YY 0284-2004 The general specification of He-Ne laser medical instrument for ILIB
YY 0284-2004 The general specification of He-Ne laser medical instrument for ILIB
Basic Information
Scope
This standard specifies the definitions, classifications, requirements, test methods, sampling and marking, labeling, packaging, and other requirements for helium-neon laser intravascular irradiation therapy devices (hereinafter referred to as intravascular irradiation devices).
This standard applies to continuous-wave, low-power helium-neon laser intravascular irradiation devices with a wavelength of 632.8 nm. The device is used for laser irradiation therapy of circulating blood in blood vessels. Multi-functional helium-neon laser irradiation devices with intravascular irradiation functions should also refer to this standard for use.
For intravascular irradiation devices with other light sources, in the absence of dedicated standards, this standard can serve as a suitable guideline for their safety requirements, but does not include the special requirements of the device.