"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??
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.
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.
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
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.
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.
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
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
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?
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.