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GB/T 14728.2-2024 English PDF

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GB/T 14728.2-2024: Assistive products for walking manipulated by both arms - Requirements and test methods - Part 2: Rollators
Status: Valid

GB/T 14728.2: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
GB/T 14728.2-2024English674 Add to Cart 5 days [Need to translate] Assistive products for walking manipulated by both arms - Requirements and test methods - Part 2: Rollators Valid GB/T 14728.2-2024
GB/T 14728.2-2008English454 Add to Cart 4 days [Need to translate] Walking aids manipulated by both arms -- Requirements ad test methods -- Part 2: Rollators Valid GB/T 14728.2-2008

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Basic data

Standard ID GB/T 14728.2-2024 (GB/T14728.2-2024)
Description (Translated English) Assistive products for walking manipulated by both arms - Requirements and test methods - Part 2: Rollators
Sector / Industry National Standard (Recommended)
Classification of Chinese Standard C45
Classification of International Standard 11.180
Word Count Estimation 34,334
Date of Issue 2024-09-29
Date of Implementation 2025-10-01
Older Standard (superseded by this standard) GB/T 14728.2-2008
Issuing agency(ies) State Administration for Market Regulation, China National Standardization Administration

GB/T 14728.2-2024: Assistive products for walking manipulated by both arms - Requirements and test methods - Part 2: Rollators


---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 11.180 CCSC45 National Standard of the People's Republic of China Replaces GB/T 14728.2-2008 Requirements and test methods for dual-arm operated walkers Part 2.Wheeled mobility aids (ISO 11199-2.2021, IDT) Released on 2024-09-29 2025-10-01 Implementation State Administration for Market Regulation The National Standardization Administration issued

Table of Contents

Preface III Introduction IV 1 Scope 1 2 Normative references 1 3 Terms and Definitions 2 4 Equipment 8 5 Test conditions 8 6 General requirements and test methods 9 6.1 Risk Analysis 9 6.2 Detachable wheeled walker 9 6.3 Fasteners 9 6.4 User mass/maximum load 9 6.5 Structural requirements 9 6.6 Brakes 9 6.7 Handle 10 7 Materials 11 7.1 General 11 7.2 Flammability 11 7.3 Biocompatibility and toxicity 11 7.4 Infection and microbial contamination 11 7.5 Corrosion resistance 11 8 Liquid enters 12 9 Temperature of the part in contact with the human body 12 10 Safety of moving parts 12 10.1 Squeeze 12 10.2 Mechanical wear 13 11 Prevent body parts from getting stuck13 11.1 Holes and gaps 13 11.2 V-shaped opening 13 12 Folding, adjusting and locking device 13 12.1 General 13 12.2 Folding device 14 12.3 Locking device 14 13 Carrying handle 14 13.1 General 14 13.2 Requirement 14 13.3 Test method 14 14 Surfaces, Angles and Edges15 15 Static stability15 15.1 Static stability requirements 15 15.2 Static stability test method 15 16 Static load strength 18 16.1 Seat static load strength 18 16.2 Static load strength of wheeled walkers 19 16.3 Backrest strength 19 17 Durability test 20 17.1 Durability test requirements 20 17.2 Durability test method 20 18 Ergonomic principles 21 19 Packaging 22 20 Information provided by the manufacturer 22 20.1 General 22 20.2 Information marked on the product 22 20.3 User Manual 23 20.4 Inspection Report 23 Appendix A (Informative) Hazard factors to be considered when designing products 25 A.1 General Principles25 A.2 Expected risks and factors of general rehabilitation assistive devices 25 A.3 Hazards of ergonomic factors for different users 25 A.4 Hazards caused by mechanical damage, inadequate maintenance and/or aging 25 Appendix B (Informative) General Recommendations 26 B.1 Subclause 7.2 - Flammability 26 B.2 Subclause 7.4.2 - Cleaning and disinfection 26 B.3 Chapter 18 - Ergonomic Principles 26 B.4 Chapter 19 - Packaging 27 Reference 28

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. This document is part 2 of GB/T 14728 "Requirements and test methods for dual-arm operated walkers". GB/T 14728 has been published The following parts. --- Part 1.Frame type walkers; --- Part 2.Wheeled walkers; --- Part 3.Desktop walkers. This document replaces GB/T 14728.2-2008 "Requirements and test methods for dual-arm operated walking aids Part 2.Wheeled walking aids" Compared with GB/T 14728.2-2008, in addition to structural adjustments and editorial changes, the main technical changes are as follows. a) Added the term and definition of "brake" (see 3.1); b) Added “risk analysis”, “detachable wheeled walker”, “fasteners” and “user mass/maximum load” (see 6.1 to 6.4); c) Changed "wheel" to "structural requirements" (see 6.5, 4.1 of the.2008 edition); d) Changed "brake" to "brake" (see 6.6, 4.3 of the.2008 edition), and added "durability of brake" (6.6.3); e) Changed the handle related content (see 6.7, 4.4 of the.2008 edition); f) Changed "materials and finishes" to "materials", "general rules" (see 7.1, 4.11 of the.2008 edition) and "surfaces, corners and edges" (see 14); g) Added "flammability", "biocompatibility and toxicity", "infection and microbial contamination" and "corrosion resistance" (see 7.2 to 7.5); h) Added a chapter on "Liquid Ingress" (see Chapter 8); i) Added a chapter on “Temperature of parts in contact with the human body” (see Chapter 9); j) Added a chapter on “Safety of Moving Parts” (see Chapter 10); k) Added a chapter on “Preventing body parts from getting stuck” (see Chapter 11); l) Changed “adjustment device” and “folding device” to “folding, adjustment and locking device” (see Chapter 12, 4.8 and 4.9 of the.2008 edition); m) Added a chapter on “Carrying handles” (see Chapter 13); n) Added "backrest strength" (see 16.3); o) Added a chapter on "Ergonomics Principles" (see Chapter 18); p) Added a chapter on "Packaging" (see Chapter 19); q) The general provisions were changed (see 20.1, 6.1 of the.2008 edition), and “document” was changed to “user manual” (see 20.3, 6.3 of the.2008 edition). This document is equivalent to ISO 11199-2.2021 "Dual-arm operated walkers Requirements and test methods Part 2.Wheeled walkers". 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. China Center for Assistive Devices and Equipment for Persons with Disabilities, China Architecture Design & Research Institute Co., Ltd., Henan Xiangyu Medical Equipment Co., Ltd. Co., Ltd., Foshan Dongfang Medical Equipment Factory Co., Ltd., and Shanghai Hubang Intelligent Rehabilitation Equipment Co., Ltd. The main drafters of this document are. Li Dongmei, He Weijie, Wang Yu, Wang Qi, He Yongzheng, Wu Ruiping, Li Jianyu, Zhao Cishun and Zhang Jian. The previous versions of this document and the documents it replaces are as follows. ---First published in.2008 as GB/T 14728.2-2008; ---This is the first revision.

Introduction

Wheeled walkers are a type of walker that is operated by both arms. People who need help walking can use wheeled walkers. Wheeled walkers It can provide stable support when people walk and stand, and reduce the risk of falling. Wheeled walkers can be equipped with rest seats, backrests or shopping Bag, but can't be moved around in the seat like a wheelchair. GB/T 14728 "Requirements and test methods for dual-arm operated walkers" is intended to consist of three parts. --- Part 1.Frame-type walkers. The purpose is to provide requirements and test methods for frame-type walkers. --- Part 2.Wheeled walkers. The purpose is to provide requirements and test methods for wheeled walkers. --- Part 3.Desktop walkers. The purpose is to provide requirements and test methods for desktop walkers. Requirements and test methods for dual-arm operated walkers Part 2.Wheeled mobility aids

1 Scope

This document defines the terms and definitions of wheeled mobility aids and specifies wheeled mobility aids without accessories (unless specified in a special test procedure). General requirements and test methods for devices, materials, liquid ingress, temperature of parts in contact with the human body, safety of moving parts, prevention of body parts from being Cards, folding, adjusting and locking devices, carrying handles, surfaces, corners and edges, static stability, static load strength, durability tests, packaging, established Ergonomic principles are given, information provided by the manufacturer is given, and test conditions are described. This document applies to wheeled walkers operated by two arms for daily use by users with a mass of not less than 35 kg. This document does not apply to wheeled walkers with horizontal forearm support, i.e. table-top walkers of ISO 11199-3.

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. symbols) Note. GB/T 16273.1-2008 Graphical symbols for equipment Part 1.General symbols (ISO 7000.20041), NEQ) 1) ISO 7000.2004 has been replaced by ISO 7000.2019. ISO 8191-2 Furniture - Assessment of the ignitability of upholstered furniture - Part 2.Ignition source. Simulated match flame Note. GB 17927.2-2011 Assessment of anti-ignition properties of soft furniture mattresses and sofas Part 2.Simulated match flame (ISO 8191-2. 1988,NEQ) ISO 10993-1 Biological evaluation of medical devices Part 1.Evaluation and testing in the risk management process Note. GB/T 16886.1-2022 Biological evaluation of medical devices Part 1.Evaluation and testing in the risk management process (ISO 10993-1.2018, IDT) ISO 13732-1 Ergonomics of the thermal environment - Methods for evaluating the response of human contact surfaces - Part 1.Thermal surfaces withsurfaces-Part 1.Hotsurfaces) ISO 14971 Medical devices - Application of risk management in medical devices Note. GB/T 42062-2022 Application of medical device risk management to medical devices (ISO 14971.2019, IDT) ISO 15223-1 Medical devices - Symbols for information provided by manufacturers - Part 1.General requirements ments) Note. YY/T 0466.1-2023 Medical devices symbols for information provided by manufacturers Part 1.General requirements (ISO 15223-1.2021, MOD)

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