It is logical that adding the week would be acceptable as long as your existing information meets the FDA (CFR) requirements. However, you may run into some challenges in dealing with the EN standards as EN 980 & EN 1041 calls out the date format per ISO 8601 to be one of the following: YYYY-MM-DD, YYYY-MM or YYYY. It is interesting that ISO 8601 also has other formats that includes the week number (YYYY-Www-D or YYYY-Www; i.e., 2010-W19-2) but those are not referenced in the aforementioned EN standards. Regards, Nick Momcilovic Product Compliance Lead Engineer GE Healthcare Magnetic Resonance
________________________________ From: [email protected] [mailto:[email protected]] On Behalf Of McInturff, Gary Sent: Tuesday, May 04, 2010 11:11 AM To: [email protected] Subject: Date code marking of Medical equipment - I think I know the answer but want to double check. A portion of the FDA marking requirements is attached below. It indicates that month and year are clearly marked. We wish to include week as well as those two items for our own tracking purposes. I don’t think the rule prevents us from additional marking it is simply indicating the minimum marking and if we chose to add the week along with the required items we are in compliance, correct? (ii) The month and year of manufacture shall be provided clearly and legibly, without abbreviation, and with the year shown as a four-digit number as follows: MANUFACTURED: (INSERT MONTH AND YEAR OF MANUFACTURE.) (b) In the case of products for which it is not feasible to affix identification labeling in accordance with paragraph (a) of this section, upon application by the manufacturer, the Director, Center for Devices and Radiological Health may approve an alternate means by which such identification may be provided. (c) Every manufacturer of an electronic product to which a standard under this subchapter is applicable shall provide to the Director, Center for Devices and Radiological Health a list identifying each brand name which is applied to the product together with the full name and address of the individual or company for whom each product so branded is manufactured. [40 FR 32257, July 31, 1975, as amended at 42 FR 18063, Apr. 5, 1977; 53 FR 11254, Apr. 6, 1988] Gary McInturff Reliability/Compliance Engineer Advanced Input Systems Esterline Corporation 600 West Wilbur Avenue Coeur d' Alene, Idaho 83815 Tel: 208 635 8306 Fax 208 635 8706 - 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.ieeecommunities.org/emc-pstc Graphics (in well-used formats), large files, etc. can be posted to that URL. 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]> - 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.ieeecommunities.org/emc-pstc Graphics (in well-used formats), large files, etc. can be posted to that URL. 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]>
