Where exactly is the “threshold” for medical device batteries? Starting with IEC 62133
In many application fields of lithium batteries, medical equipment is a special existence. It does not pursue extreme thinness like consumer electronics, nor does it emphasize energy density and fast charging speed like power batteries. Medical equipment has only one core demand for batteries: safety, predictable, verifiable and traceable safety.
From the perspective of compliance, IEC 62133 is the basic standard for the safety of portable lithium batteries, covering the safety test requirements of lithium batteries for medical equipment.. More importantly, IEC 60601-1, as the core safety standard of Medical electrical equipment, refers IEC 62133-2 to component-level safety requirements.. This means that a lithium battery that has not been tested by IEC 62133 cannot be legally listed in most major markets..
What are the requirements of these standards for PACK factories?
The first is the prudence of cell selection. Medical equipment batteries usually adopt cell solutions with small capacity and high consistency, which require much higher batch consistency and long-term reliability of cell than ordinary industrial applications. The second is the fineness of the BMS strategy. Medical equipment is not allowed to have a "sudden power off" situation. BMS needs to give an early warning at the early stage of power decay and switch to the safe shutdown process when necessary, instead of waiting until the voltage reaches the bottom. The third is the biocompatibility. Battery pack of the shell materials and packaging processes of medical equipment in direct or indirect contact with human body need to meet the biological evaluation requirements of ISO 10993..
dongguan Juneng New Energy Technology Co., Ltd. has accumulated cross-industry customization experience in the field of lithium battery PACK, covering medical devices, industrial equipment, robots and other fields. The company has more than 10 years of experience in battery pack structure design, heat management and waterproof technology, and can provide a complete design scheme from cell selection to BMS strategy for medical equipment scenarios..
For medical device manufacturers, Select battery A pragmatic judgment criterion for suppliers is: can the other party clearly explain what specific safety standards your equipment needs to meet in the target market, and what corresponding designs and tests are needed at the battery pack level. This is much more meaningful than simply comparing prices.
Dongguan Juneng New Energy Technology Co., Ltd.
137 5142 6524(Miss Gao)
susiegao@power-ing.com
Xinghuiyuan High tech Industrial Park, Dalang Town, Dongguan City, Guangdong Province



Yue Gong Wang An Bei No. 4419002007491