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How to choose medical device batteries that meet international standards?

As the requirements for portability and mobility of medical devices increase, batteries are increasingly used in medical devices. They can be used for local power supply, such as button batteries on the motherboard, or to provide power for the entire device to ensure normal operation. Batteries are mainly divided into two categories: non-rechargeable batteries and rechargeable batteries.
Non-rechargeable batteries include zinc-manganese, silver oxide, and lithium primary batteries. Rechargeable batteries include nickel-metal hydride batteries, nickel-cadmium batteries, lead-acid batteries, lithium-ion batteries, and lithium polymer batteries. However, due to the storage of chemicals and energy inside the battery, its use in medical devices may bring certain safety risks and requires special attention.
What do the symbols on medical devices mean?
We often see various graphic symbols and abbreviations in medical devices. These symbols are not designed randomly, but follow international standards and are used to quickly convey key information.
Do you recognize all these symbols?
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Manufacturer | Indicates a medical device manufacturer. | ISO 15223-1 Medical Devices - Symbols to be used with medical device labels, labeling, and information to be supplied |
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Authorized Representative in the European Community/EU | Indicates the authorized representative in the EC/EU. | ISO 15223-1 Medical Devices - Symbols to be used with medical device labels, labeling,g and information to be supplied |
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Date of manufacture (year-month-day) | Indicates the manufacturing date of the medical device. | ISO 15223-1 Medical Devices - Symbols to be used with medical device labels, labeling, and information to be supplied |
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Expiration date (year-month-day) | Indicates a date after which the medical device must not be used. | ISO 15223-1 Medical Devices - Symbols to be used with medical device labels, labeling, and information to be supplied |
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batch number | Indicates the manufacturer's batch code, which can be used to identify a batch or lot number. | ISO 15223-1 Medical Devices - Symbols to be used with medical device labels, labeling, and information to be supplied |
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Catalog Number | Indicates the manufacturer's catalog number for identification of medical devices. | ISO 15223-1 Medical Devices - Symbols to be used with medical device labels, labeling, and information to be supplied |
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Serial Number | Indicates the manufacturer's serial number to identify a specific medical device. | ISO 15223-1 Medical Devices - Symbols to be used with medical device labels, labeling, and information to be supplied |
Identifying the hazards associated with medical batteries
Battery-related hazards include overheating, gas release, liquid leakage, fire, or explosion.
Overheating may cause the housing to deform, the temperature of adjacent insulating components to exceed the limit, causing insulation failure, or the temperature of accessible parts to exceed the limit, causing burns.
Released gases may be toxic and cause personal injury, or they may be flammable and may ignite or explode if they accumulate without proper ventilation.
Leaking liquids may corrode safety-related components such as protective grounding connections, and if the liquid is conductive, it may short-circuit insulation or isolation strips, causing an electric shock to personnel.
Fire and explosion may cause personal injury and property damage.
How do you choose the right battery for your healthcare device?
Selecting the right battery can involve balancing several conflicting requirements. You want the battery to be large enough to power the device for an extended time, and to have an output voltage range that matches the needs of powering integrated circuits. Typically, you want the battery to be as small as possible to minimize the overall size of the product. Cost, availability, and shelf life are also considerations.
Here are the key things to look for when selecting a battery for medical devices.
Energy density and device size
Medical devices usually need to run for a long time, so they need batteries with high energy density (such as lithium-ion batteries), but at the same time, they need to minimize the size. Trade-offs when choosing:
Lithium-ion batteries: high energy density, suitable for portable devices (such as blood glucose meters, wearable monitoring devices).
Lithium polymer (LiPo) batteries: customizable shapes, suitable for ultra-thin or special-shaped devices.
Nickel metal-hydride (NiMH) batteries: low cost, but low energy density, suitable for some low-power devices.
Voltage stability and discharge characteristics
The electronic components of medical devices usually have strict requirements on the supply voltage, so the battery discharge curve must be stable:
Choose batteries with a low self-discharge rate to avoid running out of power after long-term storage.
Ensure that the battery can still provide a stable power supply at different temperatures (such as 0°C~40°C).
For high-precision devices (such as pacemakers, infusion pumps), constant voltage output or voltage regulation circuit design is required.
Cycle life and replacement cycle
Rechargeable batteries (such as Li-ion) are suitable for frequently used devices, but the number of charge and discharge cycles must be considered (usually the capacity decreases after 500~1000 cycles).
Non-rechargeable batteries (such as lithium primary batteries) are suitable for implantable or long-term use devices (such as hearing aids, heart monitors), and the life span can reach 5~10 years.
Cost optimization strategy
For high-volume devices (such as blood glucose meters), low-cost lithium manganese batteries can be considered.
High-end devices (such as portable ultrasound devices) can use high-energy density batteries, improving user experience despite the higher cost.
Choosing the right battery can not only improve the reliability of medical equipment but also reduce safety risks and ensure the safety of patients and medical staff.
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