Hi Gary, For the US I believe from memory it is April 1, 2017 so pretty soon. I have the EU info buried somewhere so when I get a chance (may be awhile as I am only working couple hours per day max with being post knee surgery 1 week). Thx,
Leonard (Leo) Eisner, P.E. Principal Consultant, Eisner Safety Consultants Phone: (503) 244-6151 Mobile: (503) 709-8328 Email: [email protected] Website: www.EisnerSafety.com *************** Internet E-mail Confidentiality Disclaimer *************** This e-mail message may contain privileged or confidential information. If you are not the intended recipient, you may not disclose, use, disseminate, distribute, copy or rely upon this message or attachment in any way. If you received this e-mail message in error, please return by forwarding the message and its attachments to the sender. Eisner Safety Consultants do not accept liability for any errors, omissions, corruption or virus in the contents of this message or any attachments that arise as a result of e-mail transmission. ******************************************************************************* On Jun 1, 2016, at 9:23 AM, Gary McInturff <[email protected]> wrote: > 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 > > 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 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]> > > 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]> > - ---------------------------------------------------------------- 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]>
