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GB/T 43417-2023Fitting of scoliosis orthoses for children and adolescents (English PDF)

儿童青少年脊柱侧弯矫形器的配置

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

November 27, 2023

Implementation date

November 27, 2023

Scope

GB/T 43417-2023 is the English-translated version of 儿童青少年脊柱侧弯矫形器的配置.

GB/T 43417-2023 is the Chinese national standard for fitting scoliosis orthoses to children and adolescents.

It sets the basic requirements, the requirements on the institution and its staff, and the fitting process step by step - reception, clinical examination, drawing up the fitting plan, manufacture, fitting and adjustment, the fit check, comfort evaluation, assisted exercise and the precautions given to the wearer - followed by delivery and review, follow-up records and follow-up requirements, and service evaluation, continuous improvement and complaint handling, with four informative forms for the record.

It defines scoliosis, the scoliosis orthosis and the Cobb angle measured on a standing radiograph. It applies to orthosis fitting services for children and adolescents with scoliosis aged 6 to 18. Issued on 27 November 2023, it has applied since the same day.

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Document preview — GB/T 43417-2023

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

PrefaceI
1 Scope
2 Normative references
3 Terms and Definitions
4 Basic requirements
5 Institutional and personnel requirements
6 Configuration process and requirements
6.1 Reception
6.2 Clinical examination
6.3 Develop configuration plan
6.4 Production
6.5 Wearing and debugging
6.6 Suitability check
6.7 Comfort evaluation
6.8 Assisted Exercise
6.9 Precautions
7 Delivery and Review
7.1 Delivery
7.2 Review
8 Follow-up
8.1 Follow-up record form
8.2 Follow-up requirements
9 Service and Evaluation
9.1 Service evaluation
9.2 Continuous improvement
9.3 Complaint handling
Appendix A (informative) Scoliosis orthosis configuration table
Appendix B (Informative) Scoliosis Patient Checklist
Appendix C (informative) Scoliosis orthosis fit evaluation form
Appendix D (Informative) Scoliosis Patient Review Form

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Rules of Standardization Documents" Drafting.

1 Scope

This document stipulates the basic requirements for the configuration of scoliosis orthoses for children and adolescents, institutional and personnel requirements, configuration processes and requirements, and communication Provide review, follow-up, service and evaluation.

This document is applicable to orthosis configuration services for children and adolescents with scoliosis aged 6 to 18 years old.

2 Normative reference documents

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document.

GB/T 14191.1 Prosthetics and orthotics terminology Part 1: Basic terminology for extracorporeal limb prostheses and extracorporeal orthotics

GB/T 16133 Screening for abnormal spinal curvature in children and adolescents

GB/T 16432 Classification and terminology of rehabilitation assistive devices

GB/T 19012 Quality Management Customer Satisfaction Organization Complaint Handling Guide

GB/T 19544 Classification and general technical conditions of spinal orthoses

3 Terms and definitions

The terms and definitions defined in GB/T 14191.1, GB/T 16133, GB/T 16432, GB/T 19544 and the following are applicable to this document. document.

3.1 Scoliosis

A three-dimensional spinal deformity in which one or more stages of the spine bend sideways with vertebral body rotation.

Note: The Cobb method is used to measure the degree of scoliosis on the standing X-ray of patients with scoliosis. If the angle is greater than 10° and accompanied by the rotation of the vertebral body, the spinal cord is diagnosed. Side bend.

3.2 Scoliosis orthoses

An extracorporeal device used to halt the progression of scoliosis and correct scoliosis deformity.

3.3 scoliosis orthosis configuration

Examine, prescribe, formulate plans, make, try on, adjust, deliver products, etc. for patients with scoliosis, and conduct follow-up inspections and adjustments. whole process.

3.4 CobbangleCobbangle

The Cobb method was used to measure the scoliosis angle obtained from standing X-ray films of patients with scoliosis.

Note: Draw a straight line along the upper edge of the most inclined vertebral body above the curved arc and the lower edge of the most inclined vertebral body below the curved arc. The angle between the two straight lines is is the Cobb angle.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

GB 4234.1-2026|YY 0017-2026|YY 0018-2026|YY/T 0492-2026|YY/T 2007-2026|GB 22457-2025

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