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 [...]

ANSI/AAMI/IEC TIR80002-1:2009 — Medical device software – Part 1: Guidance on the application of ISO 14971 to medical device software – Published Dec 24, ‘09
Abstract: This technical specification provides information useful for the performance of effective software risk management, as part of the overall risk management process for medical devices containing software. It does this [...]

Leo Eisner to present a regulatory update on IEC 60601-1, 3rd edition, at ‘09 IEEE PSES Conference, Medical Track
On October 27, 2009, Leo Eisner, of Eisner Safety Consultants and the Chair of the Medical Track for this Symposium, will be presenting a regulatory update on IEC 60601-1, 3rd edition at the 2009 IEEE Symposium on [...]

UL webpage on ISO 14971

UL webpage with regard to ISO 14971 – Risk Management.  Go to the bottom of this UL webpage & log-in to get a case study evaluating why a company may want ISO 14971 certification to support IEC 60601-1:2005 (3rd ed), which has heavy emphasis on ISO 14971.