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GB/T 39886-2021Hyper-extension spinal orthoses (English PDF)

脊柱过伸矫形器

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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 39886-2021 is the English-translated version of 脊柱过伸矫形器.

GB/T 39886-2021 is the Chinese national standard for hyperextension spinal orthoses. It gives the classification and the models, the technical requirements, the inspection methods, the inspection rules and the provisions on marks, labels, packaging, transport and storage.

It applies to the orthoses used to hold and to correct the spine after a thoracolumbar compression fracture, after spinal surgery, in disc disease and in kyphosis, and during the rehabilitation that follows.

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 39886-2021

National Standard of the People's Republic of China

ICS: 11.180
Classification: C 45

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

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Classification and model
5 Technical requirements
6 Inspection method
7 Inspection rules
8 Labels, packaging marks, instructions for use
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, labels, packaging, and transportation of spinal hyperextension orthoses. Import and save.

This standard applies to the fixation, rehabilitation training and correction of patients with thoracolumbar compression fractures, spinal surgery, lumbar disc disease, and kyphosis. Positive frame and three-point spinal hyperextension orthosis.

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 references, the latest version (including all amendments) applies 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 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.

3.2 Frame-type spine hyperextension orthosis

Use metal braces to form a frame structure on the front and both sides of the torso, supplemented by sternum pads, pubic pads, side pads, back lumbar pads and annulus to make the spine Orthopedic aids that remain in the hyperextension position.

3.3 Spine hyperextension orthosis, rigid front type

Use metal braces to form a rigid structure in front of the torso, supplemented by sternum pads, pubic pads, back lumbar pads and fixation belts to keep the spine in hyperextension Positional orthopedic aids.

3.4 Orthoses length

In the free state, the maximum outer profile of the spine hyperextension orthosis in the direction of the extension line between the center point of the sternum pad and the center point of the pubic pad For dimensions, see Figure 2 and Figure 4.

3.5 Orthoses internal arc length

In the free state, the frame-type spine hyperextension orthosis is perpendicular to the line between the center point of the sternum pad and the center point of the pubic pad and in the line

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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

Similar standards

GB/T 12996-2024|GB/T 44425-2024|GB/T 44665-2024|GB/T 44668-2024|GB/T 44701-2024|GB/T 24437-2023

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