Results 3 found
August 11th, 2015
FDA extends EMC standard transition date to April 1, 2017

FDA recently announced an extension to the transition date for the Medical EMC standard ANSI/AAMI/IEC 60601-1-2 to  April 1 2017.  Click here to view the official notice from the FDA. Although the transition date is now set for 2017, UL Medical EMC experts advise that FDA’s publication “Design Considerations for Devices Intended for Home Use –Guidance for… read more

November 5th, 2014
FDA extends EMC standard transition date to April 1, 2017

FDA recently announced an extension to the transition date for the Medical EMC standard ANSI/AAMI/IEC 60601-1-2 to  April 1 2017.  The official notice is at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=32630 Although the transition date is now set for 2017, UL Medical EMC experts advise that FDA’s publication “Design Considerations for Devices Intended for Home Use –Guidance for Industry and… read more

October 21st, 2014
FDA adds 4th edition of IEC 60601-1-2 to list of EMC consensus standards

On July 9, 2014, the FDA added the 4th edition of IEC 60601-1-2, “Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests” to the list of standards that can be used to show EMC compliance for medical electrical devices and systems. … read more