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  • 1.  Lithium batteries - Comparison between UN 38.3 and IEC 60086-4

    Posted 15-Jan-2020 04:40
    Hi all,

    I work in medical devices, specifically public access defibrillators, and I have a question regarding standards/regulations for lithium battery testing. We currently claim compliance to UN 38.3 via the 4th edition of the UN Manual of Tests and Criteria, we have also conducted testing to IEC 60086-4: 2014.

    Given the new requirement under UN 38.3 for the Test Summary to be made available on request, I would like to know if the 60086-4 testing is equivalent to the UN 38.3 requirements? Our UN 38.3 testing is still valid but is from 2010, whereas the 60086 testing was conducted in 2016.

    Thanks in advance for your help

    Aaron Brunt
    Regulatory Specialist

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    AARON BRUNT
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  • 2.  RE: Lithium batteries - Comparison between UN 38.3 and IEC 60086-4

    This message was posted by a user wishing to remain anonymous
    Posted 16-Jan-2020 09:20
    This message was posted by a user wishing to remain anonymous

    I am not familiar with 60086-4. I know Intertek did some nice free webinars on UN 38.3 and while there was mention of 62133, there was no mention of 60086-4. Here's a link to their list of webinars, and the three that I had watched that could of relevance are titled:

    https://www.intertek.com/knowledge-education/webinars/

    - Lithium Battery Transportation: Going Beyond the UN 38.3 Tests
    - The Basics of UN 38.3 and the Requirements for the Transportation of Lithium Batteries
    - IEC 62133 and the Lithium-ion Battery Compliance Roadmap


  • 3.  RE: Lithium batteries - Comparison between UN 38.3 and IEC 60086-4

    Posted 16-Jan-2020 12:11
    Aaron:

    Agreed with the previous person, especially the third INTERTEK webinar, IEC 62133 and the Lithium-ion Battery Compliance Roadmap.  It is worth listening to the presentation and reviewing the Slides presented.  Note that the latest IEC 62133-2:2017 does include the UN 38.3 transportation requirements.  

    NOTE:  European Commission has an approved version, EN 62133-2:2017 (2nd edition) and there is the US/Canadian harmonized version: UL 62133-2:2017/CSA C22.2 No. 62133-2:17.  The previous version of IEC 62133-2:2017 (1st edition) has a Date of Withdrawal of March 14, 2020. If your end product is to be certified after March 14, 2020, or if there has been a significant design change to the battery pack/protection system, you will need to have the battery pack and protection system certified to IEC 62133-2:2017.

    There is also a nice summary of the UN 38.3 and IEC 62133 requirements for batteries in Medical Devices from Starfish Medical:

    https://starfishmedical.com/blog/safety-and-business-implications-for-lithium-batteries-in-medical-devices/

    Rob Legault, P. Eng. RAPS


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    Robert Legault
    P. Eng.
    Pickering ON
    Canada
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  • 4.  RE: Lithium batteries - Comparison between UN 38.3 and IEC 60086-4

    Posted 17-Jan-2020 02:56
    IEC 60086-4 is for non-rechargeable primary batteries whereas IEC 62133-2:2017 is for rechargeable secondary batteries.

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    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
    ------------------------------



  • 5.  RE: Lithium batteries - Comparison between UN 38.3 and IEC 60086-4

    Posted 17-Jan-2020 09:17
    Aaron:

    Leonard is correct, IEC 60086-4:2019 and and IEC 62133-2:2017 are the latest published standard for non-rechargeable primary and rechargeable secondary lithium batteries, 

    In terms of the use, safety and transportation of primary and secondary lithium  batteries used in Medical Devices, there is a good summary from CSA Group of the recognized EU, Health Canada and FDA battery standards plus the ICAO, IATA, US DOT requirements for shipment of Lithium based batteries (they refer to the  latest UN 38.3 standard, which is UN 38.3:2019 6th edition):  

     https://www.csagroup.org/article/making-sense-regulations-medical-device-batteries/

    Rob Legault, P. Eng. RAPS IEEE
    Pickering, ON
    Canada

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    Robert Legault
    P. Eng.
    Pickering ON
    Canada
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