You face strict bms requirements when designing lithium battery packs for infusion pumps. The battery management system must deliver safety, reliability, and compliance with safety standards and certifications. You need robust fuse and safety switches, along with advanced monitoring. The following table highlights essential standards and protection features:
Standard/Feature | Description |
|---|---|
ISO 13485 | Ensures rigorous processes for medical safety and reliability in battery manufacturing. |
CE | Indicates compliance with safety standards in the EU market. |
UL | Certifies that the battery meets specific safety standards. |
IEC | Ensures international safety and performance compliance. |
Overcharging Protection | Safeguards against excessive charging, preventing battery damage. |
Short-Circuit Protection | Prevents damage from unintended electrical connections. |
Thermal Regulation | Manages temperature to avoid overheating and potential hazards. |
Key Takeaways
- Prioritize electrical safety in lithium battery packs for infusion pumps. Implement robust monitoring to prevent overheating and electrical shorts.
- Ensure compliance with IEC and FDA standards. Document all battery management system features to maintain safety and performance.
- Integrate advanced protection circuits like PCM and ASIC. These enhance safety, improve battery performance, and reduce maintenance needs.
Part1: BMS Requirements and Safety in Medical Devices
1.1 Electrical Safety for Infusion Pump Battery Packs
You must prioritize electrical safety when designing lithium battery packs for infusion pumps. The battery management system plays a critical role in protecting both patients and healthcare staff. Lithium batteries present several risks that you need to address:
Lithium-ion batteries can experience thermal runaway, which may lead to fire or explosion, especially under pressure.
In environments like hyperbaric chambers, increased oxygen levels make materials more flammable, raising the risk of ignition.
Devices must use oxygen-compatible materials to minimize fire hazards.
Battery failures can result in chemical hazards, threatening patient health and staff safety.
You need to implement robust battery management strategies to prevent these incidents. The battery management system should continuously monitor temperature, current, and voltage across each lithium cell. This monitoring helps you detect abnormal charging or discharging events, which can cause overheating or electrical shorts. You must also ensure that the battery management system includes protection features such as overcharge, overdischarge, and short-circuit prevention.
Note: Most recalls of infusion pumps stem from battery failures. These failures often result from design flaws or manufacturing defects, causing batteries to overheat and devices to shut down unexpectedly. If the low-battery alarm does not function properly, the risk to patient health increases.
You should review documented incidents to understand the consequences of inadequate electrical safety:
