GB/T 41840-2022 English PDF

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GB/T 41840-2022: Lower limb orthoses components - Polyurethane elastic ankle
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 41840-2022	189	Add to Cart	3 days	Lower limb orthoses components - Polyurethane elastic ankle	Valid

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Basic data

Standard ID: GB/T 41840-2022 (GB/T41840-2022)
Description (Translated English): Lower limb orthoses components - Polyurethane elastic ankle
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C30
Classification of International Standard: 11.180
Word Count Estimation: 10,148
Date of Issue: 2022-10-14
Date of Implementation: 2023-02-01
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration

GB/T 41840-2022: Lower limb orthoses components - Polyurethane elastic ankle

---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.
Lower limb orthoses components -- Polyurethane elastic ankle ICS 11.180 CCSC30 National Standards of People's Republic of China Lower extremity orthosis parts Polyurethane elastic ankle hinge Published on 2022-10-12 2023-02-01 Implementation State Administration for Market Regulation Released by the National Standardization Administration directory Preface I Introduction II 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Performance Requirements 1 5 Test environment, samples and equipment 2 6 Test method 4 7 Inspection rules 5 8 Marking, packaging, transportation and storage5

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. National Research Center for Rehabilitation Aids, National Center for Quality Supervision and Inspection of Rehabilitation Aids, Beijing Oriental Ruisheng Prosthetics Shape Device Development Co., Ltd., Beijing Universal Jingbo Rehabilitation Aids Technology Co., Ltd. The main drafters of this document. Yan Wei, Gu Huiru, Li Man, Yu Xiankun, Wang Xiao, and Yan Heping.

Introduction

Polyurethane elastic ankle hinge is mainly suitable for symptoms such as traumatic brain injury, foot drop caused by stroke and pointed feet caused by cerebral palsy. using polyurethane The lower extremity orthosis made of ester elastic ankle hinge can help patients limit foot drop and correct ankle joint without restricting the movement of ankle joint. Inversion and inversion, thereby offsetting or correcting abnormal joint positions. The polyurethane elastic ankle hinge does not bear the weight of the human body during use. During dorsiflexion and plantar flexion activities, the polyurethane elastic ankle hinge is Under the action of pulling and torsion force and produce deformation, products with unqualified quality will produce plastic deformation during use, and serious fracture will occur. fissure, resulting in serious secondary injury to the patient. In order to protect the personal safety of patients and improve product quality, this document is specially formulated. Lower extremity orthosis parts Polyurethane elastic ankle hinge

1 Scope

This document specifies the performance requirements, test environment, samples and equipment, test methods, inspection rules and markings of polyurethane elastic ankle hinges, packaging, transport and storage. This document applies to product design, production, sales and inspection of polyurethane elastic ankle hinges in lower extremity orthosis components.

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 18375.5 Structural inspection of prosthetic lower limb prostheses - Part 5.Inspection of auxiliary structures

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 Made of polyurethane, the part that fixes or connects the lower leg orthosis to the calf part and the footrest part (see Figure 1). 3.2 prefabricatedmodules Replacement of polyurethane elastic ankle hinges in the vacuum forming process of orthopedic sheet, parts with the same shape as polyurethane elastic ankle hinges (see figure 2). 3.3 elastic ankle hinge fixing nut nutofelasticankle Used in conjunction with screws, the parts that hold the polyurethane elastic ankle hinge in place (see Figure 3).

4 Performance requirements

4.1 Hardness requirements After the hardness is tested according to 6.2, the hardness value A of the surface of the polyurethane elastic ankle hinge should be measured in the range. 80HA≤A≤90HA. 4.2 Tensile Strength Requirements After the tensile strength is tested according to 6.3, the polyurethane elastic ankle hinge should be able to return to its original state. The elastic ankle hinge fixing nut and the polyurethane elastic ankle hinge should be able to recover. The chain is not loose and falling off. ......

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