valid EN standards are “listed„ / “harmonised” (a fixed term within this context).
“presumption of conformity” only applies to listed (harmonised) standards.
Presumption of conformity: A user who constructs or builds machinery in accordance with the specifications of a harmonised standard is “presumed” to conform to the requirements of EU directives and/or national legislation.
Example: EN ISO 13849-1 (Safety of machinery – Part 1)
If a machine builder does not apply harmonised standards (bearing in mind that, in principle, he or she is not required to do so), then there is a reversal of the burden of proof.
This means that, within 48 hours of an accident occurring, the machine builder must prepare all the documentation proving compliance with the requirements of the relevant EU directives. After an accident at work involving damage to machinery and possibly to persons too, this procedure can make a significant difference!
Implementing Standards in The EU
EU directives are aimed at member states.
Machinery Directive, Low Voltage Directive & Electromagnetic Compatibility Directive are essential considerations within the context of machinery construction.
Laws & ordinances
Generally, involve direct implementation of EU directives into national legislation Standards, Laws & ordinances are not able to set out all specifications. Standards are intended to help users comply with laws & ordinances. This can only be done with standards that have been approved by the EU (harmonised) for this purpose.