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  • 1.  Packaging lithium batteries

    This message was posted by a user wishing to remain anonymous
    Posted 10-Aug-2021 16:11
    This message was posted by a user wishing to remain anonymous

    Hello,

    We have a Class III medical device that uses a lithium ion battery. We are not manufacturing the battery; we are sourcing it from a supplier. The battery carries all the necessary certifications and is compliant with UL2054 and IEC62133-2.

    Here are the options for packaging the battery as I see them, in order of preference:
    1. Package the battery already assembled into the device.
    2. Package the battery in a subassembly with the battery cover placed on the battery but separate from the main device.
    3. Package the battery separate from the device.
    Our preference is option #1 for usability (the device is intended for an elderly population) and to simplify the BOM structure. However, if that would require any further testing by us (beyond what we have from the battery supplier), we would not want to do that. If #1 is not feasible, we would go with #2. Again, if this would require any further testing, we wouldn't want to do that and then we would resort to option #3.

    My question is: Would option #1 or #2 trigger any further testing requirements for us? Are there any other factors we should be considering?

    Thank you.


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    1. 2.  RE: Packaging lithium batteries

      Posted 10-Aug-2021 20:12
      Hi Anon

      IATA has a nice guidance summarizing rules for labeling, packaging, and documentation, depending on the size of your batteries and how you end up deciding to do it​. The risks will be different for hearing aid batteries vs wheelchair batteries...
      https://www.iata.org/contentassets/05e6d8742b0047259bf3a700bc9d42b9/lithium-battery-guidance-document-2021.pdf

      Also, if you're planning to supply batteries in Canada, you should be aware of their licencing requirements.
      https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/md-im/activit/announce-annonce/battery-notice-piles-avis-eng.pdf


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      Anne LeBlanc
      United States
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      Original Message


    2. 3.  RE: Packaging lithium batteries

      This message was posted by a user wishing to remain anonymous
      Posted 11-Aug-2021 13:02
      This message was posted by a user wishing to remain anonymous

      Hi Leo and Anne,

      Thank you both for pointing me in the right direction.

      Anne - That guidance was very helpful and answered my questions. We are not planning on going into Canada right now, but I saved that PDF for future use. I know in general to be aware that Canada has some more specific rules around batteries and licensing. As an aside - I did not know that I would be learning so much about batteries this week, but that's what makes my job interesting!

      Leo - I wrote in my initial question that certs are provided with the lithium ion battery (so not a cell; it's a secondary battery and therefore rechargeable). The cover is replaceable without a tool.

      Conclusion: We will be conducting testing (through Intertek) to the 60601-1 standard and obtaining a certificate for that standard, but relying on the supplier for the certificates / test summaries to IEC 62133-1, IEC 62133-2, and UN 38.3. Based on those standards and the guidance that Anne provided, we can package the battery contained within the device (option #1) or separately to the device (option #3).
      Original Message


    3. 4.  RE: Packaging lithium batteries

      Posted 11-Aug-2021 13:05

       

       

       

      Just to second the recommendation of IATA.  It's been decades since I had to do this, but at one point I was responsible for assuring some IVD products were appropriately labeled for air transport, but at that time I found the IATA resources to be very helpful.

       

      Best regards,

       

      Ted

       

       

       




      Original Message


    4. 5.  RE: Packaging lithium batteries

      Posted 11-Aug-2021 03:26
      The battery or battery pack you are describing it is not clear if what you are being supplied is one battery cell, multiple cells and if multiples cells are packaged in a battery pack are they tested as a battery pack and certified that way (provided with certificates for those standards).  Please advise as that will impact the reply.  Also, items #1 - #3 are not clear if there is a cover that is replaceable without the aide of a tool or not.  Are these batteries rechargeable or not.  All these items and more are issues related to batteries for medical electrical equipment in the IEC 60601-1 standard.  So, would not be able to answer the whole question without a much more detailed look at the question and details.  Not something that can reasonably be done in this forum.  I hope this helps some.


      ------------------------------
      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
      ------------------------------

      Original Message


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