The standards for lithium batteries used in medical devices include the following requirements:
1. Lithium batteries should meet the safety standards for medical devices, such as having good thermal insulation properties and short-circuit protection.
2. Lithium batteries must meet ergonomic standards to ensure that they do not cause discomfort or harm to medical staff or patients during use.
3. Lithium batteries need to be reliable and have a long lifespan to ensure that no problems or failures occur during use, thereby ensuring the normal operation of the equipment.
4. Lithium batteries should not produce substances that pollute the environment.
In addition to the above requirements, lithium batteries for medical devices must also meet the following basic requirements:
1. Lithium batteries should be made of the same or similar materials as those used in medical devices.
2. Strict control is exercised over battery voltage, current, temperature, over-discharge, and short circuit.
3. The product should use an electrolyte with strong low-current discharge capability.
4. Strict management requirements apply to batteries and chargers.
5. It must have functions to prevent overcharging, over-discharging, and short circuits.
6. It has functions to prevent "flying wires" and "flying vehicles".
Furthermore, lithium batteries used in medical devices must be certified to the ISO 27001 standard to ensure safety during use. Strict control is required at every stage of the production process.
