For EMC, Mr. Woodgate's reply is relevant, but us component mfrs will find this guidance difficult to use. But back to the original question of a 'generic' requirement for D of C. Since RoHS is now a marking directive, your widget no longer has a basis for bearing the CE mark. Also note that RoHS now has a harmonized standard for all to adore, whereas REACH is not yet a marking directive and has no harmonized standard to use as basis for presumption of conformity.
So my answer is a non-answer. An importer of components for professional installation cannot know what type of import enforcement would be applied by any particular EFT state, or how any particular official would interpret the scope of any directive. >From this side of the pond and from my experience, components for use by other mfrs in med and ITE have two principle requirements that would be looked at by the governmental people - the CE mark on the component and the declaration. If the governmental person goes further, the next document requirement would the Technical File. In fact, just recently shipped a TF on a DVD to a wonderful governmental organization in the EFT. So you really need to be ready with all of the new and wonderful document requirements in accordance with the NLF stuff. Brian -----Original Message----- From: Brian Oconnell [mailto:[email protected]] Sent: Tuesday, April 02, 2013 2:05 PM To: '[email protected]' Subject: RE: so what does a DoC look like for a subassembly that isn't usable on its own? Not much different than for end-use equipment. For my component power supplies - simple tabulation of directives and respective standards that were used as basis for presumption of conformity to whatever directives. Then add paragraph for Conditions of Acceptability and intended end-use. For last several units (more important for my stuff that is intended for PV market), added second page for stuff that would be in addition to what is being required by EU; for example, electric building code applicability and environmental definitions. Does the document perfectly reflect only the scope per ISO17050 or any particular directive? Probably not, as the importance is to use the DoC as another opportunity for another vehicle to reinforce certain expectations (that would typically only be found in install instructions or spec) for a component. Brian -----Original Message----- From: [email protected] [mailto:[email protected]]On Behalf Of McInturff, Gary Sent: Tuesday, April 02, 2013 1:18 PM To: '[email protected]' Subject: so what does a DoC look like for a subassembly that isn't usable on its own? Does one just state there are no requirements at this level on the DoC, do they reference the appropriate directives for safety and EMC for the final product. We custom design bits and pieces for end customers in EU, and we keep dancing around this issue both for ITE and medical devices. It might have a digital clock but no way to measure emissions until it's in the final enclosure. The end user would then do some final declarations and issue DoC's. We make RoHS and WEEE statements but those are not currently part of our DoC for EU Just what does a DoC for a rock look like if I wanted to ship it? Gary McInturff Reliability/Compliance Engineer Esterline Interface TechnologiesFeaturing ADVANCED INPUT, GAMESMAN, LRE MEDICAL, and MEMTRON products 600 W. Wilbur Avenue Coeur d'Alene, ID 83815-9496 Toll Free: 800-444-5923 X1XXX Tel: (208) 635-8 Fax: (208) 635-8 - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <[email protected]> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://listserv.ieee.org/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]> Mike Cantwell <[email protected]> For policy questions, send mail to: Jim Bacher: <[email protected]> David Heald: <[email protected]>
