Eisner Safety Consultants

Eisner Safety Consultants Newsletter #5 Now Online This issue we are going to focus on primarily on IEC/EN 60601-1:2005/2006 as there is some significant news within the last few weeks and more to come really soon.  Also, we would be remiss if we didn’t remind you that the MDD Amendment 2007/47/EC becomes mandatory this weekend [...]

The FDA is to Formally Recognize the Medical Electrical Safety Standard IEC 60601-1:2005, 3rd ed From AAMI March 12, 2010 press release The U.S. Food and Drug Administration (FDA) will formally recognize the electrical equipment standard IEC 60601-1/Ed.3:2006.

3rd ed 60601-1 FX Conf on 3/25 “Is Your Product Development Cycle Ready for IEC 60601-1 3rd Edition?” http://ow.ly/1j0o0

AAMI ES60601-1:2005/C1:2009 — Medical electrical equip, Gen rqrts for basic safety & essential performance, Amendment C1 http://ow.ly/1hMkV

The old UL standards for Medical Devices & X-ray devices have been withdrawn as of December 21, 2009 Yes, it is true these old standards finally have been withdrawn.  UL’s announcement on December 21, 2009 stated “UL announces the withdrawal of the seventh edition of the Standard for X-Ray Equipment, UL 187, and the fourth [...]