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YY/T 1973-2025 PDF English

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YY/T 1973-2025: Medical powered lower extremity exoskeleton robot
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Basic data

Standard ID YY/T 1973-2025 (YY/T1973-2025)
Description (Translated English) Medical powered lower extremity exoskeleton robot
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C43
Classification of International Standard 11.040
Word Count Estimation 14,134
Date of Issue 2025-06-18
Date of Implementation 2026-07-01
Issuing agency(ies) National Medical Products Administration
Summary This standard specifies the requirements for medical lower limb exoskeleton robots and describes the corresponding test methods. This document applies to medical lower limb exoskeleton robots.

YY/T 1973-2025: Medical powered lower extremity exoskeleton robot


---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.040 CCSC43 Pharmaceutical Industry Standards of the People's Republic of China Medical lower limb exoskeleton robot Published on 2025-06-18 Implemented on July 1, 2026 National Medical Products Administration issued

Table of contents

Preface III Introduction IV 1.Scope 1 2 Normative References 1 3.Terms and Definitions 1 4 Requirements 1 5.Test Methods 4 References 8

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents". Drafting. Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents. This document was proposed by the National Medical Products Administration. This document is under the jurisdiction of the medical robot standardization technical management unit (SMD/T U005). This document was drafted by. China National Institutes for Food and Drug Control, Zhejiang Provincial Institute for Medical Device Testing, and Tianjin Municipal Medical Device Quality Supervision Bureau. Supervision and Inspection Center, Shanghai Institute for Medical Device Testing, Hangzhou Chengtian Technology Development Co., Ltd., Beijing Daai Robotics Technology Co., Ltd. Guangdong Jiahuamei Certification Co., Ltd., Shenyang Siasun Robot & Automation Co., Ltd., Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center) (Rehabilitation Center), Hebei Provincial Institute for Drug and Medical Device Testing, Zhejiang University Ningbo "Five-in-One" Campus Education Development Center, Soochow University, Tianjin University. The main drafters of this document are. Zhang Chao, Meng Xiangfeng, Huang Dan, Yang Jiangang, Zhou Xue, Wang Tian, Shuai Mei, Ge Yanqing, Chen Yuxi, Qi Qi, and Wu Shaoshuai. Yang Wei, Zhang Ting, Liu Yuan, Hong Wei, and Li Hui.

Introduction

Compared to GB/T 37704-2019, this document focuses more on the characteristics of powered exoskeleton robots as medical devices. Because the scope of application and technology in this field are still evolving, the technical features and test methods specified in this document can only be based on current practices. For products that have been defined and designed, new technologies and methods adopted after careful consideration of risks are not subject to the restrictions of this document. The contents of this document are intended as helpful guidance and reference only. Medical lower limb exoskeleton robot

1 Scope

This document specifies the requirements for medical lower limb exoskeleton robots (hereinafter referred to as "exoskeleton robots") and describes the corresponding test methods. This document applies to medical lower limb exoskeleton robots.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included. For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies. This document. GB 9706.1 Medical electrical equipment - Part 1.General requirements for basic safety and basic performance GB/T 14710 Environmental requirements and test methods for medical electrical appliances GB/T 37704 General Technical Requirements for Sports Rehabilitation Training Robots YY/T 1686 Medical Electrical Equipment Using Robotics Technology. Terminology, Definitions, and Classification YY 9706.278 Medical Electrical Equipment Parts 2-78.Basic safety and Basic performance requirements

3 Terms and Definitions

The terms and definitions defined in GB 9706.1, YY 9706.278, YY/T 1686, and GB/T 37704, as well as the following terms and definitions, apply to this document. 3.1 Powered by external force, it is placed on the outside of the patient's lower limb where motor function is impaired, providing support and assisting the patient in standing upright. A walking medical robot. Note 1.The affected areas include one or more sites such as the hip, knee, ankle, and foot on one or both sides. Note 2.Figures AA.16 and AA.18 in YY 9706.278-2023 are examples of medical lower limb exoskeleton robots. Note 3.According to their intended use, medical lower limb exoskeleton robots are classified into rehabilitation training, walking assistance, etc. Note 4.Medical lower limb exoskeleton robots generally include the exoskeleton robot body and accessories.

4 Requirements

4.1 Operating Performance 4.1.1 Walking speed/cadence When using passive training mode, the exoskeleton robot's movement speed/step frequency should be adjustable. The adjustment range and tolerances should conform to the manufacturer's specifications. 4.1.2 Stride length When using passive training mode, the step length of the exoskeleton robot should be adjustable. ...

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