The FDA on May 30, 2022, same day as when the recent AAMI 60601 Amendments were Recognized, added the Interpretation Sheet 1 (ISH1) – Amendment 1 – on Essential Performance (Clause 4.3) and Single Fault Condition (Clause 4.7) based on IEC 60601-1:2005+A1:2012 Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance to:
FDA Recognition # 19-46 ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] and
FDA Recognition # 19-4 ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text).

ISH1 was added to both FDA Recognitions # 19-46 & 19-4 as a “Relevant FDA Guidance and/or Supportive Publications” not as an independent Recognized Consensus Standard.
The ISH1 was Issued 2021-03 by IEC. One reason why FDA probably didn’t include the ISH1 as a Recognized Consensus Standard is because it isn’t an ANSI and AAMI approved standard. A blog post on the ISH1 when it was issued can be viewed here.

The FDA has been reviewing Essential Performance (EP) during submission for many years, since the publication of the 3rd edition of IEC 60601-1:2005 and their Recognition of ANSI AAMI ES60601-1:2005. It was even discussed during the expert panel, May 2018, at the ASCA Workshop, which I was the expert on EP on the panel. So, expect that FDA will review your submission for EP both for the safety and the EMC side of your testing.

Questions you need to consider early in the product development:
* have you identified the clinical functions of your device that are EP,
* have you started your EP analysis,
* has the EP analysis been fully connected with your Risk Management File,
* have you written your EP so it is capable of being tested for the safety and EMC which will be tested differently,
* and so much more…

One of the next steps out of the generation of the ISH1, as noted in the blog post on ISH1, was the formation of the Project Team PT 62A-1 with a goal to generate a technical report IEC TR 60601-4-6 as a guidance document on Essential Performance. PT 62A-1 has been meeting since February of 2022 and been trying to work on figuring out how we want to provide guidance to manufacturers, test houses and regulators on Essential Performance and Faults related to EP. The main reason for this is that we have seen there is so much confusion on this subject by some manufacturers, test houses and regulators and we want to provide a document that will provide a consistent guidance on the concept of Essential Performance and Fault Safety related to EP.

Need help with Essential Performance, 60601 series standards (Medical Electrical Equipment), work thru strategic planning for your medical electrical product lines, need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.