How to comment on FDA CDRH FY11 Draft Guidance Documents? http://ht.ly/2OiXg From the FDA CDRH webpage titled “Documents the CDRH is Considering for Development (FY11)” the following is the intoduction to the page: “This is the list of guidance documents
FDA Recognizes ANSI/AAMI ES60601-1:2005 Version of Med Elect Equip Std
#FDA Recognizes ANSI/AAMI ES60601-1:2005 Version of Medical Electrical Equipment Standard http://ht.ly/2oiBH
BS EN 60601-2-43:2010 Med. elec. equip. – X-ray equip. for interventional procedures
BS EN 60601-2-43:2010 Med. elec. equip. – Particular rqrts – X-ray equip. for interventional procedures Pub. 31-JUL-10 http://ht.ly/2fSOS
BS EN 60601-1-11:2010 Medical electrical equip-Collateral std-Home healthcare environ
BS EN 60601-1-11:2010 Medical electrical equipment-Collateral standard for use in home healthcare environ Pub 31-JUL-10 http://ht.ly/2fRwW
Eisner Safety Consultants Newsletter #6 Now Online
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/