Medical electrical equipment, Part 1.12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
医用电气设备 第1.12部分:基本安全和基本性能的一般要求-附带标准:用于紧急医疗服务环境的医用电气设备和医用电气系统的要求
The objective of this Standard is to specify requirements for the basic safety and essential performance of medical electrical (ME) equipment and ME systems for use in the home healthcare environment. It applies regardless of whether the ME equipment or ME system is intended for use by a lay operator or by trained healthcare personnel.