What does “presumption of conformity” mean?


The EU has put into force several CE Directives that contain basic health and safety requirements, for instance, for machinery. These are mandatory but their phrasing is often quite general. The European standardisation associations CEN and CENELEC are therefore publishing more detailed technical rules in standards.


How can machine manufacturers use the standard as evidence? 

If the application of such a standard leads to fulfilment of the respective EU directive, the EU will publish a reference to the standard in the Official Journal (OJ).  
From the date of publication, machine manufacturers may use the standard as evidence that they have correctly applied the EU regulation.  
This concept is called “presumption of conformity”. The concept is formulated in all EU directives requiring CE Marking. As the term implies, the EU “presumes” (considers or judges) that the rules in the standard match the legal requirements and help achieve conformity with them. 

A guard must be located at “an adequate” distance from the danger zone 

As an example, take a requirement for guards that appears in the Machinery Directive in Annex I section 1.4.1. It says that a guard must be “located at an adequate distance from the danger zone”.  

This is very general explination; it does not say anywhere what distance is “adequate”. But a European and international standard does, EN ISO 13857. This standard has a “presumption of conformity” because it is listed in the OJ.  

So if a machine manufacturer designs to meet the safety distance specifications in EN ISO 13857 they have also fulfilled the respective requirement in the Machinery Directive. 

The machine manufacturer who wants to benefit from the presumption of conformity must name the standards they have applied in their Declaration of Conformity for the product, (state the number, the title, and the publishing date of each standard applied). 

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