標準解讀

GB/T 44421-2024《矯形器配置服務規(guī)范》是中國關于矯形器配置服務領域的一項國家標準，旨在提升矯形器服務的質量與安全性，確?；颊吣軌颢@得適宜、專業(yè)的矯形器配置服務。該標準詳細規(guī)定了從評估、設計、制作到后期維護等一系列服務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。以下是對該標準主要內容的概述：

  1. 服務提供方資質：明確了從事矯形器配置服務的機構或個人應具備的相關資質和條件，包括專業(yè)技術人員的資格認證、場所設施要求及質量管理體系等。

  2. 患者評估：強調在配置矯形器前必須對患者進行全面評估，包括但不限于醫(yī)學診斷、身體功能狀態(tài)、生活方式以及患者的具體需求，以確保矯形器設計的針對性和合理性。

  3. 矯形器設計與制作：規(guī)定了矯形器設計應基于評估結果，考慮材料選擇、結構設計、功能實現(xiàn)及患者舒適度等因素。同時，對矯形器的生產(chǎn)工藝、質量控制及檢驗標準進行了詳細說明，確保產(chǎn)品安全有效。

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

  5. 使用指導與培訓：強調服務提供方應對患者及其家屬進行矯形器正確使用、維護保養(yǎng)的指導和培訓，確?；颊吣苡行?、安全地使用矯形器。

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

  7. 文檔管理與隱私保護：規(guī)范了服務過程中涉及的所有文檔記錄，包括評估報告、設計圖紙、適配記錄及患者信息等的管理要求，強調了對患者個人信息的嚴格保密。


如需獲取更多詳盡信息，請直接參考下方經(jīng)官方授權發(fā)布的權威標準文檔。

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文檔簡介

ICS

11.040.40

CCS

C45

中華人民共和國國家標準

GB/T44421—2024

矯形器配置服務規(guī)范

Specificationoforthosesfittingservice

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/T44421—2024

目次

前言

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

Ⅲ

1

范圍

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

1

2

規(guī)范性引用文件

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

1

3

術語和定義

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

1

4

基本要求

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

2

4.1

服務機構

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

2

4.2

服務人員

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

2

4.3

安全要求

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

2

5

服務內容

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

2

5.1

矯形器制作與適配

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

2

5.2

矯形器使用訓練

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

3

5.3

售后服務

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3

6

服務流程

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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

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4

6.5

服務實施

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4

6.6

質量檢驗

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4

6.7

矯形器交付

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

5

7

服務評價與改進

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5

7.1

服務評價

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5

7.2

服務改進

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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

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

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《標準化工作導則第1部分：標準化文件的結構和起草規(guī)則》的規(guī)

定起草。

請注意本文件的某些內容可能涉及專利。本文件的發(fā)布機構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備標準化技術委員會(SAC/TC148)歸口。

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

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)學院（民政部培訓

中心）、中國康復研究中心、合肥九久夕陽紅新海護理院有限公司、四川省八一康復中心（四川省康復

醫(yī)院）、上海市康復器具協(xié)會、河南省民政綜合服務中心。

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、王林、劉文倬、

文淑君、劉夕東、徐祖義、王磊。

Ⅲ

GB/T44421—2024

矯形器配置服務規(guī)范

1范圍

本文件規(guī)定了矯形器配置服務的基本要求、服務內容、服務流程、服務評價與改進。

本文件適用于從事矯形器配置服務的各類機構。

2規(guī)范性引用文件

下列文件中的內容通過文中的規(guī)范性引用而構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假肢學和矯形器學術語第1部分：體外肢體假肢和體外矯形器的基本術語

GB/T16432康復輔助器具分類和術語

GB/T19012質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條件

GB/T34410上肢矯形器的分類及通用技術條件

GB/Z41083下肢矯形器的分類及通用技術條件

GB50763無障礙設計規(guī)范

3術語和定義

GB/T14191.1和GB/T16432界定的以及下列術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

預制矯形器prefabricatedorthoses

由批量生產(chǎn)的預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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