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GB/T 41697-2022 English PDF

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GB/T 41697-2022: Assistive products for persons with disability - General requirements and test methods
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PDF similar to GB/T 41697-2022


Standard similar to GB/T 41697-2022

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Basic data

Standard ID GB/T 41697-2022 (GB/T41697-2022)
Description (Translated English) Assistive products for persons with disability - General requirements and test methods
Sector / Industry National Standard (Recommended)
Classification of Chinese Standard C30
Classification of International Standard 11.180
Word Count Estimation 38,355
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 41697-2022: Assistive products for persons with disability - General requirements and test methods


---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.
Assistive products for persons with disability -- General requirements and test methods ICS 11.180 CCSC30 National Standards of People's Republic of China General requirements and test methods for rehabilitation aids Published on 2022-10-12 2023-02-01 Implementation State Administration for Market Regulation Released by the National Standardization Administration directory Foreword V 1 Scope 1 2 Normative references 1 3 Terms and Definitions 2 3.1 Rehabilitation aids and medical devices 2 3.2 Use of rehabilitation aids 3 3.3 Personnel 3 4 General Requirements 4 4.1 Risk Analysis 4 4.2 Expected performance and technical documentation 4 4.3 Removable rehabilitation aids 4 4.4 Fasteners 4 4.5 Maximum load4 4.6 Limiting device 4 4.7 Design Requirements Involving Cognitive Impairments4 5 Materials 5 5.1 Overview 5 5.2 Flammability 5 5.3 Biocompatibility 5 5.4 Contaminants and residues5 5.5 Infection and Microbial Contamination 6 5.6 Corrosion protection 6 6 Sound and Vibration 6 6.1 Noise and Vibration 6 6.2 Sound levels and frequencies of audible alarm devices 6 6.3 Feedback signal 7 7 Electromagnetic compatibility 7 7.1 General requirements7 7.2 Launch 7 7.3 Immunity 7 7.4 Power frequency magnetic field immunity 7 8 Electrical Safety7 8.1 General requirements7 8.2 Electrical system 8 8.3 Continuity of power supply 8 8.4 Battery-powered rehabilitation aids 8 8.5 Circuit protection 9 8.6 Electronic Programmable Systems 9 8.7 Rehabilitation aids with skin contact electrodes9 8.8 Liquid entry 9 9 Spills, sprays, leaks and entry of liquids 9 9.1 Liquid spills 9 9.2 Liquid spray 10 9.3 Liquid leakage 10 9.4 Liquid entry 10 10 Surface temperature 10 11 Sterile 11 11.1 General requirements 11 11.2 Sterilization methods 11 11.3 Maintaining sterility during transport 11 12 Safety of moving parts 11 12.1 Extrusion 11 12.2 Mechanical wear 12 12.3 Emergency stop function 12 13 Prevent the body from being pinched 12 13.1 Holes and gaps 12 13.2 V-shaped opening 12 14 Folding and Adjusting Devices 13 14.1 General requirements 13 14.2 Locking device 13 14.3 Guards 13 15 handle 13 15.1 General requirements 13 15.2 Test methods 13 16 Support or suspension aids 14 16.1 General requirements 14 16.2 Static loads 14 16.3 Dynamic loads 15 16.4 Requirements and test methods for foot pads 15 17 Portable and mobile rehabilitation aids 15 17.1 Portable rehabilitation aids 15 17.2 Mobile rehabilitation aids 15 18 Surfaces, edges, corners and protrusions 16 19 Handheld rehabilitation aids 16 20 Small Parts 16 21 Stability 16 22 Forces on Human Soft Tissue 17 23 Ergonomic principles 17 24 Requirements for information provided by the manufacturer 17 24.1 General requirements 17 24.2 Instructions 17 24.3 Identification 18 25 Packaging 19 26 Inspection report 19 Appendix A (Informative) Cognitive Impairment 20 A.1 Overview 20 A.2 The concept of cognitive impairment 20 A.3 Important factors to be considered in the design process20 A.4 User Information and User Interface 21 A.5 Ease of handling 22 A.6 User Participation 23 Appendix B (Informative) General Recommendation 24 B.1 Flammability 24 B.2 Cleaning and Disinfection 24 B.3 Animal Tissue 25 B.4 Noise and Vibration 25 B.5 Power frequency magnetic field immunity 25 B.6 Current Protection 26 B.7 Liquid entry 26 B.8 V-shaped opening 26 B.9 Hand-held rehabilitation aids 26 B.10 Forces on Human Soft Tissue 26 B.11 Ergonomic principles 27 B.12 Packaging 28 Reference 29 Figure 1 Handle Test 14 Figure B.1 Legend 24 for the identification of machine-washable and non-machine-washable rehabilitation aids Figure B.2 Legend 24 for the identification of rehabilitation aids intended and not available for hand-held spray/steam cleaning Table 1 Applicable standards for electrical safety8 Table 2 Safety distances between moving parts11 Table 3 Safety distances between stationary parts 12 Table 4 Suspension system loads 14 Table 5 Drop height15

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. China Association of Rehabilitation Aids, Shanghai Hubang Intelligent Rehabilitation Equipment Co., Ltd., National Research Institute of Rehabilitation Aids Research Center, China Disabled Assistive Device Center, National Rehabilitation Assistive Device Research Center Rehabilitation Assistive Device Quality Supervision and Inspection Center, Shandong Haitian Intelligent Engineering Co., Ltd., Kanghui Medical Technology (Suzhou) Co., Ltd. The main drafters of this document. Zhang Pengcheng, Zhao Cishun, He Jinming, Gu Huiru, Zhang Haiyan, Chen Lizhong, Yang Dehui, Liu Junling, Li Dongmei, Zhang Jian, Yun Xiao, Shan Xinxin, Shen Yi, Gao Jie, Dong Zhiqian. General requirements and test methods for rehabilitation aids

1 Scope

This document specifies the general requirements, materials, sound and vibration, electromagnetic compatibility, electrical safety, liquid Spills, sprays, leaks and ingress of bodies, surface temperature, sterility, safety of moving parts, protection against body entrapment, folding and adjustment devices, handles, Support or suspension aids, portable and mobile rehabilitation aids, surfaces, edges, corners and protrusions, hand-held rehabilitation aids, small Parts, stability, forces on human soft tissue, ergonomic principles, requirements for information provided by the manufacturer, packaging, and inspection reports. This document is applicable to the products and tests of medical device rehabilitation aids, and other types of rehabilitation aids refer to this document. Note. Some rehabilitation aids have corresponding product standards, such as prostheses, orthoses, wheelchairs, walkers, hearing aids, vision aids, etc., the products are given priority standard.

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, all dated citations For reference documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document. used in this document. GB/T 3767 Acoustic sound pressure method—Engineering method for determining sound power level of noise source and sound energy level of approximate free field above reflecting surface GB/T 3768 Acoustic sound pressure method to determine the sound power level and sound energy level of noise sources easy law GB/T 4208 enclosure protection class (IP code) GB 4706.1 Safety of Household and Similar Electrical Appliances Part 1.General Requirements GB 4706.2 Safety of Household and Similar Electrical Appliances Part 2.Particular Requirements for Electric Irons GB 4943.1 Information Technology Equipment Safety Part 1.General Requirements GB 8898 Audio, Video and Similar Electronic Equipment Safety Requirements GB 9706.1 Medical Electrical Equipment Part 1.General Requirements for Basic Safety and Essential Performance GB 9706.225 Medical Electrical Equipment Part 2-25.Special Requirements for Basic Safety and Basic Performance of Electrocardiographs GB/T 16432 Classification and Terminology of Rehabilitation Assistive Devices GB/T 16754 Design principles of mechanical safety emergency stop function GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in Risk Management Process GB 17625.1 Electromagnetic Compatibility Limits Harmonic Current Emission Limits (Each Phase Input Current of Equipment≤16A) GB 17625.2 Electromagnetic compatibility limit for each phase rated current ≤ 16A and unconditional access equipment in the public low-voltage power supply system Limitation of voltage variations, voltage fluctuations and flicker generated in the system GB/T 17626.3 Electromagnetic Compatibility Test and Measurement Technology Radio Frequency Electromagnetic Field Radiation Immunity Test GB/T 17626.8 Electromagnetic Compatibility Test and Measurement Technology Power Frequency Magnetic Field Immunity Test GB 17927.1 Evaluation of the ignition resistance of upholstered furniture, mattresses and sofas - Part 1.Smoldering cigarettes GB 17927.2 Evaluation of ignition resistance of upholstered furniture, mattresses and sofas - Part 2.Simulated match flame GB 18279.1 Sterilization of Healthcare Products Ethylene Oxide Part 1.Development, Validation and Routine Control of Sterilization Processes for Medical Devices system requirements GB 18280.1 Sterilization Radiation for Healthcare Products Part 1.Requirements for Development, Validation and Routine Control of Sterilization Processes for Medical Devices

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