This standard specifies the scope, definitions and terminology, requirements, test methods, inspection rules and requirements for signs, labels, packaging, etc. of liquid nitrogen cryosurgical treatment equipment. This standard is applicable to cryosurgical treatment equipment where the refrigerant is liquid nitrogen, which utilizes the latent heat of vaporization phase change for refrigeration, and the liquid nitrogen storage capacity is greater than 1L. The treatment equipment mainly produces low temperature on the target tissue and is used for cryo-necrosis, cryo-blocking, inflammatory reaction and cryo-adhesion.
YY 0677-2008 Referenced Document
GB 9706.1-2007 Medical electrical equipment.Part 1:General requirements for safety
GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment
GB/T 16886.1-2001 Biological evaluation of medical devices--Part 1: Evaluation and testing
YY 0466-2003 Medical devices-Symbols to be used with medical device labels,labelling and information to be supplied
YY 0678-2008 Standard performance and safety specification for cryosurgical medical instruments