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YY/T 1426.3-2017: Implants for surgery—Wear of total knee joint prostheses—Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test
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Implants for surgery—Wear of total knee joint prostheses—Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test
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YY/T 1426.3-2017
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Basic data | Standard ID | YY/T 1426.3-2017 (YY/T1426.3-2017) | | Description (Translated English) | Implants for surgery��Wear of total knee joint prostheses��Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 16,117 | | Date of Issue | 2017-09-25 | | Date of Implementation | 2018-10-01 | | Regulation (derived from) | China Food & Drug Administration Announcement 2017 No. 118 | | Issuing agency(ies) | State Food and Drug Administration | YY/T 1426.3-2017: Implants for surgery—Wear of total knee joint prostheses—Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test
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Implants for surgery-Wear of total knee joint prostheses-Part 3. Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test
ICS 11.040.40
C35
People's Republic of China Pharmaceutical Industry Standard
Surgical implant wear of the total knee prosthesis
Part 3. Displacement controlled wear testing machine
Load and displacement parameters and associated test environmental conditions
Part 3. Loadinganddisplacementparametersforwear-testingmachineswith
(ISO 14243-3.2014, IDT)
2017-09-25 released.2018-10-01 implementation
State Food and Drug Administration issued
Content
Foreword III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Principle 4
5 sample, lubricating fluid and sample volume 4
6 instruments and equipment 5
7 Test step 9
8 Test report 10
9 test sample processing 10
Appendix A (informative) The details of the parameters of the load and displacement during the test period described in Figure 2 to Figure 11
Foreword
YY/T 1426 "Surgical Implants Total Knee Prosthesis Wear" is divided into the following three parts.
--- Part 1. Load and displacement parameters of load-controlled wear testers and related test environmental conditions;
--- Part 2. Measurement methods;
--- Part 3. Load and displacement parameters of the wear tester for displacement control and related test environmental conditions.
This part is the third part of YY/T 1426.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This section uses the translation method equivalent to ISO 14243-3.2014 "Surgical implant total knee prosthesis wear Part 3.
The load and displacement parameters of the wear-controlled wear tester and related test environmental conditions.
The documents of our country that have a consistent correspondence with the international documents referenced in this part are as follows.
---YY/T 0924.1-2014 Surgical implant parts and total knee prosthesis parts - Part 1. Classification, definitions and dimensions
Label (ISO 7207-1.2007, MOD)
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This part is proposed by the State Food and Drug Administration.
This part is organized by the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices, orthopedic implants subcommittee (SAC/TC110/
SC1).
This section drafted by. Tianjin Medical Device Quality Supervision and Inspection Center, School of Mechanical Engineering, Xi'an Jiaotong University, China University of Mining and Technology
material science and Engineering School.
The main drafters of this section. Dong Shuangpeng, Zhang Shu, Wang Ling, Hou Yinhui, Zhang Dekun, Chen Kai.
Surgical implant wear of the total knee prosthesis
Part 3. Displacement controlled wear testing machine
Load and displacement parameters and associated test environmental conditions
1 Scope
This part of YY/T 1426 specifies the control of axial loading, buckling/extension angle motion control, front and rear displacement control and tibia
Buckling/stretching between joint components during wear testing of total knee prosthesis on a partial rotational motion controlled knee wear tester
Relative angular motion, loading mode, test speed and duration, specimen assembly and test environment requirements.
The kinematics descriptions specified in this section may not apply to highly constrained knee prosthesis designs as they may be tested early
It can cause damage to joint components and thus does not represent clinically expected performance.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
YY/T 1426.1-2016 Surgical implants - Total knee prosthesis wear - Part 1 . Load control wear test machine
Load and displacement parameters and associated test environmental conditions (ISO 14243-1.2009, IDT)
Surgical implants -- Total knee prosthesis wear -- Part 2 . Methods of measurement ( ISO 14243-2.
2009, IDT)
ISO 7207-1 Surgical implant parts and total knee prosthetic parts - Part 1. Classification, definition and dimensioning
(Implantsforsurgery-Componentsforpartialandtotalknee-jointprostheses-Part 1.Classification,
Definitionsanddesignationofdimensions)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Before and after (AP) displacement Anterior/Posterior (AP) displacement
The amount of offset of the axial force axis relative to the buckling/extension axis measured in a direction perpendicular to the axial force axis and the buckling/extension axis.
Note. This displacement is specified when the total knee prosthesis is at the reference position (3.7), and the axial force axis is relative to the reference position of the total knee prosthesis.
Set to a positive value (3.7).
3.2
Front and rear force APforce
Perpendicular to the tibial axis and the flexion/extension axis, the shear force exerted by the tibial component on the femoral component, the line of action of the force passing through the axial direction
Force axis.
Note. When the direction of action of the force is defined as positive along the tibial component from the back to the front.
3.3
Axial force axisforce
The force of the knee prosthesis tibial component applied to the femoral component in a direction parallel to the axis of the tibia.
Note. The regulation is defined as positive when the direction of force is from bottom to top (see Figures 1 and 2).
Description.
1---buckling (femoral component);
2---Tibial rotation;
3---The displacement of the tibial component before and after;
4---axial force.
Figure 1 Symbolic rule of force and motion in the left knee of the total knee arthroplasty system
Description.
1---axial force axis;
2---the humeral axis;
3---0.07w offset;
4---tibia component fixture;
5---Bone cement for fixing the tibial component;
6---the axial force applied through the freely rotating shaft;
7---force.
Figure 2 Test sample assembly drawing
3.4
Axial force axis axialforceaxis
The line of action of the axial force, which is offset from the tibia axis to the medial aspect of the tibia on the patella component of the knee joint prosthesis by 0.07 w ±
A point of 0.01w, where w is the total width of the tibial component, as indicated in ISO 7207-1.
Note. For an average width (ie 74 mm) tibial component, the 0.07w value is approximately equal to 5 mm (see Figure 2).
3.5
Flexion/extension axis flexion/extensionaxis
The nominal rotational axis of the femoral component relative to the tibial component.
Note 1. For knee prostheses with femoral condyle and meniscus components, the flexion/extension axis can be defined by the following method. first, when the femoral component is at 30° and 60°
The meandering of the femoral component is considered to be in contact with an imaginary plane perpendicular to the axis of the tibia; then four perpendicular to the two flexion angles are drawn
An imaginary plane line (contact point normal), each line passing through the contact point of the femoral component with the imaginary plane; the buckling/extension axis is made up of the above four contact normals
Pay the income.
Note 2. In the test, the axis of rotation of the femoral component does not exactly match the theoretical buckling/extension axis, but the theoretical buckling/extension axis and the axis of the simulator
Keep the lines as consistent as possible.
3.6
Load and displacement control wear tester loadanddisplacementcontrolwear-testingmachine
Wear tester that can control the following aspects. axial load control, buckling/extension angle motion control, front and rear displacement control
System and patella rotation control.
3.7
Reference position
The angular and linear position of the tibial component relative to the femoral component where the tibial component is placed along the axial force axis against the femoral component
Apply a positive axial force (the most distal end of the femoral support surface is at the lowest point of the tibial support surface) to achieve a static balance.
Note 1. The reference position is equivalent to the position of the body's 0° flexion angle (ie, full extension).
Note 2. In order to determine the reference position, the effect of friction between the tibial component and the femoral component is negligible.
Note 3. The reference position can be determined geometrically based on the three-dimensional shape of the tibia and femur surfaces. Surface shape of the tibia and femur components for computational purposes
It can be obtained from design data, or by three-coordinate measurement of an unworn total knee prosthesis.
Note 4. If the tibial component is of medium or flat design and/or the tibial component is installed with a large posterior tilt (see 7.4), the tibial bearing surface
The lowest point has a larger span in the anterior-posterior direction or at the last end of the tibial component (no disc effect). In this case, this reference bit
The definition of setting is not applicable. In this case, the prosthesis manufacturer should be consulted to determine the equilibrium position and detailed in the test report.
recording.
3.8
Tibial axis tibialaxis
The nominal longitudinal axis of the tibia coincides with the central axis of the proximal medullary cavity.
3.9
Tibia rotation tibialrotation
The rotation of the total knee prosthesis tibial component relative to the axis of the tibial shaft.
Note. The rotation is considered to be 0 when the total knee prosthesis is at the reference position (3.7). For the right knee full knee prosthesis, the humerus is considered when looking down the patella component
The piece rotates counterclockwise to positive at the reference position (3.7).
3.10
Tibial rotation torque tibialrotationtorque
Torque applied to the femoral component by the total knee prosthetic tibial component about an axis parallel to the tibial axis.
Note. From the top view of the tibial component, apply a clockwise axial torque to the left total knee prosthesis and a counterclockwise axial to the right total knee prosthesis.
The torque is positive.
3.11
Passive soaking control sample passivesoakcontrolspecimen
Place the same polymer joint component as the test sample in the same temperature, test liquid medium environment as the wear test sample
Soak for the same period of time.
3.12
Load the control sample loadedcontrolspecimen
Place the same polymer joint component as the test sample at the same temperature as the wear test sample, test the liquid medium, and
The same period of time is immersed in an axial force load with varying but no joint motion.
3.13
Humeral tibialbaseplate
An assembled knee patella component that is in contact with the tibia and is used to support a polyethylene pad component of the tibia.
4 Principle
The total knee prosthesis is mounted on a test device that applies periodically varying buckling/period to the femoral and tibial component contact surfaces.
The angle of extension, the angle of rotation of the tibia, the anteroposterior displacement and the axial force simulate the gait of a normal person. The tibial component is flexed/extended and rotated
Movement of the femoral component under rotation, anterior and posterior displacement and axial force loading. The contact force/displacement effect of the load is axial force, buckling/stretching
Rotation, front and rear displacement, and tibial rotation. All applied force/displacement actions follow a defined periodic variation law, and each force/motion action
There is also a fixed relationship between them.
The contact surfaces of the femoral and tibial components are immersed in a test medium that mimics human body lubricating fluid. Soak a control sample
Calculate the creep of the test sample and/or by the axial force load in the liquid medium and with the same periodic variation as the test sample
The quality change caused by liquid exchange. The test was carried out under controlled conditions simulating physiological conditions.
5 sample, lubricating fluid and sample volume
5.1 Liquid test medium
The liquid test medium consists of the following parts.
--- Deionized water diluted protein calf serum solution of 20g/L;
--- Under normal circumstances, the liquid test medium needs to be filtered through 2μm filter membrane/paper;
--- In order to minimize microbial contamination, the liquid test medium should be stored frozen before the test. Can add bacteriostatic agents (such as azide
sodium). The reagent may be a hazardous chemical;
--- The pH of the liquid test medium can be monitored regularly. If monitored, the test report should include the test results.
5.2 Test sample
The size combination and design details of the selected test sample should be representative of the expected most unfavourable wear of the total knee system being tested.
condition. Unless the physical characteristics of the implant system prove that it is not achievable, the tibial component should be supported on the dorsal articular surface (eg bone cement)
Or machined humeral support for imitation of the inner surface). If the articular surface of the patella component is fixed to the tibial tray by a snap ring/fastening device, the workpiece
Should be able to provide the same fixed conditions.
If the normal backing or bone cement cannot be used due to the physical characteristics of the implant system, the support system of the tibial component can simulate positive
Often design features and conditions of use, and allow for non-destructive disassembly of parts for wear measurements (if needed).
Parts may be sterilized in the same manner as clinically, as they may affect the wear properties of the material. If feasible, should
All test and control components of the specified test group were sterilized simultaneously (in the same container) to reduce the difference between the samples.
5.3 Control sample
The size combination and design of the parts should be the same as the test samples.
5.4 Number of test samples
The wear test for each type of prosthesis should use at least three test samples and two control samples. Both control samples can be used as
A soak control, or one as a passive soak control and one as a loading control.
6 instruments
6.1 Testing machine
The specified load can be applied at a frequency of 1 Hz ± 0.1 Hz according to the corresponding displacement (Fig. 3).
Table 1 Axial force changes with time
Percentage of time period /% axial force/N
Description.
X --- a percentage of a cycle, %;
Y --- axial force, N.
Figure 3 Control parameters. axial force changes with time period
6.2 Test sample installation and sealing method
Using a preservative material, the femoral and tibial components can be clamped by a similar fixation method as the intended anatomical fixation. Seal test sample
Products, isolated from third-party pollution from testing machines and air.
6.3 Centering and positioning of the test specimen of the femoral component at the reference position
After the tibial component is removed for wear measurement, the tibial component can be repeatedly mounted in the same position and orientation.
6.4 alignment and positioning of the tibial component in the lower position
After the tibial component is removed for measurement, it can be repeatedly installed in the same position and orientation.
6.5 axial force control system
Can produce the cyclic axial force required by Figure 3, and maintain the error of the force amplitude within a period of ± 5% of the specified maximum and the maximum phase
The bit error is ±3% of the full period.
Applying axial force to the tibial component of the total knee prosthesis along the axial force axis by a free axis of rotation biased to the axis of the tibia (see
Figure 3 and Table 1).
6.6 Buckling/Extension Rotation Control System
Can provide the buckling/extension motion specified in Figure 4 and Table 2, and maintain the error of the motion amplitude within a period of the specified maximum
±5% and maximum phase error are ±3% of the full period.
The relative angular motion of the femoral and tibial components, i.e., the flexion/extension motion, is measured about the flexion/extension axis.
Preparation should include adjusting the reference position of the motion control system so that when the applied flexion/extension motion reaches zero buckling as shown in Figure 4
At the angle, the total knee prosthesis is in the design reference position.
For an over-extended full knee prosthesis, a component can be used to limit the stretching moment generated by overstretching.
Table 2 Variation of buckling angle with time
Percentage of time period /% flexion angle/°
0 0
Description.
X --- a percentage of a cycle, %;
Y --- buckling angle, °.
Figure 4 Control parameters. buckling angle changes with time period
6.7 Front and rear displacement control system
Can produce the cyclic motion before and after the requirements of Figure 5 and Table 3, and keep the error of the motion amplitude within a period of the specified maximum
±5% and maximum phase error are ±3% of the full period.
The direction of the anterior and posterior displacement of the prosthesis is perpendicular to the tibial axis and the flexion/extension axis and passes through the axial force axis.
Table 3 Changes in AP motion over time
Percentage of time period /% movement before and after/mm
0 0
17 4.5
38 0.3
56 5.2
Description.
X --- a percentage of a cycle, %;
Y ---AP movement, mm.
Figure 5 Control parameters. AP movement changes with time period
6.8 humerus rotation control system
Can provide the tibial rotation motion specified in Figure 6 and Table 4, and maintain the error of the motion amplitude within a period of the specified maximum
±5% and maximum phase error are ±3% of the full period.
The tibial rotation limit signal is ignored when determining tolerances. The humerus rotates about an axis parallel to the axis of the tibia. The positive direction follows 3.9
Provisions.
Table 4 Changes in tibia rotation over time
Percentage of time period /% Rotation angle/°
0 1.6
2 1.9
16 -1.2
40 1.6
88 -5.7
100 1.6
Description.
X --- a percentage of a cycle, %;
Y --- humerus rotation, °.
Figure 6 Control parameters. changes in tibial rotation over time
6.9 front and rear force measurement system
The front and rear forces (6.7) can be measured in the direction of the back and forth motion.
This system is only required for component installation and is optional during testing.
6.10 Tibial Torque Measurement System
The tibial rotational moment (6.8) can be measured on the same axis of rotation of the humerus.
The recommended accuracy of the tibial torque measurement system is at least ±0.3 N·m and each sample can be measured separately.
This system is only required for component installation and is optional during testing.
6.11 Lubrication system
The prosthetic contact surface can be kept immersed in the liquid test medium.
Note. Use a seal to prevent evaporation of the liquid.
6.12 Temperature Control System
The temperature of the liquid test medium can be maintained at 37 ° C ± 2 ° C.
6.13 Control workstation
The periodic load as shown in Fig. 3 can be applied without generating the motion as shown in Figs. 4, 5 and 6.
Control workstations should follow the provisions of 6.2, 6.3, 6.4, 6.11 and 6.12 above.
The loading effect causes only a small fraction of the increase in liquid absorption relative to the amount of sample liquid absorbed by the lubricating fluid and temperature. If you can
It is sufficient to prove that the liquid absorption generated by loading the control sample is less than 5% of the total liquid absorption, and it is not necessary to load the control sample.
7 Test procedure
7.1 Initial measurement. Calibrate each test bench with a load cell. Calibration should be applied to all other workstations (if any)
get on.
In order to determine the amount of subsequent wear, an initial measurement of the unworn sample is required.
Note. YY/T 1426.2 gives a method for measuring wear.
7.2 After the initial state of the sample is measured, clean the test sample according to the provisions of 4.5.2~4.5.5 of YY/T 1426.2-2016.
7.3 Mounting the femoral component of the test sample on the testing machine and making measurements of the AP force measurement system and the tibial torque measurement system
Zero.
Adjust the centering of the femoral component according to the design of the testing machine so that the buckling/extension axis and the actual flexion/extension motion applied to the testing machine
The axes of rotation are identical.
7.4 Install the tibia part of the test sample on the testing machine and make the axial force direction of the test machine parallel in the error range of ±1°.
On the humeral axis. The tibial component is tilted relative to the tibial axis at the angle recommended by the manufacturer, according to clinical requirements.
If the tibia portion contains a pad with a metallic or other tibial tray, the tibial tray should be included in the test.
Note. When the tibial component is fixed by bone cement, the tibial component can be centered after filling the bone cement with a temporary adjustable support.
7.5 Place the passive soak control sample in a container and place the container in a similar temperature environment as the test sample. For active soaking control
For samples, repeat steps 7.1 to 7.4. For specific samples of the same material, shape and size, a comparison of previous tests can be used
data.
7.6 Completely immerse the contact surfaces of the test and control samples in the test liquid medium (5.1). Keep the temperature of the test liquid medium at
Temperature measurement at a position representative of the overall temperature of the liquid at 37 ° C ± 2 ° C.
7.7 Start the test machine, adjust the test machine, and within ±5% of the maximum force and ±5% of the maximum angle and line displacement value
The load and displacement specified in Figures 3 to 6 were applied to the sample, and the load specified in Figure 3 was applied to the control sample.
See Appendix A for details on the parameter settings equivalent to the tests in Figures 3 to 6. For highly constrained knee joint prostheses,
The AP force and rotational torque peaks given in Tables 3 and 4 of YY/T 1426.1-2016 to determine the appropriate AP motion and tibial rotation position
Move value.
7.8 Run the test machine at 1 Hz ± 0.1 Hz. The error of the time when the maximum and minimum values specified in Figure 3 to Figure 6 should be
Within ±3% of a cycle.
7.9 At the time of testing, deionized water is added at least daily to replenish the liquid lost by evaporation. Replace the liquid test every 5 × 105 cycles
medium.
7.10 Stop the test at least at 5 × 105 cycles and 1 × 106 cycles, and measure at least every 1 × 106 cycles later.
Until the end of the test (see 7.14).
7.11 Remove the test and control samples from the test machine for wear measurement.
7.12 After the wear measurement, the test sample and the control sample are cleaned by a suitable method and reinstalled on the test machine.
7.13 Repeat steps 7.6 to 7.12 until the end of the test (see 7.14).
7.14 Stop the test when one of the following occurs.
a) A 5 x 106 duty cycle is completed. If the sample supplier makes a request, the test may exceed this limit;
b) damage or peeling of the joint surface causes normal functional destruction of the prosthesis;
c) The test machine cannot guarantee that the test conditions are within the specified accuracy (see 7.6~7.9).
8 test report
The test report should contain the following information.
a) a reference to this part of YY/T 1426, ie. YY/T 1426.3;
b) information on the test sample specified by the sample supplier, including size, material, type, manufacturer;
c) description of the test machine, including the number of work stations, the type of system that produces motion and force, range of motion and force, and the system of motion and force measurements
Type, sample installation, joint surface lubrication solution preparation, temperature control setting, pollution particle removal method;
d) The results report includes.
---The total number of cycles of operation;
--- If the test runs less than 5 million cycles and terminates, the reason should be explained;
--- Description of the relative motion surfa...
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