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:
Scope – it sets out the field of application of the standard.
Terms and definitions
Requirements – descriptions of how to meet the more general requirements of the related directive.
Warnings, markings and instructions – this section describes how to properly instruct users about product risks and inform them about important product characteristics.
Test methods- information on how to test a product for conformity with the essential requirements of the applicable directive and document the results in the technical file.
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:
Fundamental standards that are about terminology, signs and symbols, etc.
Test methods and analysis standards that measure product characteristics
Specification standards (e.g. product standards and service activities standards)
Organisation standards, such as quality management
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.