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/
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
IEC 60601-1-11, 1st ed. published Std for Med Elec Equip & Systems used in Home Healthcare Environ
IEC 60601-1-11, 1st edition, just published Apr 28, 2010. This is the Medical electrical equipment collateral Standard for Medical electrical equipment & systems used in home healthcare environments.
US Devicemakers Given Three Year Transition to IEC 60601-1
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