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FDA extends EMC standard transition date to April 1, 2017

60601 White Paper Cover
November 5, 2014

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 Food and Drug Administration Staff” suggests using the 4th edition of IEC 60601-1-2 for Home Healthcare environments now to cover test levels which may not be appropriately addressed in the 3rd edition. For more information on EMC testing and certification of medical devices for global markets, please contact your regional UL Health Sciences team member

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