The FDA in a little over a month on 30 May 2022 (that is swift) has updated the Recognized Consensus database for the AAMI 60601 Amendmended Standards that are referenced in my previous post of May 13, 2022. The AAMI standards were published in late March 2022.
Not each Recognition was updated in the same way. Let me explain:
The two Recognized Standards that show as being updated based on an updated “date of entry” (upper right hand corner of the web page) of 05/30/2022 are & don’t have IEC equivalents in the Recognition db:
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] – the ANSI AAMI ES60601-1 AMD2:2021 is identical to Amendment 2:2020 of IEC 60601-1:2005 (post corrected 13 June)
FDA Recognition # 19-47 ANSI AAMI HA60601-1-11:2015 [Including AMD1:2021] – the ANSI AAMI HA60601-1-11 AMD1:2021 is identical to AMD1:2020 of IEC 60601-1-11:2015 (post corrected 13 June)
These 3 FDA Recognitions were NOT updated as a “Date of Entry” but the SIS were updated on 05/30/2022 which can be found @ the bottom left corner of the web page for each specific entry noted here. These 3 Recognitions include the ANSI AAMI IEC & IEC versions.
FDA Recognition # 19-36 ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] – the ANSI AAMI IEC 60601-1-2:2014 Including AMD 1:2021 is identical to AMD1:2020 of IEC 60601-1-2:2014
FDA Recognition # 5-131 ANSI AAMI IEC 60601-1-8:2006 and A1:20012 [including AMD2:2021] – the ANSI AAMI IEC 60601-1-8:2006 and A1:20012 including AMD2:2021 is identical to Amendment 2:2020 of IEC 60601-1-8:2006
FDA Recognition # 19-39 ANSI AAMI IEC 60601-1-12:2016 [Including AMD 1:2021] – the ANSI AAMI IEC 60601-1-12:2016 Including AMD 1:2021 is identical to AMD1:2020 of IEC 60601-1-12:2014
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