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Standard methods for finite element analysis (FEA) of non-modular metallic orthopaedic hip femoral stems
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Basic data Standard ID | YY/T 1714-2020 (YY/T1714-2020) | Description (Translated English) | Standard methods for finite element analysis (FEA) of non-modular metallic orthopaedic hip femoral stems | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | Classification of Chinese Standard | C35 | Classification of International Standard | 11.040.40 | Word Count Estimation | 10,139 | Date of Issue | 2020-06-30 | Date of Implementation | 2021-06-01 | Issuing agency(ies) | State Drug Administration |
YY/T 1714-2020: Standard methods for finite element analysis (FEA) of non-modular metallic orthopaedic hip femoral stems ---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.
Standard methods for finite element analysis (FEA) of non-modular metallic orthopaedic hip femoral stems
ICS 11.040.40
C35
People's Republic of China Pharmaceutical Industry Standard
Standard method for finite element analysis of non-combined metal hip joint femoral stem
2020-06-30 released
2021-06-01 implementation
Issued by the State Drug Administration
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.
This standard was proposed by the State Drug Administration.
This standard is organized by the Orthopedic Implants Sub-Technical Committee of the National Standardization Technical Committee for Surgical Implants and Orthopedic Devices (SAC/TC110/
SC1) Centralized.
Drafting organizations of this standard. Tianjin Medical Device Quality Supervision and Inspection Center, Changzhou Osmai Medical Devices Co., Ltd., Beijing Natongke
Technology Group Co., Ltd., Beijing Fuller Technology Development Co., Ltd., School of Mechanical Engineering, Xi’an Jiaotong University.
The main drafters of this standard. Zhao Binghui, Li Wenjiao, Zhang Lu, Chen Changsheng, Cao Haipeng, Li Renyao, Zhao Wenwen, Fan Guoping, Bai Yanli, Wang Ling,
Sun Changning.
Finite element analysis of non-combined metal hip joint femoral stem
Standard method
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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