标准解读
GB/T 44421-2024《矫形器配置服务规范》是中国关于矫形器配置服务领域的一项国家标准，旨在提升矫形器服务的质量与安全性，确保患者能够获得适宜、专业的矫形器配置服务。该标准详细规定了从评估、设计、制作到后期维护等一系列服务流程中的具体要求和操作规范，以保障矫形器具的个性化、有效性和舒适性。以下是对该标准主要内容的概述：
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服务提供方资质：明确了从事矫形器配置服务的机构或个人应具备的相关资质和条件，包括专业技术人员的资格认证、场所设施要求及质量管理体系等。
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患者评估：强调在配置矫形器前必须对患者进行全面评估，包括但不限于医学诊断、身体功能状态、生活方式以及患者的具体需求，以确保矫形器设计的针对性和合理性。
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矫形器设计与制作：规定了矫形器设计应基于评估结果，考虑材料选择、结构设计、功能实现及患者舒适度等因素。同时，对矫形器的生产工艺、质量控制及检验标准进行了详细说明，确保产品安全有效。
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适配与调整：要求在矫形器完成初制后，需进行细致的适配过程，根据患者的反馈进行必要的调整，直至达到最佳的舒适度和功能效果。
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使用指导与培训：强调服务提供方应对患者及其家属进行矫形器正确使用、维护保养的指导和培训，确保患者能有效、安全地使用矫形器。
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跟踪服务与反馈：要求建立完善的跟踪服务体系，定期对患者进行回访，收集使用反馈，及时解决使用过程中出现的问题，并对服务进行持续改进。
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文档管理与隐私保护：规范了服务过程中涉及的所有文档记录，包括评估报告、设计图纸、适配记录及患者信息等的管理要求，强调了对患者个人信息的严格保密。
如需获取更多详尽信息，请直接参考下方经官方授权发布的权威标准文档。
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- 2024-08-23 颁布
- 2024-12-01 实施
文档简介
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
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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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1
4
基本要求
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2
4.1
服务机构
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2
4.2
服务人员
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2
4.3
安全要求
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2
5
服务内容
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2
5.1
矫形器制作与适配
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2
5.2
矫形器使用训练
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3
5.3
售后服务
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3
6
服务流程
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3
6.1
接待
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3
6.2
检查评估
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3
6.3
开具矫形器处方
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4
6.4
签署知情同意书
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4
6.5
服务实施
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4
6.6
质量检验
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4
6.7
矫形器交付
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5
7
服务评价与改进
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5
7.1
服务评价
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5
7.2
服务改进
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5
7.3
投诉处理
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5
附录A（资料性）
矫形器配置基本信息
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6
附录B（资料性）
矫形器配置检查评估及测量表
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7
附录C（资料性）
矫形器处方
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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
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