This standard specifies the classification, requirements, test methods, sampling and requirements for marking, labeling and packaging of helium-neon laser therapy machines. This standard applies to treatment machines using continuous wave helium-neon lasers with an output laser wavelength of 632.8nm. He-Ne laser treatment machine (hereinafter referred to as treatment machine) is mainly used for irradiation treatment of human body. For therapeutic machines with interventional human body devices, in addition to the relevant provisions of this standard, the provisions of special standards should be implemented at the same time; for therapeutic machines with output laser modulation functions, the manufacturer should add regulations on its modulation functions.
2000GB 12257-2000 General specification of He-Ne laser medical equipment
0000年 GB 12257-1990
GB 12257-2000 General specification of He-Ne laser medical equipment was changed to GB/T 12257-2023 Laser therapy equipment He-Ne laser therapy machine.