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GB/T 40838-2021Wrist orthoses (English PDF)

腕矫形器

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

October 11, 2021

Implementation date

October 11, 2021

Scope

GB/T 40838-2021 is the English-translated version of 腕矫形器.

GB/T 40838-2021 is the Chinese national product standard for wrist orthoses, devices worn around the wrist joint and all or part of the hand.

It defines the terms, from soft orthoses made of textiles and composite fabrics to rigid ones built on plastic or metal frames, and orthoses that immobilise the wrist as opposed to those that correct deformities, and it sets the classification and model designation, the requirements, the inspection methods and rules, marking, labelling and instructions for use, and packaging, transport and storage.

It applies to finished and custom-made soft and rigid wrist orthoses and to their parts. Biological safety relies on the cytotoxicity, irritation and skin sensitisation tests of GB/T 16886.

Makers of rehabilitation aids and test laboratories use it. It was issued on 11 October 2021 and has applied since the same day.

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Document preview — GB/T 40838-2021

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 Requirements
6 Inspection method
7 Inspection rules
8 Logo label, instruction manual
9 Packaging, transportation and storage

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 of Standardization Documents" Drafting.

1 Scope

This document specifies the terms, classification, model, requirements, inspection methods, inspection rules, markings, packaging, transportation and storage of wrist orthoses.

This document applies to the finished, customized products and parts of soft wrist orthoses and rigid wrist orthoses.

2 Normative references

The content of the following documents constitutes an indispensable clause of this document through normative references in the text. Among them, dated quotations Only the version corresponding to the date is applicable 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 9174 General technical requirements for general cargo transportation packaging

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 16886.5 Biological Evaluation of Medical Devices Part 5: In Vitro Cytotoxicity Test

GB/T 16886.10 Biological Evaluation of Medical Devices Part 10: Irritation and Skin Sensitization Test

GB/T 23315 Velcro

3 Terms and definitions

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

3.1 Wrist orthosis

Orthopedics around the wrist joint and all or part of the hand.

3.2 Soft wrist orthosis

Wrist orthopedic aids made of soft materials such as textiles and composite fabrics.

3.3 Rigid wrist orthosis

Wrist orthopedic aids made of hard materials such as plastics and metal frames as the main body.

3.4 Immobilizing wrist orthosis

A wrist orthopedic assistive device whose main function is to fix or restrict the movement of the wrist.

3.5 Corrective wrist orthosis

Wrist orthopedic aids with the main function of correcting and preventing wrist 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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