"CE" mark self certification

[ponthirmike]

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

[Melanie]

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...

[burnsms]

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.

[malc-c]

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....

[ponthirmike]

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

[malc-c]

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.