GB/T 44421-2024 矫形器配置服务规范

ICS

11.040.40

CCS

C45

中华人民共和国国家标准

GB/T44421—2024

矫形器配置服务规范

Specificationoforthosesfittingservice

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/T44421—2024

目次

前言

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

Ⅲ

1

范围

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

1

2

规范性引用文件

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

1

3

术语和定义

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

1

4

基本要求

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

2

4.1

服务机构

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

2

4.2

服务人员

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

2

4.3

安全要求

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

2

5

服务内容

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

2

5.1

矫形器制作与适配

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

2

5.2

矫形器使用训练

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

3

5.3

售后服务

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

3

6

服务流程

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

3

6.1

接待

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

3

6.2

检查评估

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

3

6.3

开具矫形器处方

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

4

6.4

签署知情同意书

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

4

6.5

服务实施

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

4

6.6

质量检验

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

4

6.7

矫形器交付

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

5

7

服务评价与改进

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

5

7.1

服务评价

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

5

7.2

服务改进

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

5

7.3

投诉处理

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

5

附录A（资料性）

矫形器配置基本信息

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

6

附录B（资料性）

矫形器配置检查评估及测量表

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

7

附录C（资料性）

矫形器处方

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

13

Ⅰ

GB/T44421—2024

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。

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：中国康复辅助器具协会、金华德仁康复辅具有限公司、郑州品康假肢矫形器技术

有限公司、江苏天瑞医疗器械有限公司、厦门大卫科技有限公司、北京社会管理职业学院（民政部培训

中心）、中国康复研究中心、合肥九久夕阳红新海护理院有限公司、四川省八一康复中心（四川省康复

医院）、上海市康复器具协会、河南省民政综合服务中心。

本文件主要起草人：逄群、张鹏程、蒋尚武、李晓刚、张振淑、冯如智、张强、王林、刘文倬、

文淑君、刘夕东、徐祖义、王磊。

Ⅲ

GB/T44421—2024

矫形器配置服务规范

1范围

本文件规定了矫形器配置服务的基本要求、服务内容、服务流程、服务评价与改进。

本文件适用于从事矫形器配置服务的各类机构。

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。

GB/T14191.1假肢学和矫形器学术语第1部分：体外肢体假肢和体外矫形器的基本术语

GB/T16432康复辅助器具分类和术语

GB/T19012质量管理顾客满意组织投诉处理指南

GB/T19544脊柱矫形器的分类及通用技术条件

GB/T34410上肢矫形器的分类及通用技术条件

GB/Z41083下肢矫形器的分类及通用技术条件

GB50763无障碍设计规范

3术语和定义

GB/T14191.1和GB/T16432界定的以及下列术语和定义适用于本文件。

3.1

成品矫形器finishedorthoses

批量化、系列化生产的矫形装置。

3.2

预制矫形器prefabricatedorthoses

由批量生产的预制件按功能障碍者需求改制的矫形装置。

3.3

定制矫形器custom-fabricatedorthoses

根据功能障碍者需求，个性化制作的矫形装置。

3.4

矫形器配置orthosesfitting

为功能障碍者选配成品矫形器、预制矫形器或定制矫形器的过程。

3.5

矫形器处方orthosesprescription

根据功能障碍者需求，为其提供的矫形器配置方案的书面文件。

1