Eisner Safety Consultants

FDA Formally Recognized AAMI ES60601-1:2005 (National Version of IEC60601-1:2005 = 3rd edition) as Consensus Standard on 6/10/10.  The transition period indicated on the FDA Consensus Standard web page for AAMI/ANSI ES 60601-1:2005 says in summary that 2nd edition of IEC 60601-1 will be accepted until June 30,2013 and after that only ANSI/AAMI ES60601-1:2005 will be [...]

Major Regulatory Decisions on the 3rd ed. of IEC 60601-1 on UL Thought Leadership WebPage http://ht.ly/1YkCB

Updated EN60601 Series FAQ Posted on Cenelec site in regard to the MDD & AIMD & EN60601 Series The current document posted on 22 March 2010 is an update to the previously posted document issued 9 October 2009 on the CENELEC site

Devicemakers Given Three Years to Transition to New Standard From  FDA News Devices & Diagnostic Letter March 29, 2010 Devicemakers may have to pay up to 40 percent more to test the safety and effectiveness of electronic devices now that CDRH has adopted an international standard for electronic devices. Manufacturers will have three years to [...]

Eisner Safety Consultants Newsletter #5 Now Online This issue we are going to focus on primarily on IEC/EN 60601-1:2005/2006 as there is some significant news within the last few weeks and more to come really soon.  Also, we would be remiss if we didn’t remind you that the MDD Amendment 2007/47/EC becomes mandatory this weekend [...]