Last checked: 09/02/2021

Standards in Europe

Coronavirus: European standards for medical supplies

European standardisation bodies have made available for free a number of standards for medical devices and personal protective equipment:

EN 149:2009 Respiratory protective devices – Filtering half masks to protect against particles - Requirements, testing, marking (commonly referred to as 'FFP masks')
EN 14683:2019 EN Medical face masks - Requirements and test method
EN 166:2001 Personal eye-protection – Specifications
EN 14126:2003 Protective clothing - Performance requirements and tests methods for protective clothing against infective agents
EN 14605:2009 Protective clothing against liquid chemicals - performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only
EN 13795-1:2019 Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
EN 13795-2:2019 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods
EN 455-1:2000 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes (MDD)
EN 455-2:2015 Medical gloves for single use - Part 2: Requirements and testing for physical properties (MMD)
EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation (MDD)
EN 455-4:2009 EN Medical gloves for single use - Part 4: Requirements and testing for shelf life determination (MDD)

Standards and other standardisation publications are voluntary guidelines providing technical specifications for products, services, and processes - from industrial safety helmets or chargers for electronic devices to service quality levels in public transport. Standards are developed by private standardisation organisations usually on the initiative of stakeholders who see a need to apply a standard.

Although standards as such are voluntary, using them proves that your products and services reach a certain level of quality, safety, and reliability.

In some cases, standards are referenced in legislation as a preferred way or even as a mandatory requirement to comply with specific laws (i.e. safety legislation or interoperability requirements).

Main benefits of using standards

Standardised quality and safety of products help your business to build consumer confidence. For example, tools and equipment designed and tested according to standards give better protection for professionals such as firefighters and hospital staff.

Services designed according to service standards , e.g. scuba diving courses, ensure a high level of quality and safety for the consumer.

Standards help to protect the environment and the consumers' health. For example, standards provide measurement methods to monitor and control air pollution. Food hygiene standards provide classification and test methods for materials in contact with food.

Better access to markets: standards can open up markets by making your products or services compatible and comparable.

Standards can help to improve interoperability between products or services. For example, standards advise on the size of the rail tracks to ensure the safety of trains.

European standards

European standards are adopted by one of the 3 European standardisation organisations (ESOs):

European Committee for Standardisation (CEN )
European Committee for Electrotechnical Standardisation (Cenelec )
European Telecommunications Standards Institute (ETSI )

At national level, standardisation is managed by national standardisation bodies (NSBs) who adopt and publish national standards. The NSBs also transpose all European standards as identical national standards and withdraw any conflicting national standards.

Choose a country to find the relevant national standardisation body:

Choose country:

European standards are developed in close cooperation with industry and other relevant members or partners of the ESOs.

Small and medium enterprises are represented in the standard making process by the Small Business Standards association.

Harmonised standards

Harmonised standards are a specific category of European standards developed by an ESO following a request, known as a 'mandate', from the European Commission. About 20% of all European standards are developed following a standardisation request from the European Commission.

You can use harmonised standards to prove that your products or services comply with the technical requirements of the relevant EU law.

Technical requirements given in EU legislation are mandatory, while the use of harmonised standards is usually voluntary.

Harmonised standards establish technical specifications which are considered suitable or sufficient in order to comply with the technical requirements given in EU legislation.

In most cases, using harmonised standards is voluntary. As a manufacturer or service provider, you can choose another technical solution to fulfil the legal requirements.

How to find a standard

To search for a European standard you can use one of the search engines on the European standardisation organisations' portals:

Cenelec for electrotechnical standards
ETSI for telecommunication standards
CEN for all other sector standards

Each of the national standardisation bodies (NSBs) has its own search engine. To find out more about the standards valid in each country, choose a country from the list above and follow the instructions.