YY/T 1714-2020Standard methods for finite element analysis (FEA) of non-modular metallic orthopaedic hip femoral stems (English PDF)
非组合式金属髋关节股骨柄有限元分析标准方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
June 30, 2020
Implementation date
June 1, 2021
Scope
YY/T 1714-2020 is the English-translated version of 非组合式金属髋关节股骨柄有限元分析标准方法.
YY/T 1714-2020 is the Chinese pharmaceutical industry standard that sets out how finite element analysis is to be used to study the stress and strain in a monoblock metal femoral stem, that is a stem joined to its head only by the taper.
It fixes the requirements and the considerations of such a numerical study: the geometry and the mesh, the material properties, the loads and boundary conditions, the convergence to be shown and the way the results are reported and compared with test data.
It holds only where the stresses stay below the yield strength of the material. Issued on 30 June 2020, it has applied since 1 June 2021.
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Document preview — YY/T 1714-2020
National Standard of the People's Republic of China
- ICS
- 11.040.40
- Classification
- C 35
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that certain contents of this document may involve patents. Publication of this document The agency is not responsible for identifying these patents.
1 Scope
This standard specifies the use of finite element analysis (FEA) technology for non-combined metal hip joint femoral stems (that is, only those connected by cones)
The requirements and consideration factors of the numerical simulation method used in stress and strain analysis of the integrated femoral stem that matches the femoral head. This standard Only applicable when the stress is lower than the yield strength (available from the material list).
This standard stipulates that in the evaluation of non-combined metal hip joint femoral stems, the purpose is to predict the static stress and strain of the implant.
The requirements and considerations for the development of finite element models.
This standard is applicable to the worst-case evaluation of a series of implant specifications to improve High physical test efficiency. The procedures for model checking and verification are recommended in this standard to help determine whether FEA complies with the standards in this standard.
Claim. This standard recommends what should be included in the mechanical simulation engineering report.
This standard only applies to the static structural analysis of non-combined metal hip joint femoral stems, and does not include the prediction of fatigue strength.
Note. This standard uses the International System of Units.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document.
For undated references, the latest version (including all amendments) applies to this document.
GB/T 31054-2014 Mechanical Product Computer Aided Engineering Finite Element Numerical Calculation Terms
YY/T 0809.4-2018 Surgical implant parts and total hip joint prostheses Part 4: Fatigue performance test of shank femoral components Inspection and performance requirements
3 Terms and definitions
The following terms and definitions defined in GB/T 31054-2014 apply to this document.
3.1 Finite element analysis
Structural performance analysis based on finite element method.
Among them, the finite element method (finite element method) is to discretize the continuous solution domain into a finite number of elements, and use the finite element method under given constraints.
The approximate solution of the element approximates the numerical analysis method of the real physical system.
Note. Rewrite GB/T 31054-2014, definition 2.1.2 and definition 2.1.3.
3.2 Node
The hinge point between the units. Each unit only has contact with neighboring units and the outside at the node.
Note. Rewrite GB/T 31054-2014, definition 2.1.5.
3.3 Boundary conditions
Under given conditions, the geometric and physical conditions on the boundary of the domain are solved.
Note. Rewrite GB/T 31054-2014, definition 2.2.7.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 25 pages — is available in the English PDF.
Referenced standards
Normative references
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Related Standards
GB/T 31054-2014 — Computer aided engineering for mechanical products—Finite element numerical calculation—Terminology
YY/T 0809.4-2018 — Implants for surgery—Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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