This standard specifies the definition, classification, requirements, test methods, markings, instructions for use, packaging, transportation and storage of millimeter wave therapy equipment. This standard applies to millimeter wave treatment equipment (hereinafter referred to as equipment) that uses non-thermal effects to treat diseases as defined in 3.1.
YY 0898-2013 Referenced Document
GB 9706.1-2007 Medical electrical equipment.Part 1:General requirements for safety
GB 9706.15 Medical electrical equipment.Part 1:General requirements for safety.1.Collateral standard:Safety requirements for medical electrical systems
GB/T 14710 Enviromental requirement and test methods for medical electrical equipment
GB/T 191 Packaging.Pictorial marking for handling of goods
YY 0505 Medical electrical equipment.Part 1-2:General requirements for safety.Collateral standard:Electromagnetic compatibility.Requirements and tests
YY/T 0466.1 Symbols for medical devices used for information provided by manufacturers Part 1: General requirements*, 2023-09-05 Update