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.