This standard specifies the basic requirements that medical cryosurgical treatment equipment should follow in terms of cryosystem performance and reproducibility, publication, labeling, documentation and safety. The medical cryosurgical treatment equipment referred to in this standard uses the principle of phase change vaporization latent heat or the Joule-Thomson effect to generate low temperature in the cryoprobe or directly in the target tissue, which is used to produce cryonecrosis, inflammatory reaction or cryoadhesion. When medical cryosurgery equipment is used, accessories that can display the temperature of the freezing probe or freezing area are used to monitor the treatment process. The requirements of this standard apply to these accessories.
YY 0678-2008 Referenced Document
GB 15382-1994 General technique specifications for cylinder valves
GB 9706.1-2007 Medical electrical equipment.Part 1:General requirements for safety