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

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

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".

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)