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GB/T 41696-2022: Classification and general technical requirements of lower limb rehabilitation training devices
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| GB/T 41696-2022 | English | 269 |
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Classification and general technical requirements of lower limb rehabilitation training devices
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GB/T 41696-2022
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Basic data | Standard ID | GB/T 41696-2022 (GB/T41696-2022) | | Description (Translated English) | Classification and general technical requirements of lower limb rehabilitation training devices | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.040.99 | | Word Count Estimation | 14,160 | | Date of Issue | 2022-10-14 | | Date of Implementation | 2023-02-01 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 41696-2022: Classification and general technical requirements of lower limb rehabilitation training devices
---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.
Classification and general technical requirements of lower limb rehabilitation training devices
ICS 11.040.99
CCSC30
National Standards of People's Republic of China
Classification and general technical conditions of lower limb rehabilitation training equipment
Published on 2022-10-12
2023-02-01 Implementation
State Administration for Market Regulation
Released by the National Standardization Administration
directory
Preface I
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Category 2
4.1 Classification by use object 2
4.2 Classification by training pose 2
4.3 Classification by training method 2
4.4 Classification by Main Training Function 2
5 General 2
6 Requirements 3
6.1 Structural Requirements 3
6.2 Operating parameters 6
6.3 Muscle stimulators7
6.4 Safety protection function 7
6.5 Stability7
6.6 Mechanical strength 7
6.7 Operating noise 7
6.8 Other general safety requirements7
7 Test method 7
7.1 Test Environment 7
7.2 Structural Requirements Test 8
7.3 Running parameter test 8
7.4 Muscle Stimulator Test 9
7.5 Safety protection function test 9
7.6 Stability test 10
7.7 Mechanical strength test 10
7.8 Working noise test 10
7.9 Other general safety requirements test 10
8 Signs and Instructions for Use 10
8.1 Signs 10
8.2 Instructions for use 10
Reference 11
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 of Standardization Documents"
drafted.
Please note that some content of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents.
This document is proposed by the Ministry of Civil Affairs of the People's Republic of China.
This document is under the jurisdiction of the National Technical Committee on Standardization of Rehabilitation and Special Equipment for Persons with Disabilities (SAC/TC148).
This document is drafted by. National Research Center for Rehabilitation Aids, Changzhou Qianjing Rehabilitation Co., Ltd., Henan Xiangyu Medical Equipment Co., Ltd.
Co., Ltd., National Rehabilitation Aids Research Center, Rehabilitation Aids Quality Supervision and Inspection Center, Fujian Yabo Digital Technology Co., Ltd., Shanghai Electric Power Co., Ltd.
Qi Intelligent Rehabilitation Medical Technology Co., Ltd., Suzhou Haobo Medical Equipment Co., Ltd., Shanghai University of Science and Technology, Xiner (Tianjin) Medical Technology Co., Ltd.
company.
The main drafters of this document. Pan Guoxin, Xue Hufang, He Lei, Li Zhiqiang, Gu Huiru, Yu Huajun, Lin Peng, Yu Hongliu, Su Shiqiao, Yang Dehui,
Li Fei, Li Zengyong, Lan Zhi, Chen Wei, Liu Junling, Shan Xinxin, Yang Rong, Wu Qiang, Ma Lifang, Yang Xue, Li Na, Zhou Jianping, Ling Wei, Hu Bingshan, Zhang Tengyu,
Zhang Yuanyuan and Susheng.
Classification and general technical conditions of lower limb rehabilitation training equipment
1 Scope
This document specifies the classification, general rules, requirements, test methods, signs and instructions for use of lower extremity rehabilitation training equipment.
This document applies to the lower extremity rehabilitation training equipment (hereinafter referred to as the equipment) used by persons with lower extremity dysfunction and its classification.
This document does not apply to the following devices.
--- Upper/lower extremity combined training equipment, upper/lower extremity exchange training equipment;
--- Balance training equipment;
--- Assisted walking and standing equipment, such as walkers, wearable lower limb exoskeleton robots, crutches, walking sticks, standing frames, standing beds, etc.
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations
documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to
this document.
GB/T 230.1 Rockwell hardness test of metallic materials - Part 1.Test method
GB 9706.1-2020 Medical Electrical Equipment Part 1.General Requirements for Basic Safety and Basic Performance
GB/T 14775-1993 General ergonomic requirements for manipulators
GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in Risk Management Process
GB/T 19678.1 Compilation, Content and Presentation Method of Instructions for Use Part 1.General Rules and Detailed Requirements
GB 24436-2009 General requirements for the safety of rehabilitation training equipment
YY9706.102 Medical Electrical Equipment Part 1-2.General Requirements for Basic Safety and Essential Performance Collateral Standard. Electromagnetic and
Capacitive requirements and tests
YY9706.210 Medical electrical equipment Part 2-10.Particular requirements for basic safety and basic performance of nerve and muscle stimulators
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Equipment for rehabilitation training for people with lower extremity dysfunction.
3.2
safedistance
In order to avoid mechanical hazards (such as shearing, pinching, crushing, friction, etc.) in the area accessible to the human body, the moving parts of the equipment are connected to adjacent moving parts.
The gap that should be satisfied between moving parts, or between moving parts and fixed rigid parts.
3.3
power drive
A power source provided by an external source (such as an electric motor, etc.) during training.
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