Gary, Were you looking in the EMC OJ, or MDD OJ? There was a new MDD OJ in mid May. Per this link: http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=uriserv:OJ.C_.2016.173.01.0100.01.ENG
December 31st, 2018 is the DOW. Thanks, David From: Gary McInturff [mailto:[email protected]] Sent: Wednesday, June 01, 2016 11:23 AM To: [email protected] Subject: [PSES] 60601-1-2 edition 4 acceptance dates and DOW of edition 3 Are these dates still valid? US and Canada requiring 4th edition in 2017? EU accepting 4th edition but 3rd edition still acceptable for new products. What is the EU DOW. I tried hunting through the EU journal but could never find the standards dates. A link please? In February 2014, the IEC published IEC 60601-1-2:2014, ed 4.0 for Medical EMC. There are a number of changes in the 4th edition, including new immunity and risk analysis requirements. Dates For new products in the U.S., the FDA will make a decision on the 4th edition this July, with a likely 3-year transition period (2017 recognition). The FDA does not currently require retesting of legacy products unless changes are made to the product that may affect its compliance. Canada is planning to review the 4th Edition sometime in 2015 so it will not be accepted before 2015/2016. It's typically 3 years before accepted standards are required for new submittals. In Europe, CENELEC has voted affirmatively to accept the 4th edition but has not set a date to withdrawal (DOW) the 3rd edition. The DOW of the current 3rd Edition is expected in the 2017-2018 timeframe. There is no grandfathering in Europe. Gary McInturff Reliability/Compliance Engineer Esterline Interface Technologies Featuring ADVANCED INPUT, GAMESMAN, LRE MEDICAL, and MEMTRON products 600 W. Wilbur AvenueCoeur d'Alene, ID 83815-9496 Toll Free: 800-444-5923 Tel: (208) 635-8306 www.esterline.com/interfacetechnologies<http://www.esterline.com/interfacetechnologies> Technology, Innovation, Performance... "Information in or attached to this e-mail message may be subject to export control restrictions of the International Traffic in Arms Regulations (ITAR) (22 CFR pts. 120-130) or the Export Administration Regulations (EAR) (15 CFR pts. 730-774). Before exporting this information outside the United States or releasing it to a foreign person in the United States, you need to determine whether a license under the EAR or the ITAR is required to do so. If you have any questions about this obligation, please contact me." Click here<http://www.esterline.com/governance/email_disclaimer/tabid/1532/Default.aspx> to read disclaimer - ---------------------------------------------------------------- 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]<mailto:[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://www.ieee-pses.org/list.html (including how to unsubscribe)<http://www.ieee-pses.org/list.html> List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]<mailto:[email protected]>> Mike Cantwell <[email protected]<mailto:[email protected]>> For policy questions, send mail to: Jim Bacher <[email protected]<mailto:[email protected]>> David Heald <[email protected]<mailto:[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.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://www.ieee-pses.org/list.html (including how to unsubscribe) 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]>
