is a harmonised standard, meaning that all EU Member States need to adopt this standard and withdraw any conflicting national standards.
Once an ISO standard is harmonised, it is renamed EN-ISO XXXXX. Similarly, if an IEC standard is harmonised, its title changes to EN IEC XXXXX. When an EU member state translates a harmonised standard, the name of the standard changes to, for example, BS EN ISO XXXXX or BS EN IEC XXXXX.
According to Regulation on European standardisation (EU) 1025/2012, a national standard is a standard that manufacturers can use to comply with national product safety laws and policies. According to Regulation (EU) 2019/515, when a product meets a local standard of an EU Member State, other Member States must accept the product on their markets as well. However, nationals standards must not contradict EN standards.
The standardisation system in Europe is based on the national pillars, which are National Standardisation Bodies or CEN members. National standardisation bodies transpose European standards into identical national standards and withdraw conflicting standards. CEN’s National Members are the National Standardisation Bodies of the 28 EU Member States, the Republic of North Macedonia, Serbia and Turkey, and three EEA countries (Iceland, Norway and Switzerland). And, there is one member per country.
List of National Standardisation Bodies:
As a manufacturer, you are responsible for checking that your products meet all relevant safety, health, and environmental requirements before placing them on the EU market. To do so, you have to follow the CE marking process and identify the applicable safety standards. Here are a few tips on how to select your standards.
First, answering the following questions can be of help in identifying relevant product safety standards:
Second, when selecting standards, you should do the following:
Third, you can use a digital tool, such as the “Standards Finder” available in the compliance management system of Clever Compliance, to quickly identify all safety standards that apply to your product(s). This tool allows you a free search by keywords, names, titles and scope. You can also select a specific legal act (e.g. LVD or MDR) to shorten the generated result. Upon search, you will get a preview and a short description of each standard, including name, title, legal act, validity period and a reference number in the Official Journal.