The compliance with European Standards is not mandatory but it is the simplest way to achieve compliance with the Directives. Legislation may refer to European Standards which make them legal requirements. ![]() Compliance with the harmonized European standards will provide a presumption of compliance with the corresponding requirements of the Directives (52). Harmonized standards are EN requested by the European Commission designed to facilitate compliance with EU Directives however, not all ENs are harmonized standards (52). ![]() ![]() Standards (also known in Europe as ‘norms’) are publications that provide rules, guidelines or characteristics for activities or their results, for common and repeated use, to increase product safety and quality (52).Įuropean standards (prefixed EN) are adopted by the European standards organisations (ESOs) such as the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC) and the European Telecommunications Standards Institute (ETSI) (52). ![]() Holmes, in Decontamination in Hospitals and Healthcare, 2014 20.3.5 Relevant European/international/British Standards
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