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  • 1.  Performing IEC 60601-1 Tests Outside US

    This message was posted by a user wishing to remain anonymous
    Posted 08-Aug-2023 14:29
    This message was posted by a user wishing to remain anonymous

    Dear Community,

    We are considering using a test house certified to ISO 17025 by ABNT in Brazil for performing the electrical safety tests of our medical device in support of a 510K. Here are examples of the standards/tests to which the lab is certifiied to perform:

    IEC 60601-1:2005 + Amendment 1:2012 +Amendment 2: 2020 Except: 8.8.4.2 - 4th par.; 10.1; 10.3

    ABNT NBR IEC 60601-1:2010 + Amendment 1:2016 + Amendment 2:2022

    ABNT NBR IEC 60601-1-2:2017, IEC 60601-1-2: 2014 Section only: 5

    ABNT IEC 60601-1-8:2010 + Amendment 1:2014 IEC 60601-1-8:2006 + Amendment 1:2012

    Are there any drawbacks with using a non-US based ISO 17025 certified lab for electrical safety testing? Does the FDA accept such test results/reports in support of a 510K from the outside US labs?

    Your insights are appreciated.



  • 2.  RE: Performing IEC 60601-1 Tests Outside US

    Posted 09-Aug-2023 02:12

    I would be leary of this approach for the following reasons:

    1) the ABNT standards are not up to date compared to Recognized Consensus Standards that FDA expects

    a) IEC 60601-1-2 :2014 of your premarkert submission (510K) would have to be provided to the FDA by Dec 17, 2023 (end of the transition period and not allowed after this) but is not recommended as there is a newer standard that the FDA pushes in most cases which is IEC 60601-1-2:2014 + Amendment 1:2020.  You will be hard pressed not to test to this standard.  They also accept the AAMI IEC version (US adoption of IEC standard) 

    b) IEC 60601-1:2005 + Amendment 1:2012 + Amendment 2: 2020 is actually not the FDA Recognized consensus standard the current one is AAMI  ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=43309 . There is a lot more detail to discuss that I wrote a blog post of but per the RegEx posting requirements, I'm not allowed to post that link.  So, if you want that info please send me a personal request and I will send it separately but won't post it here.

    c) Similar to a) IEC 60601-1-8:2006 + A1:2012 is an older standard and has the same transition period with the FDA Dec 17, 2023 that you would need to provide to the FDA for your premarket submission. There is a newer standard which is the IEC 60601-1-8:2006 + A1:2012 + A2:2020. You will be hard pressed not to test to this standard.  They also accept the AAMI IEC version (US adoption of IEC standard).

    d) That the ABNT and/or IEC standards are excluding or only covering certain clauses is concerning and could cause major grief depending on your product.   Also, this means you won't have a complete test report if that applies to you that is a major problem.   If doesn't apply to you not as much of an issue.

    You should be able to find labs outside the US that can test to the FDA Recognized Consensus Standards.  I would check the FDA Recognized Consensus Standards db for the proper current standards at this weblink https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm



    ------------------------------
    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
    ------------------------------

    Original Message


  • 3.  RE: Performing IEC 60601-1 Tests Outside US

    Posted 09-Aug-2023 08:30

    Hello Anon

    Leonard Eisner (Eisner Safety group) is the expeet, but briefly, FDA prefers you use one of their own recognized labs, but it's not a deal killer.  What they will expect is that you test to the 2020 versions of these standards (Edition 3.2  of IEC 60601-1, Edition 4.1 of IEC 60601-1-1 EMC standard, etc.).  These labs know and can generate a required Declaration of Conformity for an FDA submission. (Now I am down in the weeds)....

    Also,  FDA will expect you to address the national deviations/versions of the standard,  so test to AAMI ES60601-1, etc. Or get a CB type report that tests to the standard and adds additional testing or discussion of the US or other country add-ons.

    OSHA is the Agency organization who requires healthcare instituitions to have safe equipment for their enployees, and the institutions can request OSHA recognized labs testing of their larger fixes installation equipment.



    ------------------------------
    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
    ------------------------------

    Original Message


  • 4.  RE: Performing IEC 60601-1 Tests Outside US

    This message was posted by a user wishing to remain anonymous
    Posted 10-Aug-2023 13:45
    This message was posted by a user wishing to remain anonymous

    Thanks for the valuable insights!

    .


    Original Message


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