This standard specifies the definition, basic parameters, requirements, test methods, sampling and marking, labeling, packaging and other requirements of continuous wave neodymium-doped yttrium aluminum garnet laser therapy machines. This standard applies to continuous wave neodymium-doped yttrium aluminum garnet laser treatment machines with a wavelength of 1064nm (hereinafter referred to as treatment machines). The healing function coagulates, vaporizes, carbonizes and melts tissue.
YY 0307-2011 Referenced Document
GB 7247.1 Safety of laser products.Part 1:Equipment classification and requirements*, 2012-12-31 Update
GB 9706.1 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance*, 2020-04-09 Update
GB 9706.19-2000 Medical electrical equipment-Part 2:Particular requirements for the safety of endoscopic equipment
GB 9706.20 Medical electrical equipment Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment
GB/T 14710-2009 Enviromental requirement and test methods for medical electrical equipment
GB/T 17736-1999 Testing method of main parameters for laser protective eyewear
GB/T 191 Packaging.Pictorial marking for handling of goods
ISO 11146 Laser and laser-related equipment - Test methods for laser beam parameters - Beam widths, divergence angle and beam propagation factor
YY 91057-1999 General specifications for medical foot switch
YY/T 0758 General requirements for medical laser fibers*, 2021-09-06 Update