batteries for medical devices

Safety and business implications for lithium batteries in medical devices

Lithium rechargeable batteries achieve some of the highest energy densities available today. Not surprisingly, medtech companies are keen to use lithium batteries in medical devices and benefit from reduced weight or increased battery life.
There are a number of safety implications to choosing these batteries as well as practical business implications.

Safety Regulations

Lithium rechargeable batteries have the potential to overheat and even catch fire. This can occur by overcharging, overloading, as well as by mechanically or environmentally over-stressing. For this reason, medical devices containing rechargeable lithium batteries must confirm to the IEC 62133 standard. This standard defines a number of mechanical, environmental and electrical tests that must be performed in order to ensure a product is safe. Usually, to meet this standard, special protection circuits and mechanical protection features must be employed. Additionally the standard risk management process dictated by the IEC 60601 and IEC 14971 standards should also consider the safety implications of using these batteries.

Lithium rechargeable batteries are considered dangerous goods and therefore there are shipping restrictions. The United Nations has defined the UN 38.3 standard which all battery packs and devices containing lithium batteries must conform to in order to be allowed to ship by air. This can be a bit of a surprise when suddenly you’re forced to send your product by ground transport only. Fortunately, the design features that will enable passing IEC 62133 usually are also effective to allow passing UN 38.3.

Business

Lithium rechargeable batteries don’t come in standard battery packs. It is often surprising that you can’t just buy a standard battery pack that has already passed the regulatory hurdles and can be dropped into a product. Although there are plenty of off-the-shelf raw lithium batteries available, these must be combined with protection circuitry, wired to connectors, and packaged in order to use them in a medical device. This invariably is a custom process, specific to each application. Fortunately there are numerous companies that specialise in the custom packaging of lithium batteries and many are equipped to provide the safety testing services required.

There are great, functional reasons to use Lithium batteries in medical devices. With some knowledge of applicable standards and some forethought, the safety, regulatory and business pitfalls that can be avoided.

Medical product designers are continually seeking to make medical equipment smaller, lighter, more ergonomically designed, as well as more reliable.

Some medical devices like wireless blood oxygen meters need a reliable and small battery but do not require high currents or high temperature. Others need to be sterilized using high temperature. These devices can best be powered by Tadiran lithium batteries, especially the SL-500 series with its extended temperature range.

Other medical devices like Automatic External Defibrillators (AEDs) require high current pulses and will take advantage of Tadiran’s PulsesPlus battery technology.

Some surgical tools require a special battery: Tadiran high power TLM Series batteries deliver precisely what the medical industry needs. They have the highest power in the smallest volume and have it available immediately when it is needed.

Applications and their best suiting battery group:

 Defibrillators
 Dispensers
 Implantable devices
 Infusion pumps
 Surgical instruments
Key:
 Lithium/Thionyl Chloride (LTC-)Batteries
 PulsesPlus-Batteries
 Tadiran Lithium Metal Oxide (TLM-)Batteries
 Tadiran Lithium Ion (TLI-)Batteries

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