GB/T 44421-2024矯形器配置服務(wù)規(guī)范

ICS

11.040.40

CCS

C45

中華人民共和國(guó)國(guó)家標(biāo)準(zhǔn)

GB/T44421—2024

矯形器配置服務(wù)規(guī)范

Specificationoforthosesfittingservice

2024-08-23發(fā)布2024-12-01實(shí)施

國(guó)家市場(chǎng)監(jiān)督管理總局發(fā)布

國(guó)家標(biāo)準(zhǔn)化管理委員會(huì)

GB/T44421—2024

目次

前言

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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(yǔ)和定義

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1

4

基本要求

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2

4.1

服務(wù)機(jī)構(gòu)

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4.2

服務(wù)人員

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2

4.3

安全要求

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2

5

服務(wù)內(nèi)容

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2

5.1

矯形器制作與適配

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2

5.2

矯形器使用訓(xùn)練

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3

5.3

售后服務(wù)

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3

6

服務(wù)流程

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3

6.1

接待

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3

6.2

檢查評(píng)估

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3

6.3

開具矯形器處方

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4

6.4

簽署知情同意書

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4

6.5

服務(wù)實(shí)施

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4

6.6

質(zhì)量檢驗(yàn)

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4

6.7

矯形器交付

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5

7

服務(wù)評(píng)價(jià)與改進(jìn)

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5

7.1

服務(wù)評(píng)價(jià)

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5

7.2

服務(wù)改進(jìn)

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5

7.3

投訴處理

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5

附錄A（資料性）

矯形器配置基本信息

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6

附錄B（資料性）

矯形器配置檢查評(píng)估及測(cè)量表

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7

附錄C（資料性）

矯形器處方

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Ⅰ

GB/T44421—2024

前

言

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

定起草。

請(qǐng)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(jī)構(gòu)不承擔(dān)識(shí)別專利的責(zé)任。

本文件由中華人民共和國(guó)民政部提出。

本文件由全國(guó)殘疾人康復(fù)和專用設(shè)備標(biāo)準(zhǔn)化技術(shù)委員會(huì)(SAC/TC148)歸口。

本文件起草單位：中國(guó)康復(fù)輔助器具協(xié)會(huì)、金華德仁康復(fù)輔具有限公司、鄭州品康假肢矯形器技術(shù)

有限公司、江蘇天瑞醫(yī)療器械有限公司、廈門大衛(wèi)科技有限公司、北京社會(huì)管理職業(yè)學(xué)院（民政部培訓(xùn)

中心）、中國(guó)康復(fù)研究中心、合肥九久夕陽(yáng)紅新海護(hù)理院有限公司、四川省八一康復(fù)中心（四川省康復(fù)

醫(yī)院）、上海市康復(fù)器具協(xié)會(huì)、河南省民政綜合服務(wù)中心。

本文件主要起草人：逄群、張鵬程、蔣尚武、李曉剛、張振淑、馮如智、張強(qiáng)、王林、劉文倬、

文淑君、劉夕東、徐祖義、王磊。

Ⅲ

GB/T44421—2024

矯形器配置服務(wù)規(guī)范

1范圍

本文件規(guī)定了矯形器配置服務(wù)的基本要求、服務(wù)內(nèi)容、服務(wù)流程、服務(wù)評(píng)價(jià)與改進(jìn)。

本文件適用于從事矯形器配置服務(wù)的各類機(jī)構(gòu)。

2規(guī)范性引用文件

下列文件中的內(nèi)容通過(guò)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(duì)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。

GB/T14191.1假肢學(xué)和矯形器學(xué)術(shù)語(yǔ)第1部分：體外肢體假肢和體外矯形器的基本術(shù)語(yǔ)

GB/T16432康復(fù)輔助器具分類和術(shù)語(yǔ)

GB/T19012質(zhì)量管理顧客滿意組織投訴處理指南

GB/T19544脊柱矯形器的分類及通用技術(shù)條件

GB/T34410上肢矯形器的分類及通用技術(shù)條件

GB/Z41083下肢矯形器的分類及通用技術(shù)條件

GB50763無(wú)障礙設(shè)計(jì)規(guī)范

3術(shù)語(yǔ)和定義

GB/T14191.1和GB/T16432界定的以及下列術(shù)語(yǔ)和定義適用于本文件。

3.1

成品矯形器finishedorthoses

批量化、系列化生產(chǎn)的矯形裝置。

3.2

預(yù)制矯形器prefabricatedorthoses

由批量生產(chǎn)的預(yù)制件按功能障礙者需求改制的矯形裝置。

3.3

定制矯形器custom-fabricatedorthoses

根據(jù)功能障礙者需求，個(gè)性化制作的