<36BDBCA75E0FD411A80100104B93ABF202C2C24B@mgcmail>, Dick Grobner <[email protected]> inimitably wrote: >Referencing the Medical Device Directive, Annex I, paragraph 13.3 The label >must bear the following particulars: (l), "year of manufacture for active >devices other than those covered by (e). This indication may be included in >the batch or serial number". >One of my colleagues (in another company) was told by their Notified Body >(BSI) that it has been interpreted (by whom?) that this means the month and >year needs to be embedded into the actual serial number, such as XXZZ00001 >whereas XX: month and ZZ: year (or similar). >We have never encountered this with our Notified Body (TUV). Our S/N's cross >back to a SN log which will reveal the month and year of manufacture. >Who is right? Does anyone know where this "official" interpitation is coming >from? The rational behind it?
The words 'MAY be included in the serial number' do not mean 'SHALL be included in the serial number'. I suspect that BSI Testing is being more Royalist than the King. BUT, I don't think that what you are doing is correct, either. The words 'must bear .... year of manufacture' mean that the year must be stated overtly, not just be deducible from your serial number records. -- Regards, John Woodgate, OOO - Own Opinions Only. Phone +44 (0)1268 747839 Fax +44 (0)1268 777124. http://www.jmwa.demon.co.uk Why not call a vertically- applied manulo-pedally-operated quasi-planar chernozem-penetrating and excavating implement a SPADE? ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson: [email protected] Dave Heald [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] All emc-pstc postings are archived and searchable on the web at: http://www.rcic.com/ click on "Virtual Conference Hall,"
