GB/T 44424-2024助行手推車要求和測試方法

ICS

11.180.10

CCS

C47

中華人民共和國國家標準

GB/T44424—2024/ISO19894:2019

助行手推車要求和測試方法

Walkingtrolleys—Requirementsandtestmethods

(ISO19894:2019,IDT)

2024-08-23發(fā)布2024-12-01實施

國家市場監(jiān)督管理總局發(fā)布

國家標準化管理委員會

GB/T44424—2024/ISO19894:2019

目次

前言

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Ⅲ

1

范圍

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1

2

規(guī)范性引用文件

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1

3

術(shù)語和定義

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2

4

一般要求和測試方法

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5

5

材料

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7

6

液體進入

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8

7

與人體接觸部分的溫度

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8

8

活動和折疊部件的安全性

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9

9

防止身體部位被卡

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10

10

折疊和調(diào)節(jié)裝置

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10

11

提起和搬運方式

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11

12

強度、扭矩、耐久性

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12

13

外觀（表面，角、邊和突出部分）

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15

14

穩(wěn)定性

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15

15

人體軟組織上的力

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19

16

一般結(jié)構(gòu)

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19

17

人類工效學原則

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21

18

制造商提供的信息

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22

19

包裝

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22

20

測試報告

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23

附錄A（資料性）

設(shè)計產(chǎn)品時考慮的危險項目

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24

附錄B（資料性）

基本原理

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25

附錄C（資料性）

環(huán)境和消費者相關(guān)指南

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27

參考文獻

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31

Ⅰ

GB/T44424—2024/ISO19894:2019

前言

本文件按照GB/T1.1—2020《標準化工作導則第1部分：標準化文件的結(jié)構(gòu)和起草規(guī)則》的規(guī)

定起草。

本文件等同采用ISO19894:2019《助行手推車要求和測試方法》。

請注意本文件的某些內(nèi)容可能涉及專利。本文件的發(fā)布機構(gòu)不承擔識別專利的責任。

本文件由中華人民共和國民政部提出。

本文件由全國殘疾人康復和專用設(shè)備標準化技術(shù)委員會（SAC/TC148）歸口。

本文件起草單位：中國殘疾人輔助器具中心、佛山市順康達醫(yī)療科技有限公司、河南翔宇醫(yī)療設(shè)備

股份有限公司、深圳市康復輔助器具智能技術(shù)應(yīng)用協(xié)會、安陽市市場監(jiān)管審評中心、佛山市東方醫(yī)療設(shè)

備廠有限公司、金華華港運動器材有限公司。

本文件主要起草人：李冬梅、張健、楊榮洪、李飛、武國興、劉海軍、李建諭、蔣磊、趙鍵榮、

江元仲。

Ⅲ

GB/T44424—2024/ISO19894:2019

助行手推車要求和測試方法

1范圍

本文件規(guī)定了助行手推車的一般要求、材料、與人體接觸部分的溫度、結(jié)構(gòu)、強度、扭矩和耐久

性、外觀、穩(wěn)定性、人體組織上的力、包裝和測試報告，確立了人類工效學原則，給出了制造商提供的

信息，描述了測試方法。

本文件適用于使用者質(zhì)量不低于35kg的作為日常使用助行輔助器具的助行手推車。

本文件不適用于ISO11199?2規(guī)定的輪式助行器。

2規(guī)范性引用文件

下列文件中的內(nèi)容通過文中的規(guī)范性引用而構(gòu)成本文件必不可少的條款。其中，注日期的引用文

件，僅該日期對應(yīng)的版本適用于本文件；不注日期的引用文件，其最新版本（包括所有的修改單）適用

于本文件。

ISO3746聲學聲壓法測定噪聲源聲功率級和聲能量級采用反射面上方包絡(luò)測量面的簡易法

（Acoustics—Determinationofsoundpowerlevelsandsoundenergylevelsofnoisesourcesusing

soundpressure—Surveymethodusinganenvelopingmeasurementsurfaceoverareflectingplane）

注：GB/T3768—2017聲學聲壓法測定噪聲源聲功率級和聲能量級采用反射面上方包絡(luò)測量面的簡易法

（ISO3746:2010，IDT）

ISO8191?1家具軟體家具可燃性的評定第1部分：火源：陰燃的香煙（Furniture—Assessmentofthe

ignitabilityofupholsteredfurniture—Part1:Ignitionsource:smolderingcigarette）

注：GB17927.1—2011軟體家具床墊和沙發(fā)抗引燃特性的評定第1部分：陰燃的香煙（ISO8191-1:1988，NEQ）

ISO8191?2家具軟體家具可燃性的評定第2部分：火源：模擬火柴火焰（Furniture—

Assessmentofignitabilityofupholsteredfurniture—Part2:Ignitionsource:match?flameequivalent）

注：GB17927.2—2011軟體家具床墊和沙發(fā)抗引燃特性的評定第2部分：模擬火柴火焰（ISO8191?2:1988，NEQ）

ISO9227人造氣氛腐蝕試驗鹽霧試驗（Corrosiontestsinartificialatmospheres—Saltspray

test）

注：GB/T10125—2021人造氣氛腐蝕試驗鹽霧試驗（ISO9227:2017，MOD）

ISO10993?1醫(yī)療器械生物學評價第1部分：風險管理過程中的評價與試驗（Biologicalevalu?

ationofmedicaldevices—Part1:Evaluationandtestingwithariskmanagementprocess）

注：GB/T16886.1—2022醫(yī)療器械生物學評價第1部分：風險管理過程中的評價與試驗（ISO10993?1:2018，IDT）

ISO12100機械安全設(shè)計通則風險評估與風險減?。⊿afetyofmachinery—Generalprin?

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