Eisner Safety Consultants Newsletter #6 – published 6/30/2010 & covers Recent news on IEC/EN 60601-1:2005/2006; Classification MedDev, Clinical Data & Usability Analysis Requirements per the Amended MDD; and Rechargeable Batteries with Inductive Coupling Download all our newsletters at http://www.EisnerSafety.com/esc-news/
NAMSA offering seminars – Biocompatibility of Med. Dvcs Aug – Oct, ’10
NAMSA is offering seminars on Biocompatibility of Medical Devices in Massachusetts, Minnesota & Singapore Aug thru Oct, 2010 http://ht.ly/25q39
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
Joint FDA/FCC public mtg 7/26-27 – Enabling Convergence of Communication & Medical Systems
Joint FDA/FCC public meeting July 26 & 27, 2010 – Enabling Convergence of Communication & Medical Systems: Update Regulatory & Info Processes http://ht.ly/20oMz Summary: The FDA and the FCC are jointly sponsoring a public meeting entitled “Enabling the Convergence of
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
