Eisner Safety Consultants

Leo Eisner will be speaking on “IEC 60601–1, 3rd Edition, Amendment 1 and its Impact on Users” at an FX Conferences event on May 2, 2013 (Thurs) at 11:00AM – Noon (Pacific), 2:00PM – 3:00PM (Eastern).  You don’t have to leave your office to join in on the presentation and as a special thank you for [...]

NOTE:  The previous posting and Events webpage was April 18, 2013 for the date of this presentation.  FX Conferences had to change the date of the presentation for unforeseen circumstances and so it now will be on May 2, 2013 (Thurs) at 11:00AM – Noon (Pacific), 2:00PM – 3:00PM (Eastern).  See below for all the details [...]

Leo Eisner will be speaking on “IEC 60601–1, 3rd Edition, Amendment 1 and its Impact on Users” at an FX Conferences event on May 2, 2013 (Thurs) at 11:00AM – Noon (Pacific), 2:00PM – 3:00PM (Eastern).  You don’t have to leave your office to join in on the presentation and as a special thank you for [...]

I have been asked in a variety of flavors if 3rd ed. of IEC 60601-1:2005 and/or 3rd ed. + Amendment 1 (A1):2012 will be required by the FDA and when? The answer isn’t exactly yes or no.  The end of the transition period for 2nd ed. of IEC 60601-1 is June 30, 2013.  By July [...]

A very useful document was recently released to be a summary of the significant and moderate changes made to IEC 60601-1:2005 based on Amendment 1 (A1) of IEC 60601-1.  This is an excellent resource (IEC TR 62348:2012, published 12 Dec ’12 and ANSI/AAMI/IEC TIR 62348:2012, published 31 Dec ’12 by AAMI & 23 Dec ’12 [...]