国际标准IEC60601-1
医用电气设备——
第一部分:安全通用要求和基本准则
MEDICAL ELECTRICAL EQUIPMENT –
Part 1: General requirements for basic safety
and essential performance
1 范围、目标和相关标准........................................................................................................................8
1.1 范围........................................................................................................................................8
1.2 目标........................................................................................................................................8
1.3 * 并列标准................................................................................................................................8
1.4 * 专用标准................................................................................................................................8
2 * 规范参考................................................................................................................................................9
3 * 术语和定义............................................................................................................................................9
3.1 调节孔盖................................................................................................................................9
3.2 可触及部分............................................................................................................................9
3.3 附件........................................................................................................................................9
3.4 随机文件..............................................................................................................................10
3.5 电气间隙..............................................................................................................................10
3.6 设备连接装置......................................................................................................................10
3.7 设备电源输入插口..............................................................................................................10
3.8 * 应用部分..............................................................................................................................10
3.9 * 基本绝缘..............................................................................................................................11
3.10 * 基本安全..............................................................................................................................12
3.11 AP类.....................................................................................................................................12
3.12 APG类...................................................................................................................................12
3.13 I类.......................................................................................................................................13
3.14 II类.....................................................................................................................................13
3.15 清晰可见..............................................................................................................................13
3.16 冷态......................................................................................................................................13
3.17 * 高完善性器件......................................................................................................................13
3.18 * 连续工作..............................................................................................................................13
3.19 爬电距离..............................................................................................................................13
3.20 * 除颤防护的应用部分..........................................................................................................13
3.21 * 可拆卸的电源线..................................................................................................................13
3.22 * 直接心脏应用......................................................................................................................13
3.23 * 双重绝缘..............................................................................................................................13
3.24 * 持续率..................................................................................................................................14
3.25 对地漏电流..........................................................................................................................14
3.26 * 外壳......................................................................................................................................14
3.27 * 基本性能..............................................................................................................................14
3.28 预期使用寿命......................................................................................................................14
3.29 F型隔离(浮动)应用部分(以下称为F型应用部分)...............................................14
3.30 固定......................................................................................................................................14
3.31 与空气混合的易燃麻醉气体..............................................................................................14
3.32 与氧或氧化亚氮混合的易燃麻醉气体..............................................................................14
3.33 * 功能连接..............................................................................................................................14
3.34 功能接地导线......................................................................................................................14
3.35 * 功能接地端子......................................................................................................................15
3.36 防护......................................................................................................................................15
3.37 手持......................................................................................................................................15
3.38 * 伤害......................................................................................................................................15
3.39 危险......................................................................................................................................15
3.40 * 危险状况..............................................................................................................................15
3.41 高压......................................................................................................................................15
3.42 水压测试压力......................................................................................................................15
3.43 绝缘配合..............................................................................................................................15
3.44 预期使用 预期用途............................................................................................................15