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CE regulations

Started by kikey, May 16, 2016, 04:30:38 PM

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kikey

Didn't know in which section I should post this.
Please move this thread if needed.

Please guide me how to handle the European CE regulations!
I suppose this must have been discussed here before but I have not been able to find much when I searched.
I need to understand what is needed to put a CE mark on a simple analog pedal.
If you have real experience of this, please share your knowledge!

So far I have found out the following:
CE is not a certification, its a declaration. The Declaration of Conformity is a special document which the manufacturer signs to say that the product meets all of the requirements of the applicable directives. Depending on the type of product there are many applicable directives.

These are probably the directives of interest:
Directive 2014/35/EU – Low Voltage Directive (LVD)
                       Do not apply for a 9V battery pedal and/or external power supply!
Directive 2014/30/EU – Electromagnetic Compatibility (EMC) Directive. (emissions and immunity)
                       For an analog circuit only immunity is of interest.
Directive 2014/2/EU/EU – Restriction of the use of certain hazardous substances (RoHS)
                       Mainly, this is a matter of PCB/assembly processes. Most PCB manufacturers are compliant.
Directive 2002/96/EC - Waste Electrical & Electronic Equipment (WEEE)
                       The WEEE Directive is not a CE marking directive, but must be applied to all Electrical and Electronic Equipment place on the market in the EU.
Directive 2005/32/EC - Ecodesign - Power supplies.
                       Do not apply for a 9V battery pedal and/or external power supply!


From 2016-04-20 there is a New Legislative Framework that seems include a few new things.
For example, a technical file consisting of technical documentation, list of the harmonized standards, test reports and analysis/assessment of the risk(s).

As I see this, for a simple analog pedal, it boils down to:
- Ensuring EMC Immunity and RoHS.
- WEEE (seems difficult for a small manufacturer...)

Comments ??
What have I missed ??

/Björn

Jdansti

I'm not an expert on this, but if CE is anything like what the US requires, you may have to have a lab test for EM emissions regardless of whether the device is analog or digital.
  • SUPPORTER
R.G. Keene: EXPECT there to be errors, and defeat them...

R.G.

If a hundred people on the internet told you sure, you're fine, but they're wrong, then what?    :icon_eek:

Put it another way - do you know the cost of getting it wrong, as opposed to the cost of doing it right?

You should not rely on internet opinions on matters of law and government regulations. The cost of getting it wrong is large. Most effects sellers simply ignore the regulations, and hope that no one notices. That works really well, until some young person at a testing agency decides to make a name for themselves by finding scofflaws.   :icon_lol:

R.G.

In response to the questions in the forum - PCB Layout for Musical Effects is available from The Book Patch. Search "PCB Layout" and it ought to appear.

armdnrdy

Just etch "CE" on the enclosure. Tell them that armdnrdy said that it was OK.  :icon_lol:

I am armdnrdy and I approve this message.  8)
I just designed a new fuzz circuit! It almost sounds a little different than the last fifty fuzz circuits I designed! ;)

kikey

Thanks guys!

I would really like to do this by the book, but its difficult and quite expensive :(
If only EMC immunity testing is needed, it might not be too expensive. But a lot of paper work.

Yes agree, I also think most builders ignore these regulations.
I have read that American companies got fines of $100k for not meeting the FCC standards (but that's for digital devices with internal oscillators >9kHz).
Found this on a British website:
"In the UK, the (EMC) Directive is enforced by the Trading Standards Service and Ofcom. Penalties for non-compliance can include three months imprisonment and a £5000 fine but generally involves a recall and replacement of the affected product."
I suppose this applies when the device emits unhealthy amounts of EMC (?)



antonis

#5
First of all, you must be sure of what kind of Declaration of Conformity is needed for the pedal..

If there is no need for it's techical file examination by a Notified Body, the manufacturer can issue a DoC (in which he should refer all standards applied - CE mark without "number"..)
"I'm getting older while being taught all the time" Solon the Athenian..
"I don't mind  being taught all the time but I do mind a lot getting old" Antonis the Thessalonian..

Jdansti

#6
>I suppose this applies when the device emits unhealthy amounts of EMC (?)


Your device can be perfect and not emit any measurable EMC, and you could still get into trouble if you haven't gone through the steps to prove it.  There's a saying: "compliance, not science". This was the situation when EHX was fined. They weren't fined because their products were emitting EMC, they were fined for not following the law.

If you could find and meet with an attorney knowledgeable in CE, he/she could give you some guidance and let you know what the steps and cost of compliance would be. The meeting would probably cost you $200-$400, at least in the US. You might find a nice attorney how would do it gratis. Alternatively, there might be a governmental office in your country where you could go and discuss your plans with a knowledgeable person.
  • SUPPORTER
R.G. Keene: EXPECT there to be errors, and defeat them...

Transmogrifox

If you're thinking of doing this "by the book" then you need to be prepared to do serious business to make it worthwhile...meaning, you expect to be making a living selling stompboxes and you expect the cost of proving compliance will be compensated.  That's the main advice:  proving and correctly documenting compliance is expensive.

I would guess you will be into it more than $10,000 (USD) to get required testing and documentation done. 

You will need to first find out what standards apply to your type of product, and you may be best served hiring a consultant just to get the requirements identified.  There are both safety and emissions regulatory requirements.  A 9V circuit probably doesn't have any real safety concerns when specified to work with a compliant low voltage power source that is current/power limited to a "safe" level.  From there you just have to show nothing in your circuit can fail in such a way that it causes a fire.  There may be testing required to prove it.

UL web site is helpful in terms of getting familiar with what the requirements will be.  What does UL have to do with CE?  They often are able to perform tests that comply with equivalent EN standards.  If requested they can give you a report from which you can defend using a CE mark.  If you are not in the US, then you would probably better off contacting a more local testing laboratory.
trans·mog·ri·fy
tr.v. trans·mog·ri·fied, trans·mog·ri·fy·ing, trans·mog·ri·fies To change into a different shape or form, especially one that is fantastic or bizarre.

R.G.

By the way, the standards are copyrighted publications of the standards organizations and are *sold*, not published freely, as well as frequently changed. I had to buy a copy of IEC60650 for around US$200 once.
R.G.

In response to the questions in the forum - PCB Layout for Musical Effects is available from The Book Patch. Search "PCB Layout" and it ought to appear.

Vitrolin

low voltage directive applyes to anything with a rated voltage between 50-1000VAC or 75-1500VDC so as long as you dont sell power supplies or have them incorporated in the pedals you should be clear of that.

RoHS states that some specified substances must not exceed x% of the product, this means that if you need some special component that is not RoHS compliant you might get away with it.
but no more soldering with leaded solder, so fume extractor gets very important.

the electronic waste thing is basically dont throw it with normal thrash but make shure it gets sorted and taken care as electronic waste for recycling

EMC i cant see why only immunty shold be of interest, analog circuits can shurely make electromagnetic distubances.

a big difference between UL and CE is that with UL everything is tested and complies with, sometimes extreme, demands, before you can start selling you product
CE you declare that all is good and as long as nothing goes wrong all is good, but the day somebody somehow claims your product is causing some kind of damage, physical harm, emc, electrical harm or whatever, YOU have to dokument that all have been testet and that it complies with the directives.

but as others said go check with some ones who knows, if you are in the EU there are govermental institutions that can guide you and the laboratories that make these kind of test are very helpfull,

R.G.

I'm going to assume that this was intended to be humorous.

Quote from: Vitrolin on May 18, 2016, 04:36:47 PM
low voltage directive applyes to anything with a rated voltage between 50-1000VAC or 75-1500VDC so as long as you dont sell power supplies or have them incorporated in the pedals you should be clear of that.
The low voltage directive applies to anything with electricity. If the only power source is a 9Vdc battery, it is much easier to prove that the unit is not hazardous. However, it's entirely possible to make something like a Taser run from low voltage batteries, and those can definitely harm people. Not connecting to the AC power line is a huge advantage in showing the product is not dangerous, but it's not a complete shield.

QuoteRoHS states that some specified substances must not exceed x% of the product, this means that if you need some special component that is not RoHS compliant you might get away with it.
It's a lot more explicit than that. Some things are forbidden outright, some are allowed by grandfathering and all of it is subject to being tightened down over time. The only way out for ordinary people without testing labs is to use only components which themselves are certified by the manufacturer to be RoHS compliant.

Quotebut no more soldering with leaded solder, so fume extractor gets very important.
No more soldering with lead solder, period for RoHS countries. It's unrelated to fume extractors. Fume extractors can't remove lead from the solder you use, only the fumes in the air.

Quotethe electronic waste thing is basically dont throw it with normal thrash but make shure it gets sorted and taken care as electronic waste for recycling
That one's right.

QuoteEMC i cant see why only immunty shold be of interest, analog circuits can shurely make electromagnetic distubances.
Yes, they can.

Quotea big difference between UL and CE is that with UL everything is tested and complies with, sometimes extreme, demands, before you can start selling you product
CE you declare that all is good and as long as nothing goes wrong all is good, but the day somebody somehow claims your product is causing some kind of damage, physical harm, emc, electrical harm or whatever, YOU have to dokument that all have been testet and that it complies with the directives.
Not quite. UL is short for "Underwriter's Laboratories", which was an invention of insurance companies in the USA. The USA has no country-wide standards for safety, only rules which allow anyone to sue anyone for anything. Insurers wanted some testing on things they were insuring to see whether they were at risk of being bankrupted by lawsuits. The insurers would give discounts to manufacturers who could show they complied with the UL rules.

UL has *NO* legal status whatsoever in the USA, and probably not anywhere else.

The general safety standards around the world have been becoming more common, and often the standards from UL, TUV, IEC, CSA, and other standards organizations are very similar. None of them are any more extreme or not than others, at least not much. Well, OK, they're all about equally extreme. In the USA, there is no "demand" to meet the requirements. In other countries and areas, you may have to show compliance before you can market goods. In some countries, not complying is a criminal offense.

In the EU, you must declare conformity to the CE standards for safety to sell. That declaration may be made based on your own testing, or on the testing of a commercial lab. You are liable for any damage to people or property, just as in the USA, whether you are declaring conformity or not. You *may* be prevented from selling any further, and may have to recall goods which are found to be non-compliant. I'm not clear on whether there are civil or criminal penalties for declaring conformance with no basis in fact. Probably both ways in different countries.

Quotebut as others said go check with some ones who knows, if you are in the EU there are govermental institutions that can guide you and the laboratories that make these kind of test are very helpfull,
My experience with safety testing labs goes back to the early 1970s. In no instance have I found a government institution or laboratory helpful in telling me what is safe, only what is not safe.
R.G.

In response to the questions in the forum - PCB Layout for Musical Effects is available from The Book Patch. Search "PCB Layout" and it ought to appear.

ElectricDruid

Quote from: R.G. on May 18, 2016, 05:49:22 PM
My experience with safety testing labs goes back to the early 1970s. In no instance have I found a government institution or laboratory helpful in telling me what is safe, only what is not safe.

Is that experience is all in the US? Sometimes things are done very differently in Europe, and this was a question specifically about CE marking.

Tom

R.G.

Quote from: ElectricDruid on May 18, 2016, 08:25:48 PM
Quote from: R.G. on May 18, 2016, 05:49:22 PM
My experience with safety testing labs goes back to the early 1970s. In no instance have I found a government institution or laboratory helpful in telling me what is safe, only what is not safe.
Is that experience is all in the US? Sometimes things are done very differently in Europe, and this was a question specifically about CE marking.
Actually, no it's not limited to the USA. I'm aware that sometimes things are done very differently in Europe. Sometimes these differences are a blessing, sometimes otherwise. Although my direct experience with European safety organizations is not as extensive as the USA. I dealt with European safety organizations a lot in the late 1970s and a little about eight years ago.

Of course, it is also possible that someone not from the USA would have a different experience. I've seen that a lot too.
R.G.

In response to the questions in the forum - PCB Layout for Musical Effects is available from The Book Patch. Search "PCB Layout" and it ought to appear.

kikey

Quote from: Vitrolin on May 18, 2016, 04:36:47 PM

EMC i cant see why only immunty shold be of interest, analog circuits can shurely make electromagnetic distubances.


From what I have found out, analog guitar pedals would typically not be of interest for EMC emissions tests.
Both FCC and EMC directive states that only digital or radio devices with clock frequencies of >9kHz are subject for testing.

https://www.namm.org/sites/www.namm.org/files_public/New%20Sensor%20FCC%20Compliance%20Guide_v8_0.pdf

Here is an interesting page listing exemptions, for example regarding LVD:
http://www.emcfastpass.com/could-your-product-be-exempt-from-emc-testing-altogether/

slacker

#14
Quote from: kikey on May 19, 2016, 09:19:08 AM
From what I have found out, analog guitar pedals would typically not be of interest for EMC emissions tests.

It depends on what you mean by analogue. Anything with a BBD in it such as analogue delays, choruses or flangers will have clock signals in them higher than 9KHz as will anything with a PT2399. Circuits with charge pumps like Klon Centaur copies would also be included.
It's also possible that you could build a circuit that unintentionally oscillated at frequencies that would require emissions testing or in some other emitted them. I don't know what the directives say about that.   

Vitrolin

QuoteQuote from: Vitrolin on 18 May 2016, 17:36:47
low voltage directive applyes to anything with a rated voltage between 50-1000VAC or 75-1500VDC so as long as you dont sell power supplies or have them incorporated in the pedals you should be clear of that.
The low voltage directive applies to anything with electricity. If the only power source is a 9Vdc battery, it is much easier to prove that the unit is not hazardous. However, it's entirely possible to make something like a Taser run from low voltage batteries, and those can definitely harm people. Not connecting to the AC power line is a huge advantage in showing the product is not dangerous, but it's not a complete shield.
sorry, not rated voltage, but input or output voltage.

QuoteQuote
RoHS states that some specified substances must not exceed x% of the product, this means that if you need some special component that is not RoHS compliant you might get away with it.
It's a lot more explicit than that. Some things are forbidden outright, some are allowed by grandfathering and all of it is subject to being tightened down over time. The only way out for ordinary people without testing labs is to use only components which themselves are certified by the manufacturer to be RoHS compliant.
It was ment so that if you really needed some very specific part that isn't RoHS compliant there mayby an small chance that you could be allowed to do so....

QuoteQuote
but no more soldering with leaded solder, so fume extractor gets very important.
No more soldering with lead solder, period for RoHS countries. It's unrelated to fume extractors. Fume extractors can't remove lead from the solder you use, only the fumes in the air.
Fume extractor is important to make shure that you don't inhale the fumes from the lead-free solder sinsce it is much more dangerous to your health than the lead-free, due to the flux used.
actually it is permittet to use leaded solder when doing service or repair because when doing int on site you cannot be certan to have fume extraction.

UL: many non-US companies that exports to the US have been forced by US distributors to get UL approval, but no it isn't mandatory by law.

QuoteQuote
but as others said go check with some ones who knows, if you are in the EU there are govermental institutions that can guide you and the laboratories that make these kind of test are very helpfull,
My experience with safety testing labs goes back to the early 1970s. In no instance have I found a government institution or laboratory helpful in telling me what is safe, only what is not safe.
well, it was ment as they will guide you in which part would apply to you,what tests you should perfom, not how to design a safe product.

Quote from: kikey on May 19, 2016, 09:19:08 AM
Quote from: Vitrolin on May 18, 2016, 04:36:47 PM

EMC i cant see why only immunty shold be of interest, analog circuits can shurely make electromagnetic distubances.


From what I have found out, analog guitar pedals would typically not be of interest for EMC emissions tests.
Both FCC and EMC directive states that only digital or radio devices with clock frequencies of >9kHz are subject for testing.

https://www.namm.org/sites/www.namm.org/files_public/New%20Sensor%20FCC%20Compliance%20Guide_v8_0.pdf

Here is an interesting page listing exemptions, for example regarding LVD:
http://www.emcfastpass.com/could-your-product-be-exempt-from-emc-testing-altogether/
the 9 kHz are from another directive on radio communications devices, se page 11 in link below

from page 53 in document linked below:
QuoteAlthough the EMC Directive does not specify a frequency range, it is
general practice to take account of the range of frequency encompassed in
the EMC assessment from 0 Hz to 400 GHz. This does not mean there is a
need to apply a full assessment within this range as certain phenomena are
limited in frequency range (e.g. for conducted high frequency emission:
the frequency range to take into account is usually 9 kHz to 30 MHz). For
some apparatus, electromagnetic phenomena are inherently limited in
frequency range by the principle of construction or the physical nature of
the apparatus.

http://ec.europa.eu/DocsRoom/documents/9863/attachments/1/translations/en/renditions/native