IEC 60601-2-75:2017 医疗电气设备 - 第2-75部分:光动力治疗和光动力诊断设备的基本安全和基本性能的特殊要求

标准编号：IEC 60601-2-75:2017

中文名称：医疗电气设备 - 第2-75部分:光动力治疗和光动力诊断设备的基本安全和基本性能的特殊要求

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

发布日期：2017-05-30

标准范围

IEC 60601-2-75:2017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。本文件范围内的医用电气设备或医用电气系统预期生理功能中固有的危害，除通用标准的7.2.13和8.4.1外，本文件的具体要求未涵盖。本文件适用于用于补偿或减轻疾病、损伤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，附加地设置有用于目标区域的功能或应用部件的设备)，这样的设备还符合规定附加功能的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；-不打算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，不用于光敏剂。本文件将与IEC 60601-1:20 05及其修正案1一起使用。

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.

标准预览图