CE marking newbie

Apr 13, 2006 29 Replies

Hello:



I'm suposed to design some products to put on the market in europe, as far as i've been able to find out, i must design them to meet the CE marking, and that implies at least compliance with emc emission and resistance.



What other standards does it need to comply with? What about safety?



The base product is small pcb with a cpu, a gsm modem, and a lithium-ion rechargeable batery (oem cell, not a pack, i.e without any electric/electronic protection circuits). It measures temperature, and responds to digital inputs with digital outputs, thru a transistor or relay.



There are 2 variations:



One is to install on car/motorcicles/trucks that includes a gps receiver and bluetooth transceiver, housed on an entirelly metalic case.



The other is a fixed instalation powered by the mains thru an off-the-shelf power suply, meant to be installed on houses or on factories, that has a keyboard, an lcd, bluetooth, and optionally a serial port, and/or a video camera input, housed on a plastic case.



Does the LVD apply? the supply input is specified as 10~40 VDC, which is bellow the 75V mentioned on the Low Voltage Directive.



The modem manufacturer design guidelines state that "it is essencial the application power supply is designed to comply with the specification in section 3. This will be sufficient to pass type approval, no RF testing will be required if it meets these specifications"



The bluetooth stack is developed in-house.



Can we really avoid the RF tests?



Sorry for the cross-post to sed but seec looks dead with only a couple of posts on the last week.



Thanks in advance.



Best Regards



Steve Sousa


I'm also a bit of a newbie to CE, and am not a lwayer ... but ... afaik you can mark anything as CE, but it's down to you to get sued if someone gets injured/killed. So although our stuff is used in an eng lab, within secure company sites, we make a long document stating how we think all requirements are met, and what reasoning behind that. So if anyone sues, we canpoint to it and say we tried our best. Some tests are performed to check emi/emc status. If the emc limits aren't met we just warn the customer, who then waives it (nice huh). Worth calling some expert who does it for a living, to check costs. If you are in UK, then the guy I know is Ian Attoe on +44 (0)1634 844400 (big site, need to ask for him), who may or may not be able to help. The costs of emc tests are bbbiiiggg though. Probably help to use a separate (certified) power supply plugged in to your unit, to avoid any worries on that side of things. hth Neil

Hi Steve,

For electrical items used in vehicles there is separate approval called the e-mark, I believe this applies only to items that are 'installed' into the vehicle, either during manufacture or after market.

CE marking applies to other electrical devices, for instance a mobile phone may be CE marked but a hands-free kit that needs to be installed into the car's electrical system would be e-marked.

Hope I've not added to the confusion,

Philip

If the product operates at below 50VAC or 75VDC it is outside the scope of the Low Voltage Directive. If this is the case it must meet the requirements of the General Product Safety Directive. The product will in both cases have to meet the requirements of the EMC Directive.

For more information on the directives please have a look at the guidance booklets on

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Regards

BillB

On Thu, 13 Apr 2006 18:25:12 GMT, snipped-for-privacy@abc.net Gave us:

Great link!

neil [ snipped-for-privacy@a.com] said

You can only self-certify if you use standards that have been published in the Official Journal (OJ) and comply with them in their entirety, otherwise you need to produce a Technical Construction File (TCF) and get it approved by a Competent Body.

It would actually be an issue, in the UK, for Trading Standards and they would deal with you. In the first instance, they would probably just stop you from selling until you fix the problem but this could stretch to a product recall if they deem it appropriate. Either of these actions could of course be quite sufficient to financially ruin a business.

Trading Standards will generally only prosecute as a last resort.

Contractual arrangements with your customers do not revoke or replace your liabilities under the law and if you are not complying with the appropriate standards in their entirety then you need to produce a TCF and get it approved by a Competent Body.

There are many views and opinions to be offered as to the appropriate way forward for any given bit of kit so it is always worth getting a few proposals and quotes.

I was recently looking to get a TCF put together and approved using the railway standards (which are not published in the OJ) and a number of different proposals were put forward with varying degrees of test and analysis with costs ranging from £10,000 to £60,000.

Is this just someone you are suggesting for free advice as you do not give this person any context? What is the company?

Out of interest, there is no requirement to actually test although for small, large volume items it is perhaps the most appropriate path. A TCF route with analysis and some (or no) testing can be a much cheaper option for large and/or low volume products even though it requires specialist expertise.

One should produce the TCF anyway as you may be called upon to produce it at anytime. The notice period for its production isn't that long either. This is whether or not a Competent Body examines the file.

In an industry where we have to support a full, up to date, safety case we view the document as the complete reference of arguments that can be used in a court of law should any incident lead us there. In other words, it is our entire defense case prepeared before we even have the consideration of any trial. If your document is that good you have probably identified all the risks you face and have dealt with them to minimise the your liabilities (in law and financially).

Any equipment that does not comply with the requirements of the EMC directive are not permitted to be brought into service in the EU (with a very few exceptions to do with research).

There are a number of links between the railway standards and standards that are recognised by the EU official journal. It takes some time to explore all the references. A published cross reference would, though, be useful. [%X]

If you, as a manufacturer or importer, are unsure of your ground seek the best expert opinions you can afford to ensure that you comply with legislation. Indications are that it is going to get tougher.

******************************************************************** Paul E. Bennett .................... Forth based HIDECS Consultancy ..... Mob: +44 (0)7811-639972 Tel: +44 (0)1235-811095 Going Forth Safely ..... EBA. www.electric-boat-association.org.uk.. ********************************************************************

There is an oligation to keep a Technical File of the product available for 'the authorities'.

A Technical Construction File is a different thing - to replace the Technical File - for products/situations where published standards are not theoretically and/or practically applicable.

Confusing the two can be *very* costly.

As there is no a legal requirement for a TCF if you self-certify there can be no requirement to "produce it at anytime."

A company might of course consider it prudent to keep appropriate documentation so as to be able to show due diligence but there is no requirement under EMC legislation to produce any document other than the Declaration Of Conformity when taking the self-certification route.

Fair enough, but that is outside of the scope of EMC legislation.

Which I think kind of what I said. :-)

And in the UK SI, the word used is "supply". ;-)

While EN50121 is harmonised, it is not in the OJ so where this is the appropriate standard, and it is for both trains and traction, there is no choice but to go TCF and Competent Body.

I am very sure thank you and was just trying to briefly explain the position to someone who was a self confessed newbie. :-)

On Fri, 14 Apr 2006 17:40:29 +0100, pooter Gave us:

If you want all of your shipments of product to europe turned back at the docks...

If want to be COMPLIANT to the spec, and want to place the logo on your product via "self certification", you had better have your firm set up correctly.

If you want to place the logo on your product via "self certification", yet do not really want to actually be compliant, it WILL eventually bite you in your dishonorable ass.

Roy L. Fuchs [ snipped-for-privacy@urfargingicehole.org] said

LOL! Stop messing about. :-)

CE Marking and EMC has little to do with how your firm is set up and everything to do with your understanding and actioning of the requirements of the law.

Not quite sure why you are posting this at someone who has just spend the last 6 months of her life getting a load of products through EMC to CE Marking and therefore knows large chunks of the legislation pretty well at this stage of the game, but in reply, unless there is a genuine and practical problem with your kit it is unlikely that there will ever be an issue whether or not the CE Marking attached to that equipment is valid or not.

Therefore your donkey will *not* inevitably get bitten.

That is a great site that I had not seen before.

H. R. (Bob) Hofmann - USA

Also have a look at

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For details of the European Directives, guides to the Directives and lists of harmonised standards.

Hope this helps.

BillB

On Fri, 14 Apr 2006 22:36:49 +0100, pooter Gave us:

You really don't know much about it then, because that is EXACTLY what they would do if you were ever found to be fraudulent.

It has to do with compliance with accepted norms and standards in the industry. Having the ability to have the logo silk screened onto your product is NOT all that is required to be capable of self certification.

That depends on what the product is. With high voltage power supplies, for instance, you can bet that the product WILL get scrutinized, and it had better pass the scrutiny.

You assume far too much. 6 months is nothing. I worked for a firm that has plants in both the US as well as the UK, and for a decade we went over self certification requisites. It isn't something they just let any maker of goods do without a fair modicum of scrutiny.

Roy L. Fuchs [ snipped-for-privacy@urfargingicehole.org] said

I know pretty well *everything* about CE Marking and EMC from a point of view of what paper work etc is required. :-p

I'm talking about CE Marking and EMC, what exactly are you talking about?

Actually it has to do with meeting the Essential Requirements of the legislation.

But you do not have to put the CEO Marking onto the product and instead can put it on the packaging, instructions or warranty - so no silk screen printing is required. :-)

And this BTW, is all that is examined at "the docks" and this is why there is some wisdom in putting it on the packaging.

Can I humbly suggest that you re-educate yourself by reading a copy of the EMC Directive and the LVD Directive. The law in the individual EU states are sometimes a little different (in the UK for example the work "supply" replaces all the other terms used in the directive and in Germany some advisory parts are treated as being nominative) but it gives 90% of the information you need.

I'd suggest that you start with the EMC Essential Requirements and then move on the the bits about what documentation is required and who it needs to be made available to.

LOL! Get off your high horse. :-)

As a full time job, it is well long enough to time to read, understand, seek advice and implement the legislation.

Perhaps you need a refresher course them, or you should maybe seek advice from someone who can actually understand what they read.

of scrutiny.

Oh yes it is.

The _whole point_ of CE Marking is to allow the free movement of goods

*without* them having to be scrutinised at every juncture.

On Sat, 15 Apr 2006 14:04:01 +0100, pooter Gave us:

But your remarks about self cert were off.

On Sat, 15 Apr 2006 14:04:01 +0100, pooter Gave us:

Again, you miss the intent of the statement.

Like I said, the capacity to place the mark on something is not all that is needed to self cert. It has to actually BE compliant, and your firm actually has to have enough brains to ensure that it is. If they know how to make a product, but do not know about the requisites of the industry, they shouldn't be self certifying.

On Sat, 15 Apr 2006 14:04:01 +0100, pooter Gave us:

The whole point of self certification is that you have enough brains to actually scrutinize it yourself, not just willy nilly claim to be self certs and willy nilly place the mark on everything you make.

Hello Steve,

With this one you might have to be careful. If it becomes an integral part of the vehicle, for example if mounted on the chassis and connected to some vital parts of the vehicle, it might need a type certification for that vehicle. Most European countries are stricter with this than the regulations you find on other continents.

When I moved to the US I was amazed by the modifications people did to their cars. In Europe they would have pulled me off the road for most of that.

Regards, Joerg

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Around here we're commonly referred to as "FREE"!

All that is mandated here is "safety" equipment... basically the brakes and steering, head and tail lights (and smog stuff) can't be arbitrarily modified... everything else is free for the playing... even neon lighting under the body and suspension systems that hop up and down on command ;-)

...Jim Thompson

| James E.Thompson, P.E. | mens | | Analog Innovations, Inc. | et | | Analog/Mixed-Signal ASIC\'s and Discrete Systems | manus | | Phoenix, Arizona Voice:(480)460-2350 | | | E-mail Address at Website Fax:(480)460-2142 | Brass Rat | | http://www.analog-innovations.com | 1962 | I love to cook with wine. Sometimes I even put it in the food.

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