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Electrical and Electromechanical Product CE Compliance with various Directives
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Electrical and Electromechanical Product CE Compliance with various Directives
Electrical and Electromechanical Product CE Compliance with various Directives
Electrical and Electromechanical Product CE Compliance with various Directives
Electrical and Electromechanical Product CE Compliance with various Directives
Electrical and Electromechanical Product CE Compliance with various Directives
Electrical and Electromechanical Product CE Compliance with various Directives
Electrical and Electromechanical Product CE Compliance with various Directives
Electrical and Electromechanical Product CE Compliance with various Directives
Electrical and Electromechanical Product CE Compliance with various Directives
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Some Related Topic Tags
ce mark and ce marking, electrical equipment, electro-mechanical equipment
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  Post Number #9  
Old 15th January 2017, 07:46 PM
Ronen E

 
 
Total Posts: 3,366
Re: Electrical and Electromechanical Product CE Compliance with various Directives

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.
Thanks to Ronen E for your informative Post and/or Attachment!

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  Post Number #10  
Old 16th January 2017, 06:47 AM
McQueenster

 
 
Total Posts: 14
Re: Electrical and Electromechanical Product CE Compliance with various Directives

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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  Post Number #11  
Old 16th January 2017, 09:40 AM
CharlieUK

 
 
Total Posts: 113
Re: Electrical and Electromechanical Product CE Compliance with various Directives

Whether a 3rd party is required depends on the Directive:
- LVD does not have any function for Notified Bodies (NBs)
- R&TTE - allows voluntary use of NBs under some conditions, and mandatory use under others.
- Machinery - requires NBs for certain product types but cannot be used for many other products.

The manufacturer must comply with the applicable Directive(s), but the application of Harmonised Standards is Voluntary, however many market enforcement authorities expect Harmonised Standards to be applied.

Documentation requirements are specified in the Directives, for example Annex III of the LVD states: 
2. Technical documentation
The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the electrical equipment’s conformity to the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the electrical equipment. The technical documentation shall, where applicable, contain at least the following elements:
Thank You to CharlieUK for your informative Post and/or Attachment!
  Post Number #12  
Old 20th January 2017, 08:34 AM
McQueenster

 
 
Total Posts: 14
Re: Electrical and Electromechanical Product CE Compliance with various Directives

@ CharlieUK thanks for providing some of the detail behind the LVD directive. I've read through the directive and the blue book. Its a lot of information to absorb but I'm getting there.

I wonder if you can provide some guidance on some products that fall outwith the scope of LVD but are still electrical and no doubt have safety requirements.
I have two product categories that I'm investigating for CE. The product has been identified as falling into electrical equipment for measurement, control,and laboratory use
1. Portable handheld equipment supplied with a low voltage external charger (240v -> 20v) and containing either a LiIon or NiMH battery.
2. Portable equipment that requires class II earthing and is provided with an external class II mains adapter (240v AC to 20v DC). The 20v adapter output plugs into the equipment and powers it through a 3.5mm jack plug
  Post Number #13  
Old 20th January 2017, 08:55 AM
CharlieUK

 
 
Total Posts: 113
Re: Electrical and Electromechanical Product CE Compliance with various Directives

The guide to the LVD, http://ec.europa.eu/DocsRoom/documents/20341, says

Battery operated equipment outside the voltage rating is obviously outside the scope of the LVD. Nevertheless, any accompanying battery-charger as well as equipment with integrated power supply unit within the voltage ranges of the Directive are in the scope of the LVD. This applies also, in the case of battery operated equipment with supply voltage rating below 50 V AC and 75 V DC, for their accompanying power supply unit (e.g. notebooks).

So strictly speaking one could say that it is only the external charger that falls under the LVD, but equipment that is sold to consumers falls under the General Product Safety Directive where other Directives (such as LVD) don't apply. Also, products used in the workplace must be safe under national health and safety legislation.

The external PSU will address some of the hazards, but rechargeable batteries, particularly LiIon, present risks.

My advice would be to apply the LVD and an appropriate standard as this is the most defensible position.
Thanks to CharlieUK for your informative Post and/or Attachment!
  Post Number #14  
Old 23rd January 2017, 05:35 AM
McQueenster

 
 
Total Posts: 14
Re: Electrical and Electromechanical Product CE Compliance with various Directives

@CharlieUK, Thanks for the pointer to the General Product Safety Directive 2001/95/EC. I see that testing battery operated equipment to the LVD standard would provide a robust defensible position should there be any safety issues with the product in the marketplace.

Regarding the self certification for products, can you confirm that the CE mark can only be applied to the product using this process if the manufacturer applies the voluntary harmonised standards? And therefore there is a presumption of conformity.
  Post Number #15  
Old 23rd January 2017, 08:25 AM
CharlieUK

 
 
Total Posts: 113
Re: Electrical and Electromechanical Product CE Compliance with various Directives

As Ronen says, you don't have to apply Harmonised Standards, however they:
- give a "presumption of conformity" with the Directive
- are what customs and market enforcement expect to see on your DoC - you don't have to do this, but using other methods would probably raise questions (I know this happens).

With any rechargeable battery, I would however recommend using a suitable Harmonised Standard. I would also only use a battery that was certified to an appropriate EU or US standard (such as IEC 62133 or UL1642).
Thank You to CharlieUK for your informative Post and/or Attachment!
  Post Number #16  
Old 23rd January 2017, 08:19 PM
Ronen E

 
 
Total Posts: 3,366
Re: Electrical and Electromechanical Product CE Compliance with various Directives

Quote:
In Reply to Parent Post by McQueenster View Post

Regarding the self certification for products, can you confirm that the CE mark can only be applied to the product using this process if the manufacturer applies the voluntary harmonised standards? And therefore there is a presumption of conformity.
Unfortunately there is no recurring theme across the 20-something CE marking directive regarding self-certification vs. 3rd party certification. The mechanics are detailed within each directive, so it depends on what set of directives are applicable.

Regarding harmonized standards, they are (voluntarily) applicable and useful to the same extent whether it's a self-certification or not.
Thanks to Ronen E for your informative Post and/or Attachment!
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