標(biāo)準(zhǔn)解讀

GB/T 44421-2024《矯形器配置服務(wù)規(guī)范》是中國關(guān)于矯形器配置服務(wù)領(lǐng)域的一項(xiàng)國家標(biāo)準(zhǔn)，旨在提升矯形器服務(wù)的質(zhì)量與安全性，確?；颊吣軌颢@得適宜、專業(yè)的矯形器配置服務(wù)。該標(biāo)準(zhǔn)詳細(xì)規(guī)定了從評估、設(shè)計(jì)、制作到后期維護(hù)等一系列服務(wù)流程中的具體要求和操作規(guī)范，以保障矯形器具的個性化、有效性和舒適性。以下是對該標(biāo)準(zhǔn)主要內(nèi)容的概述：

  1. 服務(wù)提供方資質(zhì)：明確了從事矯形器配置服務(wù)的機(jī)構(gòu)或個人應(yīng)具備的相關(guān)資質(zhì)和條件，包括專業(yè)技術(shù)人員的資格認(rèn)證、場所設(shè)施要求及質(zhì)量管理體系等。

  2. 患者評估：強(qiáng)調(diào)在配置矯形器前必須對患者進(jìn)行全面評估，包括但不限于醫(yī)學(xué)診斷、身體功能狀態(tài)、生活方式以及患者的具體需求，以確保矯形器設(shè)計(jì)的針對性和合理性。

  3. 矯形器設(shè)計(jì)與制作：規(guī)定了矯形器設(shè)計(jì)應(yīng)基于評估結(jié)果，考慮材料選擇、結(jié)構(gòu)設(shè)計(jì)、功能實(shí)現(xiàn)及患者舒適度等因素。同時(shí)，對矯形器的生產(chǎn)工藝、質(zhì)量控制及檢驗(yàn)標(biāo)準(zhǔn)進(jìn)行了詳細(xì)說明，確保產(chǎn)品安全有效。

  4. 適配與調(diào)整：要求在矯形器完成初制后，需進(jìn)行細(xì)致的適配過程，根據(jù)患者的反饋進(jìn)行必要的調(diào)整，直至達(dá)到最佳的舒適度和功能效果。

  5. 使用指導(dǎo)與培訓(xùn)：強(qiáng)調(diào)服務(wù)提供方應(yīng)對患者及其家屬進(jìn)行矯形器正確使用、維護(hù)保養(yǎng)的指導(dǎo)和培訓(xùn)，確保患者能有效、安全地使用矯形器。

  6. 跟蹤服務(wù)與反饋：要求建立完善的跟蹤服務(wù)體系，定期對患者進(jìn)行回訪，收集使用反饋，及時(shí)解決使用過程中出現(xiàn)的問題，并對服務(wù)進(jìn)行持續(xù)改進(jìn)。

  7. 文檔管理與隱私保護(hù)：規(guī)范了服務(wù)過程中涉及的所有文檔記錄，包括評估報(bào)告、設(shè)計(jì)圖紙、適配記錄及患者信息等的管理要求，強(qiáng)調(diào)了對患者個人信息的嚴(yán)格保密。


如需獲取更多詳盡信息，請直接參考下方經(jīng)官方授權(quán)發(fā)布的權(quán)威標(biāo)準(zhǔn)文檔。

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文檔簡介

ICS

11.040.40

CCS

C45

中華人民共和國國家標(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

國家市場監(jiān)督管理總局發(fā)布

國家標(biāo)準(zhǔn)化管理委員會

GB/T44421—2024

目次

前言

·····································································································

Ⅲ

1

范圍

··································································································

1

2

規(guī)范性引用文件

······················································································

1

3

術(shù)語和定義

···························································································

1

4

基本要求

······························································································

2

4.1

服務(wù)機(jī)構(gòu)

·························································································

2

4.2

服務(wù)人員

·························································································

2

4.3

安全要求

·························································································

2

5

服務(wù)內(nèi)容

······························································································

2

5.1

矯形器制作與適配

···············································································

2

5.2

矯形器使用訓(xùn)練

·················································································

3

5.3

售后服務(wù)

·························································································

3

6

服務(wù)流程

······························································································

3

6.1

接待

······························································································

3

6.2

檢查評估

·························································································

3

6.3

開具矯形器處方

·················································································

4

6.4

簽署知情同意書

·················································································

4

6.5

服務(wù)實(shí)施

·························································································

4

6.6

質(zhì)量檢驗(yàn)

·························································································

4

6.7

矯形器交付

······················································································

5

7

服務(wù)評價(jià)與改進(jìn)

······················································································

5

7.1

服務(wù)評價(jià)

·························································································

5

7.2

服務(wù)改進(jìn)

·························································································

5

7.3

投訴處理

·························································································

5

附錄A（資料性）

矯形器配置基本信息

······························································

6

附錄B（資料性）

矯形器配置檢查評估及測量表

·····················································

7

附錄C（資料性）

矯形器處方

·······································································

13

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)識別專利的責(zé)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(fù)和專用設(shè)備標(biāo)準(zhǔn)化技術(shù)委員會(SAC/TC148)歸口。

本文件起草單位：中國康復(fù)輔助器具協(xié)會、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、北京社會管理職業(yè)學(xué)院（民政部培訓(xùn)

中心）、中國康復(fù)研究中心、合肥九久夕陽紅新海護(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、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。

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

GB/T16432康復(fù)輔助器具分類和術(shù)語

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無障礙設(shè)計(jì)規(guī)范

3術(shù)語和定義

GB/T14191.1和GB/T16432界定的以及下列術(shù)語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，個性化制作的

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