This standard specifies the terms and definitions, classification, requirements, test methods, inspection rules, signs and instructions for use, packaging, transportation and storage of ultraviolet treatment equipment. This standard applies to the requirements for ultraviolet therapeutic equipment (hereinafter referred to as equipment) used in medical practice as defined in 3.1. This standard does not apply to the following equipment:
——Ultraviolet disinfection or sterilization equipment used only for irradiating instruments and materials;
——Light curing machines;
——Ultraviolet laser equipment;
——Ultraviolet photosensitive treatment equipment;
——Ultraviolet blood internal irradiation equipment .
YY 0901-2013 Referenced Document
GB 9706.1-2007 Medical electrical equipment.Part 1:General requirements for safety
GB/T 14710 Enviromental requirement and test methods for medical electrical equipment
GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*, 2022-04-15 Update
GB/T 191 Packaging.Pictorial marking for handling of goods
YY/T 0466.1 Symbols for medical devices used for information provided by manufacturers Part 1: General requirements*, 2023-09-05 Update