Eisner Safety Consultants is attending the 74th Annual IEC General Meeting in Seattle Washington thru Oct 16, 2010. As a US National Committee member of Technical Committee (TC) 62, Subcommittees (SC) 62A & 62D we are attending the committee meetings
FDA Formally Recognized AAMI ES60601-1:2005 as Consensus Std 6/10/10
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
Major Regulatory Decisions on IEC60601-1, 3rd ed. (UL White Paper)
Major Regulatory Decisions on the 3rd ed. of IEC 60601-1 on UL Thought Leadership WebPage http://ht.ly/1YkCB
Leo Eisner Speaking at IEEE PSES ’09 Conference
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
Risk Management for Medical Devices
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