GB/T 44424-2024 助行手推车 要求和测试方法

ICS

11.180.10

CCS

C47

中华人民共和国国家标准

GB/T44424—2024/ISO19894:2019

助行手推车要求和测试方法

Walkingtrolleys—Requirementsandtestmethods

(ISO19894:2019,IDT)

2024-08-23发布2024-12-01实施

国家市场监督管理总局发布

国家标准化管理委员会

GB/T44424—2024/ISO19894:2019

目次

前言

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Ⅲ

1

范围

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1

2

规范性引用文件

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1

3

术语和定义

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4

一般要求和测试方法

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5

材料

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6

液体进入

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7

与人体接触部分的温度

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8

活动和折叠部件的安全性

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9

防止身体部位被卡

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10

折叠和调节装置

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11

提起和搬运方式

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12

强度、扭矩、耐久性

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13

外观（表面，角、边和突出部分）

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14

稳定性

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15

人体软组织上的力

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16

一般结构

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17

人类工效学原则

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18

制造商提供的信息

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19

包装

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20

测试报告

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23

附录A（资料性）

设计产品时考虑的危险项目

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24

附录B（资料性）

基本原理

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25

附录C（资料性）

环境和消费者相关指南

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27

参考文献

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Ⅰ

GB/T44424—2024/ISO19894:2019

前言

本文件按照GB/T1.1—2020《标准化工作导则第1部分：标准化文件的结构和起草规则》的规

定起草。

本文件等同采用ISO19894:2019《助行手推车要求和测试方法》。

请注意本文件的某些内容可能涉及专利。本文件的发布机构不承担识别专利的责任。

本文件由中华人民共和国民政部提出。

本文件由全国残疾人康复和专用设备标准化技术委员会（SAC/TC148）归口。

本文件起草单位：中国残疾人辅助器具中心、佛山市顺康达医疗科技有限公司、河南翔宇医疗设备

股份有限公司、深圳市康复辅助器具智能技术应用协会、安阳市市场监管审评中心、佛山市东方医疗设

备厂有限公司、金华华港运动器材有限公司。

本文件主要起草人：李冬梅、张健、杨荣洪、李飞、武国兴、刘海军、李建谕、蒋磊、赵键荣、

江元仲。

Ⅲ

GB/T44424—2024/ISO19894:2019

助行手推车要求和测试方法

1范围

本文件规定了助行手推车的一般要求、材料、与人体接触部分的温度、结构、强度、扭矩和耐久

性、外观、稳定性、人体组织上的力、包装和测试报告，确立了人类工效学原则，给出了制造商提供的

信息，描述了测试方法。

本文件适用于使用者质量不低于35kg的作为日常使用助行辅助器具的助行手推车。

本文件不适用于ISO11199﹘2规定的轮式助行器。

2规范性引用文件

下列文件中的内容通过文中的规范性引用而构成本文件必不可少的条款。其中，注日期的引用文

件，仅该日期对应的版本适用于本文件；不注日期的引用文件，其最新版本（包括所有的修改单）适用

于本文件。

ISO3746声学声压法测定噪声源声功率级和声能量级采用反射面上方包络测量面的简易法

（Acoustics—Determinationofsoundpowerlevelsandsoundenergylevelsofnoisesourcesusing

soundpressure—Surveymethodusinganenvelopingmeasurementsurfaceoverareflectingplane）

注：GB/T3768—2017声学声压法测定噪声源声功率级和声能量级采用反射面上方包络测量面的简易法

（ISO3746:2010，IDT）

ISO8191﹘1家具软体家具可燃性的评定第1部分：火源：阴燃的香烟（Furniture—Assessmentofthe

ignitabilityofupholsteredfurniture—Part1:Ignitionsource:smolderingcigarette）

注：GB17927.1—2011软体家具床垫和沙发抗引燃特性的评定第1部分：阴燃的香烟（ISO8191-1:1988，NEQ）

ISO8191﹘2家具软体家具可燃性的评定第2部分：火源：模拟火柴火焰（Furniture—

Assessmentofignitabilityofupholsteredfurniture—Part2:Ignitionsource:match﹘flameequivalent）

注：GB17927.2—2011软体家具床垫和沙发抗引燃特性的评定第2部分：模拟火柴火焰（ISO8191﹘2:1988，NEQ）

ISO9227人造气氛腐蚀试验盐雾试验（Corrosiontestsinartificialatmospheres—Saltspray

test）

注：GB/T10125—2021人造气氛腐蚀试验盐雾试验（ISO9227:2017，MOD）

ISO10993﹘1医疗器械生物学评价第1部分：风险管理过程中的评价与试验（Biologicalevalu﹘

ationofmedicaldevices—Part1:Evaluationandtestingwithariskmanagementprocess）

注：GB/T16886.1—2022医疗器械生物学评价第1部分：风险管理过程中的评价与试验（ISO10993﹘1:2018，IDT）

ISO12100机械安全设计通则风险评估与风险减小（Safetyofmachinery—Generalprin﹘

ciplesfordesign—Riskassessmentandriskreduction）

注：GB/T15706—2012机械安全设计通则风险评估与风险减小（ISO12100:2010，IDT）

ISO14155用于人体的医疗器械的临床调查良好的临床实践（Clinicalinvestigationofmedical

devicesforhumansubjects—Goodclinicalpractice）

ISO14971医疗器械风险管理对医疗器械的应用（Medicaldevices—Applicationofriskman﹘

agementtomedicaldevices）

注：GB/T42062—2022医疗器械风险管理对医疗器械的应用（ISO14971:2019，IDT）

ISO22442﹘1动物源医疗器械第1部分:风险管理应用（Medicaldevicesutilizinganimaltissues

andtheirderivatives—Part1:Applicationofriskmanagement）

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