标准摘要
[中文适用范围]: 本国际标准适用于包含一个或多个波长范围为 200 nm 至 3000 nm 的光辐射源(激光辐射除外)的设备的基本安全和基本性能,旨在对人类或人类产生非视觉光生物效应。用于治疗、诊断、监测、美容/美容或兽医应用的动物;以下简称光源设备(LS EQUIPMENT)。本标准不适用于日光浴、眼科仪器或婴儿光疗设备。 [外文原描述]: IEC 60601-2-57:2011 applies to basic safety and essential performance of equipment incorporating one or more sources of optical radiation in the wavelength range 200 nm to 3 000 nm, with the exception of laser radiation, and intended to create non-visual photo-biological effects in humans or animals for therapeutic, diagnostic, monitoring, cosmetic/aesthetic or veterinary applications; hereafter referred to as light source equipment. IEC 60601-2-57:2011 does not apply to equipment for sun tanning, for ophthalmic instruments or for infant phototherapy. Light source equipment may consist of a single or multiple sources of optical radiation, with or without power supply, or may be incorporated into a complex system that includes optical, electricalor mechanical systems or sources of other radiation.
英文名称Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use