Monthly Archives: February 2023

60601 Series – FDA Transition Period Ending in 2023

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Changes to  FDA recognized consensus standards this year may catch many medical device manufacturers off-guard when preparing their medical devices for clearance or approval. The transition period for the 60601 series consensus standards listed below ends on December 17, 2023.  After this date, the FDA will no longer accept declarations of conformity to the older versions.  Some of the changes in these standards involve new tests, changes to expectations for risk management, and changes to documentation.  

New versions: 

  • ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) [Including Amendment 2 (2021)]  
  • IEC 60601-1-2 Edition 4.1 2020-09  
  • ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] 
  • IEC 60601-1-3 Edition 2.2 2021-01  
  • IEC 60601-1-6 Edition 3.2 2020-07  
  • IEC 60601-1-8 Edition 2.2 2020-07  
  • ANSI AAMI IEC 60601-1-8:2006 and A1:2012 [Including AMD 2:2021] 
  • IEC 60601-1-10 Edition 1.2 2020-07  
  • IEC 60601-1-11 Edition 2.1 2020-07  
  • ANSI/AAMI HA60601-1-11:2015 [Including AMD1:2021]  
  • IEC 60601-1-12 Edition 1.1 2020-07  
  • ANSI AAMI IEC 60601-1-12:2016 [Including AMD 1:2021] 

Old versions that will no longer be accepted: 

  • ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012   
  • IEC 60601-1-2 Edition 4.0 2014-02  
  • ANSI AAMI IEC 60601-1-2:2014 
  • IEC 60601-1-3 Edition 2.1 2013-04 
  • IEC 60601-1-6 Edition 3.1 2013-10  
  • IEC 60601-1-8 Edition 2.1 2012-11  
  • ANSI AAMI IEC 60601-1-8:2006 and A1:2012 
  • IEC 60601-1-10 Edition 1.1 2013-11  
  • IEC 60601-1-11 Edition 2.0 2015-01  
  • ANSI/AAMI HA60601-11:2015  
  • IEC 60601-1-12 Edition 1.0 2014-06  
  • ANSI AAMI IEC 60601-1-12:2016  

As you develop your compliance plan ensure you are designing and testing to the most recent standard version the FDA will accept at the time of your submission.  Also, pay attention to updated FDA guidance documents.  In some cases, the standard updates are very advantageous as the updated IEC 60601-1-2 Electromagnetic Disturbances (EMC) standard now more closely aligns with the recent FDA Guidance (see our other post, New FDA EMC Guidance – CMD MedTech).  Talk to one of our Compliance Engineers to assess potential gaps and plan appropriately to reduce the risks of FDA rejections and product launch delays.