YY 0284-2004 in English

本标准规定了氦氖激光血管内照射治疗仪的定义、分类、要求、试验方法、抽样和标志、标签、包装等要求。本标准适用于波长为632．8nm的连续波、低功率氦氖激光内照仪。该仪器用于血管内对循环血液进行激光照射治疗。具有血管内照射功能的氦氖激光多功能照射仪也应参照使用本标准。对于其他光源的内照仪，在没有专用标准的情况下，本标准可作为其安全要求的一个适用的导则，但不包括该仪器的特殊要求。

Scope

This standard specifies the definition, classification, requirements, test methods, sampling and marking, labeling, packaging and other requirements of helium-neon laser intravascular irradiation therapy equipment. This standard applies to continuous wave, low-power helium-neon laser internal illuminators with a wavelength of 632.8nm. This instrument is used for intravascular laser irradiation treatment of circulating blood. Helium-neon laser multi-function irradiators with intravascular irradiation function should also refer to this standard. For internal illuminators with other light sources, in the absence of special standards, this standard can be used as an applicable guide to the safety requirements, but does not include special requirements for the instrument.