Eisner Safety Consultants

#FDA Recognizes ANSI/AAMI ES60601-1:2005 Version of Medical Electrical Equipment Standard http://ht.ly/2oiBH

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

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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 [...]

STERIS System 1 (SS1) Resource AAMI web pg http://ow.ly/1EjJE links to background, FDA, STERIS, assess alternatives, Endoscope Reprocessing

AAMI News: Online Med Dvc Standards Portal Access to Over 2,000 Std’s & Reg’s (AAMI, ANSI, ASTM, DIN, IEC/ISO, FDA) http://ow.ly/1n2Jg