医疗电气设备. 第2-75部分: 光能疗法和光能诊断设备基本安全和基本性能的详细要求

[中文适用范围]： IEC 60601的本部分适用于光动力治疗和光动力诊断设备的基本安全和基本性能。如果某条款或子条款专门旨在仅适用于 ME 设备@或仅适用于 ME 系统@，则该条款或子条款的标题和内容将如此说明。如果情况并非如此@，则该条款或子条款同时适用于 ME 设备和相关的 ME 系统@。除通用标准 7.2.13 和 8.4.1 之外，本文件中的具体要求不涵盖本文件范围内 ME 设备或 ME 系统的预期生理功能所固有的危险。注：另见通用标准4.2。本文件适用于用于补偿或减轻疾病@伤害或残疾的光动力治疗和光动力诊断设备。在组合设备的情况下（例如，为目标区域额外提供功能或应用部件的设备），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。该特定标准不适用于： ?用于光热消融@凝固@和热疗的光疗设备； ？不适合与光敏剂一起使用的低强度激光治疗设备； ？用于观察@监测@和诊断@的照明设备，不适用于与光敏剂一起使用。 [外文原描述]： IEC 60601-2-75:2017 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.