This standard specifies the terms and definitions, classification and composition, requirements, test methods, inspection rules, markings, instructions for use, packaging, transportation and storage of battery-powered bone tissue surgical equipment (hereinafter referred to as equipment). This standard applies to battery-powered bone tissue surgery equipment. This standard does not apply to bone tissue surgical equipment with pneumatic devices. This standard does not apply to bone tissue surgical equipment powered by mains power. This standard does not apply to similar dental equipment.
YY 0904-2013 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