Guide on the use of standards for the implementation of the EMC Directive to apparatus
Edition 3, 2009-12
The EMC Directive, 2004/108/EC states that a presumption of conformity with the protection requirements (emission and immunity) related to EMC shall exist for all apparatus in conformity with those harmonised standards (ENs) that are identified as relevant by publication of their reference numbers in the Official Journal of the European Union (OJEU).
The presumption of conformity is limited to the scope of the harmonised standard(s) applied and the relevant protection requirements covered by the harmonised standard(s).
This third edition of Guide 25 updates the guidance in the light of the application of Directive 2004/108/EC, and updates the references to the standards.
Note da Assobiomedica e Preview della nuova Ed. 3 della norma ISO 14971:2019 e Guida collegata ISO/TR 24971:2019 in pubblicazione a Settembre
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