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Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 41696-2022: Classification and general technical requirements of lower limb rehabilitation training devices Status: Valid
Basic dataStandard 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 forewordThis 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 equipment1 ScopeThis 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 referencesThe 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 stimulators3 Terms and DefinitionsThe 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. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 41696-2022_English be delivered?Answer: Upon your order, we will start to translate GB/T 41696-2022_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of GB/T 41696-2022_English with my colleagues?Answer: Yes. The purchased PDF of GB/T 41696-2022_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. 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