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