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GB/T 41183-2021Antispasmodic wrist orthoses (English PDF)

抗痉挛腕矫形器

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

December 31, 2021

Implementation date

December 31, 2021

Scope

GB/T 41183-2021 is the English-translated version of 抗痉挛腕矫形器.

GB/T 41183-2021 is the Chinese national product standard for ready-made antispasmodic wrist orthoses, the orthopaedic aids used to relieve and prevent spasm of the wrist and hand.

It defines the parts these devices are built from - the thermoplastic support plate inside the orthosis, the composite fabric protective layer that wraps it and the hook-and-loop fixing belts - and explains how models are coded by form, part, function and design and improvement serial numbers.

It lays down structural, material, appearance, wearing, flexibility and biological evaluation requirements, with the matching inspection methods, including wear, Velcro adhesion and elasticity tests.

It also covers factory and type inspection, sampling, labelling, instructions for use, packaging, transport and storage, but not custom-made orthoses. It was issued on 31 December 2021 and has applied since 31 December 2021.

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Document preview — GB/T 41183-2021

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

Preface
1 Scope
2 Normative references
3 Terms and Definitions
4 Model
4.1 Form
4.2 Part code
4.3 Function code
4.4 Product Design Serial Number
4.5 Product Improvement Serial Number
5 Requirements
5.1 Structural Requirements
5.2 Material Requirements
5.3 Appearance requirements
5.4 Wearing Requirements
5.5 Flexibility Requirements
5.6 Biological Evaluation Requirements
6 Inspection method
6.1 Inspection equipment and tools
6.2 Structural inspection
6.3 Material inspection
6.4 Visual inspection
6.5 Dimensional inspection
6.6 Wear test
6.7 Velcro adhesion test
6.8 Elasticity test
6.9 Biological evaluation test
7 Inspection rules
7.1 Factory inspection
7.2 Type inspection
7.3 Sampling and Judgment Rules
8 Logo label, instruction manual
8.1 Logo Label
8.2 Instruction Manual
9 Packaging, Transportation, Storage
9.1 Packaging
9.2 Transport
9.3 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" drafted.

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 Antispasmodic wrist orthosis

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 Protective layer

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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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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