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GB/T 44421-2024Specification of orthoses fitting service (English PDF)

矫形器配置服务规范

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

August 23, 2024

Implementation date

December 1, 2024

Scope

GB/T 44421-2024 is the English-translated version of 矫形器配置服务规范.

GB/T 44421-2024 is the Chinese national standard covering specification of orthoses fitting service. Issued on 23 August 2024, it has been in force since 1 December 2024.

Document preview — GB/T 44421-2024

National Standard of the People's Republic of China

ICS: 11.040.40
Classification: C 45

Issued by: State Administration for Market Regulation; Standardization Administration of the PRC

PrefaceIII
1 Scope1
2 Normative references1
3 Terms and Definitions1
4 Basic Requirements2
4.1 Service Organizations2
4.2 Service personnel2
4.3 Safety Requirements2
5 Service Content2
5.1 Orthosis fabrication and fitting2
5.2 Orthosis training3
5.3 After-sales service3
6 Service Process3
6.1 Reception3
6.2 Inspection and Evaluation3
6.3 Prescribing orthotics4
6.4 Signing the Informed Consent Form4
6.5 Service Implementation4
6.6 Quality Inspection4
6.7 Delivery of orthosis5
7 Service Evaluation and Improvement5
7.1 Service Evaluation5
7.2 Service Improvement5
7.3 Complaints Handling5
Appendix A (Informative) Basic information on orthosis configuration6
Appendix B (Informative) Orthotic Configuration Inspection, Evaluation and Measurement Table7
Appendix C (Informative) Orthotic Prescription13

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1: Structure and drafting rules for standardization documents" Drafting is required.

Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.

This document is issued by the Ministry of Civil Affairs of the People's Republic of China.

This document is under the jurisdiction of the National Technical Committee for Standardization of Rehabilitation and Special Equipment for Persons with Disabilities (SAC/TC 148).

This document was drafted by: China Rehabilitation Assistive Devices Association, Jinhua Deren Rehabilitation Assistive Devices Co., Ltd., Zhengzhou Pinkang Prosthetics and Orthotics Technology Co., Ltd., Jiangsu Tianrui Medical Equipment Co., Ltd., Xiamen David Technology Co., Ltd., Beijing Social Management Vocational College (Training Center), China Rehabilitation Research Center, Hefei Jiujiu Sunset Red Xinhai Nursing Home Co., Ltd., Sichuan Bayi Rehabilitation Center (Sichuan Rehabilitation Hospital), Shanghai Rehabilitation Equipment Association, and Henan Provincial Civil Affairs Comprehensive Service Center.

The main drafters of this document are: Pang Qun, Zhang Pengcheng, Jiang Shangwu, Li Xiaogang, Zhang Zhenshu, Feng Ruzhi, Zhang Qiang, Wang Lin, Liu Wenzhuo, Wen Shujun, Liu Xidong, Xu Zuyi, and Wang Lei.

Orthosis Configuration Service Specifications

1 Scope

This document specifies the basic requirements, service content, service process, service evaluation and improvement of orthosis configuration services.

This document is applicable to all types of institutions engaged in orthotic device configuration services.

2 Normative references

GB/T 14191.1

GB/T 16432

GB/T 19012

GB/T 19544

GB/T 34410

GB 50763

3 Terms and definitions

The terms and definitions defined in GB/T 14191.1 and GB/T 16432 and the following apply to this document.

3.1 Finished orthoses

Orthopedic devices produced in batches and series.

3.2 Prefabricated orthoses

Orthopedic devices that are modified from mass-produced prefabricated parts to meet the needs of people with functional disabilities.

3.3 Custom-fabricated orthoses

Orthopedic devices are customized according to the needs of people with functional disabilities.

3.4 Orthoses fitting

The process of fitting an off-the-shelf, prefabricated, or custom-made orthosis to an individual with a functional impairment.

3.5 orthoses prescription

Written documentation of the configuration of orthoses provided to individuals with functional impairments based on their needs.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 pages — is available in the English PDF.

Referenced standards

Normative references

GB/T 14191.1 · GB/T 16432 · GB/T 19012 · GB 50763

Editions of GB/T 44421

Edition	Title	Revision	Status
GB/T 44421-2024	Specification of orthoses fitting service	current edition	Current

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