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GB/T 41183-2021: Antispasmodic wrist orthoses
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 41183-2021 | English | 209 |
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Antispasmodic wrist orthoses
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GB/T 41183-2021
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Basic data | Standard ID | GB/T 41183-2021 (GB/T41183-2021) | | Description (Translated English) | Antispasmodic wrist orthoses | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C45 | | Word Count Estimation | 10,132 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 41183-2021: Antispasmodic 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.
Antispasmodic wrist orthoses
ICS 11:180
CCSC45
National Standards of People's Republic of China
Antispasmodic wrist orthosis
Published on 2021-12-31
2021-12-31 Implementation
State Administration for Market Regulation
Released by the National Standardization Administration
directory
Preface III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Model 2
4:1 Form 2
4:2 Part code 2
4:3 Function code 2
4:4 Product Design Serial Number 2
4:5 Product Improvement Serial Number 2
5 Requirements 2
5:1 Structural Requirements 2
5:2 Material Requirements 3
5:3 Appearance requirements 3
5:4 Wearing Requirements 3
5:5 Flexibility Requirements 3
5:6 Biological Evaluation Requirements 3
6 Inspection method 4
6:1 Inspection equipment and tools 4
6:2 Structural inspection 4
6:3 Material inspection 4
6:4 Visual inspection 4
6:5 Dimensional inspection 4
6:6 Wear test 4
6:7 Velcro adhesion test 4
6:8 Elasticity test 4
6:9 Biological evaluation test 4
7 Inspection rules 5
7:1 Factory inspection 5
7:2 Type inspection 5
7:3 Sampling and Judgment Rules 5
8 Logo label, instruction manual5
8:1 Logo Label 5
8:2 Instruction Manual 5
9 Packaging, Transportation, Storage 6
9:1 Packaging 6
9:2 Transport 6
9:3 Storage 6
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"
drafted:
Please note that some content of this document may be patented: The issuing agency of this document assumes no responsibility for identifying patents:
This document is proposed by the Ministry of Civil Affairs of the People's Republic of China:
This document is under the jurisdiction of the National Technical Committee on Standardization of Rehabilitation and Special Equipment for Persons with Disabilities (SAC/TC148):
This document is drafted by: China Association of Rehabilitation Assistive Devices, Beijing Universal Jingbo Rehabilitation Assistive Device Technology Co:, Ltd:, Anhui Honghetang Pharmaceutical Co:, Ltd:
Housing Retail Chain Co:, Ltd:, Beijing Huici Prosthetic Medical Products Development Co:, Ltd:, Xiamen Gartley Technology Co:, Ltd:, National Rehabilitation
Assistive Devices Research Center:
The main drafters of this document: Zhang Xiaoyu, Xia Benhua, Wang Ying, Wang Xiao, Zheng Xuhui, Hou Ligang, Xu Jing, Gu Huiru, Gao Jie, Zheng Haifeng:
Antispasmodic wrist orthosis
1 Scope
This document specifies the types, requirements, inspection methods, inspection rules, labels, instructions for use, packaging, transportation and storage of antispasmodic wrist orthoses:
Save and so on:
This document applies to finished antispasmodic wrist orthoses, this document does not apply to custom antispasmodic wrist orthoses:
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text: Among them, dated citations
documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to
this document:
GB/T 191 Graphical signs of packaging, storage and transportation
GB/T 9174 General technical conditions for general cargo transport packaging
GB/T 14191:1 Prosthetics and Orthotics Terminology Part 1: Basic Terminology for External Limb Prosthetics and External Orthotics
GB/T 14484 Determination of Bearing Strength of Plastics
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 Tests
GB/T 23315 Velcro
3 Terms and Definitions
The terms and definitions defined in GB/T 14191:1 and GB/T 16432 and the following terms and definitions apply to this document:
3:1
Orthopedic aids for the relief and prevention of wrist and hand spasms:
3:2
wrist orthoses support plate
In the wrist orthosis, a built-in supporting thermoplastic sheet is used:
3:3
protectivelayer
A composite fabric cover that wraps around the outside of the wrist orthosis:
3:4
fixing belt
On the outside of the wrist orthosis, a fixed drawstring made of hook surface, wool surface and webbing:
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