ICS 11.040.01 CCS L05 团 体 标 准 T/CAMDI 152—2025 有源植入式医疗器械可充电锂离子电池寿命评估 加速试验方法 Accelerated test method for life assessment of rechargeable lithium -ion cells of active implantable medical device 2025 -02-28发布 2025 -03-01实施 中国医疗器械行业协会 发布 全国团体标准信息平台 T/CAMDI 152 —2025 I 目次 前 言 ................................ ................................ ................................ ................................ .......................... II 1 范围 ................................ ................................ ................................ ................................ ................................ ...3 2 规范性引用文件 ................................ ................................ ................................ ................................ ............... 3 3 术语和定义 ................................ ................................ ................................ ................................ ....................... 3 4 试验要求 ................................ ................................ ................................ ................................ ........................... 5 5 试验程序和方法 ................................ ................................ ................................ ................................ ............... 5 5.1 寿命试验类型 ................................ ................................ ................................ ................................ ............ 5 5.2 电池失效判据 ................................ ................................ ................................ ................................ ............ 6 5.3 贮存寿命试验程序和方法 ................................ ................................ ................................ ........................ 6 5.3.1 试验程序 ................................ ................................ ................................ ................................ ............. 6 5.3.2 样本量确定 ................................ ................................ ................................ ................................ ......... 6 5.3.3 加速模型及模型参数确定 ................................ ................................ ................................ ................. 7 5.3.4 加速因子及加速试验时间确定 ................................ ................................ ................................ ......... 7 5.3.5 试验实施 ................................ ................................ ................................ ................................ ............. 8 5.3.6 试验结果分析 ................................ ................................ ................................ ................................ .....8 5.4 倍率循环寿命试验程序和方法 ................................ ................................ ................................ ................ 8 5.4.1 试验程序 ................................ ................................ ................................ ................................ ............. 8 5.4.2 样本量确定 ................................ ................................ ................................ ................................ ......... 8 5.4.3 加速模型及模型参数确 定 ................................ ................................ ................................ ................. 8 5.4.4 加速因子及加速试验时间确定 ................................ ................................ ................................ ......... 8 5.4.5 试验实施 ................................ ................................ ................................ ................................ ............. 9 5.4.6 试验结果分析 ................................ ................................ ................................ ................................ .....9 5.5 高电压区间循环寿 命试验程序和方法 ................................ ................................ ................................ ....9 5.5.1 试验程序 ................................ ................................ ................................ ......