医用电气设备安全准则的基本方面

[中文适用范围]： 广泛，涉及各类直接用于人体或邻近人体的电气医疗设备，确保患者在诊疗过程中免受电击、过热或其他电气危害。该规范强调了对设备整体安全性的系统化考量，推动了全球范围内医用电气产品技术要求的协调一致，为医疗机构采购与使用设备提供了重要的技术支撑。 [外文原描述]： This report identifies fundamental considerations to be taken into account in developing standards to ensure the safety of medical electrical equipment. It follows closely recommendations of ISO/IEC Guide 51 and expands on matters which are unique to, or critical in, the application of medical electrical equipment.