Electrical and Electromechanical Product CE Compliance with various Directives

[CharlieUK]

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. [FONT=EUAlbertina,EU Albertina][FONT=EUAlbertina,EU Albertina]Technical documentation
[/FONT][/FONT]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:

 

[McQueenster]

@ 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

 

[CharlieUK]

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.

 

[McQueenster]

@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.

 

[CharlieUK]

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).

 

[Ronen E]

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.

 

[McQueenster]

I have found that IECEE TRF 61010-1J is a very useful checklist for EN61010 and provides many tables for assisting in product design and assessment. The only downside is that this checklist retails at 550 CHF (approx £450) on the IEC website

I haven't found similar checklists for any other harmonised standards. Does anyone know if they exist?

 

[Marcelo]

provides many tables for assisting in product design and assessment

This is not true. TRFs are checklists to verify compliance with the requirements of a standard only. You still have to have your design documentation.

Does anyone know if they exist?

There's TRFs for several standards at the IEC webstore - https://webstore.iec.ch (and they are created for the IEC standards, not the harmonized EN ones - no problem if they are the same, though).

 

[McQueenster]

The checklists certainly help me during product design and assessment. And it provides a useful cross reference to appropriate sections of the standard.

My understanding is that relevant design and build documentation shall form an important part of the technical file.

 

[Marcelo]

The checklists certainly help me during product design and assessment.

I don't disagree that they are helpful, but standards are solutions, not requirements. So they can help with finding possible agreed solutions.

My understanding is that relevant design and build documentation shall form an important part of the technical file.

It sure is, as they are the way to show how you comply with the essential requirements of the directives.