battery (electric batteries)

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    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. D

    Hazard analysis for our medical device - Hazards seem to overlap

    Hi Experts, I have a question that I believe one of you can help me with. We are working on hazard analysis for our medical device. While drafting the Hazard analysis for the medical device, the listed hazards and causes seem to overlap. How can I avoid this? Or is it acceptable? Kindly...
  3. 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
  4. D

    Gamma Sterilization of Coin Batteries (Primary Batteries)

    We're developing a disposable that includes a coin cell battery (either alkaline or Silver Oxide). We've contacted a couple of places regarding the risks involved with gamma sterilization and have gotten conflicting answers. Energizer battery's website suggests that you use gamma or ETO for...
  5. M

    UDI - Rechargeable Batteries and Charger

    Hello, I am preparing to launch a Class II 510(k) exempt biofeedback device in the US. The product (1 biofeedback device, 2 rechargeable batteries, 1 charger, 1 power cord) will be sold in a metal briefcase. Now, I am fairly certain that UDI should be applied to the biofeedback device label...
  6. 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...
  7. 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 -...
  8. 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...
  9. F

    Ambulance Battery Isolation - IEC 60601

    The 60601 standard defines (3.120) the battery of the ambulance as mains supply , does this means that is necessary to provide isolation between the battery and the rest of the circuits (i.e isolation from primary (ambulace battery) and secundary (other circuits and accesible and applied...
  10. M

    Who's name should be on component certification?

    We're getting batteries manufactured by a supplier. The supplier has batteries that meet our specifications, and prints our label on them. But because they are neither UL or IEC tested, we've agreed to pay for the battery testing/certification...which also entails surveillance audits. So...
  11. 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...
  12. D

    Exporting batteries (spare parts) to China

    Hi all, I was wondering if anybody had experience shipping batteries to China. These batteries are replacement (spare parts) for medical devices that we are currently selling in China. Some of the batteries are Nickel Metal Hydride, others Sealed Lead Acid. Is the CIQ process different...
  13. B

    Flammability Ratings for Internal Battery & Hand-Held ME Equipment

    Hello, All, Our company currently concern on the flammability ratings for EU & USA (including Canada) From IEC 60601-1 section 11.3 Constructional requirements for fire ENCLOSURES, we found that A) Enclosure ( for TRANSPORTABLE ME) need V-2 or above B) PCB need V-2 or above C) Internal wire...
  14. Q

    Medical Device Inductive charger Qi

    We are developing a medical device that is powered by rechargeable batteries. We intend to recharge with an inductive charger according to the Qi standard. There are many questions that we do not yet have answers to: - How do we deal with the requirements of current leakage, shock, etc.? - Must...
  15. 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...
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    IEC 62133 Certified Battery Manufacturers

    Does anyone know any battery type or battery manufacturer which are IEC 62133 certified? Quick search from internet didn't give any result. Does this mean that medical device companies must do IEC 62133 testing in test lab for chosen batteries and paid the test by them selves. Thanks for all...
  17. 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...
  18. R

    Loading Capacity of Hazardous Lithium Batteries

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

    Medical Device Battery Labeling Requirements in the US

    I would like to ask another question regarding the battery labeling requirement. The battery used with our medical device is also optional. Therefore we define it as an assessory to the main device. WE outsource the battery from a Chinese supplier in China. Our device has a 510K clearance, and...
  20. R

    IEC 62133 to satisfy 60601-1 3rd edition - What happen to 60086-4

    We are medical device commpany and our device has Li-ion battery one user replaceable and one embedded in in side the device non user replaceable. We are in the process of getting certified for 60601 3rd edition. Our test house is asking us for 62133 certificate for battery but I did not see...
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