GB/T 41840-2022Lower limb orthoses components—Polyurethane elastic ankle (English PDF)
下肢矫形器零部件 聚氨酯弹性踝铰链
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
October 14, 2022
Implementation date
February 1, 2023
Scope
GB/T 41840-2022 is the English-translated version of 下肢矫形器零部件 聚氨酯弹性踝铰链.
GB/T 41840-2022 covers the polyurethane elastic ankle hinge used as a component of lower limb orthoses.
It specifies the performance requirements, the test environment, samples and equipment, the test methods, the inspection rules and the marking, packaging, transport and storage, and it defines the prefabricated module used in place of the hinge during vacuum forming of the orthotic sheet and the hinge fixing nut.
Clause 4.1 asks that after the test in 6.2 the surface hardness A of the hinge lie between 80 HA and 90 HA inclusive, and clause 4.2 that after the tensile test in 6.3 the hinge return to its original state with the fixing nut neither loose nor detached. Issued on 14 October 2022, it has applied since 1 February 2023.
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Document preview — GB/T 41840-2022
National Standard of the People's Republic of China
- ICS
- 11.180
- Classification
- C 30
Issued by: State Administration for Market Regulation; Standardization Administration of the PRC
Contents
- Preface
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Performance Requirements
- 5 Test environment, samples and equipment
- 6 Test method
- 7 Inspection rules
- 8 Marking, packaging, transportation and 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.
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 polyurethane elastic ankle hinge
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
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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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
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Related Standards
GB/T 18375.5-2002 — Prosthetics -- Structural testing of lower limb prostheses -- Part 5: Supplementary structural tests
GB/T 18375.5-2004 — Prosthetics -- Structural testing of lower limb prostheses -- Part 5: Supplementary structural tests
GB/T 191-2000 — Packaging-Pictorial marking for handling of goods
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