GB/T 14728-1993Assistive products for walking manipulated by both arms - Requirements and test methods - Part 1: Walking frames (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 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".

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)