CE marking newbie

[Steve Sousa]

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

 

[neil]

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

 

[Electric dabbler]

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

 

[[email protected]]

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 http://www.dti.gov.uk/strd/strdpubs.html

Regards

BillB

 

[Roy L. Fuchs]

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 http://www.dti.gov.uk/strd/strdpubs.html

Great link!

 

[pooter]

neil [[email protected]] said

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.

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.

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.

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.

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).

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.

Worth calling some expert who does it for a living, to check costs.

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.

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.

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

The costs of emc tests are bbbiiiggg though.

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.

 

[Paul E. Bennett]

neil [[email protected]] said

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.

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.

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.

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.

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).

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.

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 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.

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]

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.

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 ....................<email://[email protected]>
Forth based HIDECS Consultancy .....<http://www.amleth.demon.co.uk/>
Mob: +44 (0)7811-639972
Tel: +44 (0)1235-811095
Going Forth Safely ..... EBA. www.electric-boat-association.org.uk..
********************************************************************

 

[RHRRC]

neil [[email protected]] said

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.

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.

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.

<snipped>

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.

 

[pooter]

Paul E. Bennett [[email protected]] said

pooter wrote:

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.

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.

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).

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

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).

Which I think kind of what I said.

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

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.

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.

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.

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

 

[Roy L. Fuchs]

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

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.

 

[pooter]

Roy L. Fuchs [[email protected]] said

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

LOL! Stop messing about.

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.

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.

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.

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.

 

[[email protected]]

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

H. R. (Bob) Hofmann - USA

 

[[email protected]]

Also have a look at
http://europa.eu.int/comm/enterprise/electr_equipment/index_en.htm
For details of the European Directives, guides to the Directives and lists
of harmonised standards.

Hope this helps.

BillB

 

[Roy L. Fuchs]

Roy L. Fuchs [[email protected]] said

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

LOL! Stop messing about.

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.

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.

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.

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.

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.

 

[pooter]

Roy L. Fuchs [[email protected]] said

Roy L. Fuchs [[email protected]] said

On Fri, 14 Apr 2006 17:40:29 +0100, pooter <[email protected]> Gave us:

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

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

LOL! Stop messing about.

You really don't know much about it then,

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

Because that is EXACTLY
what they would do if you were ever found to be fraudulent.

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

It has to do with compliance with accepted norms and standards in
the industry.

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

Having the ability to have the logo silk screened onto
your product is NOT all that is required to be capable of self
certification.

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.

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.

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.

You assume far too much. 6 months is nothing.

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.

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.

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

It isn't something they just let any maker of goods do without a fair modicum of scrutiny.

<Panto mode on>

Oh yes it is.

</PM>

The _whole point_ of CE Marking is to allow the free movement of goods
*without* them having to be scrutinised at every juncture.

 

[Roy L. Fuchs]

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

But your remarks about self cert were off.

 

[Roy L. Fuchs]

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.

Again, you miss the intent of the statement.

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.

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.

 

[Roy L. Fuchs]

The _whole point_ of CE Marking is to allow the free movement of goods
*without* them having to be scrutinised at every juncture.

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.

 

[Joerg]

Hello Steve,

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.

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

 

[Jim Thompson]

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

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