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
FDA Formally Recognize IEC 60601-1, 3rd ed.
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…
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
ANSI/AAMI HE75:2009 — Human f…
ANSI/AAMI HE75:2009 — Human factors engineering – Design of medical devices http://ow.ly/1hMzF
ANSI/AAMI/IEC TIR62354:2009 – Coming Soon
ANSI/AAMI/IEC TIR62354:2009 — General testing procedures for medical electrical equipment – Coming Soon (IEC version already published) This Technical Report will specify the general harmonized recommendations (conditions and procedures) for testing MEDICAL ELECTRICAL EQUIPMENT (as defined in Sub-clause 3.63 of