Documentation for CE
Documentation for CE
(OP)
Has anyone done the self-declaration technical file for products going into Europe? Can you provide any information about the process? Thanks.
Bruce
Bruce
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RE: Documentation for CE
RE: Documentation for CE
Thanks.
Bruce
RE: Documentation for CE
RE: Documentation for CE
The first step is to determine which EU Directives apply to your machine or product. EU Directives describe the general requirements (usually safety). The manufacturer should use the appropriate harmonized (EN) standards to demonstrate compliance with the relevant directives. It is not necessary to use EN standards but it would be more difficult to demostrate conformance without them. Small special purpose equipment may only need to conform to one directive where larger machines will probably need to comply with a couple of directives i.e. 98/37/EC Safety of Machinery, 73/23/EEC Low voltage equipment, and 89/336/EEC EMC.
A good place to start is at the offical EU site, ( www.newapproach.org/directiveList.asp ). This site lists the directives (which can be downloaded at no charge) and their harmonized standards (standards have to be purchased). If your company belongs to any trade groups check with them, they will usually have some good information for you. The European Commission has published a document "Guide to the Implementation of directives based on the New Approach and the Global Approach" which is free. I don't have the web address but it may be available on the newapproach website mentioned above. The NIST also publishes a free document "NIST Special Publication 951, A Guide to EU Standards and Conformity Assessment". This is available at ( http://ts.nist.gov/ts/htdocs/210/217/eu-guide/sp951.htm ).
RE: Documentation for CE
RE: Documentation for CE
RE: Documentation for CE
Christopher Caserta
Sr. Regulatory Engineer
ccaserta@enorthhampton.com
Ph:904-225-0360
Fax:904-225-0340
RE: Documentation for CE
RE: Documentation for CE
Your right about people taking the mark seriously but it's changing, I'm finding that more and more companies are because the market (customers)are requesting it. I've also found that large manufactures who build product for the US are trying to standardize their Bill of materials which initiates the questioning of the CE certification and the need to start conforming.
Sorry for the long response!
Christopher Caserta
Sr. Regulatory Engineer
ccaserta@enorthhampton.com
Ph:904-225-0360
Fax:904-225-0340
RE: Documentation for CE