Harmonized Standard Compliance

[farmer2]

To meet 98/37/EG, I have understood that one must meet a harmonized standard (if one exists) in order to declare conformity. However, in the New Approach website, there is a statement that "Compliance with harmonised standards remains voluntary".

If a company has been using self-declaration and there is now a harmonized standard, does that mean one has to now meet the harmonized standard or can continue self-declaration for CE compliance? If there has been a standard in only one country such as Germany, do they have to now meet the new harmonized standard or is there a choice?

Thanks,

 

[ijzer]

as long as you fulfill the essential safety requirements of the PED , you can use any standard you like. The use of Harmonized standards is not compulsery.

 

[farmer2]

Sorry, the number should be 98/37/EC (not EG). It is the Machinery Directive.

An EN standard for winches has just been approved and as I understand the rules, it will become a harmonized standard under 98/37/EC in 2 years. The standard has some requirements which are not practical or even possible without major redesign at great cost.

 

[dwt]

It's been a couple of years now, but as I recall you can declare conformity to the Machinery Directive based on any standard you want, even internal ones. However, if you meet a harmonized standard, then you have a Presumption of Conformity.
So basically if you do not use the harmonized standard the onus will be on you to demonstrate that your winch meets the requirements of the Machinery Directive. If you meet the harmonized standard, you are presumed to have meet the requirements of the Directive. Typically the only time you'll have to prove this is after there has been an "incident".
I would suggest that you have a close look at any European competitors to see how they are meeting the requirements.

 

[ggarciae]

I agree dwt.
But I'd like you to notice that standards and declarations are not the same.
Standards are for compliment of technical requirements and declarations are for declare your product fullfil those Standards and Directives.
Even if you use an harmonized standard you must go on doing self-declaration or whichever procedure fits for declaration of conformity.


Regards from Barcelona
G. García

 

[dwt]

Right on ggarciae.
"Even if you use an harmonized standard you must go on doing self-declaration or whichever procedure fits for declaration of conformity."

You still have to do your homework and due diligence.