标准摘要
[中文适用范围]： 本部分IEC 60601适用于光动力疗法和光动力诊断设备的基本安全和基本性能。如果条款或子条款专门适用于ME设备或ME系统，则该条款或子条款的标题和内容将说明。如果没有说明，则该条款或子条款适用于ME设备和ME系统（如适用）。本文件范围内的ME设备或ME系统的预期生理功能所固有的危险不包括在本文件的具体要求中，除非在通用标准的7.2.13和8.4.1中有规定。本文件适用于用于补偿或缓解疾病、损伤或残疾的光动力疗法和光动力诊断设备。对于组合设备（例如，还提供目标区域的功能或应用部分的设备），此类设备还应符合规定附加功能安全要求的任何特定标准。本特定标准不适用于：• 用于光热消融、凝固和热疗的光疗设备；• 不用于光敏剂的低强度激光治疗设备；• 用于观察、监测和诊断的照明设备，不用于光敏剂。 [外文原描述]： IEC 60601-2-75:2017+AMD1:2023 CSV applies to the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. This document applies to photodynamic therapy and photodynamic diagnosis equipment used for compensation or alleviation of disease, injury or disability. In the case of combined equipment (e.g. equipment additionally provided with a function or an applied part for the target area), such equipment also comply with any particular standard specifying safety requirements for the additional function. This particular standard does not apply to: - light therapy equipment intended for use in photothermal ablation, coagulation, and hyperthermia; - low-level laser therapy equipment not intended for use with a photosensitizer; - illumination equipment intended for use in observation, monitoring, and diagnosis, not intended for use with a photosensitizer. This document is to be used with IEC 60601-1:2005 and its amendment 1.
英文名称Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment