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Standard test method for evaluating tibial insert endurance and deformation under high flexion
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YY/T 1736-2020
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Basic data | Standard ID | YY/T 1736-2020 (YY/T1736-2020) | | Description (Translated English) | Standard test method for evaluating tibial insert endurance and deformation under high flexion | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 14,11 | | Date of Issue | 2020-06-30 | | Date of Implementation | 2021-06-01 | | Issuing agency(ies) | State Drug Administration |
YY/T 1736-2020: Standard test method for evaluating tibial insert endurance and deformation under high flexion ---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 test method for evaluating tibial insert endurance and deformation under high flexion
ICS 11.040.40
C35
People's Republic of China Pharmaceutical Industry Standard
Evaluation of knee tibia pads under high flexion conditions
Durability and deformation test method
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. The issuing agency of this document 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., Shandong Weigao Bone
Science Materials Co., Ltd., Beijing Natong Technology Group Co., Ltd., School of Mechanical Engineering, Xi'an Jiaotong University.
The main drafters of this standard. Zhang Shu, Zhao Binghui, Wang Tao, Wang Jian, Chen Changsheng, Lu Chenglin, Huang Wenxiang, Li Renyao, Zhao Wenwen, Wang Ling.
Evaluation of knee tibia pads under high flexion conditions
Durability and deformation test method
1 Scope
This standard specifies the ultra-high molecular weight polyethylene (UHMWPE) tibial pad components in the design of double-compartment or three-compartment knee joint prostheses
Test method for determining durability and deformation under specified laboratory conditions.
This standard applies to gasket parts made of ultra-high molecular weight polyethylene.
Note. The single-compartment total knee replacement system (TKR) can also be tested with reference to this standard, provided that the single-compartment system has sufficient constraints to be able to use this test
This standard does not apply to testing two single-compartment knee systems as a double-compartment system.
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 article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
YY/T 0772.3 Surgical implants Ultra-high molecular weight polyethylene Part 3.Accelerated aging method
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Femoral anatomical (mechanical) axis
The straight line from the center of the femoral head to the center of the femoral condyle of the knee joint.
3.2
Liner
The mirror image of the femoral joint surface in the anteroposterior direction.
Note. For tibial pads of asymmetrical design, the appropriate tibial pad centerline is determined according to the positioning principle.
3.3
Pad restraint mechanism
A mechanical method to prevent separation of the tibial tray from the tibial pad.
3.4
Femoral component centerline
A straight line located between the femoral condyles in the anteroposterior direction and parallel to the femoral condyles.
Note. The straight line is equidistant from the two condyles. For asymmetric or non-parallel condyle designs, determine the appropriate centerline.
3.5
Pad fixed system
Including a knee joint prosthesis system composed of femoral components and tibial components, in which the tibial articular surface and tibial tray are not expected to move.
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