This standard specifies the terms and definitions, classification and composition, requirements, test methods, inspection rules, signs, instructions for use, packaging, transportation and storage of limb compression physiotherapy equipment (hereinafter referred to as equipment). This standard applies to equipment specified in 3.1. This standard does not apply to the following equipment:
——Hemostatic equipment;
——Anti-decubitus air cushions;
——Shock wave therapy equipment;
——Cupping devices;
——Balloon-type external counterpulsation devices.
YY 0833-2011 Referenced Document
GB 9706.1-2007 Medical electrical equipment.Part 1:General requirements for safety
GB/T 14710-2009 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 191-2008 Packaging.Pictorial marking for handling of goods
YY/T 0466.1-2009 Medical devices.Symbols to be used with medical device labels,labelling and information to be supplied.Part 1:General requirements
YY 0833-2011 history
2020YY 0833-2020 General technical requirements for limb compression physiotherapy equipment
2011YY 0833-2011 Compression physiotherapy equipment for limbs