Hi Dick, Section (e) deals with items that have an shelf life (i.e. sterile products). Having the actual month and year makes perfect sense.
Active devices usually are not date sensitive, except for "usable lifetime" (i.e. 10 years) as defined by the manufacture. The year of manufacture only, needs to be on the label per 13.3.l. It was my understanding that the actual year should be on the label. Symbol 6.16 of ISO 15223 can be used or the year (i.e. "01") has to be an integral part of the serial number. If it was a code in the serial number, how would the user know when the usable lifetime is up? Ned Devine Ned Devine Program Manager III Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 616 248 9671 Phone 616 574 9752 Fax [email protected] e-mail -----Original Message----- From: Dick Grobner [mailto:[email protected]] Sent: Monday, June 25, 2001 7:02 PM To: IEEE EMC-PSTC E-Mail Forum (E-mail) Subject: Serial Number Format - Medical Devices A question to the group: 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? Thank You Dick Grobner Medical Graphics Corporation 350 Oak Grove Parkway St Paul MN 55127 651-766-3395 651-766-3389 (fax) [email protected] ------------------------------------------- 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," ------------------------------------------- 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,"
