Harmonized Standards

Harmonized Standards are technical specifications adopted by European standardisation bodies (CEN, CENELEC, or ETSI) following a mandate from the European Commission. Unlike generic international standards, these are specifically published in the Official Journal of the European Union (OJEU). For North American manufacturers, these standards represent the most efficient "safe harbor" for compliance.

While EU Directives outline broad safety goals, Harmonized Standards provide the specific technical benchmarks—such as exact guard distances or electrical test methods—needed to achieve them. The critical legal benefit they offer is the "presumption of conformity."

If you design your machinery strictly according to these standards (for example, using ISO 12100 for risk methodology), authorities legally presume you have satisfied the relevant Essential Health & Safety Requirements (EHSRs). This significantly lowers the burden of proof in your Technical File, making it much harder for a Notified Body or customs official to challenge your equipment's safety during an audit.