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GB/T 14728.1-2024 | English | 674 |
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Assistive products for walking manipulated by both arms - Requirements and test methods - Part 1: Walking frames
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GB/T 14728.1-2024
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GB/T 14728.1-2006 | English | 274 |
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Walking aids manipulated by both arms -- Requirements and test methods -- Part 1: Walking frames
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GB/T 14728.1-2006
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GB/T 14728-1993 | English | 399 |
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Walking frames
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PDF similar to GB/T 14728.1-2024
Basic data Standard ID | GB/T 14728.1-2024 (GB/T14728.1-2024) | Description (Translated English) | Assistive products for walking manipulated by both arms - Requirements and test methods - Part 1: Walking frames | Sector / Industry | National Standard (Recommended) | Classification of Chinese Standard | C45 | Classification of International Standard | 11.180 | Word Count Estimation | 34,388 | Date of Issue | 2024-09-29 | Date of Implementation | 2025-10-01 | Older Standard (superseded by this standard) | GB/T 14728.1-2006 | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration |
GB/T 14728.1-2024: Assistive products for walking manipulated by both arms - Requirements and test methods - Part 1: Walking frames ---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 14728.1-2006
Requirements and test methods for dual-arm operated walkers
Part 1.Frame-type walkers
(ISO 11199-1.2021, 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 V
1 Scope 1
2 Normative references 1
3 Terms and Definitions 2
4 Equipment 7
5 Test conditions 7
6 General requirements and test methods 8
6.1 Risk Analysis 8
6.2 Detachable frame walker 8
6.3 Fasteners 8
6.4 User mass/maximum load 8
6.5 Structural requirements 8
6.6 Brakes 9
6.7 Handle 9
6.8 Legs and feet 9
7 Materials 9
7.1 General 9
7.2 Flammability 10
7.3 Biocompatibility and toxicity 10
7.4 Infection and microbial contamination 10
7.5 Corrosion resistance 10
8 Liquid enters 10
9 Temperature of the part in contact with human skin 10
10 Safety of moving parts11
10.1 Squeeze 11
10.2 Mechanical wear 11
11 Prevent body parts from getting stuck
11.1 Holes and gaps 11
11.2 V-shaped opening 12
12 Folding, adjusting and locking device 12
12.1 General 12
12.2 Folding device 12
12.3 Locking device 13
13 Lifting and carrying handles13
13.1 General 13
13.2 Requirement 13
13.3 Test method 13
14 Surfaces, Angles and Edges14
15 Static stability 14
15.1 Static stability requirements 14
15.2 Static stability test method 14
16 Static load strength 17
16.1 Static load strength of frame type walker 17
16.2 Static load strength of legs with foot pads 18
17 Durability test19
17.1 General requirements 19
17.2 Durability requirements 19
17.3 Durability test method 19
18 Ergonomic principles19
19 Packaging 20
20 Information provided by the manufacturer 20
20.1 General 20
20.2 Information marked on the product 21
20.3 User Manual 21
20.4 Inspection Report 22
Appendix A (Informative) Hazard factors to be considered when designing products 23
A.1 General Principles23
A.2 Expected risks and factors of general rehabilitation assistive devices 23
A.3 Hazards of ergonomic factors for different users 23
A.4 Hazards caused by mechanical damage, inadequate maintenance and/or aging 23
Appendix B (Informative) General Recommendations 24
B.1 Article 7.2 - Flammability 24
B.2 Article 7.4.2 - Cleaning and disinfection 24
B.3 Chapter 18 - Ergonomic Principles 24
B.4 Chapter 19 - Packaging 25
Reference 26
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 1 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 14728.1-2006 "Dual-arm-operated walkers - Requirements and test methods - Part 1.Frame-type walkers"
Compared with GB/T 14728.1-2006, in addition to structural adjustments and editorial changes, the main technical changes are as follows.
a) The definition of frame-type walker has been changed (see 3.16, 3.14 of the.2006 edition), and brakes (see 3.1), parking brakes (see
3.9), terms and definitions of pressure brake (see 3.10), service brake (see 3.13), and wheel width (see 3.17);
b) Added a chapter on "Equipment" (see Chapter 4);
c) The test conditions have been changed (see Chapter 5, 5.1 of the.2006 edition);
d) Added “Risk analysis” (see 6.1), “Detachable frame walker” (see 6.2), “Fasteners” (see 6.3), “User quality/maximum
"Large load" (see 6.4), "brake" (see 6.6);
e) Changed “reference index” to “structural requirements” and added wheel size requirements (see 6.5, 4.3 of the.2006 edition);
f) The requirements for handles (see 6.7, 4.4 of the.2006 edition) and the requirements for legs and foot pads (see 6.8, 4.5 of the.2006 edition) have been changed;
g) Changed "materials and finished products" to "materials" in the "General Principles" (see 7.1, 4.7 of the.2006 edition);
h) Added "flammability", "biocompatibility and toxicity", "infection and microbial contamination" and "corrosion resistance" (see 7.2 to 7.5);
i) Added a chapter on "Liquid Ingress" (see Chapter 8);
j) Added a chapter on “Temperature of parts in contact with human skin” (see Chapter 9);
k) Added a chapter on “Safety of Moving Parts” (see Chapter 10);
l) Added a chapter on "Preventing various parts of the body from getting stuck" (see Chapter 11);
m) Changed “adjustment device” to “folding, adjusting and locking device” (see Chapter 12, 4.6 of the.2006 edition);
n) Added a chapter on “Lifting and carrying handles” (see Chapter 13);
o) Added a chapter on "Ergonomics Principles" (see Chapter 18);
p) Added a chapter on "Packaging" (see Chapter 19);
q) Added "General Principles" (see 20.1) and "User Manual" (see 20.3);
r) Changed “marking and labeling” to “information marked on the product” (see 20.2, Chapter 6 of the.2006 edition);
s) The inspection report requirements have been changed (see 20.4, Chapter 7 of the.2006 edition).
This document is equivalent to ISO 11199-1.2021 "Dual-arm-operated walkers - Requirements and test methods - Part 1.Frame-type walkers"
"Instrument".
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 for Persons with Disabilities, Foshan Dongfang Medical Equipment Factory Co., Ltd., Tianjin Eshoutongbiao Technology
Co., Ltd., Shenzhen Comprehensive Service Center for Persons with Disabilities, and Shanghai Hubang Intelligent Rehabilitation Equipment Co., Ltd.
The main drafters of this document are. Li Dongmei, Li Jianyu, Wang Qi, Xiu Chunyang, Wu Ruiping, Li Fei, Wu Guoxing, Zhong Lei, and Zhao Cishun.
The previous versions of this document and the documents it replaces are as follows.
--- First published as GB/T 14728.1-1993, first revised in.2006;
---This is the second revision.
Introduction
A frame walker is a type of two-arm operated walker. People who need help walking can use a frame walker.
The device can provide stable support when people walk and stand, and reduce the risk of falling.
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 1.Frame-type walkers
1 Scope
This document defines the terms and definitions of frame-type walkers and specifies the use of frame-type walkers without accessories (unless specified in a special test procedure).
The general requirements of the device are. material, liquid ingress, temperature of the part in contact with human skin, safety of moving parts, prevention of body parts from being stuck, fracture
Stacking, adjusting and locking devices, lifting and carrying handles, surfaces, corners and edges, static stability, static load strength, durability tests, establish human engineering
The principles of ergonomics are given, information provided by the manufacturer is given, and the test methods are described.
This document applies to frame-type walkers operated by two arms for daily use with a user mass of not less than 35 kg as specified by the manufacturer.
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 flammability 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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