YY/T 1563-2017_English: PDF (YY/T1563-2017)
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Spinal implants—Test method for functional, kinematic and wear assessment of total disc prostheses
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YY/T 1563-2017
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Standard ID | YY/T 1563-2017 (YY/T1563-2017) | Description (Translated English) | Spinal implants--Test method for functional, kinematic and wear assessment of total disc prostheses | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | Classification of Chinese Standard | C35 | Classification of International Standard | 11.040.40 | Word Count Estimation | 18,197 | Date of Issue | 2017-03-28 | Date of Implementation | 2018-04-01 | Drafting Organization | Tianjin Medical Device Quality Supervision and Inspection Center, Xi'an Jiaotong University School of Mechanical Engineering | Administrative Organization | National Surgical Implants and Orthopedic Instruments Standardization Technical Committee Orthopedic Implants Sub-Technical Committee (SAC/TC 110/SC 1) | Proposing organization | China Food and Drug Administration | Issuing agency(ies) | State Food and Drug Administration |
YY/T 1563-2017
Spinal implants-Test method for functional, kinematic and wear assessment of total disc prostheses
ICS 11.040.40
C35
People's Republic of China Pharmaceutical Industry Standard
Spinal implant total intervertebral disc prosthesis function,
Exercise and wear evaluation test method
Released on.2017-03-28
2018-04-01 implementation
State Food and Drug Administration issued
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 organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Food and Drug Administration.
This standard is administered by the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices, orthopedic implants subcommittee (SAC/TC110/
SC1).
This standard was drafted. Tianjin Medical Device Quality Supervision and Inspection Center, School of Mechanical Engineering, Xi'an Jiaotong University.
The main drafters of this standard. Zhang Shu, Dong Shuangpeng, Wang Ling, Pang Xiaoqiang.
introduction
The wear was evaluated by the method of mass loss in the test medium defined in the standard.
This standard does not address any potential failure modes associated with the fixation of the implant and bone interface.
The purpose of this standard is to test different intervertebral disc prostheses under specified conditions and to compare wear and fatigue performance.
However, it should be recognized that there are many possible variables in in vivo conditions, and that a single laboratory may not have a simulation by fixed parameters.
Representative of all over.
Most intervertebral disc prostheses fall into two main categories. ball-and-socket joint prostheses; elastic or compliant prostheses. For the former, this standard is mainly
Explain type 1 wear [see 3.13a)]; however, for the latter, this standard describes the movement and/or load of the implant when it is within a certain range.
Potential failure modes of the prosthesis under conditions of physiological motion and load range.
For joint components, this standard focuses on Type 1 wear testing. Users should be aware that other types of wear may occur, which may
It has an effect on the function and performance of the intervertebral disc prosthesis. Therefore, the user should consider the effect of other types of wear on the performance of the prosthesis.
In order to make data between different laboratories reproducible and comparable, it is important to establish a uniform test procedure. The subject of this standard
It is a trial and data report for the use of a unified disc replacement prosthesis.
Due to the lack of important clinical search history of intervertebral disc prosthesis, the actual loading conditions and load curves are not fashionable in writing this standard.
The law is described. Therefore, the use of the loads and motion conditions specified in this standard does not necessarily accurately reproduce conditions in the body. Of course, this standard
A functional method for evaluating the boundary or endpoint conditions used in the design of the prosthesis is provided.
Spinal implant total intervertebral disc prosthesis function,
Exercise and wear evaluation test method
1 Scope
This standard specifies test methods for evaluating the wear and/or functional properties of a total intervertebral disc prosthesis. This standard is applicable to the total intervertebral disc prosthesis
Guidance on wear and/or fatigue testing under sexual and motor conditions.
This standard applies to lumbar and cervical prostheses. Because the loading and movement of the lumbar vertebrae and the cervical vertebrae are inconsistent, this standard
Do not elaborate.
This standard does not apply to partial disc replacement prostheses, such as nucleus replacement prostheses or facet joint replacement.
This standard does not serve as a performance standard. It is the responsibility of the user of this standard to characterize the safety and effectiveness of the prosthesis to be evaluated.
This standard is not intended to address all of the security issues involved, even those related to their use. establish
Appropriate safety and health practices, as well as the applicability of clear management restrictions prior to application, are the responsibility of the users of this standard.
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 1428 Spinal implant related terminology
YY/T 0959 Spinal implant interbody fusion cage mechanical properties test method
3 Terms and definitions
The functional and motor test terminology defined by YY/T 1428 and YY/T 0959, as well as the following terms and definitions, apply to this document.
3.1
Axial load
Applied to the upper or lower clamp-endplate, the combined force F-axis of the load that the intervertebral disc prosthesis (original healthy intervertebral disc) is subjected to in the body.
Note. For human health intervertebral discs, the primary component force is the axial compression force FZ along the negative Z axis of the global coordinate and passes through the origin of the intervertebral disc prosthesis. In the XY plane
The shear forces are FX and FY, respectively. When the axial load does not pass through the origin of the intervertebral disc prosthesis, a lateral bending moment MX around the origin is generated, buckling/stretching
Bending moment MY.
3.2
Coordinate system/axis coordinatesystem/axes
The overall XYZ Cartesian coordinate system is defined according to the right-handed Cartesian coordinate system. The XY plane is equally divided in the coordinate system to simulate the adjacent vertebral body.
The angle between the sagittal plane between the upper and lower surfaces of the endplate. The overall coordinate system is stationary relative to the lower endplate fixture of the intervertebral disc prosthesis, under
The side end plate clamp is also stationary relative to the test machine frame. Xyz represents the local Cartesian coordinate system, moving the local Cartesian coordinate system to make it
The side end plate clamps are connected and their initial orientation is coincident with the XYZ axis of the overall coordinate system. Specify the upper end plate clamp relative to the lower side
Three-dimensional motion of the endplate fixture, and the three-dimensional motion is measured from the rotation of the continuous Euler angle around the xyz axis respectively (z. axis
Rotation; x. side bend; y. buckling - extension).
3.2.1
Origin origin
The center of the global coordinate system is positioned at the initial position of the instantaneous rotational center (COR) of the total disc replacement prosthesis.
Note. Some artificial prostheses do not have a single center of rotation. Instead, there is a movable center of rotation or multiple defined rotations.
Heart, it depends on the direction of the movement. In this case, the user should determine the origin according to the definition principle of the origin.
3.2.2
X-axis X-axis
Relative to the axis fixed in the overall coordinate system of the tester base, the forward direction is the forward direction relative to the initial unloaded position of the sample.
3.2.3
Y-axis Y-axis
Relative to the axis fixed in the overall coordinate system of the tester base, the forward direction is the lateral direction relative to the initial unloaded position of the sample.
3.2.4
Z-axis Z-axis
Relative to the axis fixed in the overall coordinate system of the tester base, the forward direction is the direction above the initial unloaded position of the sample.
3.2.5
X-axis x-axis
Relative to the fixed coordinate axis of the intervertebral disc prosthesis, and can be moved relative to the overall coordinate system, its forward direction is relative to the prosthesis.
3.2.6
Y-axis y-axis
Relative to the fixed coordinate axis of the intervertebral disc prosthesis, and movable relative to the overall coordinate system, its forward direction is lateral with respect to the prosthesis.
3.2.7
Z-axis z-axis
Relative to the fixed coordinate axis of the intervertebral disc prosthesis, and movable relative to the overall coordinate system, its forward direction is relative to the top of the prosthesis.
3.3
Degraded degradation
Loss of material, function or material properties caused by non-wear related causes.
3.4
Liquid absorption fluidabsorption
The liquid absorbed by the implant material during the test.
3.5
Functional failure functionalfailure
The total failure of the intervertebral disc (IVD) prosthesis due to permanent deformation or wear, or the prosthesis cannot bear the load/motion, or
This leads to a reduction in the clinically relevant movement of the prosthesis or a secondary effect of a reduction in the intended movement of the prosthesis.
3.6
Interval net volume wear rate of cycle interval i VRI intervalnetvolumetricwearrateVRiduringcycleintervali
VRi=
WRi
(1)
In the formula.
ρ---Abrasion material mass density (eg, in g/mm3).
Note. VRi, unit. mm3/million cycles.
3.7
Interval net wear rate of cycle interval i WRI intervalnetwearrateWRiduringcycleintervali
WRi=
NWi-NWi-1
Number of wears in the cycle interval i × 10
6 (2)
Note 1. For i=1, NWi-1=0.
Note 2. WLi, unit. g/million cycles.
3.8
Intervertebral disc (IVD) prosthesis intervertebraldisc (IVD) prosthesis
An abiotic structure intended to restore (or partially restore) the support and movement between adjacent vertebral bodies.
3.9
Motion condition kinematicprofile
The relative motion experienced by the intervertebral disc prosthesis between adjacent vertebral bodies.
3.10
Limit limit
A significant change in stiffness under a particular motion indicates that the implant has reached the end of its designed range of motion.
3.11
Load condition loadprofile
The load that the implant needs to withstand under the applied motion conditions, or the load that the intervertebral disc prosthesis needs to withstand when using load control.
3.12
Mechanical failure mechanicalfailure
This may or may not result in work due to material defects (eg, fatigue cracks) or failures due to bonding between materials.
Can fail.
3.13
Joint wear design for various wear types wearmodesforarticulatingtypedesigns
a) Type 1. It occurs only on the articular surface between the two main bearing surfaces.
b) Type 2. occurs between the surface of the primary joint and the secondary, non-load bearing surface.
c) Type 3. occurs on the surface of the two main bearing surfaces that are still common as the articular surface, but the three-body particles are already trapped between the two articular surfaces.
d) Type 4. Contact and movement that occurs between two minor, non-bearing surfaces.
3.14
Net wear of worn samples NWi netwearNWiofwearspecimen
NWi=(W0-Wi) (Si-S0) (3)
The mass loss of the test sample is corrected for the amount of absorption of the liquid at the end of the cycle interval i.
Note. NWi, unit. g.
3.15
Net volume wear of worn samples NVi netvolumetricwearNViofwearspecimen
At the end of the loop interval i
NVi=
NWi
(4)
In the formula.
ρ---Abrasion material mass density (eg, in g/mm3).
Note. NVi, unit. mm3.
3.16
Termination (number of cycles) runout(cycles)
The maximum number of cycles a test sample can withstand if no functional failure has occurred.
3.17
Wear wear
An incremental mass loss of material due to relative motion between the surfaces of the implant to measure the intervertebral disc prosthesis or intervertebral disc prosthesis
The mass loss of the part is characterized.
Note. Or in the case of a non-articular surface, a compliant disc prosthesis, wear is simply defined as the mass loss of the prosthesis. Underside of the implant component
The interface with the upper side and the bone is not in this definition, see 5.2.2.
3.18
Soak the quality of the control sample Si weightSiofsoakcontrolspecimen
S0 is the initial point of the loop interval i, and Si is the end point.
Note. Si, unit. g.
3.19
The quality of the worn sample Wi weightWiofwearspecimen
W0 is the initial point of the loop interval i, and Wi is the end point.
Note. Wi, unit. g.
4 Significance and application
4.1 This standard is used to determine the fatigue and wear performance of the intervertebral disc prosthesis. The prosthesis needs to undergo a large number of functional and kinematic loads/motion cycles.
Rings (eg, different designs, materials, manufacturing processes, and other design parameters for the specific design of the intervertebral disc prosthesis can be used in this standard
Line evaluation).
4.2 This standard is intended for use in intervertebral disc prostheses that support the load and transmit motion by forming joints (or using compliant materials). pottery
Porcelain, metal, polymeric materials or combinations thereof have been applied to intervertebral disc prostheses. The purpose of this standard is to serve as a guidance document for different materials and classes.
Types of prostheses are compared for kinematic wear and/or fatigue.
5 test equipment
5.1 total intervertebral disc prosthesis parts
Total intervertebral disc prostheses may have different shapes and structural compositions. Currently known structural components include ball and socket joints, with one freedom
A biconcave joint that moves or semi-constrains the third body, a metal endplate that incorporates an elastic core, and a uniaxial hinge joint.
5.2 Spinal test device
5.2.1 Laboratory room
For test machines capable of accommodating multiple sets of samples, the test rooms should be isolated from each other to avoid contamination of the test samples. Test room overall
It should be made of corrosion-resistant materials, such as acrylic or stainless steel, and the test chamber can be easily removed from the test machine for testing.
Thoroughly clean the test chamber when the test is stopped.
5.2.2 Fixtures/tooling components
Since the purpose of the trial was to characterize the wear and/or fatigue of the intervertebral disc prosthesis under functional and kinematic conditions, the group in the test chamber
The installation method shall not affect the accuracy of the assessment of mass loss or stiffness variation during the test. For example, with complex expectations and bones
Prostheses that contact the upper and lower surfaces of the contact [eg, sintered beads, hydroxyapatite (HA) coating, plasma spray], these prostheses are
Specially manufactured to change the surface, this does not affect the simulated wear.
5.2.3 Fixed
The implant should be securely (rigidly) attached to the matching test tool at the interface of its bone-implant.
5.2.4 degrees of freedom
The movement of the upper tooling relative to the lower tooling shall be unconstrained in three dimensions, unless movement is specified in certain directions.
Load.
5.2.5 Load and motion (see Tables 1 and 2 for components)
5.2.5.1 The axial load is the compressive load and is applied in the negative direction along the Z axis. Deviation from the initial position with the movement of the intervertebral disc prosthesis
As the shear components FX, FY and bending moments MX, MY.
5.2.5.2 The buckling load and motion are positive moments, and MY and rotation are respectively around the y-axis.
5.2.5.3 The extension load and motion are negative moments, and MY and rotation respectively surround the y-axis.
5.2.5.4 Lateral bending loads and motions are positive and negative bending moments, with MX and rotation surrounding the x-axis, respectively.
5.2.5.5 Torsional loads and motions are positive and negative moments, and MZ and rotation are respectively around the z-axis.
Table 1 Cervical intervertebral disc prosthesis test conditions and related parameters
Test conditions
Axial load
Preferred displacement control.
Range of motion (ROM)a
(°)
Alternative load control.
Applied bending moment range
N·m
Flexion/extension 100 ± 7.5 ± 2.0
Side bend /
Rotate
±6 ±2.0
±6 ±4.0
a Users of this standard should determine whether the range of motion is equally divided by buckling and stretching, or more inclined to one of them.
Table 2 Lumbar disc prosthesis test conditions and related parameters
Test conditions
Axial load
Cyclic axial load
(minimum ~ maximum)
Preferred displacement control.
Range of motion (ROM)
(°)
Alternative load control.
Applied bending moment a
N·m
Flexion/Stretch 1200 900~1850 ±7.5b ±10
Rotate 1200 900~1850 ±3 ±10
Side bend 1200 900~1850 ±6 ±12
a General based on a review of range of motion, average flexibility, and stiffness factor.
b Depending on the product design, the balance of motion range should be similar to the expected clinical situation.
5.2.6 Frequency
The user of this standard should determine and verify the test frequency if there is insufficient proof to ensure that the motion (load) conditions are within the specified tolerances.
Within the range, and the wear and functional properties of the intervertebral disc prosthesis are not significantly affected, the frequency should not exceed 2 Hz, see 6.1.5.
5.2.7 Loop Counter
A complete cycle is to go through the entire motion interval from the starting position (or to the entire load interval when the load is controlled) and back
A complete interval of the starting position (load). The number of cycles is counted using an automatic counting device.
6 reagents and materials
6.1 Test medium
6.1.1 Dilute to 20 g/L bovine serum solution with deionized water as the test medium.
6.1.2 In order to inhibit bacterial growth, serum should be stored refrigerated before the test. In addition, the test medium should contain 0.2% sodium azide (or other
Applicable antibiotics or antibiotics to prevent the growth of microorganisms (mold, yeast, bacteria, etc.), microbial growth will reduce the lubrication of serum
Force, and contaminate samples of wear particles extracted from serum. Other lubricants should be evaluated to determine suitable storage conditions.
6.1.3 It is recommended to add 20mmol/L ethylenediaminetetraacetic acid (EDTA) to the serum to bind the calcium in the solution and reduce the carrying table.
Precipitation of calcium phosphate. Calcium phosphate deposition has been shown to severely affect friction and wear properties, especially for polyethylene/ceramic composite surfaces. If will
EDTA is added to other test media and should be evaluated.
6.1.4 The overall temperature of the test medium shall be maintained within the range of (37 ± 3) °C unless otherwise specified.
6.1.5 Users should be aware that typical uninterrupted joint wear simulations result in higher actual temperatures of the load bearing surface and/or contact lubricant.
Body temperature, that is, motion is usually interrupted periodically. Temperature increases are related to a range of factors, including but not limited to joint friction, materials
Hysteresis, implant-tooling material conductivity, design and test frequency. Under these conditions, the carrier material and/or lubricant will cause non-
Physiological thermal damage (eg, lubricant protein degradation). This will in turn lead to increased friction, further increase in temperature, and temperatures above most
Number of situations encountered in the body. Therefore, it is recommended that the test should closely monitor the phenomenon of high temperature and correct it if necessary. Included at low frequencies
The test is carried out, the test is periodically stopped to cool the bearing surface and the lubricant, and the temperature can be lowered by a water bath, such as by a cooling device.
7 sampling and test samples
7.1 It is recommended that the minimum number of samples for each kinematic/load condition test be 5 pieces. However, considering the experimental comparison, the total required
The total number of samples depends on the magnitude of the difference established, the repeatability of the test results (standard deviation), and the level of statistical significance desired.
7.2 The test components (ie, the intervertebral disc prosthetic components in the test device) shall be labeled for traceability and shall be maintained in a clean environment
Avoid pollution. The test assembly structure should be detachable to facilitate inspection of surface conditions.
8 Equipment preparation
8.1 In order to be as close as possible to the actual use, the functional part of the prosthesis to be tested (the part that can move between the vertebral bodies) should be used and implantable.
The intervertebral disc prosthesis is manufactured in an equivalent manner, including sterilization.
8.2 Non-functional features that affect the measurement of wear/fatigue functions can be removed. For example, the bone-implant interface can be removed, such as HA, titanium, etc.
Sub-spraying, sintering beads, as it may scratch the tooling, which may result in unintended functional and non-functional parts wearing particles
Mixture (see 5.2.2).
8.3 Allows the creation of completely different bone-implant interface components (ie, the upper and lower surfaces), provided that this modification does not substantially change the dummy
Body wear and functional properties. For example, manufacturing a ball and socket joint prosthesis includes polishing a joint component (ie, a functional surface or feature of the implant) and
It is mounted directly on the other side of the test machine, thus simplifying the fixture requirements.
8.4 Sample preparation section should follow ASTMF1714.
9 test steps
9.1 For weight control in the test, at least two equivalent soaked loading control samples shall be used and placed in the test medium (see
6.1). In other words, the same static axial load component should be applied to the loaded soaked control sample, as shown in Figure 1. The reason is the load
Can significantly affect the absorption of liquids.
Note. Users of this standard may demonstrate that no immersion control samples (such as all-metal parts) are used under certain circumstances. Before the start of the test, and before the pre-soaking week
All specified time intervals (defined by the user) for the period (defined in ASTM F1714), wear parts and soaked control samples should be taken from the soaking bath
Remove, wash, dry, and weigh three times, maintaining the same sample sequence each time. The average of 3 weighings was used for wear calculations. Should use precision
Analytical balance of at least ±10 μg. The sensitivity of the weighing is necessary to detect a slight loss of quality of the highly wear-resistant material.
a) equilibrium position (t=0) b) flexion position at angle θ(t)
Description.
γ---The angle of the loaded axis relative to the Z axis of the global coordinate system.
Figure 1 Two-dimensional (XZ plane only) loading diagram showing the F-load and the resultant reaction force -
Moment component, which acts on the initial physiological rotation center of the intervertebral disc prosthesis
9.2 Weigh only in clean, dry conditions (see A.4 of Appendix A of ASTM F1714). Place the parts in a dust-free container
And use clean tools and/or gloves to prevent contamination and affect the weight of the measurement.
9.3 Record quality, W0 and S0 as the initial weight of the wear and control samples, respectively. Place the control sample in a dip containing the test medium
In the chamber, the total surface area exposed to the test medium was the same as the worn sample tested in the test machine. Unless otherwise stated,
The temperature of the soaking chamber was maintained within the range of (37 ± 3) °C.
9.4 For all components, the geometric dimensions of the relevant functional surface or feature shall be measured prior to the start of the test. For example, the joint should measure the bearing surface
product. The prosthesis combined with the core of the polymer should measure the external geometry, such as the initial perimeter (to calculate the change caused by the "equator" bulge
Change) and the height of the prosthesis.
9.5 Before the start of the wear test, the limits of the range of motion of the prosthesis in the flexion/extension, left (right) side and left (right) axial torsion should be determined.
If there is no limit to the prosthesis in a given direction, it should be recorded to replace the limit.
9.6 For the control and test samples, the test media, temperature and component removal cycle should be eq......
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