Several NRTLs, who are currently recognized for UL 60601-1, have applied to OSHA to add ANSI AAMI ES60601 + Amendment 1 to their scope of recognition. OSHA is currently reviewing these applications and anticipates the final recognition for these NRTLs
Which 60601-1, 3rd ed. Standard Applicable for FDA?
I have been asked in a variety of flavors if 3rd ed. of IEC 60601-1:2005 and/or 3rd ed. + Amendment 1 (A1):2012 will be required by the FDA and when? The answer isn’t exactly yes or no. The end of
Leo Eisner Presenting @ DesignMed on IEC60601-1-11 Home Healthcare
Topic: “Make sense of the IEC 60601-1-11 standard” The Medical Electrical Device Collateral Standard in the Home Healthcare Environment Presenters: Leo Eisner of Eisner Safety Consultants will be co-presenting with Joseph Murnane of Underwriters Laboratories When: Feb 10, 2011 (Thursday)
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