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lithium ion batteries

  1. F

    IEC 62133 cell vs. Battery Pack - Certification on the cell only

    We are a medical device manufacturer using an IEC62133 certified, single cell Li-ion battery pack (not user accessible) for a portable device. The pack we are using is no longer going to be available and we are in the market for a replacement. I am able to find replacement packs that have...
  2. E

    IEC 60335-1 li-ion battery requirements

    Good day, I have read 60335-1 standard and did not find any specific requirements for li-ion batteries (e. g. the specific standard for such batteries is stated in 60601-1). Does it mean that for manufacturer who installs batteries into household appliance is enough to comply with 60335-1 or...
  3. T

    Operational setup of how FIFO / Process Map on Lithium Batteries is done

    Hi, I would like to know if someone has an FIFO instructions / Process map available which describes the operational setup of how FIFO is done. We have identified 'Lithium batteries' as a critical item due to short shelf life. The batteries are supplied by a supplier and then assembled in our...
  4. C

    Lithium battery powered Medical Device - 15.3.3 Impact test, broken enclosure

    Hello everybody, I'm a long time reader of the forum and this is my first post. We are developing a body worn, lithium battery powered, medical device. Think of it like a wearable headset + pocket unit. After undergoing the impact test of 15.3.3 (which, by the way, seems quite hard as...
  5. E

    IEC 60601 Main requirements for the certification of a device with a Li-ion batt

    Dear. I need help in the following question: Dear. I need help in the following question I work in the development of a wearable device and its main use is to record ECG signals. This is powered by a 3.7V Li-ion battery. This battery is not accessible to the user, but to charge it through...
  6. S

    Safety requirements for secondary cells and batteries

    One of the changes introduced with the 3.1 edition is the requirement to test secondary lithium batteries according to IEC 62133. Do any of you have experience with that? time, cost and if it's feasible to do it in-house instead of external lab. Thanks, Shimon
  7. K

    IEC 62133 Test Report for Lithium Battery Certification

    One of our product is under IEC 60601-1 testing, in which we are using android device (Mobile). We have developed android app which is installed on android device for controlling medical devices motions. We have provided the Android device certification for IEC 60950-1 for IT equipment...
  8. S

    IEC 60601 Main requirements for Lithium Ion Battery Powered Device

    Dear All, We have a ECG medical device with embedded Rechargeable Li-ion battery (CE Certified - Non Removable by the user) which is intended to be charged using a USB cable/USB charger/Power Tank or (importantly) a computer for both charging and data transfer. So the max voltage is (5V)...
  9. M

    UN/Dot 38.3 Questions - Shipping Lithium Batteries

    Hi, I am looking into making battery packs out of lithium iron batteries, and have a couple of questions about shipping them. Do I need the UN/DOT 38.3 certification if I were to just ship via ground as a class 9 hazardous good? I read a paper that said: "Also, unless a company intends to be...
  10. B

    Primary lithium battery protection and vented gas

    We are working on preparing a battery powered medical device for FDA and I am currently going through 60601-1. It is a 3V primary LiPo battery that has UL 1620 and IEC 60086-4. We have reverse polarity protection and a fuse on our PCB but there is nothing on the battery itself. Is it...
  11. R

    Disposing of a Medical Device

    My customer has returned a medical device that was in use. It was determined that it cannot be repaired and my customer has asked me to dispose of it. It is not contaminated with any body fluids or such. It contains a lithium battery so I will be removing that and processing that through our...
  12. R

    Measuring LiON Battery State of charge - Transporting batteries by Air

    Hi all As of June this year we have a lot of new restrictions of transporting batteries by Air. A lot is around documentation - which we have sorted. Another requirement is that we need to ensure that none are over 30% charged (I am talking lithium ion obviously). So this is my dilemma -...
  13. H

    Secondary button cells (LIR2540) in medical products

    Hi, we are currently researching if we can use secondary button cells (LIR2540) in a medical product we develop. As to EN 60601 secondary lithium-ion cells have to apply to IEC 62133 - but IEC 62133 just applies to all lithium-ioncells EXCEPT button cells. [Btw. anyone knows WHY they are let...
  14. M

    IEC 60601 Charger requirement for Lithium Ion Battery Powered Device

    Hi, We are in the process of designing a class I medical device that is powered by a 18650 lithium ion rechargeable battery. The battery is not removable by the user. So the device itself is solely powered by the battery enclosed, and a separate wall mount power adapter is used only for...
  15. E

    Can I use CE marked Li-Ion external power bank for medical device?

    I want to use an external power banks for powering my device (with BF applied part). Power banks are very common and come in different capacities. I see that they are also CE certified. Can I use such CE certified power banks for my device? Doesn't CE certified means it already complies with 62133?
  16. E

    Requirements for Using Lithium battery instead of Alkaline

    I want to design battery (like CR2032 or AA or AAA sized) powered medical device. Instead of alkaline batteries, I want to use Lithium batteries. These are not the Li ion or Li polymer batteries. Are there any special requirements for using such Li battery in medical device. I couldn't find in...
  17. D

    Battery Powered Medical Device Battery Requirements

    We are building a small battey powered medical devices power is supplied by a 3.7 volt lithium battery and the circuit draws 100mA max I am planning to buy batteries from China do these need CE marking for use within my device? I would like to thank you in advance for your time and effort...
  18. T

    Polymer Lithium Ion Battery and Ventilation Requirements

    Dear all We have a Medical equipment with Ip clasification IPX4 than supplied from a polymer lithium ion battery with capacity up to 1000 mAhr. The battery is in separate container in the case of the device. IEC 60601-1 ed 3.1 in clause refer the need of ventilation of this...
  19. K

    Li Ion battery for medical device: transportation safety

    Hello, Wi develop a portable medical device with a Li ion battery inside. The battery is rechargeable and non-replaceable. The device with a battery inside is required to be Ok when shipped by air. Could you please help me to sort out which transportation safety certificates our battery...
  20. R

    Loading Capacity of Hazardous Lithium Batteries

    Hello, which loading capacity requires application of IEC 60601-1 ? Thanks for the answers. Robin E.
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