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.
YY 0284-2004 history
2004YY 0284-2004 The general specification of He-Ne laser medical instrument for ILIB