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GB/T 39871-2021Cervicothoracic orthoses (English PDF)

颈胸矫形器

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

March 9, 2021

Implementation date

March 9, 2021

Scope

GB/T 39871-2021 is the English-translated version of 颈胸矫形器.

GB/T 39871-2021 is the Chinese national standard for cervicothoracic orthoses. It gives the classification and the models, the technical requirements, the inspection methods, the inspection rules and the provisions on marks, packaging, transport and storage.

It applies to plastic cervicothoracic orthoses, to the finished parts of brace type orthoses and to custom made ones, the braces that hold the neck and the upper trunk after an injury or an operation.

Orthotic workshops, hospitals and inspectors use it. Issued on 9 March 2021, it applies from the same date.

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Document preview — GB/T 39871-2021

National Standard of the People's Republic of China

ICS
11.180.01
Classification
C 45

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

Contents

  • Foreword
  • 1 Scope
  • 2 Normative references
  • 3 Terms and definitions
  • 4 Classification and model
  • 5 Technical requirements
  • 6 Inspection method
  • 7 Inspection rules
  • 8 Marks, packaging marks, instructions for use and inspection certificates
  • 9 Packaging, transportation and storage

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

1 Scope

This standard specifies the classification and model, technical requirements, inspection methods, inspection rules, signs, packaging, transportation, and Store.

This standard applies to plastic cervico-thoracic orthoses, finished products and parts of brace cervico-thoracic orthoses, and custom-made cervical-thoracic orthoses, etc.

The product is used for the fixation, protection, support and correction of cervical spine injury, cervical spine inflammation and other cervical spine diseases, as well as the auxiliary before and after cervical spine surgery. Help recovery.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document. For undated reference documents, the latest version (including all amendments) is applicable to this document.

GB/T 191 Packaging, storage and transportation pictorial signs

GB/T 10000 Chinese adult human body size

GB/T 14191.1 Terminology of prosthetics and orthotics-Part 1: Basic terminology of external limb prostheses and external orthoses

GB/T 16432 Classification and terminology of rehabilitation assistive devices

GB/T 19544-2004 Classification and general technical conditions of spinal orthoses

3 Terms and definitions

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

3.3 Corrective cervicothoracic orthosis

Rehabilitation aids whose main function is to correct cervical deformities, such as torticollis orthoses.

3.4 Restrictive cervicothoracic orthosis

Rehabilitation aids whose main function is to restrict cervical spine movement or reduce cervical spine pressure.

4 Classification and model

4.1 Classification

4.1.1 Classification by material

Cervical-thoracic orthoses are classified into plastic cervical-thoracic orthoses and brace-type cervical-thoracic orthoses according to their materials.

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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

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GB/T 39871-2021

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