Electrical and Electromechanical Product CE Compliance with various Directives

McQueenster

Starting to get Involved
#1
Hello,
I'm new to the world of CE marking and currently navigating my way around the official EU CE websites to figure out the directives that apply to my electrical and electromechanical products and the corresponding harmonized standards.

During my search I have found that this phrase explains the EC marking process perfectly:
"The CE compliance and marking process is not difficult but it is complex"

I've come to the conclusion that a matrix linking directives with harmonized standards would be a great visual aid to identify applicable directive and trace the harmonized standards that apply (and would remove some of the mystery of CE marking).

I'm probably not the first person to see the benefit of this and wondered if anyone on the forum has created such a matrix that they can share?
 
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McQueenster

Starting to get Involved
#3
Thanks for the link Marcelo.

Are you able to help me find the harmonised standards applicable to the directives from this?

For example if I click on the link for Low Voltage (LVD) I am taken to a page that provides the LVD Directive document and a Framework document that appears only to reference certain sections of the harmonised standards and not the entire documents. For example there is a reference to EN 61010-2-030:2010. Are you able to help me understand why EN61010 is not just referenced in its entirety within the framework of implementation document?
 

McQueenster

Starting to get Involved
#5
Thanks, your reply and link has helped and clarified to me the way the harmonized standards are numbered and referenced.

I had assumed (incorrectly) that EN 61010 was the overarching standard and contained the subsections -1, -2-010, 2-030 etc. However I now see that EN 61010 is essentially a collection of standards (a multi part document).

EN61010 consists ofmany sections:
EN 61010-1 general requirements
EN 61010-2-010 Heating of materials
EN 61010-2-030 testing and measuring circuits
etc

Is there a way to reverse the applicable standards process and find out which Directives each standard applies to? For example EMC standard EN 61000-4-5 Surge immunity does not appear to be referenced in either the Low Voltage Directive or the EMC Directive which surprises me. Is it easy to find out which directive references EN 61000-4-5 Surge immunity?
 

Marcelo

Inactive Registered Visitor
#6
However I now see that EN 61010 is essentially a collection of standards (a multi part document).
Yes, 61010-1 is the general standard of the series, and the other ones are particular standards.

Is there a way to reverse the applicable standards process and find out which Directives each standard applies to?
Nope. In fact, the harmonization process is somewhat obscure. Also, the applicability of a standard does not link directly to a directive (or to only one directive). For example, the 61010 series also applies to some medical devices.

For example EMC standard EN 61000-4-5 Surge immunity does not appear to be referenced in either the Low Voltage Directive or the EMC Directive which surprises me. Is it easy to find out which directive references EN 61000-4-5 Surge immunity?
Surge is one of the aspects of EMC, in fact, there's a lot of standards that may be applicable to one product. However, generally the product standard call for other standards (for example, IEC 60601-1-2 is the applicable standard for EMC for medical electrical equipment, it calls for the application of several standards of the 61000 series).
 

Marcelo

Inactive Registered Visitor
#7
Also, from your comments, you seem to lack some knowledge on standards and how they are created/applied. I would suggest you read some of the threads on standards in Elsmar.

You should also read the Blue Guide to understand how standards are applied in the case of EU Directives.
 

CharlieUK

Quite Involved in Discussions
#8
I've seen a few people attempt to create a matrix, but never seen one that worked for a sufficiently wide range of products that is it could be both useful and not misleading.

If you post some more information about your product then I'm sure people here can point you are the correct directives, but generally you will need to look at:
EMC; LVD or Machinery; RoHS.
And then you've for R&TTE/RED for radio; ERP/EUP for number of energy using products.
 

Ronen E

Problem Solver
Staff member
Moderator
#9
From the narrow perspective of CE marking, you don't have to apply any harmonized standards. They are a voluntary path to compliance with some requirements in applicable directives.

You do have to comply with all applicable directives, regulations, commission decisions etc., and by the way, "applicable directives" is not limited to the CE marking directives (20-something in number). The first step is to identify all the applicable legislation.

Once you've identified the applicable directives you need to decide what to do to comply with them - make a high level plan. For complying with the CE directives, consider applying some of (or all) the applicable harmonized standards. Review the list under each directive (please note that those lists are updated 1-2 times a year) and see which ones are relevant to your products. Then consider the burden (costs, work) and decide which ones you want to apply. You can choose to apply a standard in part, and benefit the presumption of conformity in part, accordingly. The point is that wherever you don't apply a standard (or a part of it), or where an applicable requirement is not covered by a harmonized standard, you must define, implement and document the way(s) in which you demonstrate compliance.

For a better understanding of the CE marking scheme I recommend The Blue Guide (2014 version). It's available free online.

Cheers,
Ronen.
 

McQueenster

Starting to get Involved
#10
Hi Ronen E, thanks for your reply.

I have found that your comment about not having to apply any harmonized standards leads some business people to believe that compliance is voluntary. I have had some difficulty persuading colleagues that some documented method of assessing the product is required. I understand the harmonized standards are voluntary. However if these are not used then the manufacturer looking to CE mark their product must demonstrate compliance with the directive which can be much more difficult if the harmonized standard is not used.

If the harmonized standards are not used then I believe it normally requires the use of a third party for independent assessment for this approach and self certification is not an option.

Thanks for the link to the blue book.
 
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