Using standards to comply with the essential requirements of the CE directives

Yesterday I received an interesting question from Graham Ritchie about how standards can be used to comply with the essential requirements from CE directives. I believe his question and my reply can be useful for others and so I post it here.

Han,
I have had some discussion with some of my colleagues on CE marking and the requirement to meet the relevant directives before equipment can be CE marked.
The train of thought is that to meet the relevant Directive for example the Machinery Directive equipment has to meet IEC or EN standards.
I have read the blue book and the machinery directive and it states that equipment has to meet the EHSR’s and if it meets IEC or EN standards it is presumed to meet the requirements “Products manufactured in compliance with harmonised standards benefit from a presumption of conformity with the corresponding essential requirements” . But it does not state that these are mandatory therefore if a  manufacturer has other relevant standards that they use can be proven to meet the relevant EHSR’s for example by using an applicable API then equipment can be CE marked using this as justification” Application of harmonised or other standards remains voluntary, and the manufacturer may always apply other technical specifications to meet the requirements”..

The quotes are taken from the blue book
Can you please give me your thoughts on my interpretation
 
Thank you
Regards
 
Graham Ritchie
Senior Project Engineer

I replied Graham as follows:

Dear Graham,

You are correct that the European CE Directives refer to standards as a way to prove compliance with the Essential Health and Safety Requirements (ESHRs). 

Please note that this ‘presumption of conformity’ only is accepted for European harmonized standards, which are EN standards that have been published by the European Commission on a list. IEC standards or ISO standards do not lead to this presumption of conformity, but some IEC or ISO standards are also adopted as EN standards (and through their status as EN standard these ISO/IEC standards would lead to a presumption of conformity).

The application of standards is not obligatory. Only the ESHRs are obligatory. The application of standards is beneficial. As said, some standards (European harmonized standards published on a list) lead to a presumption of conformity. And that means they provide a clear and easy way to prove compliance. But even when there are no European harmonized standards available it is useful to use other standards, as standards are consensus documents and refer to industry practice. 

I can recommend the following procedure to deal with ESHRs and standards:
1. Study the ESHRs of the applicable directives and determine which requirements apply.
2. Determine if your product complies with the applicable ESHRs.
3. Study the list(s) of European harmonized standards that pertain to the applicable European CE Directives, and make an inventory of the standards that apply. First search on the list for product specific standards. These are standards that are written specifically for your products (for example the EN 415-8 is the standard for strapping packaging machines) . If there are no product specific standards, search for standards that apply to the aspects of the product (for example EN 349-1 is about safety of machinery – minimum gaps to avoid crushing of parts of the human body), or generic standards (for example EN-ISO 12100 is about safety of machinery). 
If you cannot find any applicable standard on the lists of the European Commission, but you have found other standards, you may apply them. However, please note that you always should start with applying European harmonized standards, and not with other standards. Note also that standards that are not published on the aforementioned list do not have the benefit of ‘presumption of conformity’
4. Determine if your product complies with the applicable standards.”

I hope this reply to Graham is helpful for you too.

You may know that as our member, you have access to the section in our Library where you can find the latest versions of the lists of European harmonized standards that the European Commission publishes for the various CE directives. In our ‘How to do CE Marking Self-Certification: the Definite Course’ we also include checklists with which you can easily document the conformity assessment against the ESHRs and even some standards.

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