"CE" mark self certification


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  1. #1
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    Default "CE" mark self certification

    Hi, I have a problem and I am getting no assistance from the EU, their Market Surveillance folks - nobody. Hopefully one of you folks can assist me.

    My company manufactures test equipment that is directed by the Boeing Aircraft Company in their aircraft manuals to be used on the aircraft to test/verify components of the jet engine. The LVD annex II says that "Specialized Electronic Equipment" used on the aircraft is exempted from the LVD standard and therefore would not need the "CE" mark. However, we have a customer that is making noise about our equipment requiring the "CE" approval. He says that equipment being used "ON" the aircraft means that it flies with the aircraft. Our equipment is used on the ground, on the aircraft to test and verify.

    If we decide to self certify our equipment (which I beleive it will pass) what standard(s) should we use? Is there a general standard that is easy to pass? Or is there some special standard we must use because we sell test equipment used on aircraft? Anyone have any ideas??

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    Lets just stick to CE marking and not muddy the waters about any form of flight certification which has NOTHING to do with CE marking.

    If your product meets ANY Directive, you are entitled to stick a CE mark on it and certify saying so. So pick one that you just can't fail on. Let's forget the fact that your product radiates spurious emissions further than Chernobyl, if it passes something like...

    Machinery Directive 94/44/EEC
    or The Low Voltage Directive 93/68/EEC
    or The Low Voltage Equipment Regulations (Safety) 1989
    or EN 50082-1
    or EN 50082-2
    or many others...

    then you're entitled to write a little dinky self certification certificate and nail a CE mark on your product.

    CE is regulated in the UK by Trading Standards... who have more work on their plate trying to protect the General Public from unhealthy eateries than they can cope with... like you're EVER going to get a Trading Standards Officer knocking on your door armed with anthing other than a spot thermometer and saying that for public helath reasons your product should be stored in the fridge at below 4C.

    Just to look intelligent in case a TS Officer ever came calling, I've a copy of "EMC for Product Designers - Meeting the European Directive" ISBN 0750649305 sitting on my shelf. It's only for show... I've never bothered to look inside.

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    Quote Originally Posted by Melanie
    if it passes something like...

    Machinery Directive 94/44/EEC
    or The Low Voltage Directive 93/68/EEC
    or The Low Voltage Equipment Regulations (Safety) 1989
    or EN 50082-1
    or EN 50082-2
    or many others...

    then you're entitled to write a little dinky self certification certificate and nail a CE mark on your product.
    Hi Melanie,

    Do you have any links to sites that explain those directives in plain english that a normal person can understand without a degree in legalease.

    I tried to find simple explanations but couldnt find any and as far as I could see you need to spend serious money to get an official copy of any directive which would then take you the rest of your life to read (based on the fact that you would lose the will to live!)

    I did buy a book that was recommended to me but still cant figure out what you *should* do
    Keith

    www.diyha.co.uk
    www.kat5.tv

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    Quote Originally Posted by GaryAviation
    Hi, I have a problem and I am getting no assistance from the EU, their Market
    Surveillance folks - nobody.
    Hi,

    Not surprising.
    Same as "I don't get help from the legislator and the court judge for my case of drunk driving".
    Two options, hire a lawyer or defend yourself without a lawyer.

    See these links:
    http://www.ce-mag.com/suppliers/cat/341.html

    Best regards,

    Luciano

  5. #5
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    Quote Originally Posted by GaryAviation
    .. He says that equipment being used "ON" the aircraft means that it flies with the aircraft. Our equipment is used on the ground, on the aircraft to test and verify.

    If we decide to self certify our equipment (which I beleive it will pass) what standard(s) should we use? Is there a general standard that is easy to pass? Or is there some special standard we must use because we sell test equipment used on aircraft? Anyone have any ideas??
    Well,well... Generally any equipment used in aircraft manufacturing process (and testing) needs to be certified..

    If u're about 95%, or say at least 80%, sure that nobody wont get killed after that equipment of yours been used to test that crashed aircraft, I'd say it's pretty safe to put that self certified CE-sticker in it and never bother your head with the matter again.. I know that this is the way things have been done for last 10 or 15 yearsin in some "southern countries of Europe" - they do write those CoC's without any quilt.. then again - if u need to play safe, then it just might be a good idea to do some homework.. one rule: list all standards your equipment meets, and if you are not 100% sure - don't list it..

    Personally u're pretty safe as long as you don't put your signature into any piece of paper (CoC).. That does not acquit your boss and the company u work in.. If you have already signed even one CoC, then your ass is mine.. be sure that once your ass is on the line-some sunny day someone will burn _your_ ass... o:-)

    And if u ever quote me, I'll straightforwardly deny everything... o:-)
    Last edited by oldtoddler; - 12th March 2006 at 22:18.

  6. #6
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    Default Change in Standard #s ??

    Folks: Thanks to all who replied to my question(s) on CE certification. I took your advice and ordered EN 50082-1 and EN 50082-2. PROBLEM ?? I did not receive either. I received the following:

    BS EN 61000-6-1:2001 and BS EN 61000-6-2:2005

    Are these two officially replacing the EN 50082-1 and EN 50082-2? And on my self certification document, I can simply list one of these and call it a day?

    Thanks

  7. #7
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    Default They have us running scared

    Quote Originally Posted by Melanie
    If your product meets ANY Directive, you are entitled to stick a CE mark on it and certify saying so.
    Melanie, You are actually in the UK right? I say that because those of us across the pond (USA) have been given a much more restrictive warning about CE marks. I sold a product to Darsbury University and needed the CE mark. I "self" certified as is allowed and saved the $8000 EMC and Low Voltage directive testing, but I really felt like I was pushing my luck. Everything I read about CE indicated that I needed to check off ALL directives that the product fell under and then show that the product met ALL directives before affixing the mark. (sidebar- can you believe there are companies selling the gif image for CE? As if we can't find the image elsewhere and photoshop it.)

    I think the fear is not that some postal inspector will catch you, but rather the fact that one of your EU competitors might rat on you to the authorities in order to get your product banned.

    I would love to have you dissuade my fears, because I just got a quote from a testing company for a new product. $12500 to certify it for EMC and Low voltage directives.

  8. #8
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    Default Sorry Gary

    To answer your original question -- Yes.

    EN61000:2001 is the new EMC standard.
    I think the sub chapters followed the old 50082 numbers.

    A good web search will yield all the right numbers for you.

    John

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    Speaking as somebody that has been through not only the certification process for products that we manufacture and market, but also as someone who has been through the mill when prosecuted for non compliance under the EMC directive, I think i'm fairly well positioned in saying that:

    Many people attach the CE mark without testing correctly or even understanding exactly what directives apply. They "get way with it" because they are not challenged.

    You do need to test and you do need to understand which directives apply. You are accountable ( not the company, but the signatory on the compliance statement).

    If you are supplying to a gov't agency or any client likely to carry out due dilligence, i.e any one that specifically asks for CE, be sure to ensure that you have thourougly researched the relevent directives.

    (The same applies to RoHS)

    I dont have it to hand, but if you PM me i'll point you to two excellent books that will spell it out for you. And if you like to call me, i'll explain what happenms when OfCom get wind of a non compliant product, via the local trading standards officer or by Govt agency.

    Rememebr that in the UK failure to comply is a criminal office, with a penalty that can include not only a fine but also imprisonment.

    A two year battle resulted in my name being cleared, the company receiving a fine and 15000 GBP in costs.

    And that was related to failure to comply with the legislation on a product that was exempt form CE, under Functionality, use and End User.

    There is also a case in the UK where a company building home PC's for retail sale, used all CE marked parts, but failed to test the fully built product. They assumed that by using CE marked parts they could CE mark the final product, without further testing. WRONG, resulted in 3 MONTHS prison sentence for the company director and a big fine.


    My advice, dont take advise from non qualified peers, anecdotal evidence is no defence. If it all goes pear shaped, the court will not accept "so and so on the forum said it would be OK"

    BUT, you are in the USA, yes? So the importer is the responsible party, and thats your client
    ------------------------------o0o---------------------------------
    I just deleted a whole load of advsie that i'm pretty sure is correct, but i'm not qualified to give. (legal stuff, that i learned during our prosecution)

    PM me or call me if you wish.


    BTW, I learned so much during our prosecution, that ending up with a clear name and paying 15000 GBP, was actually well worth the money (when viewed in commercial terms), made loads of really good contacts, including those on the presecution team, who i'm still in touch with. Even went for a drink with one of them after the case.

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    Actually i just read this thread again,

    If you were in the UK you're flying really close to the wind.

    Just the content of this thread, in the hands of prosecution, are enough to counter any mitigation that you might plead if you failed to comply.

    its scary.

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    Default Death to fascism

    Quote Originally Posted by lester
    Even went for a drink with one of them after the case.
    Keep your friends close, and your enemies closer!
    Regards Lester,
    JS

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    Yep it pays

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    Default I hear you loud and clear Lester.

    I am confused about one thing though, and I ask it on the forum so that others may find clarity in your answer. Are you saying that when some professor at a university asks a little grey-haired lady in purchasing to buy a thingamabob from this guy across the pond, then she is the importer and is therefore the responsible party?

    I'm not selling the particular device anymore to EU, but I did do quite a bit of research and the technical construction file ... blah moot point now.

    I am planning on selling something else in the future. I'll just make sure I make a boat load of money over here first then pay for a qualified independent lab analysis for CE, or find a partner over the pond to import and distribute after doing their own analysis.

  14. #14
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    Default Ps

    Can somebody over there slap Melanie in the hand for her earlier "advice"? The poor guy is probably sitting in prison now.

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    Quote Originally Posted by hansknec
    The poor guy is probably sitting in prison now...
    And nobody knows why he doesn't want to join
    the correctional education (CE) program.....

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    What Melanie said was in some parts correct. The CE mark refers only to the stated use when the product is put onto the market. So you test to meet the stated use.

    My point is that it's not straight forward, you cannot simply interpret the legislation such that it suits you. So you can't test for one thing that's an easy pass, CE mark your product and then put it on to the market knowing full well that it will be used in a completely different way. (well you can, but that's neglecting your responsibility)

    You cannot stop the consumer using the product outside of the stated purpose, but you do have a responsibility to ensure that you meet the EMC directives relevant to probable use.

    Its not that difficult to identify the correct EMC directives and to understand exactly what OTHER areas you need to test and state compliance in. Read the legislation or get advise.

    DONT rely on people like me or Melanie, (i'm not qualified to give definitive answers).

    Like it or not, if you import into or manufacture and put a product onto the market in the EU you have a responsibility and if challenged you need to show that you have conformed to the relative legislation. Don't rely on the challenger being more ignorant than you, it might not be the case.

    Actually its pretty much the same situation as when you're developing your product, you read the data sheets don't you?

    Oh, and YES if the prof gets the little lady in purchasing to import a product it needs to meet the legislation and the importer is responsible...BUT educational use is different, there are massive exemptions there, so maybe CE and EMC testing is not required... READ THE LEGISLATION, ITS NOT DIFFICULT.

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    Quote Originally Posted by Melanie
    Lets just stick to CE marking and not muddy the waters about any form of flight certification which has NOTHING to do with CE marking.

    If your product meets ANY Directive, you are entitled to stick a CE mark on it and certify saying so. So pick one that you just can't fail on. Let's forget the fact that your product radiates spurious emissions further than Chernobyl, if it passes something like...

    Machinery Directive 94/44/EEC
    or The Low Voltage Directive 93/68/EEC
    or The Low Voltage Equipment Regulations (Safety) 1989
    or EN 50082-1
    or EN 50082-2
    or many others...

    then you're entitled to write a little dinky self certification certificate and nail a CE mark on your product.

    CE is regulated in the UK by Trading Standards... who have more work on their plate trying to protect the General Public from unhealthy eateries than they can cope with... like you're EVER going to get a Trading Standards Officer knocking on your door armed with anthing other than a spot thermometer and saying that for public helath reasons your product should be stored in the fridge at below 4C.

    Just to look intelligent in case a TS Officer ever came calling, I've a copy of "EMC for Product Designers - Meeting the European Directive" ISBN 0750649305 sitting on my shelf. It's only for show... I've never bothered to look inside.

    NO, Here Malanie is bending the rules.

    Yes "If your product meets ANY Directive, you are entitled to stick a CE mark on it and certify saying so"

    BUT you are required to test to standards that are relevant to the use of the product, so you can't do as Melanie suggested AND stay legal.

  18. #18
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    Default The part that hurts the most

    When Melanie said:
    Quote Originally Posted by Melanie
    I've a copy of "EMC for Product Designers - Meeting the European Directive" ISBN 0750649305 sitting on my shelf.
    This in itself wouldn't "officially" be enough. How can you say something meets the standard if you don't have an actual copy of the standard?

    Even Lester says "just read the legislation, it's not difficult".

    Here is the problem with the whole system. They "SELL" the standards. They aren't free to download for review. It really makes it hard on the small entrepreneur to get a product into Europe. Some of them aren't cheap either. I'm in the laser safety business and IEC 60825 alone has 15 parts which cost ~$65 each. On top of that I need the machinery directive, the low voltage directive, the EMC directive, and most likely something else I've never thought of.

    I guess paying for a testing house to tell you that your product meets the standards is worth the $6k to $12k.

    In the end, I think Europe loses out on some innovative products because people are afraid to introduce something new. At the very least, movement of products into Europe is delayed because of the added bureaucracy.

    They say it will take something like 20 years to get back to where we can put a man on the moon. It's hard to believe we once did it in 8. It all boils down to bureauracy.

    John

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    John I ahve to agree with your sentiments. Right now the bureaucracy in the EC is at a crzy level and does not look like its going to ease.

    Yes its sensible to have harmonisation of standards, but when it's implimented as it is right now, it is simply restrictive.

    Maybe thats why we have so many poeple working in software and so few in hardware and firmware.

    AND, with so much legislation that is both costly and difficult to identify, its easy to see why we end up with "the blind leading the blind" which ultimately defeats the very purpose of the legislation.

    However it works both ways, I find it really difficult to find a route to FCC Type approval that does not cost over 3 times as much as EMC testing and CE marking!

    Incidentally, there is one supplier over here in the UK, that has a rather novel approach in sales incentives. They have their own EMC test facility and if you use parts supplied by them in your design, they will allow you to use their test facility for free. They have a qualified engineer on hand to assist.

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    A note aside:

    We have witnessed here that a lot of Chinese suppliers have been providing "CE" and all kinds of other documents to their customers at sampling stage.

    When the customer(s) tests and approves the samples, they place the order as they have the documents provided by the supplier.

    However, what the suppliers ship are not the same quality as the samples they had provided.

    In order for this kind of supplier to get the approval for CE and other types of standards, they make a real good samples and submit these good samples to the testing labs. The samples pass and get the approval.

    When the customer receives the shipment, the products are still good and do the job with no problem at customer's side. But if you submit a sample from this shipped lot to the labs, it will not pass.

    -------------------
    "If the Earth were a single state, Istanbul would be its capital." Napoleon Bonaparte

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    Quote Originally Posted by lester
    Incidentally, there is one supplier over here in the UK, that has a rather novel approach in sales incentives. They have their own EMC test facility and if you use parts supplied by them in your design, they will allow you to use their test facility for free. They have a qualified engineer on hand to assist.
    Lester, could you expand on this please

    Thanks
    Keith

    www.diyha.co.uk
    www.kat5.tv

  22. #22
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    Default To sum it all up . . .

    Hi, this is GaryAviation. Thanks to all of you who have provided a post since last Spring. Please allow me to provide you folks with an update on my company’s progress with “CE” certification.

    We hired a professional firm here in the US to evaluate and test our product to meet the required CE standards. Based on their evaluation of our product and their recommendation of the EMC standard; we tested and certified our product to the EMC standard and our product passed. Great. We then “Self-Certified”. Great.

    Then one of our customers challenged our certification (one of over a 100) by saying that we need the LVD standard. None of our other customers had a problem with what we did. To make a long story short, we went back to the professional firm we hired and asked why they did not recommend the LVD the first time around?? They answered that “Anyone in the UK can challenge your CE certification. They can also demand that you test to any standard that they think is relevant.”

    Folks, please excuse me, but this is a big pile of crap! In a nutshell (and I use that term for several reasons – this whole thing is NUTS), it seems to me that, as a user of the CE self-certification, there are several issues that need addressing. Allow me to explain.

    1. The intent of the CE certification seems to me to be a great idea. HOWEVER . . .

    2. The application of the CE certification is best described as follows: “An idea someone thought up and then never though through.”

    3. I have done a lot of research on this subject since my first post last Spring. To date, I have not found two people that agree on any relevant information or guidance concerning this CE certification program. Everyone has their own idea of what to do when and how. One person says certify my equipment to “Choking hazard for small children” and another person says certify to “LVD”.

    4. The main problem here is that nobody in the CE certification body, OFCOM or the League of Extraordinary Gentlemen (whatever they want to call themselves) has taken the time to think out the certification process. What needs to be tested to what standard is harder to figure out than the 9,955th digit in the answer of Pi. Sorry, Lester – with all due respect – I have read the legislation and (true it is easy reading) but it is also full of ambiguity. There is no clear guidance that the average man or woman could make a decision on.

    5. I totally agree with the post from “Hansknec” who basically stated that you could spend thousands of $$ of standards and 10 of thousands of $$ of testing and not even be sure that you have tested to the right standard.

    6. To sum it up – CE certification is a GREAT program in theory. In practice – Good Luck! ! ! ! !

    Once again – seriously, thanks to everyone who has provided their insight on this project of mine.
    Last edited by GaryAviation; - 18th December 2006 at 15:28.

  23. #23
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    To GaryAviation,

    So one of over one hundred customers is challenging your certification? Does this halt your sales or can you simply tell this one customer to take a hike? Losing <1% of your customers doesn't seem too bad, or is this process of filing a complaint more formal?

    A more generic question perhaps someone can answer: I have interpreted the Low Voltage Directive in such a way that it is my understanding that a device powered by an external 24VDC Wall Wart power supply would NOT fall under the directive. The device does not accept or provide any voltages higher than 24VDC. The Wall Wart is CE certified and of course would plug into the mains.

    Thanks,

    John

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    Thumbs down European Agencies can re-interpret Directives...

    About 10 years ago I worked for a company that had units sold into Germany. About 4 years after they were sold RWTUV tagged the units as not meeting CE, and made the company shut them down until my company had fixed the problem. Interesting thing to note, is that we were being accused of not meeting certain parts of the Low Voltage Directive, even though we had previously been given a clean bill of health by TUV Rhienland based here in the US.

    In order to try and make things right, we invited RWTUV from Germany, and TUV Rhienland to meet with us. This turned out to be nothing more than a big waste of time and money. Neither TUV agency could come to an agreement, and it actually turned into a very heated argument, with both parties dropping in and out of German as they spoke (very unprofessional, considering that we had no idea of what they were saying). Of course we were footing the bill to get RWTUV over here in the first place.

    After many more meetings, and some very expensive proof-of-concept tests, we were finally able to establish what was minimally required to satisfy RWTUV (they had problems with contactor sizing, safety loop wiring, and indicator light colors). Funny thing is, they even re-interpreted the LV Directive's indicator light clause pertaining to one light we were using to indicate that a high pressure fault had occurred. In the directive it states that an AMBER colored light should be used to indicate a fault or cautionary condition has occurred, one that requires no user intervention (automatic shutdown). In our case this is exactly how were implementing it, since the light would only appear following the system shutdown for high pressure. Well guess what? RWTUV insisted that the indicator light needed to be RED. They would not budge on this, and we were ultimately forced to change the LED we were using on our system control board to RED. Just another case of a standard that really isn't.

    To sum it all up; we had to submit to whatever changes RWTUV wanted in order to be allowed to continue selling units into Germany, and to prevent all existing systems from getting shutdown for non-compliance to CE. So even when you think you have done everything right, used a third party agency for verification, and paid out tons of money, you can still be cited for non-compliance.

    As it was explained to me; the Directives are simply guidelines, and not law. What CE should have been, a declaration of having met a unified European standard, has never come to pass. There is no simple answer when it comes to European compliance, and it changes depending upon which country and/or agency you are dealing with.

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    Quote Originally Posted by Melanie View Post
    Lets just stick to CE marking and not muddy the waters about any form of flight certification which has NOTHING to do with CE marking.

    If your product meets ANY Directive, you are entitled to stick a CE mark on it and certify saying so. So pick one that you just can't fail on. Let's forget the fact that your product radiates spurious emissions further than Chernobyl, if it passes something like...

    Machinery Directive 94/44/EEC
    or The Low Voltage Directive 93/68/EEC
    or The Low Voltage Equipment Regulations (Safety) 1989
    or EN 50082-1
    or EN 50082-2
    or many others...

    then you're entitled to write a little dinky self certification certificate and nail a CE mark on your product.

    CE is regulated in the UK by Trading Standards... who have more work on their plate trying to protect the General Public from unhealthy eateries than they can cope with... like you're EVER going to get a Trading Standards Officer knocking on your door armed with anthing other than a spot thermometer and saying that for public helath reasons your product should be stored in the fridge at below 4C.

    Just to look intelligent in case a TS Officer ever came calling, I've a copy of "EMC for Product Designers - Meeting the European Directive" ISBN 0750649305 sitting on my shelf. It's only for show... I've never bothered to look inside.
    Not actually correct. You must ensure that your product meets all the relevent new approach directives so If it comes under the EMC directive and the LVD directive it must meet both of them. You can't just stick a CE mark on a product because it meets one of the directives

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    As has been stated already - your testing very much depends on the target market.

    There are HUNDREDS of directives. They're not free - you have to BUY them (which is a personal annoyance, because if somebody makes a Law you are forced to comply with - then they should tell you and not force you to splash out $350 just to figure if it applies to you or not). Well if it doesn't, then tough, pick another one and splash out another $350. One product I designed could be classified under TWELVE different directives depending on application. That's $4000 and two days worth of reading just to figure if they apply to you! And you haven't started testing yet...

    Yes, we DO test our products - we have to. I have $50K's worth of equipment sitting at my right elbow just for the purposes of compliance. But that doesn't stop me maintaining that this subject is the biggest waste of time, money and effort on the face of this planet, and that if there is any possible exemption or loophole (eg like stating that your product is for INDUSTRIAL rather than DOMESTIC usage), that you exploit it fully, because rest assured, your competitors will be doing just that.

    Thank Gawd there's no directive (yet) on software... otherwise we'll all be in trouble!

    So, subscribe to the Toyota principle of business:- Kanban? JIT? No, as long as nothing falls off when chewed by a three-year old - it's good to go... If I earned Akio Toyoda's salary, I wouldn't mind grovelling to congress once in a while either...

  27. #27
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    Exclamation Clarifications for CE marking.

    This advice is provided based on my experiences and is not meant to be legal advice.

    Just wanted to clarify some information that I have read in here. Hopefully this will help at least one person out there to avoid making mistakes. I have worked at a test lab for six years and in industry doing compliance for over eight years. I have been on both sides of the testing.

    Currently to CE mark a product you will need to meet ALL applicable directives a stated by ponthirmike. Previously you could just meet the EMC directive for instance and apply the CE mark. (I have tried to find the date of this transition and will post it here once I do.)

    For the Low Voltage Directive (LVD) there are a just a few standards that cover a majority of products. Some of these standards have a part 2 (especially medical) which may apply specifically to your product so don't neglect to check any part two standards.

    EN 60335-1 for Household Equipment
    EN 60950-1 for Information Technology Equipment
    EN 60601-1 for Medical Equipment
    EN 60065-1 for Audio Visual Equipment

    Note: these standards are "harmonized" with US and Canadian equivalents i.e. UL 60950-1, so you can do the testing once with a Nationally Recognized Testing Laboratory (NRTL) with the country specific deviations and obtain approval for US, CAN, and EU. If you need more counties investigate obtaining a CB scheme approval at the same time.

    Complete list http://ec.europa.eu/enterprise/polic...s/low-voltage/

    For EMC Directive standards are listed here:http://ec.europa.eu/enterprise/polic...y/index_en.htm

    If you are doing testing for the EMC directive, for a little bit extra the labs should be able to do your FCC Part 15, and Industry Canada testing at the same time. If you have a radio transmitter in your product, seek the advice of a testing lab if you are not familiar with the requirements.

    If you do not know which standards to use contact a local lab. Ask for a quote to meet the applicable directives for your device. You may want to get a quote from a few labs to make sure they agree on the testing that needs to be done. If you don't agree work with the lab ask for explanations.

    Intertek (ETL), UL, and CSA have labs all over. If you are in Europe, TUV, Semko, Nemko, Demko etc. A helpful lab I have used is ACS ACStestlab.com they do EMC testing and are an agent for some NRTLs.

    Directives are free to view and download. However, the standards that you must comply with to meet the directives cost money. I agree these should be provided free or at cost to manufacturers, but usually a couple of hundred dollars spent on standards could save thousands (or more) if you avoid costly redesigns. Having the applicable standards that apply to your products is important to have during the design phase. Safety standards contain information like spacings required between mains voltage parts and low voltage parts, temperature limits, protection requirements are all included. If you make a mistake during your initial design, delays re-spinning a board or changing your enclosure material because you chose the wrong flammability of plastic could cost a lot in sales in the time you are making these changes.

    Most labs will allow you to come in and view their copy of standards especially if they expect you to bring your business to them.

  28. #28
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    Hi,

    As a lot of of you guys have been through the process could someone please clarify something for me.

    I've been working on a project since December 2009, initially for my own personal use. The device is mains (240v) powered and drives mains heaters at the same voltage. I've just had a small batch of PCB's made to prove the schematic and I'm in the process of making the prototype. I've had lots of interest from others who have suggested that I make these units available on a small commercial basis. My concern is that whilst I'm confident the device is sound and fit for purpose in my own home (the original prototype has been running for almost three months without a problem) I don't want to be responsible or help liable by any 3rd party in the event of a fire or electrocution.

    I gather that any device marketed in the EU needs to be CE approved, and given the fact the previous poster is in the testing / compliance business would like to hear what directives my device should comply with and what the typical cost in getting a mains powered thermostatic device through the testing.

    What would be the implications if I sold such a device privately without any CE certification - is that actually legal now ? I personally don't have the funds to meet any £15K fine and don't fancy spending time inside....

  29. #29


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    Default CE mark self certification

    malc-c,
    In summary, if you want to market a product in the EU and it falls within the New Approach Directives, it will need a CE mark. The CE mark is not a mark of safety, quality, etc, it is a "statement" from the manufacturer (or distributor if it is manufactured outside the EU) that it complies with the directives.
    So - what directives. These can be specific, ie the Toy directive or generic such as the Low Voltage Directive. The new approach directives require adherence to the essential requirements - ie the product must be safe, must not intefere with radio bands, etc. It is for the manufacturer to decide how he meets those directives. Normally we use harmonised standards which then provide a "presumption of conformity". For your product, the previous post identified the relevent LVD standards (there is another one BSEN61010 which is related to test and measurement equipment) If your product has electonics within (ie a microprocessor or some logic which has an oscillator, etc) it may need approval to the EMC directive as well!!!.
    The route to CE marking can be self assessment, ie you as a manufacturer make a declaration of conformity that it meets the relevent directives but you need to be able to show proof, test records, etc. For small producers, the use of a test house is usual and unfortunately it can be expensive - £5k to £10K for an LVD assessment and emc testing.

    The European Union have produced a "blue book" which covers the whole approach to the New Product Directives - for the EU it is not a bad book (might send you to sleep though) Find it at http://ec.europa.eu/enterprise/polic...ts/blue-guide/

    Hope this helps - let me know if you want any more information.

    regards

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    Quote Originally Posted by hansknec View Post
    To GaryAviation,

    So one of over one hundred customers is challenging your certification? Does this halt your sales or can you simply tell this one customer to take a hike? Losing <1% of your customers doesn't seem too bad, or is this process of filing a complaint more formal?

    A more generic question perhaps someone can answer: I have interpreted the Low Voltage Directive in such a way that it is my understanding that a device powered by an external 24VDC Wall Wart power supply would NOT fall under the directive. The device does not accept or provide any voltages higher than 24VDC. The Wall Wart is CE certified and of course would plug into the mains.


    Thanks,

    John
    Hi,
    If the "wal mart" power supply is CE marked and the secondary voltage is below 48v then you will not need your product to meet the LVD (unless it is a radio device where the directive states that the voltage limits are zero!!). However, if the product is electronic in nature it may still need to meet the EMC directive

  31. #31
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    Hi, Malc

    I believed "CE" was standing for "Crabbe Engineering" ...

    Alain
    ************************************************** ***********************
    Why insist on using 32 Bits when you're not even able to deal with the first 8 ones ??? ehhhhhh ...
    ************************************************** ***********************
    IF there is the word "Problem" in your question ...
    certainly the answer is " RTFM " or " RTFDataSheet " !!!
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  32. #32
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    Quote Originally Posted by Acetronics View Post
    Hi, Malc

    I believed "CE" was standing for "Crabbe Engineering" ...

    Alain
    LOL !

    Nice one

  33. #33
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    Quote Originally Posted by ponthirmike View Post
    malc-c,
    In summary, if you want to market a product in the EU and it falls within the New Approach Directives, it will need a CE mark. The CE mark is not a mark of safety, quality, etc, it is a "statement" from the manufacturer (or distributor if it is manufactured outside the EU) that it complies with the directives.
    So - what directives. These can be specific, ie the Toy directive or generic such as the Low Voltage Directive. The new approach directives require adherence to the essential requirements - ie the product must be safe, must not intefere with radio bands, etc. It is for the manufacturer to decide how he meets those directives. Normally we use harmonised standards which then provide a "presumption of conformity". For your product, the previous post identified the relevent LVD standards (there is another one BSEN61010 which is related to test and measurement equipment) If your product has electonics within (ie a microprocessor or some logic which has an oscillator, etc) it may need approval to the EMC directive as well!!!.
    The route to CE marking can be self assessment, ie you as a manufacturer make a declaration of conformity that it meets the relevent directives but you need to be able to show proof, test records, etc. For small producers, the use of a test house is usual and unfortunately it can be expensive - £5k to £10K for an LVD assessment and emc testing.

    The European Union have produced a "blue book" which covers the whole approach to the New Product Directives - for the EU it is not a bad book (might send you to sleep though) Find it at http://ec.europa.eu/enterprise/polic...ts/blue-guide/

    Hope this helps - let me know if you want any more information.

    regards

    Many thanks for information. I'll have a look at the "blue book" and what you've said sorta matches what I've found in my research. It seems that these directives are very much open to interpretation - so that because it measures temperature it could be classed as a test instrument., because it has both mains and 6Vdc it needs to comply with both the directive covering the type of mains plugs, and the LVD. And as you have stated, because it has a processor running at 48Mhz, and a RTC which is crystal controlled it need EMC testing.

    Bottom line is that you have to second guess what anyone might interpret the use of the device and make sure you've had it tested to comply with any such directive for that use. Net result £15K-£20K for testing and documentation to contest any such claim.

    I'm investigating any "loop holes" such as supplying the unit as a kit of parts with full instructions. But like most things governmental find a definitive "yes" or "no" is not easy. If not then this project is dead in the water.. I would need to have some serious investment behind me to tool up and have the units mass produced to recover the costs of CE approval and production. That's assuming that there is a market to take those production numbers, bearing in mind that it's aimed at a specialist market.

  34. #34
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    Quote Originally Posted by lester View Post

    There is also a case in the UK where a company building home PC's for retail sale, used all CE marked parts, but failed to test the fully built product. They assumed that by using CE marked parts they could CE mark the final product, without further testing. WRONG, resulted in 3 MONTHS prison sentence for the company director and a big fine.

    Lester,

    This seams strange. I've been in consulation with our H&S director where I work and he stated that as I've purcahsed components through such suppliers as Farnell, RS etc these components would of had to of been tested to comply with these directives. Therefore there would be no real requirement to have a lab test the assembled device. This would be the equivelent of your example above.

    It seems that this process is somewhat of a mind field and nothing is black and white

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    Unfortunately a system of parts which are CE approved does not automatically make the System CE compliant.

    I have had a specific case where I used a CE compliant radio module in a product but still had to have the product approved to the R&TTE directive. On a brighter note (?) the use of CE approved parts DOES reduce the overall system approval (ie using a CE approved Power Supply will dramatically reduce, or in some cases, remove the need for the assessment to the Low Voltage Directive

  36. #36
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    This does really get confusing..

    So assuming I gathered all the data and compliance sheets for the components and parts used, which should mean that the parts to be sold would already be CE marked or compliant, it still means the final unit has to be tested? - Bummer !!!

    I'm awaiting a call from the business section of our local trading standards office (well they are apparently responsible for policing the CE marking) to hear their view point. I'll let you know the outcome

  37. #37
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    Well I've received a call from a very helpful lady at my local trading standards office. Cutting a long story short, I would only need to comply for the directives under the CE declaration if I was a business. If the sales are private, and in effect an extension of a hobby (which it is) then it doesn't need to be CE marked and really only needs to comply with "basic" standards. Here is a quote from her e-mail

    The Consumer Protection Act 1987 defines a supply of goods by a person in the "course of a business" in relation to the offenses of breaching safety regulations, therefore, it could be argued that the action you propose, is not done as a business but more of a "hobby". Therefore, you would be exempt from the legislative requirements. Please note though that this an interpretation of the law and what is deemed as a 'hobby' or in course of a business is ultimately the decision of a Judge.

    If you produce the product following the legal requirements or a relevant British or European Harmonised Standard (BS/EN) such as any plug supplied should comply and be labelled as such with BS1363 or complying with the essential requirements of the electrical equipment safety regulations, then it could be argued that you have taken steps of due diligence to ensure the product is safe, but also been mindful of potentially foreseeable risk hazards and design them out.
    There are still gray areas such as what point does a hobby become a business, and obviously I could still find myself in trouble should someone pursue a civil case against me, but that could be the case if I was running this as a business and selling 1000's a year or an individual selling 10 !

    I still want to undertake a lot more testing of my own, but I feel happy to know that I can still recover some of my costs by building and selling the remaining 5 units without breaking the law.

  38. #38
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    Default Re: "CE" mark self certification

    Just hopped by...

    I have spoken with both my local TS office AND two companies that do LVD and EMC testing, reading the need for CE.

    My product would be made up of already-marked CE items (only a few), and while TS say the WHOLE package must be CE marked again, one of the LVD/EMC companies said it was not as if I was a manufacturer, while the other sided with TS.

    I'm minded to think very strongly that if you bring together two or more components, and I'm talking electrical components here, and even if they are CE marked themselves, then you DO, in fact, have to certify the whole lot.

    Cheers

  39. #39
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    Default Re: "CE" mark self certification

    The company that I work for is developing a new device. I've idenitified the EMC and LVD directives to be used. I am going to use the standard EN 60204-1 and EN 61010-1 for LVD. I am going to use EN 61326-1 for EMC. My question is can we test under these standards in house. I'm pretty confident about the safty standards. As far as the EMC standard I'm not so sure about. I'm not sure what equipment is needed for that testing or if it would be better to have someone else test it?

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    Default Re: "CE" mark self certification

    You need some fairly expensive gear to test EMC and an RF anechoic chamber, or an open field site in a quiet remote area. It is also difficult to calibrate, ground, get baseline references... and interpret results. Honestly, this one makes sense to contract out, especially if you and not planning on doing the test regularly.

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