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.   

In June of 2022 the FDA issued an updated guidance for “Electromagnetic Compatibility (EMC) of Medical Devices”.  This guidance offers significantly more detail than the 2016 guidance as it describes the relevant information that should be considered and provided in an FDA submission to support a claim of electromagnetic compatibility (EMC) for medical devices and in vitro diagnostic devices (IVDs). 

Key areas of focus and additions: 

• Intended Use Environments 
• EMC risk assessments (ISO 14971) 
• Risk Considerations that may not be adequately covered in existing consensus standards due to technology evolution (i.e. 5G, MRI, NFC, WPT) 
• Applicable consensus standards and considerations in addition to or in lieu of IEC 60601-1-2 
• Immunity acceptance criteria and Essential Performance 
• Labeling for EMC 
• Leveraging existing EMC results vs new EMC testing 
• Emitters – specifically RFID: Now includes consideration of AIM 7351731 RFID immunity standard ”or” IEC 60601-1-2:2020 Clause 8.11 (61000-4-39) ”or” equivalent methods with justification 
• Recommended that Investigation Device Exemptions (IDE) and Investigational New Drug (IND) submissions also consider this guidance 

While the guidance helps clarify at a high level the expectations and considerations, the selection of the appropriate standards, test method implementation, and acceptance criteria are the manufacturer’s responsibility as they are specific to each product and intended use.   Many of the expectations of the guidance are typically addressed in the risk management file as well as an adequate EMC test plan and test report. 

An EMC test plan, created by the manufacturer and reviewed and aligned with by the test lab, at minimum should clearly capture Essential Performance and acceptance criteria, how performance is observed, description of the intended use and use environment, tests and test levels, deviations and special equipment used.  Additionally, it documents the test configurations including connections, voltages and frequencies, software, and modes of operation.  To fully test with respect to potential EMC risks multiple modes of operation or configurations may need to be evaluated.    

For any questions or assistance with compliance of your product please contact us using our contact page.

To see the FDA guidance please visit Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices.