How medical device vendors choose lithium medical batteries

  • November 01, 2024
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With the development of lithium battery technology, more and more medical devices are choosing to use lithium batteries, such as pacemakers, cochlear implants, smart bracelets and watches, portable respiratory machines, portable imaging equipment, portable analyzers, intelligent medical management systems, and so on. Since the medical lithium battery is a key component of medical equipment, its quality, safety, and performance directly affect the operating effectiveness of medical equipment and the life safety of patients. Therefore, medical lithium batteries should be more stringent than commonly used batteries in terms of heat-resistant performance, prevention of short-circuit, and other functions. So, when choosing a medical battery, you need to pay attention to the following five points.

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 I. Qualification and Certification 

Due to the special application of medical device products in saving lives, preventing diseases, and curing illnesses, the management of medical device products is very strict in various countries. Medical product manufacturers and service providers need to meet the ISO 13485 ‘Medical Device Quality Management System for Regulatory Requirements’.

As a key component of medical equipment, the battery manufacturer must also have the appropriate qualifications and certifications, such as ISO 9001, ISO 27001, CE, UL, and others.

 II. Safety 

As medical devices are usually used to diagnose and treat diseases, their operational stability is directly related to the safety of patients' lives. Therefore, it should have functions to prevent overheating, short-circuit, leakage, overcharging, and over-discharging, so as to prevent the instability and unsafe conditions of the battery from affecting the medical equipment, which could lead to safety hazards and cause incalculable losses to medical institutions and manufacturers of medical equipment. 

III. Performance Requirements 

Reliability

Medical lithium batteries should demonstrate stability and consistency in various medical environmental conditions to ensure that the equipment can work properly at critical moments.

High Life Expectancy

As the medical lithium battery is a component of medical equipment, it needs to have a long service life to reduce the replacement frequency and maintenance costs. Therefore, attention must be paid to the number of battery cycles.

High Energy Density

As the production of medical equipment has certain requirements, the size of the battery has strict limitations. In the case of the same size, you need to choose a battery with high energy density, which has a larger capacity to meet the medical equipment's need for longer operation.

Dischargeability

Medical lithium batteries should have good discharge performance, including regular discharge, high-rate discharge, and low-temperature discharge, to meet the needs of different medical equipment.

Voltage and Current Control

The voltage, current, and other parameters of medical lithium batteries need to be strictly controlled to avoid fluctuations in current and voltage affecting the stable operation of medical equipment.

IV. Environmental Requirements 

Medical lithium batteries, as a special type of battery, have more stringent environmental requirements. They should be made of environmentally friendly, harmless materials, avoiding the use of materials containing lead, chromium, mercury, and other toxic and hazardous substances. Priority should be given to the selection of materials that are easy to recycle and reuse, reducing resource consumption and environmental pollution. 

V. Compatibility Requirements 

Medical lithium batteries need to have good compatibility with medical equipment, including matching the battery interface, voltage, current, and other parameters to ensure the normal operation of medical equipment. The battery should be equipped with a special charger that matches the medical equipment to ensure safe and efficient charging of the battery.

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