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GB/T 37112-2018Cervical orthoses (English PDF)

颈部矫形器

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

December 28, 2018

Implementation date

July 1, 2019

Scope

GB/T 37112-2018 is the English-translated version of 颈部矫形器.

GB/T 37112-2018 is the Chinese national product standard for cervical orthoses, which surround all or part of the neck.

It covers their classification and models, with soft orthoses made of composite fabric or EVA foam, rigid ones made of plastic or a metal frame, and orthoses whose main function is to immobilize the neck or to correct and prevent deformities.

It sets the requirements, the test methods and the inspection rules, together with marking, labels, the instruction manual, packaging, transport and storage. The referenced standards include those on adult body dimensions, the cytotoxicity, irritation and skin sensitization tests for medical devices and hook-and-loop tape.

It applies to finished orthoses and their parts used for neck injuries and diseases and for rehabilitation around neck surgery. It was issued on 28 December 2018 and has applied since 1 July 2019.

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Document preview — GB/T 37112-2018

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 Requirements
6 Test Method
7 Inspection rules
8 logo label, instruction manual
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, model, requirements, inspection methods, inspection rules, marking, packaging, transportation and storage of neck orthoses.

This standard applies to soft neck orthosis, hard neck orthosis finished products, fixed products and parts, this product is used for neck injury, neck Fixation, correction, protection, support, etc. of inflammation and other neck diseases, as well as assisted rehabilitation before and after neck surgery.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB/T 191 packaging storage and transportation icon

GB/T 9174 General technical conditions for general cargo transportation and packaging

GB/T 10000 Chinese adult body size

GB/T 14191.1 Prosthetics and orthotics - Part 1. Basic terms for external limb prostheses and external orthoses

GB/T 16432 Classification and terminology of rehabilitation aids

GB/T 16886.5 Biological evaluation of medical devices - Part 5: In vitro cytotoxicity test

GB/T 16886.10 Biological evaluation of medical devices - Part 10: Stimulation and skin sensitization test

GB/T 23315 Velcro tape

3 Terms and definitions

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

3.1 Neck orthosis

An orthosis that surrounds all or part of the cervical region.

3.2 Soft neck orthosis

A neck orthosis made of a soft material such as a composite fabric or an ethylene-vinyl acetate copolymer (EVA) foam.

3.3 Hard neck orthosis

A neck orthosis made of a hard material such as plastic or metal frame.

3.4 Fixed neck orthosis

A neck orthosis with a fixed neck or neck movement as the main function.

3.5 Corrective neck orthosis

A neck orthosis with a primary function of correcting and preventing neck deformities.

......
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/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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