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YY/T 1762-2020: Standard test method for cyclic fatigue of metal tibial tray components of unicondylar knee joint replacements
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1762-2020 | English | 189 |
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Standard test method for cyclic fatigue of metal tibial tray components of unicondylar knee joint replacements
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YY/T 1762-2020
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Basic data | Standard ID | YY/T 1762-2020 (YY/T1762-2020) | | Description (Translated English) | Standard test method for cyclic fatigue of metal tibial tray components of unicondylar knee joint replacements | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C45 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 10,122 | | Date of Issue | 2020-09-27 | | Date of Implementation | 2021-09-01 | | Regulation (derived from) | Announcement No. 108 (2020) of the National Medical Products Administration | | Issuing agency(ies) | State Drug Administration | YY/T 1762-2020: Standard test method for cyclic fatigue of metal tibial tray components of unicondylar knee joint replacements
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Standard test method for cyclic fatigue of metal tibial tray components of unicondylar knee joint replacements
People's Republic of China Pharmaceutical Industry Standards
Released on 2020-09-27
Implementation of 2021-09-01
Issued by the National Medical Products Administration
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Significance and application 1
5 Select sample 2
6 Test device 2
7 Equipment performance 4
8 Test procedure 4
9 Test termination 5
10 Report 5
Appendix A (informative appendix) Basic principles 6
Reference 7
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the 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 prepared 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, Medical Device Technology Review under the State Drug Administration
Heart, Beijing Montain Medical Equipment Co., Ltd., Just Huajian Medical Equipment (Tianjin) Co., Ltd., Beijing Aikang Yicheng Medical Equipment Co., Ltd.
Company, Johnson & Johnson (Shanghai) Medical Equipment Co., Ltd.
The main drafters of this standard. Zhang Shu, Zhao Binghui, Li Wenjiao, Wang Tao, Min Yu, Li Zheng, Xu Zhiyong, Cao Shoufan, Xing Jianshuo, Wang Xiang, Meng Yu,
Li Xinyu, Kong Weiping, Chen Yanfeng.
Unicondylar knee joint replacement prosthesis metal tibial tray component
Dynamic fatigue performance test method
1 Scope
This standard specifies the fatigue test method for the metal tibial tray component of the unicondylar knee replacement prosthesis, including passing the constant amplitude of the metal tibial tray
Cyclic load realizes the procedure of fatigue test.
This standard applies to medial or lateral tibial trays.
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 reference documents, the latest version (including all amendments) is applicable to this document.
GB/T 24176 Metallic material fatigue test data statistical scheme and analysis method
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
The load ratio is the ratio of the minimum load to the maximum load (minimum load/maximum load).
Note. Rewrite GB/T 10623-2008, the term 7.17.
3.3
A straight line passing through the center of the fixture and parallel to the front and rear center lines.
3.4
A straight line passing through the center of the tibial tray, parallel to the coronal plane (or forehead plane) and perpendicular to the load line.
3.6
The vertical distance between the front and back centerline of the tibial component and the loading point.
4 Significance and application
4.1 This test method is used to evaluate the effects of materials, manufacturing and design parameters on the fatigue performance of metal tibial trays under cyclic loading with a high number of cycles
influences.
4.2 In general, the load received by the tibial tray in the body is different from the load specified in this standard. The results obtained in this standard cannot be directly
It is used to predict in vivo performance, but this standard is used to compare the fatigue performance of different metal tibial tray designs under similar conditions.
4.3 In order to make the fatigue data comparable and reproducible, and to correlate the data of different laboratories, it is necessary to establish a unified test method.
necessary.
4.4 The specially designed tibial tray can be modified using this test method.
4.5 The purpose of this test method is to provide a practical, consistent and reproducible fatigue performance of the metal tibial tray that lacks support in the middle part of the condyle.
Current information.
5 Select samples
Samples with the same geometric dimensions, processing process and surface treatment conditions as the final product should be selected as the test parts.
6 Test device
6.1 The tibial tray is installed as a three-point bending test. Care should be taken to avoid abnormal stress concentration caused by the three-point bending fixture, which may cause
This part of the failure mode changes, especially in the two support positions. The supporting position should include a cylindrical roller with a diameter of 6mm to avoid increased failure
The binding force of the load. Any deviation of the cylindrical roller shaft or its diameter shall be demonstrated in the test method. Figure 1 shows a front and back part
There are restraining walls on both the inner and outer parts. In the relatively high frequency fatigue test, the restraining wall is necessary to prevent the implant from rotating and turning over.
means. The friction between the implant and the restraining wall should be minimized.
6.1.1 The implant should be placed on the roller, and the distance between the centers of the two rollers should not be less than 80% of the front-to-back distance shown in Figure 1.Roller
The contact area (with the sample) should cover part of the front and rear centerline, and in Figure 1, the bending moment of the rotation around the axis is the lowest.
6.1.2 The implant should be rigidly supported so that it has the lowest bending moment around the front and rear shafts and the inner and outer shafts while bearing the bending force. These bending moments will lead to
Cause the test to be unstable. Sometimes, these positions will cover the worst-case internal and external loading positions, and analysis should be performed to find the physiologically least
The position is convenient, and the fixture needs to be adjusted according to this position.
6.2 Place the tibial tray and ensure that the anterior and posterior midline is parallel to the midline of the fixture, and the accuracy in the X-axis direction is within ±1mm, in the X-Z plane
The internal accuracy is within ±2° (see Figure 1).
Figure 1 Recommended test setup
6.3 If the design of the tibial tray includes a keel or other support, sufficient space should be left under the tibial tray to prevent the keel from occurring during deformation.
collision.
6.4 Apply a load through a spherical indenter with a diameter of 32mm, or use a femoral component to set the tibial-femoral flexion angle between 0° and 60° to make the femoral
The smallest contact surface is produced between the contact surface of the bone and the tibia, no matter which of the contact surface and the cylindrical indenter is smaller, use it as the most unfavorable loading bar
Pieces. The gasket should have sufficient rigidity and creep resistance (for example, ultra-high molecular weight polyethylene, acetal copolymer), and it is recommended to be placed on the tibial tray and
The indentation area used for the pad between the loading indenter is a circle with a diameter of 13mm (see Figure 2). Use the worst support for partial constraints or overall design
The calculated situation may be more appropriate. The selected support should be demonstrated in the final report. The load applicator should be a spherical indenter or the expected femur
Component, the femoral component is fixed at a bending angle consistent with the curvature of the geometric shape of the contact surface representing the walking gait. The groove of the gasket should be larger than
Or equal to the diameter of the load applicator.
6.4.1 The spacer should be placed on the groove of the tibial condyle. The purpose of the spacer is to distribute the load on the tibial tray and eliminate the difference between the metal indenter and the tibial tray.
The possibility of fretting fatigue caused by contact.
6.4.2 The thickness of the gasket should be measured at the thinnest point between the plane and the contact surface of the indenter as the thickness of the gasket, and it should not be greater than the thinnest part of the tibial gasket.
The equivalent size of the thin part.
6.5 The fixture structure should ensure that the applied load is perpendicular to the undeformed upper surface of the tibial tray.
6.6 Use one of the following two methods to determine the location of the loading point.
6.6.1 For tibial articular surfaces that include curved surfaces, the loading point should be located at the intersection of the tibial tray and a straight line, which is perpendicular to the tibia
Hold and pass through the deepest part of the articular surface.
6.6.2 For other tibial designs, the femoral component, tibial articular surface and tibial tray should be assembled at the position of 0° flexion angle, and the pressure should be determined
Heart position. The loading point should be the intersection of a straight line perpendicular to the tibial tray and the center of the pressure contact surface.
Note 1.As an option, the most unfavorable situation can be determined with reference to the translation and/or potential rotation of the femoral component relative to the transverse plane of the tibial base, and apply
6.6.1 and 6.6.2.The report includes the principle of selecting the position of the femoral component relative to the tibial base. The femoral loading position can produce the most
Unfavorable stress concentration can be considered to achieve the most unfavorable loading position.
The report can record the basic principle of selecting the position of load application (A.6 of Appendix A is an example of changes caused by misalignment of the tibial base). This kind of
In this case, the tester can choose the position of the thinnest tibial pad instead of the pad.
Note. Since the tibial tray design may require a small diameter disc, the actual size of the spacer may vary. It is recommended that the upper surface is a concave gasket, and the cut surface is shown in the side view below.
Figure 2 Schematic diagram of gasket
7 Equipment performance
7.1 Use a fatigue testing machine with sufficient loading capacity to carry out the test.
7.2 Analyze the action of the testing machine to ensure that the expected waveform and periodic force amplitude are maintained during the test, see GB/T 16825.1.
7.3 The testing machine should have a load and deflection monitoring system, such as mounting the sensor on the sample. Continuously monitor the test load and
The deflection is then periodically monitored to keep the load cycle in line with expectations. Through suitable real-time dynamic verification, keep the changing load in the applied
The maximum compression force is within ±2%. Before the test starts, a certain number of initial cycles may be required to achieve the expected load parameters.
The load applied at the initial stage of the test is outside the limit of ±2% deviation does not prove that the test is invalid. But these cycles cannot be counted in the whole
Within the number of systemic cycles. Once the count has started, all cycles should be counted and the applied force should be kept within the deviation limit.
8 Test procedure
8.1 The tester determines the size of the tibial tray component and records it in the report.
The most unfavorable case analysis should be performed, and the implant size should be tested. This process can use finite element analysis. With the most unfavorable case analysis
Deviations should be demonstrated.
8.2 Since the surface of the tibial tray will not remain perpendicular to the load axis during the loading process, install the test sample so that the load axis is perpendicular to the tibial tray without deviation.
The upper surface of the turn.
For implants without a flat upper surface, the positioning of the loading axis should be demonstrated.
8.3 Install the tibial component on the jig (see Figure 1).
8.4 After centering, fix the clamp on the testing machine. Use appropriate constraints on the fixture to maintain the front and rear shafts and the inner and outer shafts as shown in Figure 1.
8.5 Pass the spherical indenter with a radius of 16mm, or the minimum contact area between the femur and tibia cushion between 0° and 60° flexion angle, whichever is
The applied load with a small space (area) is regarded as the most unfavorable loading condition.
8.6 The user determines the amplitude of the applied load and the number of samples, and demonstrates it. Refer to Appendix A. 8.
8.7 Test frequency. The test frequency is generally not greater than 20Hz, to ensure that the test machine maintains the applied load at the selected frequency and does not send out
Resonance.
8.8 R value. all test load ratios are 0.1.
Note. Strictly speaking, since the compressive force applied on the tibial tray, the maximum force is the force value at the highest point of the waveform, so the R value is equal to
10.For the bending moment applied by the cantilever beam plane, the R value is 0.1.
8.9 Record the position of the actuator during the test, and record the maximum deflection in the report.
9 Test termination
The test should continue until the tibial tray breaks or the predetermined number of test cycles is reached. The recommended number of cycles is 10 million, see A. 8.
Failure may be. fracture of the tibial tray, crack formation detected by visual inspection, fluorescent surface penetration or other non-destructive means, or exceeding the predetermined
The deflection limit.
10...
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