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GB/T 40838-2021: Wrist orthoses
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 40838-2021 | English | 189 |
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Wrist orthoses
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GB/T 40838-2021
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Basic data | Standard ID | GB/T 40838-2021 (GB/T40838-2021) | | Description (Translated English) | Wrist orthoses | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C45 | | Word Count Estimation | 10,149 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 40838-2021: Wrist orthoses---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Wrist orthoses
ICS 11.180
CCSC45
National Standards of People's Republic of China
Wrist orthosis
Released on 2021-10-11
2021-10-11 implementation
State Administration for Market Regulation
Issued by the National Standardization Management Committee
Table of contents
Foreword Ⅰ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Classification and model 2
5 Requirements 3
6 Inspection method 5
7 Inspection rules 6
8 Logo label, instruction manual 6
9 Packaging, transportation and storage 7
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.
Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying patents.
This document was proposed by the Ministry of Civil Affairs of the People's Republic of China.
This document is under the jurisdiction of the National Standardization Technical Committee for Rehabilitation and Special Equipment for the Disabled (SAC/TC148).
Drafting organizations of this document. China Association of Rehabilitation Assistive Devices, Beijing Global Jingbo Rehabilitation Assistive Technology Co., Ltd., Huaibei Feilong Helping the Disabled
Prosthetics Co., Ltd., Jinhua Deren Rehabilitation Aids Co., Ltd., Beijing Huici Prosthetic Medical Products Development Co., Ltd., National Rehabilitation Aids
Research Center, Henan Youde Medical Equipment Co., Ltd.
The main drafters of this document. Zhang Xiaoyu, Xia Benhua, Wang Ying, Hou Ligang, Xu Jing, Gu Huiru, Ma Haitao, Jiang Luohui, Gao Feng, Li Qiang.
Wrist orthosis
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
Orthopedics around the wrist joint and all or part of the hand.
3.2
Wrist orthopedic aids made of soft materials such as textiles and composite fabrics.
3.3
Wrist orthopedic aids made of hard materials such as plastics and metal frames as the main body.
3.4
A wrist orthopedic assistive device whose main function is to fix or restrict the movement of the wrist.
3.5
Wrist orthopedic aids with the main function of correcting and preventing wrist deformities.
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