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GB/T 41183-2021 English PDF

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GB/T 41183-2021: Antispasmodic wrist orthoses
Status: Valid
Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
GB/T 41183-2021209 Add to Cart 3 days Antispasmodic wrist orthoses Valid

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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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