GB/T 44665-2024General requirements for upper and lower limb motor function rehabilitation equipment with assessment and training (English PDF)

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part

1.Structure and drafting rules for standardization documents" Drafting. Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is issued by the Ministry of Civil Affairs of the People's Republic of China. This document is under the jurisdiction of the National Technical Committee for Standardization of Rehabilitation and Special Equipment for Persons with Disabilities (SAC/TC148). This document was drafted by: National Rehabilitation Assistive Devices Research Center, Xiamen Weian Technology Co., Ltd., Changzhou Qianjing Rehabilitation Co., Ltd., Chongqing University, Shenzhen Zuowei Technology Co., Ltd., the Third Affiliated Hospital of Sun Yat-sen University, Qilu Hospital of Shandong University, and Angela Technology (Hangzhou) Co., Ltd. Company, China Academy of Building Research Co., Ltd., South China University of Technology, Zhejiang University, Beijing Zhongke Yikang Chinese Medicine Research Institute, Shenzhen Ai Li Special Medical Technology Co., Ltd., Shanghai Yidong Medical Technology Co., Ltd., Lanxi Wangao Sports Equipment Co., Ltd., Xiamen Weiyou Intelligent Technology Co., Ltd., Beijing Jinfa Technology Co., Ltd., Shenzhen Huaquejing Medical Technology Co., Ltd., Shenzhen Yingzhi Technology Co., Ltd., Gaopingwei EN TECHNOLOGY LIMITED. The main drafters of this document are. Zhang Jingsha, Li Zengyong, Li Qi, Xu Gongcheng, Pan Guoxin, Zhang Tengyu, Xue Hufang, Li Chunmei, Liu Qi, Hou Wensheng, Dou Zulin, Li Xin, Peng Shuiping, Wang Yonghui, Zhou Haizhu, Li Zhelin, Li Luya, Wang Jianhui, Wang Shaobai, Shen Weiliang, Zhang Ye, Zhao Fengjie, Ma Yong, Guo Guanlian, Zhao Qichao, Yu Linggang, Xu Feng, Wu Jianhuang. General requirements for upper and lower limb motor function assessment and training equipment

1 Scope

GB/T 44665-2024 sets the general requirements for equipment that both assesses and trains upper and lower limb motor function - the robotic and mechanised trainers used after stroke and spinal injury. Combining assessment with training is what distinguishes this class of device: the machine measures range, strength, smoothness and assistance required while it works, and adjusts the training on that basis, which makes the validity of its measurements a clinical matter and not only a metrological one. The standard sets the categories, by user and by training method, then the requirements on appearance, structure, software, the motor function assessment and analysis, the rehabilitation training function, working noise, safety protection, additional functions and electrical safety, together with the corresponding test methods, the inspection rules and the marking, packaging, transport and storage provisions. It takes effect on 1 January 2025.

This document provides the classification of upper and lower limb motor function assessment and training equipment, and specifies the upper and lower limb motor function assessment and training equipment Requirements, marking, packaging, instructions for use, and the corresponding test methods are described. This document is applicable to equipment for assessing and training upper and/or lower limb muscle strength, muscle tension, and joint range of motion for people with limb dysfunction.

2 Normative references

The contents of the following documents constitute essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document.

GB/T 191 Pictorial markings for packaging, storage and transportation

GB 9706.1-2020 Medical electrical equipment Part

3 Terms and definitions

The terms and definitions defined in GB 9706.1-2020, GB 24436, YY/T 1626-2019 and the following apply to this document.

3.1 muscle strength The maximum voluntary contraction capacity of skeletal muscle.

3.2 Isometric muscle The strength of a muscle during isometric contraction (3.1).

Note. Isometric contraction, also known as static contraction, refers to a form of contraction in which the muscle tension increases without shortening its length.

3.3 isotonicmuscle The strength of a muscle during isotonic contraction (3.1).

Note. Isometric contraction is also called concentric contraction or dynamic contraction, which refers to the contraction form in which the muscle overcomes external force and shortens in length (the starting and ending points approach each other).

3.4 isokinetic muscle The strength of a muscle when it contracts isokinetically (3.1).