Brian, I'm in a bit of a rush this evening so I can't spend as much time on this as perhaps it deserves, but maybe the following questions/observations will help to carry this forward:
On 4 Jan 2012, at 17:38, Kunde, Brian wrote: > > Our company makes laboratory equipment (the red-headed step child) which has > no defined category of its own so it generally falls under the LVD unless it > has a moving part to which it is now subject to the machinery directive > (which is a new nightmare for me). But like many products produced these > days, our products are built-to-order with dozens of variations and possibly > hundreds of different combinations. We evaluate each model family in its > maximum configuration with all possible variations installed for EMC and > Safety which generally includes a sample loader or autoloader (moving parts). > So we evaluate, test, and declare compliance to the Machinery Directive and > generate a DOC for that product family. > > Question #1 > > When a customer orders a configuration that does not include the sample > loader (moving part), can we still declare compliance to the MD or in these > cases do we have to generate a different DOC declaring to the LVD? In this > case, would we have to establish a system to produce custom DOCs for each > device produced depending on the options ordered by the customer? Can you not perhaps issue separate Declarations for each part of the system, plus one over-arching Declaration for a system which consists of all the possible options/permutations (which deals with the Machinery Directive 'co-ordinated machinery' aspect)? > > Question #2 > > Because the MD requires an accompanying unique signed DOC for each such > device built and to include the specific model number (based on options > ordered) and serial number, how do most companies logistically handle this? I > don’t imagine that each company has a “Managing Director” sitting at the end > of the product line signing, copying, packing, and filing the DOC for each > product built. So how can this be reasonably done and still meet the intent > of the Directive? > > There is no requirement for there to be a serial number, and even where there is, one Declaration can cover a range of serial numbers. Here is what the Machinery Guide says: As a general rule, the serial number of the machinery covered by the EC Declaration of Conformity shall be indicated. In the case of machinery produced in large series, it is possible to draw up a single EC Declaration of Conformity covering a range of serial numbers or batches, in which case the range covered by the declaration must be specified and a new EC Declaration of Conformity must be issued for each new range of serial numbers or batches. In any case, the necessary identification must be provided to ensure the link between each item of machinery and the EC Declaration of Conformity that applies to it. I think you need to consider what is practical as well as the exact letter of the law. It is sometimes helpful to consider this from the angle of what the Technical File says - if you do a separate risk assessment for every model built then a unique, signed, individual DofC for each unit is probably appropriate, but if you use a risk assessment which covers a range of models and serial numbers then it is probably appropriate to issue a Declaration which covers the same range. Happy to continue this correspondence privately if you wish! Nick. Nick Williams email: [email protected] ----- Conformance Ltd - Product safety, approvals and CE-marking consultants The Old Methodist Chapel, Great Hucklow, Buxton, SK17 8RG England Tel. +44 1298 873800, Fax. +44 1298 873801, www.conformance.co.uk Registered in England, Company No. 3478646 - ---------------------------------------------------------------- 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]>
