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GB/T 41172-2021Antispasmodic ankle foot orthoses (English PDF)

抗痉挛踝足矫形器

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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 41172-2021 is the English-translated version of 抗痉挛踝足矫形器.

GB/T 41172-2021 specifies finished antispasmodic ankle-foot orthoses, the orthopaedic aids used to relieve and prevent ankle-foot spasm.

It sets the model designation, built from form, part code, function code and design and improvement serial numbers, and requirements for structure, materials, appearance, wearing, flexibility and biological evaluation.

The test methods cover structural, material, visual and dimensional inspection, wear tests, Velcro adhesion, elasticity and biological evaluation, followed by inspection rules, labelling, the instruction manual, packaging, transport and storage.

Custom-made antispasmodic ankle-foot orthoses are outside its scope. Manufacturers, suppliers of rehabilitation aids and testing bodies use it. It was issued on 31 December 2021 and has applied since 31 December 2021.

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Document preview — GB/T 41172-2021

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
4.6 Example
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 Test 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 models, requirements, test methods, inspection rules, signs and labels, instructions for use and packaging, transportation, storage, etc.

This document applies to finished antispasmodic ankle-foot orthoses. This document does not apply to custom antispasmodic ankle-foot 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 14484 Determination of Bearing Strength of Plastics

GB/T 14191.1 Prosthetics and Orthotics Terminology Part 1: Basic Terminology for External Limb Prosthetics and External Orthotics

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 ankle-foot orthosis

Orthopedic aids for relieving and preventing ankle-foot spasms.

3.2 Ankle-foot orthosis support plate

In the ankle-foot orthosis, a built-in supporting thermoplastic sheet is used.

3.3 Protective layer

A composite fabric cover that wraps around the outside of an ankle-foot orthosis.

3.4 Fixing belt

On the outside of the wrist orthosis, a fixed drawstring made of hook surface, wool surface and webbing.

......
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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